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==Deployment==
==Deployment==
{{COVID-19 vaccination data}}
{{Excerpt|Deployment of COVID-19 vaccines}}

As of 17 January 2021, 39.17&nbsp;million doses of COVID‑19 vaccine had been administered worldwide based on official reports from national health agencies.<ref name="ourworldindata.org"/>

During a pandemic on the rapid timeline and scale of COVID‑19 infections during 2020, international organizations like the WHO and CEPI, vaccine developers, governments, and industry are evaluating the distribution of the eventual vaccine(s).<ref name="who-accel" /> Individual countries producing a vaccine may be persuaded to favor the highest bidder for manufacturing or provide first-service to their own country.<ref name="gates2" /><ref name="gates1" /><ref name="reuters" /> Experts emphasize that licensed vaccines should be available and affordable for people at the frontline of healthcare and having the greatest need.<ref name="gates2" /><ref name="gates1" /><ref name="reuters" /> In April, it was reported that the UK agreed to work with 20 other countries and global organizations including France, Germany and Italy to find a vaccine and to share the results and that UK citizens would not get preferential access to any new COVID‑19 vaccines developed by taxpayer-funded UK universities.<ref name="gartner" /> Several companies plan to initially manufacture a vaccine at [[loss leader|artificially low pricing]], then increase prices for [[Profit (economics)|profitability]] later if annual vaccinations are needed and as countries build stock for future needs.<ref name="reuters" />

An April 2020 CEPI report stated: "Strong international coordination and cooperation between vaccine developers, regulators, policymakers, funders, public health bodies, and governments will be needed to ensure that promising late-stage vaccine candidates can be manufactured in sufficient quantities and equitably supplied to all affected areas, particularly low-resource regions."<ref name="thanh" /> The WHO and CEPI are developing financial resources and guidelines for global deployment of several safe, effective COVID‑19 vaccines, recognizing the need is different across countries and population segments.<ref name="thanh2" /><ref name="who-accel" /><ref name="yamey" /><ref name="solidarity-vacc" /> For example, successful COVID‑19 vaccines would likely be allocated first to [[Health care|healthcare personnel]] and populations at greatest risk of severe illness and death from COVID‑19 infection, such as the elderly or [[poverty|densely-populated impoverished people]].<ref name="covax-gavi">{{cite web|year=2020|title=COVAX: Ensuring global equitable access to COVID-19 vaccines|url=https://www.gavi.org/covid19/covax-facility|url-status=live|archive-url=https://web.archive.org/web/20200925122717/https://www.gavi.org/covid19/covax-facility/|archive-date=25 September 2020|access-date=28 August 2020|publisher=GAVI}}</ref><ref name="who-blueprint">{{Cite web|date=1 March 2020|title=R&D Blueprint: A coordinated global research roadmap – 2019 novel coronavirus|url=https://www.who.int/blueprint/priority-diseases/key-action/Coronavirus_Roadmap_V9.pdf?ua=1|url-status=live|archive-url=https://web.archive.org/web/20200515101822/https://www.who.int/blueprint/priority-diseases/key-action/Coronavirus_Roadmap_V9.pdf?ua=1|archive-date=15 May 2020|access-date=10 May 2020|publisher=World Health Organization}}</ref> The WHO, CEPI, and GAVI have expressed concerns that affluent countries should not receive priority access to the global supply of eventual COVID‑19 vaccines, but rather protecting healthcare personnel and people at high risk of infection are needed to address public health concerns and reduce economic impact of the pandemic.<ref name="thanh" /><ref name="yamey" /><ref name="covax-gavi" />

=== Phased distribution ===
[[File:Covid-Vaccine-67 (50753109591).jpg|thumb|left|Health officials distribute the Moderna COVID‑19 vaccine to front line health workers and first responders in Baltimore County, Maryland on 23 December 2020.]]
Many countries have implemented phased distribution plans that prioritize those at highest risk of complications such as the elderly and those at high risk of exposure and transmission such as healthcare workers.<ref name="Beaumont"/>

In the United States, the CDC's [[Advisory Committee on Immunization Practices]] (ACIP) voted on 1 December that the first doses of the vaccine should be prioritized for healthcare workers and residents and staff of nursing homes.<ref>{{cite journal|display-authors=6|vauthors=Dooling K, McClung N, Chamberland M, Marin M, Wallace M, Bell BP, Lee GM, Talbot HK, Romero JR, Oliver SE|date=December 2020|title=The Advisory Committee on Immunization Practices' Interim Recommendation for Allocating Initial Supplies of COVID-19 Vaccine – United States, 2020|url=https://www.cdc.gov/mmwr/volumes/69/wr/pdfs/mm6949e1-H.pdf|journal=MMWR Morb Mortal Wkly Rep|volume=69|issue=49|pages=1857–9|doi=10.15585/mmwr.mm6949e1|pmid=33301429|pmc=7737687|doi-access=free}}</ref> ACIP recommended that the second phase of distribution (Phase 1b) include persons aged ≥75 years and non-healthcare frontline essential workers.<ref>{{Cite journal|last=Dooling|first=Kathleen|date=2021|title=The Advisory Committee on Immunization Practices' Updated Interim Recommendation for Allocation of COVID-19 Vaccine — United States, December 2020|url=https://www.cdc.gov/mmwr/volumes/69/wr/mm695152e2.htm|journal=MMWR. Morbidity and Mortality Weekly Report|volume=69|issue=5152|pages=1657–1660|doi=10.15585/mmwr.mm695152e2|pmid=33382671|issn=0149-2195|doi-access=free}}</ref> However, states control the final plans for prioritization, distribution, and logistics of vaccinating everyone as supply becomes available.<ref>{{Cite news|last1=Sun|first1=Lena H.|last2=Stanley-Becker|first2=Isaac|title=Health-care workers and nursing home residents should be the first to get coronavirus vaccines, CDC advisory group says|work=[[The Washington Post]]|url=https://www.washingtonpost.com/health/2020/12/01/vaccine-priority-groups-covid/|access-date=3 December 2020|name-list-style=vanc}}</ref>

The European Union began phased vaccine rollout on 27 December. Each member state is managing distribution with a common focus on prioritizing healthcare workers, people at high risk of exposure, the elderly, and those with serious health conditions.<ref>{{Cite web|date=2020-12-02|title=Overview of COVID-19 vaccination strategies and vaccine deployment plans in the EU/EEA and the UK|url=https://www.ecdc.europa.eu/en/publications-data/overview-current-eu-eea-uk-plans-covid-19-vaccines|access-date=2021-01-01|website=European Centre for Disease Prevention and Control }}</ref><ref>{{Cite news|last=Pietsch|first=Bryan|date=2020-12-27|title=E.U. Starts Effort to Vaccinate 450 Million|work=[[The New York Times]]|url=https://www.nytimes.com/live/2020/12/27/world/covid-19-coronavirus-updates|access-date=2021-01-01|name-list-style=vanc }}</ref>

The [[COVID‑19 vaccination programme in the United Kingdom|COVID‑19 vaccination program in the United Kingdom]] prioritized elder care facility residents and carers, followed by healthcare workers and those over 80 years of age. Subsequent phases are based largely on age, declining from 75 years in 5-year increments.<ref>{{Cite web|title=Joint Committee on Vaccination and Immunisation: advice on priority groups for COVID-19 vaccination, 30 December 2020|url=https://www.gov.uk/government/publications/priority-groups-for-coronavirus-covid-19-vaccination-advice-from-the-jcvi-30-december-2020/joint-committee-on-vaccination-and-immunisation-advice-on-priority-groups-for-covid-19-vaccination-30-december-2020|access-date=2021-01-02|website=GOV.UK}}</ref>

=== Equitable access ===
{{cleanup-rewrite|it has redundant statements and is too long|section|date=January 2021}}
During 2020, as the COVID‑19 pandemic escalated globally and vaccine development intensified, the WHO COVAX Facility adopted the phrase, "No one is safe unless everyone is safe", to emphasize the need for equitable distribution of COVID‑19 vaccines authorized for marketing.<ref name="who-equitable">{{cite web|year=2020|title=COVAX: Working for global equitable access to COVID-19 vaccines|url=https://www.who.int/initiatives/act-accelerator/covax|access-date=18 December 2020|publisher=World Health Organization}}</ref> Yet, by mid-December, some 16 countries representing only 14% of the world's population had preordered more than 10&nbsp;billion vaccine doses or about 51% of the available world supply.<ref name="mullard" /><ref name="So" /> Specifically, Canada, Australia, and Japan {{ndash}} having only 1% of the world's COVID‑19 cases {{ndash}} had collectively reserved some one billion vaccine doses,<ref name="So" /> while the COVAX Facility, with a goal to supply vaccines to nearly 100 low-to-middle income countries that cannot fully afford to pay for COVID‑19 vaccines, had reserved only a few hundred million doses.<ref name="who-equitable" /> Preorders from rich countries were made during 2020 with 13 different vaccine manufacturers, whereas those for low-to-middle income countries were made primarily for the AstraZeneca-Oxford vaccine, which is lowest in cost and has no special refrigeration needs.<ref name="mullard" /><ref name="So" />

Due to the high demand for preorders in 2020–21 by wealthy countries, people in developing countries may be excluded from vaccinations until 2023–24 from the first vaccines to be authorized.<ref name="So" /> On 18 December, the COVAX Facility announced it had established agreements with vaccine manufacturers to supply 1.3&nbsp; billion doses for 92 low-middle income countries in the first half of 2021.<ref name="who12-18">{{cite web|date=18 December 2020|title=COVAX announces additional deals to access promising COVID-19 vaccine candidates; plans global rollout starting Q1 2021|url=https://www.who.int/news/item/18-12-2020-covax-announces-additional-deals-to-access-promising-covid-19-vaccine-candidates-plans-global-rollout-starting-q1-2021|access-date=18 December 2020|publisher=World Health Organization}}</ref> To execute its equitable distribution plan in 2021, COVAX remains in an urgent fundraising campaign to raise {{US$|6.8}}{{nbsp}}billion for vaccine purchases and delivery to participating countries in proportion to their populations.<ref name="who-equitable" />

As many of the efforts on vaccine candidates have open-ended outcomes, including a high potential for failure during human testing, CEPI, WHO, and charitable vaccine organizations, such as the Gates Foundation and GAVI, raised over {{US$|20}}{{nbsp}}billion during the first half of 2020, to fund vaccine development and preparedness for vaccinations, particularly for children in [[least developed countries|under-developed countries]].<ref name="waked">{{Cite web|last=Wake|first=Damon|date=4 May 2020|title=EU spearheads $8 billion virus fundraiser|url=https://finance.yahoo.com/news/eu-hosts-virus-telethon-seeking-first-7-5-003500556.html|url-status=live|archive-url=https://web.archive.org/web/20200629033556/https://finance.yahoo.com/news/eu-hosts-virus-telethon-seeking-first-7-5-003500556.html|archive-date=29 June 2020|access-date=4 May 2020|publisher=Yahoo! Finance|name-list-style=vanc}}</ref><ref name="gavi-summit">{{Cite web|title=Global Vaccine Summit 2020: World leaders make historic commitments to provide equal access to vaccines for all|url=https://www.gavi.org/news/media-room/world-leaders-make-historic-commitments-provide-equal-access-vaccines-all|access-date=4 June 2020|publisher=Global Alliance for Vaccines and Immunisation|date=4 June 2020|archive-url=https://web.archive.org/web/20200606161748/https://www.gavi.org/news/media-room/world-leaders-make-historic-commitments-provide-equal-access-vaccines-all|archive-date=6 June 2020|url-status=live}}</ref><ref name="hbr" /> CEPI had stated that governments should ensure implementation of a globally-fair allocation system for eventual vaccines, using a coordinated system of manufacturing capacity, financing and purchasing, and indemnification from liability to offset risks taken by vaccine developers.<ref name="yamey" /> Having been created to monitor fair distribution of infectious disease vaccines to low- and middle-income countries,<ref name="bolly">{{Cite journal|last1=Bollyky|first1=Thomas J.|last2=Gostin|first2=Lawrence O.|last3=Hamburg|first3=Margaret A.|date=7 May 2020|title=The equitable distribution of COVID-19 therapeutics and vaccines|journal=JAMA|volume=323|issue=24|pages=2462–63|doi=10.1001/jama.2020.6641|pmid=32379268|doi-access=free|name-list-style=vanc}}</ref><ref name="huney">{{Cite journal|last1=Huneycutt|first1=Brenda|last2=Lurie|first2=Nicole|last3=Rotenberg|first3=Sara|last4=Wilder|first4=Richard|last5=Hatchett|first5=Richard|date=24 February 2020|title=Finding equipoise: CEPI revises its equitable access policy|journal=Vaccine|volume=38|issue=9|pages=2144–48|doi=10.1016/j.vaccine.2019.12.055|pmc=7130943|pmid=32005536|name-list-style=vanc}}</ref> CEPI revised its equitable access policy that was published in February to apply to its COVID‑19 vaccine funding: 1) "prices for vaccines will be set as low as possible for territories that are or may be affected by an outbreak of a disease for which CEPI funding was used to develop a vaccine;" 2) "information, know-how and materials related to vaccine development must be shared with (or transferred to) CEPI" so that it can assume responsibility for vaccine development if a company discontinues expenditures for a promising vaccine candidate; 3) CEPI would have access to, and possible management of, intellectual property rights (i.e., patents) for promising vaccines; 4) "CEPI would receive a share of financial benefits that might accrue from CEPI-sponsored vaccine development, to re-invest in support of its mission to provide global public health benefit"; and 5) data transparency among development partners should maintain the WHO Statement on Public Disclosure of Clinical Trial Results, and require results to be published in [[Open access|open-access]] publications.<ref name="huney" /> Some vaccine manufacturers opposed parts of these proposals.<ref name="cbcr" /><ref name="huney" />

International groups, such as the Centre for Artistic Activism and [[Universities Allied for Essential Medicines]], advocate for equitable access to licensed COVID‑19 vaccines.<ref>{{Cite web|date=22 March 2020|title=Vaccine for COVID-19|url=https://c4aa.org/2020/03/join-us-free-the-vaccine-for-covid-19|url-status=live|archive-url=https://web.archive.org/web/20200609001355/https://c4aa.org/2020/03/join-us-free-the-vaccine-for-covid-19|archive-date=9 June 2020|access-date=8 June 2020|publisher=The Center for Artistic Activism}}</ref><ref>{{Cite web|year=2020|title=UAEM response to COVID-19|url=https://uaem.org/|url-status=live|archive-url=https://web.archive.org/web/20200421083204/https://uaem.org/|archive-date=21 April 2020|access-date=9 June 2020|publisher=Universities Allied for Essential Medicines}}</ref> Scientists have encouraged that the WHO, CEPI, corporations, and governments collaborate to assure evidence-based allocation of eventual COVID‑19 vaccines determined on infection risk,<ref name="bolly" /><ref name="huney" /> particularly urgent vaccinations provided first for healthcare workers, vulnerable populations, and children.<ref name="gates1" /><ref name="hbr" /><ref name="cbcr" /> Similar to the development of the first [[polio vaccine]] that was never patented, an effective COVID‑19 vaccine would be available for production and approval by a number of countries and pharmaceutical manufacturing centers worldwide, therefore allowing for a more even and cost-effective distribution on a global scale.<ref>Ferrucci A. (5 May 2020). [https://www.edc-online.org/en/home-en/news/16033-more-than-100-scientists-call-for-covid-19-vaccines-to-be-in-the-public-domain.html "More than 100 scientists call for Covid 19 vaccines to be in the public domain"] {{Webarchive|url=https://web.archive.org/web/20200814075506/https://www.edc-online.org/en/home-en/news/16033-more-than-100-scientists-call-for-covid-19-vaccines-to-be-in-the-public-domain.html|date=14 August 2020}}. ''edc.online.org.'' Retrieved 21 July 2020.</ref>

In the initial period of availability, states have prioritized certain groups such as health workers or the elderly to be vaccinated.
However, since the Moderna and Pfizer-BioNTech vaccines have a validity of hours after being prepared for administration, ready doses may remain after the day's scheduled persons have been vaccinated (due to last-moment rejection or illness).
Due to the scarcity of the vaccine, these doses should be applied rather than discarded.
This case may lead to improvisation with ensuing criticism on the choices made.<ref name="SobrantesRodríguez">{{cite news |last1=Rodríguez |first1=Pau |title=Por qué las dosis sobrantes de la vacuna pueden ser un nuevo rompecabezas |url=https://www.eldiario.es/catalunya/dosis-sobrantes-vacuna-nuevo-rompecabezas_1_6751490.html |access-date=15 January 2021 |work=ElDiario.es |date=14 January 2021 |language=es}}</ref>

===Sovereignty===
Favored distribution of vaccines within one or a few select countries, called "vaccine sovereignty", is a criticism of some of the vaccine development partnerships,<ref name="cbcr" /><ref name="bolly" /> such as for the AstraZeneca-University of Oxford vaccine candidate, concerning whether there may be prioritized distribution first within the UK and to the "highest bidder" – the United States, which made an [[advance payment]] of {{US$|1.2}}{{nbsp}}billion to secure 300{{nbsp}}million vaccine doses for Americans, even before the AstraZeneca-Oxford vaccine or a [[Sanofi]] vaccine was proved safe or effective.<ref name="ahmed" /><ref>{{Cite web|last1=Aakash|first1=B|last2=Faulconbridge|first2=Guy|last3=Holton|first3=Kate|date=22 May 2020|title=U.S. secures 300 million doses of potential AstraZeneca COVID-19 vaccine|url=https://www.theguardian.pe.ca/news/world/astrazeneca-gets-first-supply-agreements-for-covid-19-vaccine-452225/|url-status=live|archive-url=https://web.archive.org/web/20200610002524/http://www.theguardian.pe.ca/news/world/astrazeneca-gets-first-supply-agreements-for-covid-19-vaccine-452225/|archive-date=10 June 2020|access-date=10 June 2020|work=[[The Guardian]]|agency=Reuters|name-list-style=vanc}}</ref><ref name="paton">{{Cite news|last1=Paton|first1=James|last2=Griffin|first2=Riley|last3=Koons|first3=Cynthia|title=U.S. likely to get Sanofi vaccine first if it succeeds|work=Bloomberg|url=https://www.bloombergquint.com/business/u-s-to-get-sanofi-covid-vaccine-first-if-it-succeeds-ceo-says|url-status=live|access-date=8 June 2020|archive-url=https://web.archive.org/web/20200608182905/https://www.bloombergquint.com/business/u-s-to-get-sanofi-covid-vaccine-first-if-it-succeeds-ceo-says|archive-date=8 June 2020|name-list-style=vanc}}</ref> Concerns exist about whether some countries producing vaccines may impose [[Protectionism|protectionist controls]] by export restrictions that would [[stockpile]] a COVID‑19 vaccine for their own population.<ref name="bolly" />

The Chinese government pledged in May that a successful Chinese vaccine would become a "global, public good", implying enough doses would be manufactured for both national and global distribution.<ref>{{Cite news|last=Gretler|first=Corinne|date=18 May 2020|title=China pledges to make its coronavirus vaccine a 'public good'|work=National Post|publisher=Bloomberg|url=https://nationalpost.com/news/world/china-pledges-to-make-its-coronavirus-vaccine-a-public-good|url-status=live|access-date=9 June 2020|archive-url=https://web.archive.org/web/20201101220836/https://nationalpost.com/news/world/china-pledges-to-make-its-coronavirus-vaccine-a-public-good|archive-date=1 November 2020|name-list-style=vanc}}</ref> Unlike mRNA vaccines, which have to be stored at subzero temperatures, inactivated vaccines from Sinovac and Sinopharm require ordinary refrigeration<ref>{{Cite journal|last=Cohen|first=Jon|date=11 December 2020|title=China's vaccine gambit|url=https://science.sciencemag.org/content/370/6522/1263|journal=Science|volume=370|issue=6522|pages=1263–1267|doi=10.1126/science.370.6522.1263|issn=0036-8075|pmid=33303601|doi-access=free}}</ref> and may have more appeal in developing countries.<ref>{{Cite web|last=Ng|first=Abigail|date=30 November 2020|title=China's vaccines may have 'appeal' in developing countries, economist says|url=https://www.cnbc.com/2020/11/30/covid-china-vaccines-have-an-appeal-in-developing-countries.html|access-date=12 December 2020|publisher=CNBC}}</ref>

In June, the [[Serum Institute of India]] (SII) – a major manufacturer of global vaccines – reached a licensing agreement with AstraZeneca to make {{nowrap |1 billion doses}} of vaccine for low-and-middle income countries,<ref name="kyle" /> of which half of the doses would go to India.<ref name="unequal" /> Similar preferential homeland distribution may exist if a vaccine is manufactured in Australia.<ref name="khamsi">{{Cite journal|last=Khamsi|first=Roxanne|date=9 April 2020|title=If a coronavirus vaccine arrives, can the world make enough?|journal=Nature|volume=580|issue=7805|pages=578–80|bibcode=2020Natur.580..578K|doi=10.1038/d41586-020-01063-8|pmid=32273621|doi-access=free|name-list-style=vanc}}</ref>

=== Cost ===
An effective vaccine for COVID‑19 could save [[trillion]]s of dollars in global economic impact, according to one expert, and would, therefore, make any price tag in the billions look small in comparison.<ref name="gates3">{{Cite web|last=Gates|first=Bill|date=23 April 2020|title=The first modern pandemic: The scientific advances we need to stop COVID-19|url=https://www.gatesnotes.com/Health/Pandemic-Innovation|url-status=live|archive-url=https://web.archive.org/web/20200513122415/https://www.gatesnotes.com/Health/Pandemic-Innovation|archive-date=13 May 2020|access-date=6 May 2020|publisher=The Gates Notes|name-list-style=vanc}}</ref> In early stages of the pandemic, it was not known if it would be possible to create a safe, reliable and affordable vaccine for this virus, and it was not known exactly how much the vaccine development could cost.<ref name="gates2" /><ref name="gates1" /><ref name="sanger" /> There was a possibility that billions of dollars could be invested without success.<ref name="reuters" />

Once an effective vaccine would be developed, billions of doses would need to be manufactured and distributed worldwide. In April 2020, the Gates Foundation estimated that manufacturing and distribution could cost as much as {{US$|25}}{{nbsp}}billion.<ref>{{Cite news|last=Blanchfield|first=Mike|date=30 April 2020|title=Global philanthropists, experts call for COVID-19 vaccine distribution plan|work=Toronto Star|url=https://www.thestar.com/news/canada/2020/04/30/global-philanthropists-experts-call-for-covid-19-vaccine-distribution-plan.html|url-status=live|access-date=6 May 2020|archive-url=https://web.archive.org/web/20200507230428/https://www.thestar.com/news/canada/2020/04/30/global-philanthropists-experts-call-for-covid-19-vaccine-distribution-plan.html|archive-date=7 May 2020|name-list-style=vanc}}</ref> From Phase I clinical trials, 84–90%<ref name="thanh" /><!-- 90% failure --><ref name="bio" /><!-- 16.2% succces p.20 --> of vaccine candidates fail to make it to final approval during development, and from Phase III, 25.7% fail<ref name="bio" /><!-- 74.3% succces p.20 -->{{snd}}the investment by a manufacturer in a vaccine candidate may exceed {{US$|1}}{{nbsp}}billion and end with millions of useless doses given advanced manufacturing agreements.<ref name="gates2" /><ref name="reuters" /><ref name="sanger" />

As of November 2020, companies subsidized under the United States' Operation Warp Speed program have set initial pricing at {{US$|19.50}} to {{US$|25}} per dose, in line with the [[influenza vaccine]].<ref>{{Cite web|last=Jennings|first=Katie|date=17 November 2020|title=How Much Will A Covid-19 Vaccine Cost?|url=https://www.forbes.com/sites/katiejennings/2020/11/17/how-much-will-a-covid-19-vaccine-cost/|access-date=6 December 2020|website=Forbes}}</ref> In December 2020, a Belgian politician briefly published the confidential prices agreed between vaccine producers and the EU:<ref>{{cite web|date=18 December 2020|title=European vaccine prices revealed in Belgian Twitter blunder|url=https://www.brusselstimes.com/news/belgium-all-news/146038/european-vaccine-prices-revealed-in-belgian-twitter-blunder-n-va-covid-19-eva-de-bleeker-open-vld-pfizer-biontech-astra-zeneca-sanofi-gsk-johnson-moderna-curevac-peter-de-roover-frank-vandenbroucke/|website=[[The Brussels Times]]}}</ref>
{| class="wikitable sortable"
!Manufacturer
!EU price per dose<ref>{{Cite web|last=Bossaert|first=Jeroen|date=17 December 2020|title=Zoveel gaan we betalen voor de coronavaccins: staatssecretaris zet confidentiële prijzen per ongeluk online|url=https://www.hln.be/binnenland/zoveel-gaan-we-betalen-voor-de-coronavaccins-staatssecretaris-zet-confidentiele-prijzen-per-ongeluk-online~a3dceef4/|access-date=18 December 2020|website=[[Het Laatste Nieuws]]}}</ref>
|-
|AstraZeneca
|{{Euro|1.78}}
|-
|Johnson&Johnson
|{{US$|8.50}}
|-
|Sanofi/GSK
|{{Euro|7.56}}
|-
|Pfizer/BioNTech
|{{Euro|12.00}}
|-
|CureVac
|{{Euro|10.00}}
|-
|Moderna
|{{US$|18.00}}
|}

==Supply chain==
[[File:South Carolina National Guard receives first shipment of Moderna COVID-19 vaccines (50747385983).jpg|thumb|Moderna vaccine box packed with insulation and cold packs.]]
Deploying a COVID‑19 vaccine may require worldwide transport and tracking of 10–19&nbsp;billion vial doses, an effort readily becoming the largest [[supply chain management|supply chain]] challenge in history.<ref name=gates2/><ref name="wef">{{cite web |title=How the massive plan to deliver the COVID-19 vaccine could make history – and leverage blockchain like never before |url=https://www.weforum.org/agenda/2020/07/blockchain-role-in-distributing-covid-19-vaccine-could-make-history/ |publisher=World Economic Forum |access-date=16 September 2020 |date=17 July 2020 |archive-date=16 September 2020 |archive-url=https://web.archive.org/web/20200916062816/https://www.weforum.org/agenda/2020/07/blockchain-role-in-distributing-covid-19-vaccine-could-make-history/ |url-status=live }}</ref><ref name="unequal">{{cite journal |last1=Callaway |first1=Ewen |title=The unequal scramble for coronavirus vaccines – by the numbers |journal=Nature |date=27 August 2020 |volume=584 |issue=7822 |pages=506–07 |doi=10.1038/d41586-020-02450-x |pmid=32839593 |bibcode=2020Natur.584..506C |s2cid=221285160 |doi-access=free }}</ref> As of September 2020, supply chain and logistics experts expressed concern that international and national networks for distributing a licensed vaccine were not ready for the volume and urgency, due mainly to deterioration of resources during 2020 pandemic lockdowns and downsizing that degraded supply capabilities.<ref name=wef/><ref name="murray">{{cite news|title=The world's supply chain isn't ready for a Covid-19 vaccine|work=Bloomberg World|url=https://www.bloomberg.com/news/articles/2020-07-25/the-supply-chain-to-save-the-world-is-unprepared-for-a-vaccine|authors=Brendan Murray and Riley Griffin|date=24 July 2020|access-date=13 September 2020|archive-date=28 August 2020|archive-url=https://web.archive.org/web/20200828193152/https://www.bloomberg.com/news/articles/2020-07-25/the-supply-chain-to-save-the-world-is-unprepared-for-a-vaccine|url-status=live}}</ref><ref name="scott">{{cite news |first1=Scott Duke | last1=Kominers |first2=Alex | last2=Tabarrok | name-list-style=vanc |title=Vaccines use bizarre stuff. We need a supply chain now |url=https://www.bloomberg.com/opinion/articles/2020-08-18/a-resilient-covid-19-vaccine-supply-chain-starts-now |access-date=13 September 2020 |work=Bloomberg Business |date=18 August 2020 |archive-date=29 August 2020 |archive-url=https://web.archive.org/web/20200829033725/https://www.bloomberg.com/opinion/articles/2020-08-18/a-resilient-covid-19-vaccine-supply-chain-starts-now |url-status=live }}</ref> Globally, supplies critical to vaccine research and development are increasingly scarce due to international competition or national [[Sequestration (law)|sequestration]].<ref name="takada2">{{Cite news|last1=Takada|first1=Noriyuki|last2=Satake|first2=Minoru|date=2 May 2020|title=US and China unleash wallets in race for coronavirus vaccine|work=Nikkei Asian Review|url=https://asia.nikkei.com/Spotlight/Coronavirus/US-and-China-unleash-wallets-in-race-for-coronavirus-vaccine|url-status=live|access-date=3 May 2020|archive-url=https://web.archive.org/web/20200510111134/https://asia.nikkei.com/Spotlight/Coronavirus/US-and-China-unleash-wallets-in-race-for-coronavirus-vaccine|archive-date=10 May 2020|name-list-style=vanc}}</ref>

Addressing the worldwide challenge faced by coordinating numerous organizations – the COVAX partnership, global pharmaceutical companies, contract vaccine manufacturers, inter- and intranational transport, storage facilities, and health organizations in individual countries – [[Seth Berkley]], chief executive of GAVI, stated: "Delivering billions of doses of vaccine to the entire world efficiently will involve hugely complex logistical and programmatic obstacles all the way along the supply chain."<ref name="unicef-now">{{cite web |title=The time to prepare for COVID-19 vaccine transport is now |url=https://www.unicef.org/press-releases/time-prepare-covid-19-vaccine-transport-now |publisher=UNICEF |access-date=13 September 2020 |date=10 September 2020 |archive-date=13 September 2020 |archive-url=https://web.archive.org/web/20200913091315/https://www.unicef.org/press-releases/time-prepare-covid-19-vaccine-transport-now |url-status=live }}</ref>

As an example highlighting the immensity of the challenge, the [[International Air Transport Association]] stated that 8,000 [[Boeing 747]] cargo planes – implemented with equipment for precision vaccine cold storage – would be needed to transport just one dose for people in the more than 200 countries experiencing the COVID‑19 pandemic.<ref name="desai">{{cite news |first1=Devika | last1=Desai | name-list-style=vanc |title=Transporting one single dose of COVID-19 vaccine could take up to 8,000 jumbo planes, says aviation body |url=https://nationalpost.com/news/transporting-one-single-dose-of-covid-19-vaccine-could-take-up-to-8000-jumbo-planes-says-aviation-body |access-date=13 September 2020 |work=National Post |date=10 September 2020|quote=The IATA estimated that 8,000 747 cargo planes, at minimum, would be needed to transport a single dose of the vaccine worldwide, but more equipment could be required as administering the vaccine might mean several doses. Vaccines would also have to be stored at a temperature range between two and eight degrees Celsius, which could rule out the use of some types of planes.}}</ref> GAVI states that "with a fast-moving pandemic, no one is safe, unless everyone is safe."<ref name=covax-gavi/>

In contrast to the multibillion-dollar investment in vaccine technologies and early-stage clinical research, the post-licensing supply chain for a vaccine has not received the same planning, coordination, security or investment.<ref name=wef/><ref name=murray/><ref name="pharmiweb">{{cite web | last=Quelch | first=Rich | title=COVID-19 vaccine delivery – overcoming the supply chain challenges | publisher=PharmiWeb.com | date=14 August 2020 | url=https://www.pharmiweb.com/article/covid-19-vaccine-delivery-overcoming-the-supply-chain-challenges | access-date=13 September 2020|quote=Delivering a new vaccine for COVID-19 worldwide will be one of the greatest challenges faced by modern pharma. The difficulties are intensified by pre-existing shortcomings in the supply chain.}}</ref> A major concern is that resources for vaccine distribution in [[developing country|low- to middle-income countries]], particularly for vaccinating children, are inadequate or non-existent, but could be improved with cost efficiencies if procurement and distribution were centralized regionally or nationally.<ref name=covax-gavi/><ref name="seidman">{{cite journal | last1=Seidman | first1=Gabriel | last2=Atun | first2=Rifat | title=Do changes to supply chains and procurement processes yield cost savings and improve availability of pharmaceuticals, vaccines or health products? A systematic review of evidence from low-income and middle-income countries | journal=BMJ Global Health | volume=2 | issue=2 | year=2017 | issn=2059-7908 | pmid=28589028 | pmc=5435270 | doi=10.1136/bmjgh-2016-000243 | page=e000243}}</ref> In September, the COVAX partnership included 172 countries coordinating plans to optimize the supply chain for a COVID‑19 vaccine,<ref name="gavi9-4">{{cite web |title=172 countries and multiple candidate vaccines engaged in COVID-19 Vaccine Global Access Facility |url=https://www.gavi.org/news/media-room/172-countries-multiple-candidate-vaccines-engaged-covid-19-vaccine-global-access |publisher=GAVI |access-date=15 September 2020 |date=4 September 2020 |archive-date=16 September 2020 |archive-url=https://web.archive.org/web/20200916232718/https://www.gavi.org/news/media-room/172-countries-multiple-candidate-vaccines-engaged-covid-19-vaccine-global-access |url-status=live }}</ref> and [[UNICEF|the United Nations Children's Fund]] joined with COVAX to prepare the financing and supply chain for vaccinations of children in 92 developing countries.<ref name="unicef">{{cite web |title=UNICEF to lead procurement and supply of COVID-19 vaccines in world's largest and fastest ever operation of its kind |url=https://www.unicef.org/press-releases/unicef-lead-procurement-and-supply-covid-19-vaccines-worlds-largest-and-fastest-ever |publisher=UNICEF |access-date=15 September 2020 |date=4 September 2020 |archive-date=16 September 2020 |archive-url=https://web.archive.org/web/20200916152249/https://www.unicef.org/press-releases/unicef-lead-procurement-and-supply-covid-19-vaccines-worlds-largest-and-fastest-ever |url-status=live }}</ref><ref name="cook">{{cite web |first1=Emily | last1=Cook | name-list-style=vanc |title=UNICEF to lead supply chain for COVID-19 vaccine |url=https://www.manufacturingglobal.com/procurement-and-supply-chain/unicef-lead-supply-chain-covid-19-vaccine |publisher=Manufacturing |access-date=13 September 2020 |date=4 September 2020 |archive-date=1 November 2020 |archive-url=https://web.archive.org/web/20201101220835/https://www.manufacturingglobal.com/procurement-and-supply-chain/unicef-lead-supply-chain-covid-19-vaccine |url-status=live }}</ref>

===Logistics===

Logistics vaccination services assure necessary equipment, staff, and supply of licensed vaccines across international borders.<ref name="hessel">{{cite journal | last=Hessel | first=Luc | title=Pandemic influenza vaccines: meeting the supply, distribution and deployment challenges | journal=Influenza and Other Respiratory Viruses | volume=3 | issue=4 | year=2009 | issn=1750-2640 | pmid=19627373 | pmc=4634681 | doi=10.1111/j.1750-2659.2009.00085.x | pages=165–70}}</ref> Central logistics include vaccine handling and monitoring, cold chain management, and safety of distribution within the vaccination network.<ref name="who-log">{{cite web |title=Vaccine management and logistics support |url=https://www.who.int/immunization/programmes_systems/supply_chain/resources/tools/en/ |publisher=World Health Organization |access-date=14 September 2020 |year=2020 |archive-date=13 September 2020 |archive-url=https://web.archive.org/web/20200913154344/https://www.who.int/immunization/programmes_systems/supply_chain/resources/tools/en/ |url-status=live }}</ref> The purpose of the COVAX Facility is to centralize and equitably administer logistics resources among participating countries, merging manufacturing, transport, and overall supply chain infrastructure.<ref name=covax-gavi/><ref name=pharmiweb/> Included are logistics tools for vaccine forecasting and needs estimation, in-country vaccine management, potential for wastage, and stock management.<ref name=who-log/>

Other logistics factors conducted internationally during distribution of a COVID‑19 vaccine may include:<ref name=wef/><ref name="jarrett">{{cite journal | last1=Jarrett | first1=Stephen | last2=Yang | first2=Lingjiang | last3=Pagliusi | first3=Sonia | title=Roadmap for strengthening the vaccine supply chain in emerging countries: Manufacturers' perspectives | journal=Vaccine X| volume=5 | date=9 June 2020 | issn=2590-1362 | pmid=32775997 | pmc=7394771 | doi=10.1016/j.jvacx.2020.100068 | page=100068}}</ref><ref name="lloyd">{{cite journal | last1=Lloyd | first1=John | last2=Cheyne | first2=James | title=The origins of the vaccine cold chain and a glimpse of the future | journal=Vaccine | volume=35 | issue=17 | year=2017 | issn=0264-410X | doi=10.1016/j.vaccine.2016.11.097 | pages=2115–20 | pmid=28364918 | doi-access=free }}</ref>
* visibility and traceability by [[barcode]]s for each vaccine vial
* sharing of supplier audits
* sharing of [[chain of custody]] for a vaccine vial from manufacturer to the individual being vaccinated
* use of vaccine temperature monitoring tools
* temperature stability testing and assurance
* new packaging and delivery technologies
* stockpiling
* coordination of supplies within each country ([[personal protective equipment]], [[diluent]], syringes, needles, rubber stoppers, refrigeration fuel or power sources, waste-handling, among others)
* communications technology
* environmental impacts in each country

A logistics shortage in any one step may derail the whole supply chain, according to one vaccine developer.<ref name="wef-manuf">{{cite web |title=How can we make enough vaccine for 2&nbsp;billion people? |url=https://www.weforum.org/agenda/2020/08/covid-vaccine-manufacture-distribute-2-billion-doses/ |publisher=World Economic Forum |access-date=16 September 2020 |date=25 August 2020 |archive-date=16 September 2020 |archive-url=https://web.archive.org/web/20200916165424/https://www.weforum.org/agenda/2020/08/covid-vaccine-manufacture-distribute-2-billion-doses |url-status=live }}</ref> If the vaccine supply chain fails, the economic and human costs of the pandemic may be extended for years.<ref name=scott/>

===Manufacturing capacity===

By August 2020, when only a few vaccine candidates were in Phase III trials and were many months away from establishing safety and efficacy, numerous governments pre-ordered more than two billion doses at a cost of more than US$5&nbsp;billion.<ref name=unequal/><ref name=wef-manuf/><ref>{{cite news |title=Coronavirus vaccine pre-orders worldwide top 5&nbsp;billion |url=https://www.japantimes.co.jp/news/2020/08/12/world/science-health-world/pre-orders-coronavirus-vaccines/ |access-date=13 September 2020 |work=[[The Japan Times]] |date=12 August 2020 |archive-date=20 September 2020 |archive-url=https://web.archive.org/web/20200920183450/https://www.japantimes.co.jp/news/2020/08/12/world/science-health-world/pre-orders-coronavirus-vaccines/ |url-status=live }}</ref> Pre-orders from the British government for 2021 were for five vaccine doses per person, a number dispiriting to organizations like the WHO and GAVI which are promoting fair and equitable access worldwide, especially for developing countries.<ref name=unequal/> In September, CEPI was financially supporting basic and clinical research for nine vaccine candidates, with nine more in evaluation, under financing commitments to manufacture two billion doses of three licensed vaccines by the end of 2021.<ref name=gavi9-4/> Before 2022, 7–10&nbsp;billion COVID‑19 vaccine doses may be manufactured worldwide, but the sizable pre-orders by affluent countries – called "vaccine nationalism" – threaten vaccine availability for poorer nations.<ref name=gates2/><ref name=wef-manuf/><ref name=unequal/>

After joining COVAX in October, China initially shared that it would produce 600&nbsp;million vaccine doses before the end of 2020 and another one billion doses in 2021, although it was unsure how many would be for the country's own population of 1.4&nbsp;billion.<ref>{{Cite web|last=C|first=Hannah|date=10 October 2020|title=China Commits to Producing 600 Million Vaccine Doses by the End of 2020|url=https://www.sciencetimes.com/articles/27653/20201010/china-producing-600-million-vaccine-2020.htm|access-date=10 October 2020|website=Science Times|archive-date=10 October 2020|archive-url=https://web.archive.org/web/20201010154916/https://www.sciencetimes.com/articles/27653/20201010/china-producing-600-million-vaccine-2020.htm|url-status=live}}</ref> [[Sinopharm]] said it may have the capacity to produce more than 1&nbsp;billion doses in 2021,<ref>{{Cite news|date=20 October 2020|title=Sinopharm says may be able to make over 1&nbsp;billion coronavirus vaccine doses in 2021|publisher=Reuters|url=https://www.reuters.com/article/health-coronavirus-china-vaccine-int-idUSKBN2750WM|access-date=7 December 2020}}</ref> while its Dubai partner G42 Healthcare aimed to produce up to 100&nbsp;million doses in 2021 focused on the middle east.<ref>{{Cite news|date=8 October 2020|title=UAE company nears end of Chinese Covid-19 vaccine trial|publisher=Reuters|url=https://www.reuters.com/article/health-coronavirus-emirates-vaccine-int-idUSKBN26T1N5|access-date=12 December 2020}}</ref> Sinovac aimed to complete a second production line by February 2021 to increase production of [[CoronaVac]] to 1 billion doses from 500 million,<ref>{{Cite news|last=Staff|first=Reuters|date=2021-01-13|title=China's Sinovac to double annual COVID-19 vaccine capacity to 1 billion doses|language=en|work=Reuters|url=https://www.reuters.com/article/us-health-coronavirus-vaccine-sinovac-idUSKBN29I0YN|access-date=2021-01-17}}</ref> while its Brazilian partner [[Instituto Butantan]] planned to produce 100&nbsp;million doses<ref>{{Cite web|title=Sao Paulo starts building production plant for China's Sinovac vaccine – governor|url=https://financialpost.com/pmn/business-pmn/sao-paulo-starts-building-production-plant-for-chinas-sinovac-vaccine-governor-2|access-date=12 December 2020|website=financialpost}}</ref> and its Indonesian partner [[Bio Farma]] planned to produce up to 250&nbsp;million doses of CoronaVac a year.<ref>{{Cite web|last=hermesauto|date=12 October 2020|title=Indonesia aims to start administering coronavirus vaccines in early November|url=https://www.straitstimes.com/asia/se-asia/indonesia-aims-to-start-administering-coronavirus-vaccines-in-early-november|access-date=12 December 2020|website=The Straits Times}}</ref>

The [[Serum Institute of India]] plans to produce at least one billion vaccine doses, although the institute has stated that half the doses will be used in India.<ref name="unequal" />

AstraZeneca CEO, [[Pascal Soriot]], stated: "The challenge is not making the vaccine itself, it's filling vials. There just aren't enough vials in the world."<ref name="molteni">{{cite web |first1=Megan | last1=Molteni | name-list-style=vanc |title=Vaccine makers turn to microchip tech to beat glass shortages |url=https://www.wired.com/story/vaccine-makers-turn-to-microchip-tech-to-beat-glass-shortages/ |work=Wired |access-date=17 September 2020 |date=26 June 2020 |archive-date=16 September 2020 |archive-url=https://web.archive.org/web/20200916152242/https://www.wired.com/story/vaccine-makers-turn-to-microchip-tech-to-beat-glass-shortages/ |url-status=live }}</ref> Preparing for high demand in manufacturing vials, an American glass producer invested $163&nbsp;million in July for a vial factory.<ref name="glass">{{cite web |first1=Fraiser | last1=Kansteiner | name-list-style=vanc |title=With COVID-19 vaccines coming, SiO2 injects $163M into vial production plant |url=https://www.fiercepharma.com/manufacturing/sio2-injects-163-million-into-glass-vial-production-plant |publisher=FiercePharma, Questex LLC |access-date=17 September 2020 |date=8 July 2020 |archive-date=5 October 2020 |archive-url=https://web.archive.org/web/20201005120516/https://www.fiercepharma.com/manufacturing/sio2-injects-163-million-into-glass-vial-production-plant |url-status=live }}</ref> Glass availability for vial manufacturing and contaminant control are issues of concern,<ref name="burger">{{cite news |first1=Ludwig | last1=Burger |first2=Matthias | last2=Blamont | name-list-style=vanc |title=Bottlenecks? Glass vial makers prepare for COVID-19 vaccine |url=https://www.reuters.com/article/us-health-coronavirus-schott-exclusive-idUSKBN23J0SN |access-date=17 September 2020 |publisher=Reuters |date=11 June 2020 |archive-date=29 September 2020 |archive-url=https://web.archive.org/web/20200929040220/https://www.reuters.com/article/us-health-coronavirus-schott-exclusive-idUSKBN23J0SN |url-status=live }}</ref> indicating higher production costs with lower profit potential for developers amid demands for vaccines to be affordable.<ref name=covax-gavi/><ref name=unequal/><ref name=scott/>

Vaccines must be handled and transported using international regulations, be maintained at controlled temperatures that vary across vaccine technologies, and be used for immunization before deterioration in storage.<ref name=unequal/><ref name=wef-manuf/> The scale of the COVID‑19 vaccine supply chain is expected to be vast to ensure delivery worldwide to vulnerable populations.<ref name=gates2/><ref name=murray/> Priorities for preparing facilities for such distribution include temperature-controlled facilities and equipment, optimizing infrastructure, training immunization staff, and rigorous monitoring.<ref name=murray/><ref name=unicef-now/><ref name=unicef/> [[Radiofrequency identification|RFID]] technologies are being implemented to track and authenticate a vaccine dose from the manufacturer along the entire supply chain to the vaccination.<ref name="kaplan">{{cite web |first1=Deborah Abrams | last1=Kaplan | name-list-style=vanc |title=3 applications for RFID in the fight against COVID-19 |url=https://www.supplychaindive.com/news/coronavirus-rfid-sensor-tracking-hospital-supply-chain/581066/ |publisher=Supply Chain Dive |access-date=17 September 2020 |date=7 July 2020 |archive-date=2 October 2020 |archive-url=https://web.archive.org/web/20201002013438/https://www.supplychaindive.com/news/coronavirus-rfid-sensor-tracking-hospital-supply-chain/581066/ |url-status=live }}</ref>

In September 2020, [[Grand River Aseptic Manufacturing]] agreed with [[Johnson & Johnson]] to support the manufacture of its vaccine candidate, including [[technology transfer]] and [[fill and finish]] manufacturing.<ref name="contract">{{cite web|title=Ramping Up COVID-19 Vaccine Fill and Finish Capacity|url=https://www.contractpharma.com/content-microsite/covid-19/2020-11-03/ramping-up-covid-19-vaccine-fill-and-finish-capacity|publisher=Contract Pharma|first=Kristin | last=Brooks |date=3 November 2020|access-date=25 November 2020}}</ref> In October 2020, it was announced that the Moderna vaccine candidate will be manufactured in [[Visp]], [[Switzerland]] by its partner [[Lonza Group]], which plans to produce the first doses in December 2020.<ref name="swiss">{{cite web|url=https://www.swissinfo.ch/eng/sci-tech/swiss-factory-rushes-to-prepare-for-moderna-covid-19-vaccine/46081656|title=Swiss factory rushes to prepare for Moderna Covid-19 vaccine |date=7 October 2020 |publisher=SwissInfo| access-date=1 November 2020}}</ref> The newly built 2,000-square-metre facility will ramp up production to 300&nbsp;million doses annually. The ingredient will be shipped frozen at −70&nbsp;°C to Spain's Laboratorios Farmacéuticos Rovi SA for the final stage of manufacturing.<ref name=swiss/> Lonza's site in [[Portsmouth]], [[New Hampshire]], aims to start making vaccine ingredients exclusively for the U.S. as early as November.<ref name=swiss/>

===Cold chain===
{{see also|ULT freezer}}
[[File:Delta delivers COVID-19 vaccine shipments (50734277477).jpg|thumb|COVID‑19 vaccine shipment protected by thermal wrapping while in transit. (Delta, 16 December 2020)]]
Different vaccines have different shipping and handling requirements. For example, the [[Pfizer-BioNTech COVID‑19 vaccine]] must be shipped and [[ULT freezer|stored]] between {{Convert|-80|and|-60|C|F|abbr=}},<ref name="Vaccination Storage">{{cite web|title=Pfizer-BioNTech COVID-19 Vaccine Vaccination Storage & Dry Ice Safety Handling|url=https://www.cvdvaccine-us.com/product-storage-and-dry-ice|access-date=17 December 2020|publisher=Pfizer}}</ref> must be used within five days of thawing,<ref name="Vaccination Storage" /> and has a minimum order of 975 doses, making it unlikely to be rolled out in settings other than large, well-equipped hospitals.<ref>{{Cite web|date=9 October 2020|title=7 looming questions about the rollout of a Covid-19 vaccine|url=https://www.statnews.com/2020/10/09/7-looming-questions-about-the-rollout-of-a-covid-19-vaccine/|url-status=live|archive-url=https://web.archive.org/web/20201010225321/https://www.statnews.com/2020/10/09/7-looming-questions-about-the-rollout-of-a-covid-19-vaccine/|archive-date=10 October 2020|access-date=10 October 2020|website=[[Stat (website)|Stat]]}}</ref> The Moderna vaccine vials require storage above {{convert|-40|C|F}} and between {{convert|-25|and|-15|C|F}}.<ref name="Moderna fact sheet">{{cite web|title=Fact Sheet for Healthcare Providers Administering Vaccine|url=https://www.fda.gov/media/144637/download|publisher=ModernaTX, Inc.|format=PDF}}</ref> Once refrigerated, the Moderna vaccine can be kept between {{convert|2|and|8|C|F}} for up to 30 days.<ref name="Moderna fact sheet" />

Vaccines (and adjuvants) are inherently unstable during temperature changes, requiring [[cold chain]] management throughout the entire supply chain, typically at temperatures of {{convert|2|-|8|C}}.<ref name="lloyd" /><ref name="karto">{{cite journal | last1=Kartoglu | first1=Umit | last2=Milstien | first2=Julie | title=Tools and approaches to ensure quality of vaccines throughout the cold chain | journal=Expert Review of Vaccines | volume=13 | issue=7 | date=28 May 2014 | issn=1476-0584 | pmid=24865112 | pmc=4743593 | doi=10.1586/14760584.2014.923761 | pages=843–54}}</ref> Because COVID‑19 vaccine technologies are varied among several novel technologies, there are new challenges for cold chain management, with some vaccines that are stable while frozen but labile to heat, while others should not be frozen at all, and some are stable across temperatures.<ref name="karto" /> Freezing damage and inadequate training of personnel in the local vaccination process are major concerns.<ref name="hanson">{{cite journal | last1=Hanson | first1=Celina M. | last2=George | first2=Anupa M. | last3=Sawadogo | first3=Adama | last4=Schreiber | first4=Benjamin | title=Is freezing in the vaccine cold chain an ongoing issue? A literature review | journal=Vaccine | volume=35 | issue=17 | date=19 April 2017 | issn=0264-410X | pmid=28364920 | doi=10.1016/j.vaccine.2016.09.070 | pages=2127–33 | doi-access=free }}</ref> If more than one COVID‑19 vaccine is approved, the vaccine cold chain may have to accommodate all these temperature sensitivities across different countries with variable climate conditions and local resources for temperature maintenance.<ref name="karto" /> [[China National Pharmaceutical Group|Sinopharm]] and [[Sinovac Biotech|Sinovac]]'s vaccines are examples of [[inactivated vaccine]]s in Phase III testing which can be transported using existing cold chain systems at {{convert|2|-|8|C}}.<ref>{{Cite news|title=China's Sinopharm vaccine 86% effective, say United Arab Emirates officials {{!}} CBC News|publisher=Canadian Broadcasting Corporation|url=https://www.cbc.ca/news/world/vaccine-sinopharm-uae-1.5833823|access-date=11 December 2020}}</ref><ref>{{Cite web|date=1 November 2020|title=CoronaVac: Doses will come from China on nine flights and can...|url=https://alkhaleejtoday.co/international/5246732/CoronaVac-Doses-will-come-from-China-on-nine-flights-and-can.html|access-date=15 November 2020|website=AlKhaleej Today|language=ar}}</ref>

modRNA vaccine technologies in development may be more difficult to manufacture at scale and control degradation, requiring ultracold storage and transport.<ref name=scott/> As examples, Moderna's RNA vaccine candidate requires cold chain management just above freezing temperatures between {{Convert|2|and|8|C}} with limited storage duration (30 days),<ref>{{cite press release | title=Moderna Announces Longer Shelf Life for its COVID-19 Vaccine Candidate at Refrigerated Temperatures | website=Moderna, Inc. | date=16 November 2020 | url=https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-longer-shelf-life-its-covid-19-vaccine | access-date=17 December 2020}}</ref> but the Pfizer-BioNTech RNA candidate requires [[ULT freezer|storage]] between {{Convert|-80|and|-60|C|F|abbr=}},<ref name="Vaccination Storage" /> or colder throughout deployment until vaccination.<ref name="blankenship">{{cite web |first1=Kyle | last1=Blankenship | name-list-style=vanc |title=Pfizer, Moderna's coronavirus shot rollouts could freeze up, experts say, citing cold-storage needs |url=https://www.fiercepharma.com/manufacturing/pfizer-moderna-s-covid-19-shot-rollouts-could-be-ice-as-analysts-question-cold |publisher=FiercePharma, Questex LLC |access-date=11 November 2020 |date=28 August 2020}}</ref><ref name="odonnell">{{cite news |first1=Carl | last1=O'Donnell | name-list-style=vanc |title=Why Pfizer's ultra-cold COVID-19 vaccine will not be at the local pharmacy any time soon |url=https://www.reuters.com/article/us-health-coronavirus-vaccines-distribut/why-pfizers-ultra-cold-covid-19-vaccine-will-not-be-at-the-local-pharmacy-any-time-soon-idUSKBN27P2VI |access-date=11 November 2020 |publisher=Reuters |date=9 November 2020}}</ref>

After a vaccine vial is punctured to administer a dose, it is viable for only six hours, then must be discarded, requiring attention to local management of cold storage and vaccination processes.<ref name=gates2/><ref name="weise">{{cite news |first1=Elizabeth | last1=Weise | name-list-style=vanc |title='Mind-bogglingly complex': Here's what we know about how COVID-19 vaccine will be distributed when it's approved |url=https://www.usatoday.com/story/news/health/2020/09/06/covid-vaccine-complex-distribution-supply-chain-follow-approval/5712053002/ |access-date=13 September 2020 |work=USA Today |date=6 September 2020 |archive-date=12 September 2020 |archive-url=https://web.archive.org/web/20200912170618/https://www.usatoday.com/story/news/health/2020/09/06/covid-vaccine-complex-distribution-supply-chain-follow-approval/5712053002/ |url-status=live }}</ref> Because the COVID‑19 vaccine will likely be in short supply for many locations during early deployment, vaccination staff will have to avoid spoilage and waste, which typically are as much as 30% of the supply.<ref name=wef/><ref name=weise/> The cold chain is further challenged by the type of local transportation for the vaccines in rural communities, such as by motorcycle or [[delivery drone]], need for booster doses, use of diluents, and access to vulnerable populations, such as healthcare staff, children and the elderly.<ref name=gates2/><ref name=unicef/><ref name="durbha">{{cite web |first1=Madhav | last1=Durbha | name-list-style=vanc |title=The extra mile: preparing a supply chain for a COVID-19 vaccine |url=https://www.europeanpharmaceuticalreview.com/article/122358/the-extra-mile-preparing-a-supply-chain-for-a-covid-19-vaccine/ |publisher=European Pharmaceutical Review |access-date=13 September 2020 |date=29 June 2020 |archive-date=11 September 2020 |archive-url=https://web.archive.org/web/20200911074323/https://www.europeanpharmaceuticalreview.com/article/122358/the-extra-mile-preparing-a-supply-chain-for-a-covid-19-vaccine/ |url-status=live }}</ref>

===Air and land transport===

Coordination of international [[air cargo]] is an essential component of time- and temperature-sensitive distribution of COVID‑19 vaccines, but, as of September 2020, the air freight network is not prepared for multinational deployment.<ref name=murray/><ref name=desai/><ref name="iata">{{cite web |title=The time to prepare for COVID-19 vaccine transport is now |url=https://www.iata.org/en/pressroom/pr/2020-09-09-01/ |publisher=International Air Transport Association |access-date=13 September 2020 |date=9 September 2020 |archive-date=12 September 2020 |archive-url=https://web.archive.org/web/20200912232217/https://www.iata.org/en/pressroom/pr/2020-09-09-01/ |url-status=live }}</ref> "Safely delivering COVID‑19 vaccines will be the mission of the century for the global air cargo industry. But it won't happen without careful advance planning. And the time for that is now. We urge governments to take the lead in facilitating cooperation across the logistics chain so that the facilities, security arrangements and border processes are ready for the mammoth and complex task ahead," said IATA's Director General and CEO, [[Alexandre de Juniac]], in September 2020.<ref name=iata/>

For the severe reduction in passenger air traffic during 2020, airlines [[layoff|downsized]] personnel, trimmed destination networks, and put aircraft into long-term storage.<ref name=murray/><ref name=iata/> As the lead agencies for procurement and supply of the COVID‑19 vaccine within the WHO COVAX Facility, GAVI and UNICEF are preparing for the largest and fastest vaccine deployment ever, necessitating international air freight collaboration, customs and border control, and possibly as many as 8,000 cargo planes to deliver just one vaccine dose to multiple countries.<ref name=unicef/><ref name=iata/>

Two of the first approved vaccines, Pfizer and BioNTech's [[Pfizer-BioNTech COVID‑19 vaccine]] and Moderna's mRNA-1273, must be kept cold during transport. Keeping the temperatures sufficiently low is accomplished with specially-designed containers{{efn|With a steady supply of dry ice, the Pfizer-designed containers can insulate the vaccine for up to 30 days.<ref>{{cite web | title=Questions and Answers About Pfizer-BioNTech COVID-19 Vaccine | publisher=Pfizer | url=https://www.cvdvaccine-us.com/faqs | access-date=16 December 2020}}</ref><ref name="tcs-paul-2020"/>}} and [[dry ice]], but dry ice is only allowed in limited quantities on airplanes as the gases released via [[sublimation (phase transition)|sublimation]] may be toxic. In the United States, the [[Federal Aviation Administration]] (FAA) limits the amount of dry ice on a [[Boeing 777]]-224 to {{convert|3000|lb|kg|abbr=on}}, but it temporarily allowed [[United Airlines]] to transport up to {{convert|15000|lb|kg|abbr=on}}—nearly 1&nbsp;million doses—between [[Brussels]] and Chicago. The CDC has tasked [[McKesson]] with vaccine distribution in the US; the company will handle all major vaccines except Pfizer's. [[American Airlines]], [[Boeing]], and [[Delta Airlines]] are also working to increase dry ice transportation capacity, and American, Delta, and United each operate their own cold storage networks in the US. [[FedEx]] and [[United Parcel Service|UPS]] have installed ultra-cold freezers at air cargo hubs in Europe and North America, and UPS can manufacture {{convert|1200|lb|kg|abbr=on}} of dry ice per hour.<ref name="chokshi-nyt-2020">{{cite news |last1=Chokshi |first1=Niraj |title=Airlines Gear Up to Transport Vaccines That Could Revive Travel |url=https://www.nytimes.com/2020/12/10/business/airlines-vaccines-coronavirus.html |access-date=11 December 2020 |work=[[The New York Times]] |date=10 December 2020}}</ref>

===Security and corruption===

Medicines are the world's largest [[Quackery|fraud market]], worth some $200&nbsp;billion per year, making the widespread demand for a COVID‑19 vaccine vulnerable to [[counterfeit]], theft, [[Confidence trick|scams]], and [[cyberattack]]s throughout the supply chain.<ref name=pharmiweb/><ref name="unodc">{{cite web |title=COVID-19-related trafficking of medical products as a threat to public health |url=https://www.unodc.org/documents/data-and-analysis/covid/COVID-19_research_brief_trafficking_medical_products.pdf |publisher=United Nations Office on Drugs and Crime |access-date=16 September 2020 |year=2020 |archive-date=19 September 2020 |archive-url=https://web.archive.org/web/20200919040248/https://www.unodc.org/documents/data-and-analysis/covid/COVID-19_research_brief_trafficking_medical_products.pdf |url-status=live }}</ref> The vaccine has been referred to as "the most valuable asset on earth"; Interpol called it "liquid gold" and warned of an "onslaught of all types of criminal activity".<ref name="nyt-castle-peltier-2020"/> [[Anticorruption]], transparency, and accountability safeguards are being established to reduce and eliminate corruption of COVID‑19 vaccine supplies.<ref name=unodc/><ref name="kohler">{{cite journal | last1=Kohler | first1=Jillian Clare | last2=Dimancesco | first2=Deirdre | title=The risk of corruption in public pharmaceutical procurement: how anti-corruption, transparency and accountability measures may reduce this risk | journal=Global Health Action | volume=13 | issue=sup1 | date=3 February 2020 | issn=1654-9716 | pmid=32194011 | pmc=7170361 | doi=10.1080/16549716.2019.1694745 | page=1694745 | name-list-style=vanc}}</ref> Absence of harmonized regulatory frameworks among countries, including low technical capacity, constrained access, and ineffective capability to identify and track genuine vs. counterfeit vaccines, may be life-threatening for vaccine recipients, and would potentially perpetuate the COVID‑19 pandemic.<ref name=unodc/> [[Tracking system]] technologies for packaging are being used by manufacturers to trace vaccine vials across the supply chain,<ref name=pharmiweb/> and to use digital and [[biometric]] tools to assure security for vaccination teams.<ref name=kaplan/><ref name="subra">{{cite news |first1=Samanth | last1=Subramanian | name-list-style=vanc |title=Biometric tracking can ensure billions have immunity against Covid-19 |url=https://www.bloomberg.com/features/2020-covid-vaccine-tracking-biometric/ |access-date=16 September 2020 |work=Bloomberg Businessweek |date=13 August 2020 |archive-date=16 September 2020 |archive-url=https://web.archive.org/web/20200916185242/https://www.bloomberg.com/features/2020-covid-vaccine-tracking-biometric/ |url-status=live }}</ref> In December 2020, [[Interpol]] warned that [[organized crime]] could infiltrate the vaccine supply chain, steal product through physical means, and [[data theft]], or even offer counterfeit vaccine kits.<ref>[https://www.interpol.int/en/News-and-Events/News/2020/INTERPOL-warns-of-organized-crime-threat-to-COVID-19-vaccines "INTERPOL warns of organized crime threat to COVID‑19 vaccines]". Interpol (Orange Notice). Retrieved 10 December 2020.</ref> Further, vaccines which require constant freezing temperatures are also susceptible to sabotage.<ref name="nyt-castle-peltier-2020">{{cite news |last1=Castle |first1=Stephen |last2=Peltier |first2=Elian |title=After Botched Covid Response, U.K. Tackles Giant Vaccine Rollout |url=https://www.nytimes.com/2020/12/07/world/europe/covid-uk-vaccine-pfizer.html |access-date=11 December 2020 |work=[[The New York Times]] |date=7 December 2020 | name-list-style=vanc}}</ref>

GPS devices will be used in the United States to track the vaccines. In [[Colorado]], the vaccine shipments will be escorted by [[Colorado State Patrol]] officers from [[Denver International Airport]] to the state's eight distribution points; the exact plans are confidential and law enforcement will "maintain a low-key profile".<ref name="tcs-paul-2020">{{cite news |last1=Paul |first1=Jesse |title=Colorado's final coronavirus vaccine preparations include practicing for high-stakes delivery road trips |url=https://coloradosun.com/2020/12/09/colorado-coronavirus-vaccine-transport-test/ |access-date=11 December 2020 |work=[[The Colorado Sun]] |date=9 December 2020 | name-list-style=vanc}}</ref>

Peripheral businesses may also be affected. An [[IBM]] security analyst told ''[[The New York Times]]'' that petrochemical companies are being targeted by hackers due to their central role in producing dry ice.<ref name="nyt-castle-peltier-2020"/>

===National infrastructure===
The WHO has implemented an "Effective Vaccine Management" system,<ref name="who-evm">{{cite web |title=Effective Vaccine Management (EVM) Initiative:Vaccine Management Handbook |url=https://www.who.int/immunization/programmes_systems/supply_chain/evm/en/index5.html |publisher=World Health Organization |access-date=16 September 2020 |date=9 September 2020 |archive-date=5 October 2018 |archive-url=https://web.archive.org/web/20181005102131/http://www.who.int/immunization/programmes_systems/supply_chain/evm/en/index5.html |url-status=live }}</ref> which includes constructing priorities to prepare national and subnational personnel and facilities for vaccine distribution, including:
* Trained staff to handle time- and temperature-sensitive vaccines
* Robust monitoring capabilities to ensure optimal vaccine storage and transport
* Temperature-controlled facilities and equipment
* Traceability
* Security

Border processes for efficient handling and customs clearance within individual countries may include:<ref name=hessel/><ref name=who-evm/>
* Facilitating flight and landing permits
* Exempting flight crews from [[quarantine]] requirements
* Facilitating flexible operations for efficient national deployment
* Granting arrival priority to maintain vaccine temperature requirements


==Liability==
==Liability==

Revision as of 23:33, 18 January 2021

For potential therapeutic drugs for COVID-19, see COVID-19 drug development and COVID-19 drug repurposing research.

Part of a series on the
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Timeline
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Impacts
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virus icon COVID-19 portal
A US airman receiving a COVID-19 vaccine.
Map of countries by approval status
  Approved for general use, mass vaccination underway
  EUA granted, mass vaccination underway
  EUA granted, limited vaccination
  Approved for general use, mass vaccination planned
  EUA granted, mass vaccination planned
  EUA pending

A COVID‑19 vaccine is a vaccine intended to provide acquired immunity against COVID‑19. Prior to the COVID‑19 pandemic, work to develop a vaccine against the coronavirus diseases SARS and MERS had established knowledge about the structure and function of coronaviruses, which accelerated development during early 2020 of varied technology platforms for a COVID‑19 vaccine.

By January 2021, 69 vaccine candidates were in clinical research, including 43 in Phase I–II trials and 26 in Phase II–III trials.[1] In Phase III trials, several COVID‑19 vaccines demonstrated efficacy as high as 95% in preventing symptomatic COVID‑19 infections. As of January 2021, nine vaccines have been authorized by at least one national regulatory authority for public use: two RNA vaccines (the Pfizer-BioNTech vaccine and the Moderna vaccine), three conventional inactivated vaccines (BBIBP-CorV from Sinopharm, BBV152 from Bharat Biotech and CoronaVac from Sinovac), two viral vector vaccines (Sputnik V from the Gamaleya Research Institute and the Oxford–AstraZeneca vaccine), and one peptide vaccine (EpiVacCorona).

Many countries have implemented phased distribution plans that prioritize those at highest risk of complications, such as the elderly, and those at high risk of exposure and transmission, such as healthcare workers.[2] As of 14 January 2021, 32.64 million doses of COVID‑19 vaccine had been administered worldwide based on official reports from national health agencies.[3] Pfizer, Moderna, and AstraZeneca predicted a manufacturing capacity of 5.3 billion doses in 2021, which could be used to vaccinate about 3 billion people (as the vaccines require two doses for a protective effect against COVID‑19). By December, more than 10 billion vaccine doses had been preordered by countries,[4] with about half of the doses purchased by high-income countries comprising only 14% of the world's population.[5]

Background

Prior to COVID‑19, a vaccine for an infectious disease had never been produced in less than several years--and no vaccine existed for preventing a coronavirus infection in humans.[6] However, vaccines have been produced against several animal diseases caused by coronaviruses, including (as of 2003) infectious bronchitis virus in birds, canine coronavirus, and feline coronavirus.[7] Previous projects to develop vaccines for viruses in the family Coronaviridae that affect humans have been aimed at severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). Vaccines against SARS[8] and MERS[9] have been tested in non-human animals.

According to studies published in 2005 and 2006, the identification and development of novel vaccines and medicines to treat SARS was a priority for governments and public health agencies around the world at that time.[10][11][12] As of 2020, there is no cure or protective vaccine proven to be safe and effective against SARS in humans.[13][14] There is also no proven vaccine against MERS.[15] When MERS became prevalent, it was believed that existing SARS research may provide a useful template for developing vaccines and therapeutics against a MERS-CoV infection.[13][16] As of March 2020, there was one (DNA based) MERS vaccine which completed Phase I clinical trials in humans[17] and three others in progress, all being viral-vectored vaccines: two adenoviral-vectored (ChAdOx1-MERS, BVRS-GamVac) and one MVA-vectored (MVA-MERS-S).[18]

The urgency to create a vaccine for COVID‑19, led to compressed schedules that shortened the standard vaccine development timeline, in some cases combining clinical trial steps over months, a process typically conducted sequentially over years.[19] Multiple steps along the entire development path are evaluated, including the level of acceptable toxicity of the vaccine (its safety), targeting vulnerable populations, the need for vaccine efficacy breakthroughs, the duration of vaccination protection, special delivery systems (such as oral or nasal, rather than by injection), dose regimen, stability and storage characteristics, emergency use authorization before formal licensing, optimal manufacturing for scaling to billions of doses, and dissemination of the licensed vaccine.[6][20] Timelines for conducting clinical research – normally a sequential process requiring years – are being compressed into safety, efficacy, and dosing trials running simultaneously over months, potentially compromising safety assurance.[21][19] As an example, Chinese vaccine developers and the government Chinese Center for Disease Control and Prevention began their efforts in January 2020,[22] and by March were pursuing numerous candidates on short timelines, with the goal to showcase Chinese technology strengths over those of the United States, and to reassure the Chinese people about the quality of vaccines produced in China.[19][23]

Vaccines by type

Potential candidates for forming SARS-CoV-2 proteins to prompt an immune response

As of September 2020, nine different technology platforms – with the technology of numerous candidates remaining undefined – were under research and development to create an effective vaccine against COVID‑19.[24] Most of the platforms of vaccine candidates in clinical trials are focused on the coronavirus spike protein and its variants as the primary antigen of COVID‑19 infection.[24] Platforms being developed in 2020 involved nucleic acid technologies (nucleoside-modified messenger RNA and DNA), non-replicating viral vectors, peptides, recombinant proteins, live attenuated viruses, and inactivated viruses.[6][25][24][26]

Many vaccine technologies being developed for COVID‑19 are not like vaccines already in use to prevent influenza, but rather are using "next-generation" strategies for precision on COVID‑19 infection mechanisms.[25][24][26] Vaccine platforms in development may improve flexibility for antigen manipulation and effectiveness for targeting mechanisms of COVID‑19 infection in susceptible population subgroups, such as healthcare workers, the elderly, children, pregnant women, and people with existing weakened immune systems.[25][24]

COVID‑19 vaccine technology platforms, January 2021[1]
Molecular platform[i] Total number
of candidates 		Number of candidates
in human trials
Inactivated virus
19
5[ii]
Non-replicating viral vector
35
4[ii]
RNA-based
36
3[ii]
Protein subunit
80
2[ii]
DNA-based
23
2[ii]
Virus-like particle
19
1[ii]
Replicating viral vector
23
0
Live attenuated virus
4
0
  1. ^ Technologies for dozens of candidates are unannounced or "unknown".[1]
  2. ^ a b c d e f One or more candidates in Phase II or Phase II–III trials.

The effectiveness of a new vaccine is defined by its efficacy.[27] In the case of COVID‑19, a vaccine efficacy of 67% may be enough to slow the pandemic, but this assumes that the vaccine confers sterilizing immunity, which is necessary to prevent transmission. Vaccine efficacy reflects disease prevention, a poor indicator of transmissibility of SARS-CoV-2 since asymptomatic people can be highly infectious.[28] The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have set a cut-off of 50% as the efficacy required to approve a COVID‑19 vaccine.[29][30] As of 7 January, authorized and approved vaccines have shown efficacies ranging from 62%-90% for the Oxford–AstraZeneca vaccine (various dosage regimens) to 95% for the Pfizer-BioNTech COVID‑19 vaccine.

BBV152 has not published efficacy results as of 7 January.[31]

In mid-December 2020, a new SARS-CoV-2 variant (VOC-202012/01) was identified in the UK. While preliminary data indicates that this variant showed an estimated increase in reproductive number (R) by 0.4 or greater and an increased transmissibility of up to 70%, there is as yet no evidence for lower vaccine effectiveness.[32]

RNA vaccines

Cumulative incidence curves for symptomatic COVID‑19 infections after the first dose of the Pfizer-BioNTech vaccine (tozinameran) or placebo in a double-blind clinical trial. (red: placebo; blue: tozinameran)[33]

An RNA vaccine contains RNA which, when introduced into a tissue, acts as messenger RNA (mRNA) to cause the cells to build the foreign protein and stimulate an adaptive immune response which teaches the body how to identify and destroy the corresponding pathogen or cancer cells. RNA vaccines often, but not always, use nucleoside-modified messenger RNA. The delivery of mRNA is achieved by a co-formulation of the molecule into lipid nanoparticles which protect the RNA strands and helps their absorption into the cells.[34][35][36][37]

RNA vaccines were the first COVID-19 vaccines to be authorized in the United States and European Union. As of January 2021, authorized vaccines of this type are the Pfizer-BioNTech COVID‑19 vaccine[38][39][40] and Moderna COVID-19 vaccine.[41][42]

Adenovirus vector vaccines

These vaccines are examples of non-replicating viral vector vaccines, using an adenovirus shell containing DNA that encodes a SARS-CoV-2 protein.[citation needed]

As of January 2021, authorized vaccines of this type are the British Oxford–AstraZeneca COVID-19 vaccine,[a][b][46][47][48] Russian Sputnik V, and Chinese Convidicea. Vaccines in clinical trials include Ad26.COV2.S.[49][50]

Inactivated virus vaccines

Inactivated vaccines consist of virus particles that have been grown in culture and then are killed using a method such as heat or formaldehyde to lose disease producing capacity, while still stimulating an immune response.[51]

As of January 2021, authorized vaccines of this type are the Chinese CoronaVac[52][53][54] and BBIBP-CorV[55] as well as the Indian Covaxin. Vaccines in clinical trials include the Valneva COVID-19 vaccine.[56][57]

With BBIBP-CorV, Sinopharm announced a vaccine's efficacy was 79.34%, which was lower than the 86% announced by the United Arab Emirates (UAE) on 9 December. The UAE based its results on an interim analysis of Phase III trials conducted from July.[58] While the UAE said it had reviewed Sinopharm's interim data analysis, there was no indication it had independently analyzed the raw data. It is unclear how Sinopharm drew conclusions from the data, since the UAE did not state critical details of the analysis, such as the number of COVID‑19 cases or the volunteers' ages.[59]

With CoronaVac, after three delays in releasing results,[60] Instituto Butantan announced in January 2021 that the vaccine was 78% effective in mild cases and 100% effective against severe and moderate infections based on 220 COVID‑19 cases from 13,000 volunteers. Butantan declined to elaborate how the efficacy rate was calculated.[61] Previously, in late December 2020, Butantan said the vaccine is between 50% and 90% effective in Brazil, but withheld full results at Sinovac's request.[60][62] Separately on 24 December, Turkey released Phase III results from an interim analysis of 29 cases which showed an efficacy rate of 91.25% based on the data of 1,322 participants in a trial involving 7,371 volunteers, a confusing readout compared to Brazil.[63][64][62]

Subunit vaccines

Subunit vaccines present one or more antigens without introducing whole pathogen particles. The antigens involved are often protein subunits, but can be any molecule that is a fragment of the pathogen.[65]

As of January 2021, the only authorized vaccine of this type is the peptide vaccine EpiVacCorona.[66] Vaccines in clinical trials include the Novavax COVID-19 vaccine[67] and RBD-Dimer.[1] The V451 vaccine was previously in clinical trials, which were terminated because it was found that the vaccine may potentially cause incorrect results for subsequent HIV testing.[68][69]

Other types

Additional types of vaccines that are currently in clinical trials include multiple DNA plasmid vaccines,[70][c][71][72][73][74][75] at least two lentivirus vector vaccines,[76][77] a virus-like particle,[78] and a vesicular stomatitis virus displaying the SARS-CoV-2 spike protein.[79]

Scientists investigated whether existing vaccines for unrelated conditions could prime the immune system and lessen the severity of COVID‑19 infection.[80] There is experimental evidence that the BCG vaccine for tuberculosis has non-specific effects on the immune system, but no evidence that this vaccine is effective against COVID‑19.[81][82]

Other aspects of vaccine formulation and delivery

As of September 2020, eleven of the vaccine candidates in clinical development use adjuvants to enhance immunogenicity.[24] An immunological adjuvant is a substance formulated with a vaccine to elevate the immune response to an antigen, such as the COVID‑19 virus or influenza virus.[83] Specifically, an adjuvant may be used in formulating a COVID‑19 vaccine candidate to boost its immunogenicity and efficacy to reduce or prevent COVID‑19 infection in vaccinated individuals.[83][84] Adjuvants used in COVID‑19 vaccine formulation may be particularly effective for technologies using the inactivated COVID‑19 virus and recombinant protein-based or vector-based vaccines.[84] Aluminum salts, known as "alum", were the first adjuvant used for licensed vaccines, and are the adjuvant of choice in some 80% of adjuvanted vaccines.[84] The alum adjuvant initiates diverse molecular and cellular mechanisms to enhance immunogenicity, including release of proinflammatory cytokines.[83][84]

On 6 January 2021, it was announced that the first coronavirus vaccine "smart patch" was being developed at Swansea University in Wales. The disposable device will use micro-needles to both administer the vaccine and to monitor its efficacy by measuring the body's immune response. A prototype would be developed by the end of March, anticipating possible clinical trials. Researchers aimed to make the device commercially available within three years. The project received Welsh Government and European funding as part of the global response to the COVID pandemic, although it was also hoped it could be used to treat other infectious diseases.[85]

Table of vaccines

Authorized and approved vaccines

National regulatory authorities have granted emergency use authorizations for nine vaccines.

Vaccines authorized for emergency use or approved for full use
Vaccine candidates,
developers, and sponsors 		Technology Current phase (participants)
design 		Completed phase[d] (participants)
Immune response 		Authorization
Pfizer-BioNTech COVID-19 vaccine (Comirnaty)[38][39][40]
BioNTech, Pfizer, Fosun Pharma 		modRNA Phase III (43,448)
Randomized, placebo-controlled.
Positive results from an interim analysis were announced on 18 November 2020[86] and published on 10 December 2020 reporting an overall efficacy of 95%.[87][88] 		Phase I–II (45)
Strong RBD-binding IgG and neutralizing antibody response peaked 7 days after a booster dose, robust CD4+ and CD8+ T cell responses, undetermined durability.[90]
Emergency (21)
Full (9)
Moderna COVID-19 vaccine[41][42]
Moderna, NIAID, BARDA, CEPI 		Lipid nanoparticle dispersion containing modRNA Phase III (30,000)
Interventional; randomized, placebo-controlled study for efficacy, safety, and immunogenicity.
Positive results from an interim analysis were announced on 15 November 2020[130] and published on 30 December 2020 reporting an overall efficacy of 94.1%.[131] 		Phase I–II (720)[132][133]
Dose-dependent neutralizing antibody response on two-dose schedule; undetermined durability.[134][135][136]
Emergency (5)
Full (5)
Oxford–AstraZeneca COVID-19 vaccine[f][g][46][47][48]
University of Oxford, AstraZeneca, CEPI 		Modified chimpanzee adenovirus vector (ChAdOx1) Phase III (30,000)
Interventional; randomized, placebo-controlled study for efficacy, safety, and immunogenicity.[153]
Positive results from an interim analysis of four ongoing trials were announced on 23 November 2020 and published on 8 December 2020.[154] Overall efficacy was 70%, ranging from 62% to 90% with different dosing regimens, with a peer-reviewed safety profile.[154] 		Phase I–II (543)
Spike-specific antibodies at day 28; neutralizing antibodies after a booster dose at day 56.[157]
Emergency (10)
Full (0)
  • None yet
Gam-COVID-Vac (Sputnik V)
Gamaleya Research Institute of Epidemiology and Microbiology 		Non-replicating viral vector (adenovirus) Phase III (40,000)
Randomized double-blind, placebo-controlled to evaluate efficacy, immunogenicity, and safety[171]
Efficacy is stated at 91.4% based on data analysis of the final control point of clinical trials. Efficacy against severe cases of coronavirus is 100%.[172] 		Phase I–II (76)
Neutralizing antibody and T cell responses.[178]
Emergency (11)
Full (0)
  • None yet
CoronaVac[52][53][54]
Sinovac 		Inactivated SARS-CoV-2 Phase III (33,620)
Double-blind, randomized, placebo-controlled to evaluate efficacy and safety.
Positive results from an interim analysis of a small sample were announced by Turkey on 24 December 2020, with an efficacy of 91%.[190] Additional results were announced by Indonesia on 11 January, with an overall efficacy of 65.3%.[191] The vaccine was 50.4 per cent effective at preventing symptomatic infections in a Brazilian trial.[192] 		Phase II (600)
Immunogenicity eliciting 92% seroconversion at lower dose and 98% at higher dose after 14 days[196]
Emergency (5)
Full (0)
  • None yet
BBIBP-CorV[55]
Sinopharm: Beijing Institute of Biological Products, Wuhan Institute of Biological Products 		Inactivated SARS-CoV-2 (vero cells) Phase III (48,000)
Randomized, double-blind, parallel placebo-controlled, to evaluate safety and protective efficacy.
Sinopharm's internal analysis indicated a 79% efficacy.[201] 		Phase I–II (320)
Neutralizing antibodies at day 14 after 2 injections[206]
Emergency (2)
Full (3)
Ad5-nCoV (Convidicea)
CanSino Biologics, Beijing Institute of Biotechnology of the Academy of Military Medical Sciences 		Recombinant adenovirus type 5 vector Phase III (40,000)
Global multi-center, randomized, double-blind, placebo-controlled to evaluate efficacy, safety and immunogenicity. 		Phase II (508)
Neutralizing antibody and T cell responses[219]
Emergency (1)
Full (0)
  • None yet
EpiVacCorona[66]
Vector 		Vaccine based on peptide antigens[66] Phase III (40,000)
Randomized double-blind, placebo-controlled to evaluate efficacy, immunogenicity, and safety 		Phase I–II (100)
Simple, blind, placebo-controlled, randomized study of safety, reactogenicity and immunogenicity[66]
Emergency (1)
Full (0)
  • None yet
BBV152 (Covaxin)
Bharat Biotech, Indian Council of Medical Research 		Inactivated SARS-CoV-2 Phase III (25,800)
Randomised, observer-blinded, placebo-controlled[226] 		Phase I (375)
Dose-dependent neutralizing antibody response on two-dose schedule. Pending Phase II reports.[228]
Emergency (1)
Full (0)
  • None yet

Vaccine candidates

COVID‑19 candidate vaccines in Phase I–III trials[1][229][230]
Vaccine candidates,
developers, and sponsors 		Technology Current phase (participants)
design 		Completed phase[h] (participants)
Immune response 		Pending authorization
Ad26.COV2.S[49][50]
Janssen Pharmaceutica (Johnson & Johnson), BIDMC 		Non-replicating viral vector (adenovirus serotype 26) Phase III (40,000)
Randomized, double-blinded, placebo-controlled
Temporarily paused on 13 October 2020, due to an unexplained illness in a participant.[231] Johnson & Johnson announced, on 23 October, that they are preparing to resume the trial in the US.[232][233] 		Phase I–II (1,045)
Neutralizing-antibody titers against wild-type virus were detected in 90% or more of all participants on day 29 after the first vaccine dose and reached 100% by day 57 with a further increase in titers, regardless of vaccine dose or age group. Titers remained stable until at least day 71.[234]
Emergency (3)
NVX-CoV2373[67]
Novavax, CEPI 		SARS-CoV-2 recombinant spike protein nanoparticle with adjuvant Phase III (45,000)
Randomised, observer-blinded, placebo-controlled trial[237] 		Phase I–II (131)
IgG and neutralizing antibody response with adjuvant after booster dose.[240]
ZF2001 (RBD-Dimer)[1]
Anhui Zhifei Longcom Biopharmaceutical Co. Ltd. 		Recombinant subunit vaccine Phase III (29,000)
Randomized, double-blind, placebo-controlled[241] 		Phase II (900)
Interventional; randomized, double-blind, placebo-controlled[244]
Zorecimeran (CVnCoV)
CureVac, CEPI 		modRNA Phase III (36,500)[245]
Phase 2b/3: Multicenter efficacy and safety trial in adults 		Phase I–II (944)[246][247]
Phase 1 (284): Partially blind, controlled, dose-escalation to evaluate safety, reactogenicity and immunogenicity.
Phase 2a (660):Partially observer-blind, multicenter, controlled, dose-confirmation.
ZyCoV-D[70]
Cadila Healthcare 		DNA plasmid expressing SARS-CoV-2 S protein Phase III (26,000)[248] Phase I–II (1,000)
Interventional; randomized, double-blind, placebo-controlled[250][251]
CoVLP[78]
Medicago, GSK 		Recombinant, plant-based virus-like particles[i] with AS03 Phase II–III (30,612)
Event-driven, randomized, observer blinded, placebo-controlled[253] 		Phase I (180)
Neutralizing antibodies at day 42 after the first injection (day 21 after the second injection) were at levels 10x that of COVID-19 survivors.
IIBR-100 (Brilife)[79]
The Israel Institute for Biological research 		Recombinant vesicular stomatitis virus Phase II (1,000)[254] Phase I (80)[79]
Subjects (18-55 years old) randomly receiving a single administration of IIBR-100 at the low, mid, or high dose of saline or two administrations at a low dose, or saline, 28 days apart.
INO-4800[c][71][72]
Inovio, CEPI, Korea National Institute of Health, International Vaccine Institute 		DNA plasmid delivered by electroporation Phase I–II (40) Preclinical
Pending Phase I report.
Unnamed[255]
Chinese Academy of Medical Sciences 		Inactivated SARS-CoV-2 Phase I–II (942)
Randomized, double-blinded, single-center, placebo-controlled
AG0301-COVID‑19[73]
AnGes Inc.,[256] AMED 		DNA plasmid Phase I–II (30)
Non-randomized, single-center, two doses
Lunar-COV19/ARCT-021[257][258]
Arcturus Therapeutics 		mRNA Phase I–II (92)
Randomized, double-blinded
VLA2001[56][57]
Valneva 		Inactivated SARS-CoV-2 Phase I–II (150)
Randomized, multi-center, double-blinded
COVID‑19/aAPC[76]
Shenzhen Genoimmune Medical Institute[259] 		Lentiviral vector with minigene modifying aAPCs Phase I (100)
LV-SMENP-DC[77]
Shenzhen Genoimmune Medical Institute[259] 		Lentiviral vector with minigene modifying DCs Phase I (100)
LNP-nCoVsaRNA[260]
MRC clinical trials unit at Imperial College London 		mRNA Phase I (105)
Randomized trial, with dose escalation study (15) and expanded safety study (at least 200)
GRAd-COV2[261][262]
ReiThera, Lazzaro Spallanzani National Institute for Infectious Diseases 		Modified chimpanzee adenovirus vector (GRAd) Phase I (90)[263]
Subjects (two groups: 18-55 and 65-85 years old) randomly receiving one of three escalating doses of GRAd-COV2 or a placebo, then monitored over a 24-week period. 92.5% of subjects who received GRAd-COV2 developed anti-bodies.
GX-19[74][75]
Genexine consortium,[264] International Vaccine Institute 		DNA Phase I (40)
SCB-2019[265][266]
Clover Biopharmaceuticals,[267] GSK, CEPI 		Spike protein trimeric subunit with AS03 Phase I (150)
COVAX-19[268]
Vaxine Pty Ltd[269] 		Recombinant protein Phase I (40)
Unnamed[270]
PLA Academy of Military Science, Walvax Biotech[271] 		mRNA Phase I (168)
HGC019[272]
Gennova Biopharmaceuticals, HDT Biotech Corporation[273] 		mRNA Phase I (120)[274]
Unnamed[275]
Biological E. Limited, Baylor College of Medicine[276] 		Inactivated SARS-CoV-2 using an antigen Phase I–II (360)[277]
Randomized, Parallel Group Trial
SARS-CoV-2 Sclamp/V451[68][69]
UQ, Syneos Health, CEPI, Seqirus 		Molecular clamp stabilized spike protein with MF59 Terminated (120)
Randomised, double-blind, placebo-controlled, dose-ranging.
False positive HIV test found among participants.
  1. ^ Serum Institute of India will be producing the ChAdOx1 nCoV-19 vaccine for India[43] and other low and middle income countries.[44]
  2. ^ Oxford name: ChAdOx1 nCoV-19. Manufacturing in Brazil to be carried out by Oswaldo Cruz Foundation.[45]
  3. ^ a b South Korean Phase I–II in parallel with Phase I in the US
  4. ^ Latest Phase with published results.
  5. ^ a b US authorization also includes the three sovereign nations in the Compact of Free Association: Palau, the Marshall Islands, and Micronesia.[113][114]
  6. ^ Serum Institute of India will be producing the ChAdOx1 nCoV-19 vaccine for India[150] and other low and middle income countries.[151]
  7. ^ Oxford name: ChAdOx1 nCoV-19. Manufacturing in Brazil to be carried out by Oswaldo Cruz Foundation.[152]
  8. ^ Latest Phase with published results.
  9. ^ Virus-like particles grown in Nicotiana benthamiana[252]

Planning and investment

Since early 2020, vaccine development has been expedited via unprecedented collaboration in the multinational pharmaceutical industry and between governments.[24] According to the Coalition for Epidemic Preparedness Innovations (CEPI), the geographic distribution of COVID‑19 vaccine development puts North American entities having about 40% of the activity compared to 30% in Asia and Australia, 26% in Europe, and a few projects in South America and Africa.[24][25]

Commitment to first-in-human testing of a vaccine candidate represents a substantial capital cost for vaccine developers, estimated to be from US$14 million to US$25 million for a typical Phase I trial program, but possibly as much as US$70 million.[278][279] For comparison, during the Ebola virus epidemic of 2013–16, there were 37 vaccine candidates in urgent development with only one becoming a licensed vaccine at a total cost to confirm efficacy in Phase II–III trials of about US$1 billion.[278]

International organizations

Access to COVID‑19 Tools (ACT) Accelerator

Main article: Access to COVID-19 Tools Accelerator
This section is an excerpt from Access to COVID-19 Tools Accelerator.[edit]
The Access to COVID-19 Tools Accelerator (ACT Accelerator or ACT-A), or the Global Collaboration to Accelerate the Development, Production and Equitable Access to New COVID-19 diagnostics, therapeutics and vaccines, is a G20 initiative announced by pro-tem Chair Mohammed al-Jadaan on 24 April 2020.[280] A call to action was published simultaneously by the World Health Organization (WHO) on 24 April.[281] As of January 2022, it was the largest international effort to achieve equitable access to COVID-19 health technologies.[282]

National governments

Canada announced CA$275 million in funding for 96 research vaccine research projects at Canadian companies and universities, with plans to establish a "vaccine bank" that could be used if another coronavirus outbreak occurs.[283][284] A further investment of CA$1.1 billion was added to support clinical trials and develop manufacturing and supply chains for vaccines.[285] On 4 May, the Canadian government committed CA$850 million to the WHO's live streaming effort to raise US$8 billion for COVID‑19 vaccines and preparedness.[286]

China provided low-rate loans to a vaccine developer through its central bank and "quickly made land available for the company" to build production plants.[21] As of June 2020, six of the eleven COVID‑19 vaccine candidates in early-stage human testing were developed by Chinese organizations.[19] Three Chinese vaccine companies and research institutes are supported by the government for financing research, conducting clinical trials, and manufacturing the most promising vaccine candidates, prioritizing rapid evidence of efficacy over safety.[287] On 18 May, China had pledged US$2 billion to support overall efforts by the WHO for programs against COVID‑19.[288] On 22 July, China announced plans to provide a US$1 billion loan to make its vaccine accessible for Latin America and the Caribbean.[289] On 24 August, Chinese Premier Li Keqiang announced it would provide Cambodia, Laos, Myanmar, Thailand, and Vietnam priority access to the vaccine once it was distributed.[290]

US Government Accountability Office diagram comparing a traditional vaccine development timeline to a possible expedited timeline

Great Britain formed a COVID‑19 vaccine task force in April 2020 to stimulate local efforts for accelerated development of a vaccine through collaborations of industry, universities, and government agencies. It encompassed every phase of development from research to manufacturing.[291] The vaccine development initiatives at the University of Oxford and Imperial College of London were financed with £44 million.[292][293]

In the United States, the Biomedical Advanced Research and Development Authority (BARDA), a federal agency funding disease-fighting technology, announced investments of nearly US$1 billion to support American COVID‑19 vaccine development and manufacture of the most promising candidates. On 16 April, BARDA made a US$483 million investment in vaccine developer Moderna and its partner, Johnson & Johnson.[21][294] BARDA has earmarked an additional US$4 billion for development. It will have a role in other programs for development of six to eight vaccine candidates destined for clinical study into 2021 by companies such as Sanofi Pasteur and Regeneron.[294][295] On 15 May, the government announced funding for a fast-track program called Operation Warp Speed to place multiple vaccine candidates into clinical trials by the fall of 2020 and manufacture 300 million doses of a licensed vaccine by January 2021. The project's chief advisor is Moncef Slaoui and its chief operating officer is General Gustave Perna.[296][297] In June, the Warp Speed team said it would work with seven companies developing vaccine candidates: Moderna, Johnson & Johnson, Merck, Pfizer, the University of Oxford in collaboration with AstraZeneca, and two others,[298] although Pfizer later stated that "all the investment for R&D was made by Pfizer at risk."[299]

Pharmaceutical companies

Large pharmaceutical companies with experience in making vaccines at scale, including Johnson & Johnson, AstraZeneca, and GlaxoSmithKline (GSK), formed alliances with biotechnology companies, governments, and universities to accelerate progression to an effective vaccine.[21][19] To combine financial and manufacturing capabilities for a pandemic adjuvanted vaccine technology, GSK joined with Sanofi in an uncommon partnership of multinational companies to support accelerated vaccine development.[300]

By June 2020, tens of billions of dollars were invested by corporations, governments, international health organizations, and university research groups to develop dozens of vaccine candidates and prepare for global vaccination programs to immunize against COVID‑19 infection.[301][302][303][304] The corporate investment and need to generate value for public shareholders raised concerns about a "market-based approach" in vaccine development, costly pricing of eventual licensed vaccines, preferred access for distribution first to affluent countries, and sparse or no distribution to where the pandemic is most aggressive, as predicted for densely-populated, impoverished countries unable to afford vaccinations.[301][19][303] The collaboration of the University of Oxford with AstraZeneca (a global pharmaceutical company based in the UK) raised concerns about price and sharing of eventual profits from international vaccine sales, arising from whether the British government and university as public partners had commercialization rights.[304] AstraZeneca stated that initial pricing of its vaccine would not include a profit margin for the company while the pandemic was still expanding.[304]

In early June, AstraZeneca made a US$750 million deal allowing CEPI and GAVI to manufacture and distribute 300 million doses if its Oxford vaccine candidate proved to be safe and effective, reportedly increasing the company's total production capacity to over 2 billion doses per year.[305] Commercialization of pandemic vaccines is a high-risk business venture, potentially losing billions of dollars in development and pre-market manufacturing costs if the candidate vaccines fail to be safe and effective.[301][21][19][302] Pfizer indicated it was not interested in a government partnership, considering it to be a "third party" slowing progress.[306] Further, there are concerns that rapid-development programs–like Operation Warp Speed–are choosing candidates mainly for their manufacturing advantages rather than optimal safety and efficacy.[306]

Development

CEPI classifies development stages for vaccines as "exploratory" (planning and designing a candidate, having no evaluation in vivo), "preclinical" (in vivo evaluation with preparation for manufacturing a compound to test in humans), or initiation of Phase I safety studies in healthy people.[24] Some 321 total vaccine candidates were in development as either confirmed projects in clinical trials or in early-stage "exploratory" or "preclinical" development, as of September.[24]

Early development

NIAID (NIH) scientist researching COVID‑19 vaccine examines agar plate. (30 January 2020)

After a coronavirus was isolated in December 2019,[307] its genetic sequence was published on 11 January 2020, triggering an urgent international response to prepare for an outbreak and hasten development of a preventive vaccine.[25][301][308]

In February 2020, the WHO said it did not expect a vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative virus, to become available in less than 18 months.[309] The rapidly growing infection rate of COVID‑19 worldwide during early 2020 stimulated international alliances and government efforts to urgently organize resources to make multiple vaccines on shortened timelines,[310] with four vaccine candidates entering human evaluation in March (see the table of clinical trials started in 2020, below).[25][311]

In April 2020, the WHO estimated a total cost of US$8 billion to develop a suite of three or more vaccines having different technologies and distribution.[310]

By April 2020, "almost 80 companies and institutes in 19 countries" were working on this virtual gold rush.[312] Also in April, CEPI estimated that as many as six of the vaccine candidates against COVID‑19 should be chosen by international coalitions for development through Phase II–III trials, and three should be streamlined through regulatory and quality assurance for eventual licensing at a total cost of at least US$2 billion.[24][311][6] Another analysis estimates ten candidates will need simultaneous initial development, before a select few are chosen for the final path to licensing.[6]

In July 2020, Anglo-American intelligence and security organisations of the respective governments and armed forces, as the UK's National Cyber Security Centre, together with the Canadian Communications Security Establishment, the United States Department for Homeland Security Cybersecurity Infrastructure Security Agency, and the US National Security Agency (NSA) alleged that Russian state-backed hackers may have been trying to steal COVID‑19 treatment and vaccine research from academic and pharmaceutical institutions in other countries; Russia has denied it.[313]

Preclinical research

COVID‑19 vaccine research samples in NIAID lab freezer. (30 January 2020)

In April 2020, the WHO issued a statement representing dozens of vaccine scientists around the world, pledging collaboration to speed development of a vaccine against COVID‑19.[314] The WHO coalition is encouraging international cooperation between organizations developing vaccine candidates, national regulatory and policy agencies, financial contributors, public health associations, and governments, for eventual manufacturing of a successful vaccine in quantities sufficient to supply all affected regions, particularly low-resource countries.[25]

Industry analysis of past vaccine development shows failure rates of 84–90%.[25][315] Because COVID‑19 is a novel virus target with properties still being discovered and requiring innovative vaccine technologies and development strategies, the risks associated with developing a successful vaccine across all steps of preclinical and clinical research are high.[25]

To assess the potential for vaccine efficacy, unprecedented computer simulations and new COVID‑19-specific animal models are being developed multinationally during 2020, but these methods remain untested by unknown characteristics of the COVID‑19 virus.[25] Of the confirmed active vaccine candidates, about 70% are being developed by private companies, with the remaining projects under development by academic, government coalitions, and health organizations.[24]

Most of the vaccine developers are small firms or university research teams with little experience in successful vaccine design and limited capacity for advanced clinical trial costs and manufacturing without partnership by multinational pharmaceutical companies.[24][25]

Historically, the probability of success for an infectious disease vaccine candidate to pass preclinical barriers and reach Phase I of human testing is 41–57%.[278]

Challenges

The rapid development and urgency of producing a vaccine for the COVID‑19 pandemic may increase the risks and failure rate of delivering a safe, effective vaccine.[26][25][316] One study found that between 2006 and 2015, the success rate of obtaining approval from Phase I to successful Phase III trials was 16.2% for vaccines,[315] and CEPI indicates a potential success rate of only 10% for vaccine candidates in 2020 development.[25]

Research at universities is obstructed by physical distancing and closing of laboratories.[317][318]

Biosafety

Early research to assess vaccine efficacy using COVID‑19-specific animal models, such as ACE2-transgenic mice, other laboratory animals, and non-human primates, indicates a need for biosafety-level 3 containment measures for handling live viruses, and international coordination to ensure standardized safety procedures.[26][25]

Antibody-dependent enhancement

Main article: Antibody-dependent enhancement

Although the quality and quantity of antibody production by a potential vaccine is intended to neutralize the COVID‑19 infection, a vaccine may have an unintended opposite effect by causing antibody-dependent disease enhancement (ADE), which increases the virus attachment to its target cells and might trigger a cytokine storm if a vaccinated person is later attacked by the virus.[26][319] The vaccine technology platform (for example, viral vector vaccine, spike (S) protein vaccine or protein subunit vaccine), vaccine dose, timing of repeat vaccinations for the possible recurrence of COVID‑19 infection, and elderly age are factors determining the risk and extent of ADE.[26][319] The antibody response to a vaccine is a variable of vaccine technologies in development, including whether the vaccine has precision in its mechanism,[26] and choice of the route for how it is given (intramuscular, intradermal, oral, or nasal).[319]

Trials

Volunteer receives CoronaVac injection during Phase III trial by Sinovac in Indonesia.

In April 2020, the WHO published an "R&D Blueprint (for the) novel Coronavirus" (Blueprint). The Blueprint documented a "large, international, multi-site, individually randomized controlled clinical trial" to allow "the concurrent evaluation of the benefits and risks of each promising candidate vaccine within 3–6 months of it being made available for the trial." The Blueprint listed a Global Target Product Profile (TPP) for COVID‑19, identifying favorable attributes of safe and effective vaccines under two broad categories: "vaccines for the long-term protection of people at higher risk of COVID‑19, such as healthcare workers", and other vaccines to provide rapid-response immunity for new outbreaks.[310] The international TPP team was formed to 1) assess the development of the most promising candidate vaccines; 2) map candidate vaccines and their clinical trial worldwide, publishing a frequently-updated "landscape" of vaccines in development;[230] 3) rapidly evaluate and screen for the most promising candidate vaccines simultaneously before they are tested in humans; and 4) design and coordinate a multiple-site, international randomized controlled trial – the "Solidarity trial" for vaccines[310][320] – to enable simultaneous evaluation of the benefits and risks of different vaccine candidates under clinical trials in countries where there are high rates of COVID‑19 disease, ensuring fast interpretation and sharing of results around the world.[310] The WHO vaccine coalition will prioritize which vaccines should go into Phase II and III clinical trials, and determine harmonized Phase III protocols for all vaccines achieving the pivotal trial stage.[310]

Phase I trials test primarily for safety and preliminary dosing in a few dozen healthy subjects, while Phase II trials – following success in Phase I – evaluate immunogenicity, dose levels (efficacy based on biomarkers) and adverse effects of the candidate vaccine, typically in hundreds of people.[321][322] A Phase I–II trial consists of preliminary safety and immunogenicity testing, is typically randomized, placebo-controlled, while determining more precise, effective doses.[322] Phase III trials typically involve more participants at multiple sites, include a control group, and test effectiveness of the vaccine to prevent the disease (an "interventional" or "pivotal" trial), while monitoring for adverse effects at the optimal dose.[321][322] Definition of vaccine safety, efficacy, and clinical endpoints in a Phase III trial may vary between the trials of different companies, such as defining the degree of side effects, infection or amount of transmission, and whether the vaccine prevents moderate or severe COVID‑19 infection.[323][324][325]

Enrollment of participants

Vaccine developers have to invest resources internationally to find enough participants for Phase II–III clinical trials when the virus has proved to be a "moving target" of changing transmission rate across and within countries, forcing companies to compete for trial participants.[323] As an example in June, the Chinese vaccine developer Sinovac formed alliances in Malaysia, Canada, the UK, and Brazil among its plans to recruit trial participants and manufacture enough vaccine doses for a possible Phase III study in Brazil where COVID‑19 transmission was accelerating during June.[323] As the COVID‑19 pandemic within China became more isolated and controlled, Chinese vaccine developers sought international relationships to conduct advanced human studies in several countries, creating competition for trial participants with other manufacturers and the international Solidarity trial organized by the WHO.[323] In addition to competition over recruiting participants, clinical trial organizers may encounter people unwilling to be vaccinated due to vaccine hesitancy[326] or disbelieving the science of the vaccine technology and its ability to prevent infection.[327]

Having an insufficient number of skilled team members to administer vaccinations may hinder clinical trials that must overcome risks for trial failure, such as recruiting participants in rural or low-density geographic regions, and variations of age, race, ethnicity, or underlying medical conditions.[323][328]

Adaptive design for the Solidarity trial

A clinical trial design in progress may be modified as an "adaptive design" if accumulating data in the trial provide early insights about positive or negative efficacy of the treatment.[329][330] The WHO Solidarity trial of multiple vaccines in clinical studies during 2020, will apply adaptive design to rapidly alter trial parameters across all study sites as results emerge.[320] Candidate vaccines may be added to the Solidarity trial as they become available if priority criteria are met, while vaccine candidates showing poor evidence of safety or efficacy compared to placebo or other vaccines will be dropped from the international trial.[320]

Adaptive designs within ongoing Phase II–III clinical trials on candidate vaccines may shorten trial durations and use fewer subjects, possibly expediting decisions for early termination or success, avoiding duplication of research efforts, and enhancing coordination of design changes for the Solidarity trial across its international locations.[320][329]

Proposed challenge studies

Main article: Human challenge study

Challenge studies are a type of clinical trial involving the intentional exposure of the test subject to the condition tested, an approach that can significantly accelerate vaccine development.[331][332][333][334] Human challenge studies may be ethically controversial because they involve exposing test subjects to dangers beyond those posed by potential side effects of the substance being tested.[332][333] Challenge studies have been used for diseases less deadly than COVID‑19 infection, such as common influenza, typhoid fever, cholera, and malaria.[333][334] The World Health Organization has developed a guidance document with criteria for conducting COVID‑19 challenge studies in healthy people, including scientific and ethical evaluation, public consultation and coordination, selection and informed consent of the participants, and monitoring by independent experts.[335] Beginning in January 2021, dozens of young adult volunteers will be deliberately infected with COVID‑19 in a challenge trial conducted in a London hospital under management by the British government COVID‑19 Vaccine Taskforce.[336] Once an infection dose of COVID‑19 is identified, two or more of the candidate COVID‑19 vaccines will be tested for effectiveness in preventing infection.[336]

Authorizations and licensure

At the beginning of the COVID‑19 pandemic in early 2020, the WHO issued a guideline as an Emergency Use Listing of new vaccines, a process derived from the 2013–16 Ebola epidemic.[337] It required that a vaccine candidate developed for a life-threatening emergency be manufactured using GMP and that it complete development according to WHO prequalification procedures.[337]

Even as new vaccines are developed during the COVID‑19 pandemic, licensure of COVID‑19 vaccine candidates requires submission of a full dossier of information on development and manufacturing quality. In the UK and the EU, companies may use a "rolling review process", supplying data as they become available during Phase III trials, rather than developing the full documentation over months or years at the end of clinical research, as is typical. This rolling process allows the UK's regulator (MHRA) and the European Committee for Medicinal Products for Human Use to evaluate clinical data in real time, enabling a promising vaccine candidate to be approved on a rapid timeline by both the UK's MHRA and the European Medicines Agency (EMA).[338] A rolling review process for the Moderna vaccine candidate was initiated in October by Health Canada and the EMA,[339] and in November in Canada for the Pfizer-BioNTech candidate.[340]

On 24 June 2020, China approved the CanSino vaccine for limited use in the military and two inactivated virus vaccines for emergency use in high-risk occupations.[341] On 11 August 2020, Russia announced the approval of its Sputnik V vaccine for emergency use, though one month later only small amounts of the vaccine had been distributed for use outside of the phase 3 trial.[342] In September, the United Arab Emirates approved emergency use of Sinopharm's vaccine for healthcare workers,[343] followed by similar emergency use approval from Bahrain in November.[344]

In the United States, an Emergency Use Authorization (EUA) is "a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID‑19 pandemic."[345] Once an EUA is issued by the FDA, the vaccine developer is expected to continue the Phase III clinical trial to finalize safety and efficacy data, leading to application for licensure (approval) in the United States.[345] In mid-2020, concerns that the FDA might grant a vaccine EUA before full evidence from a Phase III clinical trial was available raised broad concerns about the potential for lowered standards in the face of political pressure.[346][347][348] On 8 September 2020, nine leading pharmaceutical companies involved in COVID‑19 vaccine research signed a letter, pledging that they would submit their vaccines for emergency use authorization only after Phase III trials had demonstrated safety and efficacy.[349]

Pfizer-BioNTech COVID-19 vaccine.

The Pfizer-BioNTech partnership submitted an EUA request to the FDA for the mRNA vaccine BNT162b2 (active ingredient tozinameran) on 20 November 2020.[350][351] On 2 December 2020, the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) gave temporary regulatory approval for the Pfizer–BioNTech vaccine,[111][352] becoming the first country to approve this vaccine and the first country in the Western world to approve the use of any COVID‑19 vaccine.[110][353][354] On 8 December 2020, 90-year-old Margaret Keenan received the vaccine at University Hospital Coventry, becoming the first person known to be vaccinated outside of a trial,[355] as the UK's vaccination programme began.[356] However, other vaccines had been given earlier in Russia.[357] On 11 December 2020, the US Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) for the Pfizer-BioNTech vaccine.[358][359] The vaccine has subsequently been approved for use by a number of national health authorities.[citation needed] On 19 December 2020, the Swiss Agency for Therapeutic Products (Swissmedic) approved the Pfizer-BioNTech vaccine for regular use, two months after receiving the application. This was the first authorization by a stringent regulatory authority under a standard procedure for any COVID‑19 vaccine.[129][360] On 23 December, a 90-year-old Lucerne resident became the first person to receive the vaccine in continental Europe.[361]

As of 21 December, many countries and the European Union[119] have authorized or approved the Pfizer-BioNTech COVID‑19 vaccine. Bahrain and the United Arab Emirates granted emergency marketing authorization for BBIBP-CorV, manufactured by Sinopharm.[362][363] In the United Kingdom, 138,000 people had received the Pfizer-BioNTech COVID‑19 vaccine Cominarty by 16 December, during the first week of the UK vaccination programme.[364] On 11 December 2020, the United States Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID‑19 vaccine.[358] A week later, they granted an EUA for mRNA-1273, the Moderna vaccine.[142][143][365] Vaccine manufacturers are awaiting full approvals to name their vaccines.[366][367]

Moderna submitted a request for an EUA for mRNA-1273 to the FDA on 30 November 2020.[368][369] On 18 December 2020, the FDA granted an EUA for the Moderna vaccine.[142][143][365]

The UK's regulator (MHRA) gave the first approval to the Oxford/AstraZeneca vaccine on 30 December 2020, as their second vaccine to enter the national rollout.[370]

Australia

In October 2020, the Australian Therapeutic Goods Administration (TGA) granted provisional determinations to AstraZeneca Pty Ltd in relation to its COVID‑19 vaccine, ChAdOx1-S [recombinant] and to Pfizer Australia Pty Ltd in relation to its COVID‑19 vaccine, BNT162b2 [mRNA].[371][372] Janssen Cilag Pty Ltd was granted a provisional determination in relation to its COVID‑19 vaccine, Ad26.COV2.S, in November 2020.[373]

European Union

In October 2020, the Committee for Medicinal Products for Human Use (CHMP) started 'rolling reviews' of the vaccines known as COVID‑19 Vaccine AstraZeneca (ChAdOx1-SARS-CoV-2) and Pfizer-BioNTech COVID‑19 Vaccine (BNT162b2).[374][375][376] The EMA released an update on the status of its rolling review of the COVID‑19 Vaccine AstraZeneca in December 2020, after the UK granted a temporary authorization of supply for the vaccine.[377]

In November 2020, the EMA published a safety monitoring plan and guidance on risk management planning (RMP) for COVID‑19 vaccines.[378] The plan outlines how relevant new information emerging after the authorization and uptake of COVID‑19 vaccines in the pandemic situation will be collected and promptly reviewed.[378] All RMPs for COVID‑19 vaccines will be published on the EMA's website.[378] The EMA published guidance for developers of potential COVID‑19 vaccines on the clinical evidence to include in marketing authorization applications.[379]

In November 2020, the CHMP started a rolling review of the Moderna vaccine for COVID‑19 known as mRNA-1273.[380]

In December 2020, the EMA received application for conditional marketing authorizations (CMA) for the mRNA vaccines BNT162b2 and mRNA1273 (Moderna Covid‑19 vaccine).[381][382] The assessments of the vaccines are scheduled to proceed under accelerated timelines with the possibility of opinions issued within weeks.[381][382][383][384]

In December 2020, the CHMP started a rolling review of the Ad26.COV2.S COVID‑19 vaccine from Janssen-Cilag International N.V.[235]

On 21 December 2020, the CHMP recommended granting a conditional marketing authorization for the Pfizer-BioNTech COVID‑19 vaccine, Comirnaty (active ingredient tozinameran), developed by BioNTech and Pfizer.[385][386][119] The recommendation was accepted by the European Commission the same day.[385][387]

In January 2021, the EMA received an application for conditional marketing authorization (CMA) for the COVID‑19 vaccine known as COVID‑19 Vaccine AstraZeneca, developed by AstraZeneca and Oxford University.[388]

Deployment

This section is an excerpt from Deployment of COVID-19 vaccines.[edit]

Share of population fully vaccinated against COVID‑19 relative to a country's total population. See date on map.
Share of population which has received at least one dose of a COVID‑19 vaccine relative to a country's total population. See date on map.
COVID‑19 vaccine doses administered per 100 people by country. See date on map.

As of 12 August 2024, 13.53 billion COVID-19 vaccine doses have been administered worldwide, with 70.6 percent of the global population having received at least one dose.[389][390] While 4.19 million vaccines were then being administered daily, only 22.3 percent of people in low-income countries had received at least a first vaccine by September 2022, according to official reports from national health agencies, which are collated by Our World in Data.[391]

During a pandemic on the rapid timeline and scale of COVID-19 cases in 2020, international organizations like the World Health Organization (WHO) and Coalition for Epidemic Preparedness Innovations (CEPI), vaccine developers, governments, and industry evaluated the distribution of the eventual vaccine(s).[392] Individual countries producing a vaccine may be persuaded to favor the highest bidder for manufacturing or provide first-class service to their own country.[393][394][395] Experts emphasize that licensed vaccines should be available and affordable for people at the frontlines of healthcare and in most need.[393][395]

In April 2020, it was reported that the UK agreed to work with 20 other countries and global organizations, including France, Germany, and Italy, to find a vaccine and share the results, and that UK citizens would not get preferential access to any new COVID‑19 vaccines developed by taxpayer-funded UK universities.[396] Several companies planned to initially manufacture a vaccine at artificially low prices, then increase prices for profitability later if annual vaccinations are needed and as countries build stock for future needs.[395]

The WHO had set out the target to vaccinate 40% of the population of all countries by the end of 2021 and 70% by mid-2022,[397] but many countries missed the 40% target at the end of 2021.[398][399]

Liability

On 4 February 2020, US Secretary of Health and Human Services Alex Azar published a notice of declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID‑19, covering "any vaccine, used to treat, diagnose, cure, prevent, or mitigate COVID‑19, or the transmission of SARS-CoV-2 or a virus mutating therefrom", and stating that the declaration precludes "liability claims alleging negligence by a manufacturer in creating a vaccine, or negligence by a health care provider in prescribing the wrong dose, absent willful misconduct".[400] The declaration is effective in the United States through 1 October 2024.[400]

In the European Union the COVID‑19 vaccines are licensed under a Conditional Marketing Authorisation which does not exempt manufacturers from civil and administrative liability claims.[401] While the purchasing contracts with vaccine manufacturers remain secret, they do not contain liability exemptions even for side-effects not known at the time of licensure.[402]

Society and culture

Misinformation

Main article: Misinformation related to the COVID-19 pandemic § Vaccine misinformation

Social media posts have previously promoted a conspiracy theory that a COVID‑19 vaccine was already available when it was not. The patents cited by these various social media posts had references to existing patents for genetic sequences and vaccines for other strains such as the SARS coronavirus, but not for COVID‑19.[403][404]

On 21 May 2020, the FDA made public the cease-and-desist notice it had sent to North Coast Biologics, a Seattle-based company that had been selling a purported "nCoV19 spike protein vaccine".[405]

Vaccine hesitancy

Some 10% of the public perceives vaccines as unsafe or unnecessary, refusing vaccination – a global health threat called vaccine hesitancy[406] – which increases the risk of further viral spread that could lead to COVID‑19 outbreaks.[326] In mid-2020, estimates from two surveys were that 67% or 80% of people in the U.S. would accept a new vaccination against COVID‑19, with wide disparity by education level, employment status, race, and geography.[346][407]

A poll conducted by National Geographic and Morning Consult demonstrated a gender gap on willingness to take a COVID‑19 vaccine in the U.S., with 69% of men polled saying they would take the vaccine, compared to only 51% of women. The poll also showed a positive correlation between education level and willingness to take the vaccine.[408]

In an effort to demonstrate the vaccine's safety, prominent politicians have received it on camera, with others pledging to do so.[409][410][411]

See also

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Footnotes

Further reading

Vaccine protocols

Wikiquote has quotations related to COVID-19 vaccine.
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