Deployment of COVID-19 vaccines

Source: Wikipedia, the free encyclopedia.

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 25 October 2021, 6.88 billion COVID-19 vaccine doses had been administered worldwide, with 48.7 per cent of the global population having received at least one dose. While 24.06 million vaccines were then being administered daily, only 3.1 per cent of people in low-income countries had received at least a first vaccine by October 2021, according to official reports from national health agencies, which is collated by Our World in Data.[1]

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).[2] Individual countries producing a vaccine may be persuaded to favor the highest bidder for manufacturing or provide first-service to their own country.[3][4][5][6][excessive citations] Experts emphasize that licensed vaccines should be available and affordable for people at the frontline of healthcare and having the greatest need.[3][4][6]

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 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.[7] Several companies planned to initially manufacture a vaccine at artificially low pricing, then increase prices for profitability later if annual vaccinations are needed and as countries build stock for future needs.[6]

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."[8] 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.[2][9][10][11][excessive citations] For example, successful COVID‑19 vaccines would be allocated early to healthcare personnel and populations at greatest risk of severe illness and death from COVID‑19 infection, such as the elderly or densely-populated impoverished people.[12][13]

Distribution

Note about table to the right: Number and percentage of people who have received at least one dose of a COVID-19 vaccine (unless noted otherwise). May include vaccination of non-citizens, which can push totals beyond 100% of the local population. Table is updated daily by a bot.[note 1]

Location Vaccinated[a] %[b]
World[c] 3,838,352,700 48.7%
China China 1,154,856,151 80.0%
India India 718,444,141 51.6%
European Union European Union 307,252,487 68.7%
United States United States[d] 220,519,217 65.6%
Brazil Brazil 158,464,224 74.0%
Indonesia Indonesia 113,424,379 41.0%
Japan Japan 97,181,292 77.1%
Mexico Mexico 69,974,180 53.7%
Pakistan Pakistan 68,666,464 30.5%
Germany Germany 57,515,720 68.5%
Turkey Turkey 55,214,596 64.9%
Russia Russia 52,861,352 36.2%
Vietnam Vietnam 51,883,474 52.9%
Iran Iran 51,158,858 60.2%
France France 50,987,174 75.5%
United Kingdom United Kingdom 49,715,228 72.9%
Italy Italy[e] 46,500,037 77.0%
South Korea South Korea 40,847,884 79.6%
Bangladesh Bangladesh 40,281,045 24.2%
Thailand Thailand 38,137,096 54.5%
Spain Spain 37,979,234 81.2%
Philippines Philippines 33,879,661 30.8%
Argentina Argentina 32,890,914 72.1%
Canada Canada 29,733,360 78.1%
Colombia Colombia 29,331,273 57.2%
Malaysia Malaysia 25,389,590 77.5%
Saudi Arabia Saudi Arabia 24,108,157 68.2%
Morocco Morocco 23,662,317 63.4%
Poland Poland 20,117,277 53.2%
Australia Australia 18,866,828 73.2%
Peru Peru 18,426,050 55.2%
Egypt Egypt 16,744,829 16.1%
Chile Chile 16,305,900 84.9%
Taiwan Taiwan 16,105,123 67.5%
Sri Lanka Sri Lanka 14,987,889 69.7%
South Africa South Africa 14,742,868 24.6%
Cambodia Cambodia 13,658,227 80.6%
Uzbekistan Uzbekistan 13,213,836 38.9%
Netherlands Netherlands 12,953,100 75.4%
Ecuador Ecuador 11,800,967 66.0%
Myanmar Myanmar 11,223,285 20.5%
Venezuela Venezuela 9,926,613 34.6%
Cuba Cuba 9,802,963 86.6%
United Arab Emirates United Arab Emirates 9,593,822 96.0%
Ukraine Ukraine 9,151,478 21.1%
Portugal Portugal 8,995,352 88.5%
Belgium Belgium 8,679,018 74.6%
Nepal Nepal 8,562,365 28.9%
Kazakhstan Kazakhstan 8,168,114 43.0%
Sweden Sweden 7,233,886 71.2%
Romania Romania 7,120,167 37.2%
Dominican Republic Dominican Republic 6,623,121 60.5%
Greece Greece 6,602,102 63.7%
Israel Israel 6,222,551 70.8%
Czech Republic Czechia 6,174,643 57.6%
Algeria Algeria 6,017,036 13.5%
Hungary Hungary 5,941,073 61.7%
Austria Austria 5,857,338 64.8%
Switzerland Switzerland 5,693,286 65.3%
Iraq Iraq 5,621,027 13.7%
Nigeria Nigeria 5,526,303 2.6%
Tunisia Tunisia 5,485,746 46.0%
Guatemala Guatemala 5,195,331 28.5%
Azerbaijan Azerbaijan 5,060,409 49.5%
Singapore Singapore 4,751,524 80.6%
Hong Kong Hong Kong 4,594,042 60.8%
Angola Angola 4,511,991 13.3%
Denmark Denmark 4,473,156 77.0%
Bolivia Bolivia 4,357,421 36.8%
El Salvador El Salvador 4,292,505 65.8%
Finland Finland 4,210,212 75.9%
Norway Norway 4,198,845 76.8%
Jordan Jordan 3,898,463 38.0%
Honduras Honduras 3,841,202 38.2%
Republic of Ireland Republic of Ireland 3,803,472 76.3%
New Zealand New Zealand 3,646,869 75.0%
Rwanda Rwanda 3,632,110 27.4%
Costa Rica Costa Rica 3,597,302 70.0%
Kenya Kenya 3,513,683 6.4%
Zimbabwe Zimbabwe 3,287,996 21.8%
Ethiopia Ethiopia 3,201,732 2.7%
Laos Laos 3,178,111 43.1%
Serbia Serbia 3,120,462 45.2%
Oman Oman 3,065,137 58.7%
Panama Panama 2,968,949 67.8%
Paraguay Paraguay 2,959,491 41.0%
Uruguay Uruguay 2,758,169 79.1%
Kuwait Kuwait 2,668,082 61.6%
Tajikistan Tajikistan 2,632,058 27.0%
Belarus Belarus 2,608,819 27.6%
Uganda Uganda 2,575,021 5.5%
Slovakia Slovakia 2,490,447 45.6%
Qatar Qatar 2,360,308 80.5%
Mongolia Mongolia 2,254,570 67.7%
Ivory Coast Ivory Coast 2,205,593 8.2%
Mozambique Mozambique 1,973,519 6.1%
Ghana Ghana 1,901,831 6.0%
Croatia Croatia 1,887,251 46.2%
Lithuania Lithuania 1,798,255 66.8%
Lebanon Lebanon 1,728,149 25.5%
Libya Libya 1,493,267 21.5%
Guinea Guinea 1,432,839 10.6%
State of Palestine Palestine 1,416,215 27.1%
Bulgaria Bulgaria 1,407,830 20.4%
Senegal Senegal 1,281,042 7.5%
Slovenia Slovenia 1,183,937 57.0%
Bahrain Bahrain 1,173,571 67.1%
Sudan Sudan 1,154,253 2.6%
Latvia Latvia 1,103,281 59.1%
Georgia (country) Georgia 1,013,828 25.5%
Albania Albania 994,446 34.6%
Kyrgyzstan Kyrgyzstan 953,834 14.4%
Nicaragua Nicaragua 944,476 14.1%
Malawi Malawi 926,939 4.7%
Mauritius Mauritius 891,593 70.0%
Tanzania Tanzania 885,579 1.4%
Togo Togo 867,386 10.2%
Kosovo Kosovo 834,857 47.0%
Afghanistan Afghanistan 828,601 2.1%
Moldova Moldova 824,986 20.5%
North Macedonia North Macedonia 820,863 39.4%
Estonia Estonia 784,076 59.2%
Bosnia and Herzegovina Bosnia and Herzegovina 734,195 22.5%
Syria Syria 714,300 3.9%
Mauritania Mauritania 712,117 14.9%
Fiji Fiji 624,413 69.2%
Botswana Botswana 618,979 25.8%
Trinidad and Tobago Trinidad and Tobago 618,345 44.1%
Cyprus Cyprus 601,675 67.2%
Bhutan Bhutan 585,993 75.1%
Jamaica Jamaica 580,421 19.5%
East Timor Timor-Leste 520,137 38.7%
Niger Niger 479,613 1.9%
Armenia Armenia 466,785 15.7%
Macau Macau 451,006 68.5%
Malta Malta 428,042 83.2%
Luxembourg Luxembourg 424,732 66.9%
Cameroon Cameroon 411,601 1.5%
Maldives Maldives 393,946 72.5%
Madagascar Madagascar 381,633 1.3%
Guyana Guyana 375,640 47.5%
Somalia Somalia 361,937 2.2%
Burkina Faso Burkina Faso 348,158 1.6%
Lesotho Lesotho 347,836 16.1%
Brunei Brunei 347,147 78.6%
Central African Republic Central African Republic 329,627 6.7%
Mali Mali 327,313 1.6%
Sierra Leone Sierra Leone 318,380 3.9%
Zambia Zambia 311,049 1.6%
Yemen Yemen 308,025 1.0%
Namibia Namibia 302,500 11.7%
Cape Verde Cabo Verde 292,866 52.1%
Republic of the Congo Republic of the Congo 289,849 5.1%
Iceland Iceland 282,644 82.3%
Northern Cyprus Northern Cyprus 275,175 72.0%
Liberia Liberia 262,220 5.1%
Montenegro Montenegro 255,509 40.7%
Suriname Suriname 247,070 41.8%
Comoros Comoros 245,694 27.6%
Eswatini Eswatini 239,875 20.5%
Equatorial Guinea Equatorial Guinea 239,425 16.5%
Benin Benin 216,527 1.7%
The Gambia Gambia 214,880 8.6%
Belize Belize 199,932 49.4%
Papua New Guinea Papua New Guinea 183,856 2.0%
New Caledonia New Caledonia 174,092 60.4%
French Polynesia French Polynesia 156,445 55.4%
Chad Chad 155,038 0.9%
Barbados Barbados 146,106 50.8%
The Bahamas Bahamas 136,110 34.3%
Gabon Gabon 125,804 5.5%
Solomon Islands Solomon Islands 121,778 17.3%
Guinea-Bissau Guinea-Bissau 117,488 5.8%
Samoa Samoa 115,545 57.7%
Democratic Republic of the Congo Democratic Republic of the Congo 109,579 0.1%
Guernsey Guernsey 103,064[f]
Curaçao Curaçao 100,129 60.8%
South Sudan South Sudan 84,839 0.8%
Aruba Aruba 82,417 76.9%
Seychelles Seychelles 81,021 81.9%
Haiti Haiti 79,404 0.7%
Jersey Jersey 78,537 77.7%
São Tomé and Príncipe Sao Tome and Principe 75,837 34.0%
Isle of Man Isle of Man 67,434 79.0%
Djibouti Djibouti 66,010 6.6%
Vanuatu Vanuatu 65,982 21.0%
Cayman Islands Cayman Islands 56,106 84.4%
Antigua and Barbuda Antigua and Barbuda 55,703 56.4%
Andorra Andorra 54,312 70.2%
Kiribati Kiribati 54,026 44.5%
Tonga Tonga 51,048 47.8%
Saint Lucia Saint Lucia 49,423 26.8%
Bermuda Bermuda 45,291 72.9%
Gibraltar Gibraltar 40,546 120.3%
Greenland Greenland 40,104 70.5%
Faroe Islands Faroe Islands 39,114 79.7%
Grenada Grenada 37,675 33.3%
Turkmenistan Turkmenistan 32,240 0.5%
Turks and Caicos Islands Turks and Caicos Islands 28,305 72.2%
Dominica Dominica 27,412 38.0%
Monaco Monaco 26,672 67.5%
Sint Maarten Sint Maarten 26,220 60.4%
Saint Kitts and Nevis Saint Kitts and Nevis 25,763 48.1%
San Marino San Marino 25,084 73.8%
Liechtenstein Liechtenstein 24,843 64.9%
Saint Vincent and the Grenadines Saint Vincent and the Grenadines 23,187 20.8%
Caribbean Netherlands Caribbean Netherlands 19,109 72.3%
British Virgin Islands British Virgin Islands 17,765 58.4%
Cook Islands Cook Islands 12,297 70.0%
Anguilla Anguilla 9,548 63.1%
Nauru Nauru 7,612 70.0%
Tuvalu Tuvalu 6,209 52.1%
Wallis and Futuna Wallis and Futuna 5,897 53.1%
Saint Helena, Ascension and Tristan da Cunha Saint Helena, Ascension and Tristan da Cunha 4,361 71.8%
Falkland Islands Falkland Islands 2,632 75.6%
Montserrat Montserrat 1,502 30.1%
Niue Niue 1,184 73.2%
Tokelau Tokelau 968 70.8%
Burundi Burundi 287
Pitcairn Islands Pitcairn Islands 47 100.0%
  1. ^ Number of people who have received at least one dose of a COVID-19 vaccine (unless noted otherwise).
  2. ^ Percentage of population that has received at least one dose of a COVID-19 vaccine. May include vaccination of non-citizens, which can push totals beyond 100% of the local population.
  3. ^ Countries which do not report the number of people who have received at least one dose are not included in the world total.
  4. ^ Includes Freely Associated States
  5. ^ Includes Vatican City
  6. ^ This country's data are the number of vaccine doses administered, not the first dose only.

Phased distribution

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.[15]

In the United States, the CDC's Advisory Committee on Immunization Practices (ACIP) voted on 1 December 2020, that the first doses of the vaccine should be prioritized for healthcare workers and residents and staff of nursing homes.[16] ACIP recommended that the second phase of distribution (Phase 1b) include persons aged ≥75 years and non-healthcare frontline essential workers such as those employed in grocery stores, restaurants, military, law enforcement, fire departments, retail, sanitation, schools, public transportation, self-storage, hotels, warehousing, and news media.[17] However, states control the final plans for prioritization, distribution, and logistics of vaccinating everyone as supply becomes available.[18]

The European Union began phased vaccine rollout on 27 December 2020. 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.[19][20]

The COVID‑19 vaccination programme 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.[21]

Some countries used accelerated dose 1 plans with extended dose 2 intervals after the first dose in order to extend vaccination to as many people as possible until vaccine availability improved.[22][23][24][25][excessive citations] Data suggests that people who have recovered from COVID-19 may only require a single dose of an mRNA vaccine to reach full two dose immunity.[26]

Mixed series

The use of the different vaccines in a two-shot regimen is not widespread; there is no data on the efficacy of mixed series for COVID-19 vaccines but such series are not expected to be unsafe or ineffective.[27] The US's CDC recommends the use of a mixed series only in exceptional circumstances, such as where a second dose of the same vaccine cannot be delivered in a reasonable timeframe.[28] In Canada, authorities were investigating the effectiveness of a mixed series and ultimately recommended the use of a first shot consisting of the Oxford-AstraZeneca COVID-19 vaccine, followed by one of the mRNA vaccines.[29][30][31] In June 2021, German authorities recommended using mRNA vaccines as a second shot after an AstraZeneca shot in younger people as a precaution to avoid a rare blot clotting side effect associated with the AstraZeneca vaccine.[32] Thailand began mixing-and-matching doses of the AstraZeneca and Sinovac vaccines in July 2021 amid concerns about the Sinovac vaccine's long-term protection.[33]

Equitable access

Health officials distribute the Moderna COVID-19 vaccine to frontline health workers and first responders in Baltimore County, Maryland, United States

During 2020, as the COVID‑19 pandemic escalated globally and vaccine development intensified, the WHO COVAX Facility adopted the motto "No one is safe unless everyone is safe" to emphasize the need for equitable vaccination.[34] The Facility set a goal of supplying COVID‑19 vaccines to nearly 100 low-to-middle income countries that could not afford them. COVAX sought to fundraise US$6.8 billion to purchase and deliver vaccines to participating countries in proportion to their populations.[34] On 18 December 2020, the Facility announced agreements with vaccine manufacturers to supply 1.3  billion doses for 92 low-middle income countries in the first half of 2021.[35]

Yet, by mid-December, some 16 countries representing only 14% of the world's population had preordered more than 10 billion vaccine doses or about 51% of the available world supply.[36][37] Specifically, Canada, Australia, and Japan – having only 1% of the world's COVID‑19 cases – had collectively reserved some one billion vaccine doses,[37] while the COVAX Facility had reserved only a few hundred million doses.[34] Concerns were raised that wealthy countries may receive their vaccines in 2020–21 while developing countries may be excluded from vaccinations until 2023–24.[37] Data from April 2021 comports with this expectation since 25% of the population in high income countries have been vaccinated compared to only 0.2% in low income countries.[38] At the Group of Seven summit in June 2021, the United States promised to distribute 500 million vaccine doses internationally; this distribution began on 17 August.[39]

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 Oxford–AstraZeneca COVID-19 vaccine, which is lowest in cost and has no special refrigeration needs.[36][37]

World Health Organization communication describing factors involved in National Plans for Vaccines

CEPI, WHO, and charitable vaccine organizations, such as the Gates Foundation and GAVI, raised over US$20 billion during the first half of 2020 to fund vaccine development and preparedness for vaccinations, particularly for children in under-developed countries.[5][40][41] CEPI, which was created to monitor fair distribution of infectious disease vaccines to low- and middle-income countries,[42][43] has recommended considering manufacturing capacity, financing and purchasing, and releasing vaccine developers from liability.[10] Despite opposition from some vaccine manufacturers,[43][44] CEPI revised its February 2020 equitable access policy to apply specifically 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 publications.[43]

International groups, such as the Centre for Artistic Activism and Universities Allied for Essential Medicines, advocate for equitable access.[45][46] Scientists have encouraged collaboration between the WHO, CEPI, corporations, and governments to ensure that vaccines are distributed in an evidence-based manner based on infection risk[42][43] and to prioritize healthcare workers, vulnerable populations, and children.[4][5][44]

By mid-March 2021, 67 countries, mostly in Africa and the Middle East, had not yet reported any vaccinations.[47] Countries that had begun vaccinations were generally prioritizing populations such as health workers or the elderly. It has also been suggested that elective surgery recipients should be prioritized since a patient recovering from surgery would be more vulnerable than average.[48] Some expressed concern over the short shelf-life of the Moderna and Pfizer-BioNTech vaccines, which expire within hours after being removed from the freezer; they argued that, once the vaccine is unfrozen, it is better to apply these doses to anyone who can be found rather than discard the doses.[49]

As of March 2021, the United States had ordered twice the necessary doses to cover its own population, but it remained unclear when it might share surplus doses with other countries.[50][51] In April 2021, Vanity Fair reported that it would be difficult to share surplus doses with other countries because the U.S. government had expressly agreed in its contracts with vaccine manufacturers to use doses only in the United States and its territories.[52] The manufacturers requested this clause because most other countries do not have liability protections for vaccines as expansive as the Public Readiness and Emergency Preparedness Act.[52]

The head of the World Health Organization said on 4 August 2021 that rich countries had administered about 100 doses per 100 people while poor countries had administered only about 1.5 doses for every 100 people, and therefore, in his estimation, it was important to prioritize vaccination in poor countries before offering booster vaccines in rich countries.[53]

Intellectual property

The first polio vaccine was never patented; some have argued that similar treatment of an effective COVID‑19 vaccine could enable fair distribution.[54]

Initially, negotiations at the World Trade Organization (WTO) on the issue of waiving patent rights were blocked for months by resistance by the US, Switzerland, Norway, and the EU.[55] Initially one observer considered the US position unlikely to change,[56] but as of April 2021 the US administration was discussing the issue[57] and then reversed course and announced its support for a patent waiver for COVID-19 vaccines on 5 May 2021.[58] 400 non-profit organizations and 115 members of the European Commission have signed a letter urging the United States and Europe to side with the WTO members in the global south.[59]

However, some question if patent waiver proposals formulated for small molecule drugs can be applied to complex biologics like vaccines.[60][61][62] One vaccine production expert argued that "there is an unrecognized gap in understanding ... nearly all of the people who are providing views on the value of removing patent protections have zero experience in vaccine development and manufacturing.”[62]

Small molecule drugs are easy to copy and can be quickly brought to market by generic drug manufacturers who are not required to run their own full-scale clinical trials because they can piggyback on regulatory approvals obtained by original drug manufacturers.[63] In contrast, "there is no such thing as generic vaccines".[63] The manufacturer of each independently developed vaccine (including a purported copy of an existing vaccine) must run its own clinical trials to establish safety and efficacy.[63] Independent copying of an existing first-generation vaccine is so hard that the resulting second-generation vaccine is often a significant improvement over the first-generation technology and is itself patentable.[63] Another concern is that allowing independent parties to simultaneously attempt vaccine production could worsen supply bottlenecks[64] by diverting materials from experienced producers to stockpiles waiting for inexperienced producers to scale up, or worse wasted on spoiled batches.

Although Moderna has stated that it will not seek enforcement of its patents during the pandemic,[65] a patent waiver (voluntary or involuntary) would not force a vaccine manufacturer to disclose the complete knowledge (i.e., know-how) for making a vaccine, which is not found in patents.[60] The WHO has promoted the COVID-19 Technology Access Pool to facilitate disclosures, but participation is voluntary and none of the vaccine manufacturers have joined.[66] Without access to the original vaccine manufacturer's know-how, reverse engineering the manufacturing process is difficult and expensive with no guarantee of success.[60][67] Even if a third party succeeds, they must prove that fact to the satisfaction of regulatory authorities.[63] For small molecule drugs, proving bioequivalence of a generic drug to the original drug costs only about US$1 to $2 million; but for biologics, proving biosimilarity of a third-party product to the original product requires clinical trials, with costs ranging from US$100 to $250 million.[67] One financial analyst specializing in pharmaceuticals estimated that it would take a minimum of two years after patent waiver for the first independent reproductions of a COVID-19 vaccine to reach the market,[68] which may be too long to have any net impact on global public health.[61] While discussing the idea of "open source" COVID-19 vaccine manufacturing, Bill Gates said: "There’s not a single additional vaccine that would have come out of that .... no free IP would have improved anything related to this pandemic."[69] His foundation has instead helped other countries reach licensing deals as in the case of the Oxford/AstraZeneca vaccine being produced by India's Serum Institute.[69]

This is why some conclude that voluntary technology transfers are the superior option for producing more doses[60][61]—since the transferor's active assistance can help the transferee bypass time-consuming clinical trials by taking advantage of existing approvals for the transferor's vaccine[65]—and others describe patent waiver proposals as "more symbolic than practical".[70] Derek Lowe has characterized the U.S. government's May 2021 announcement of support for patent waiver proposals as "almost as much of a PR move as anything else".[71] Tedros Adhanom Ghebreyesus has rejected the dichotomy between waiving patents and initiating technology transfers by including both measures as part of a list of four steps towards increasing vaccine production. He pointed out that the TRIPS agreement signed by all members of the WTO already allows for an emergency waiver of intellectual property rights in countries with free manufacturing capacities.[72]

Several observers have noted that the vaccine patent waiver debate involves an issue expected to outlast the COVID-19 pandemic: who will control the broader technology of RNA therapeutics.[65][73][74][75][excessive citations]Howard Dean has accused Narendra Modi of trying to gain access to such technology by promoting the "disingenuous" claim that patent waivers will accelerate vaccine production.[74] Josh Rogin has pointed out that control of mRNA technology has "national security implications" for the United States, and that its development was initially funded by U.S. taxpayers through DARPA for that reason.[75][76]

Central to the debate is whether profits from strong intellectual property rights are necessary to ensure that someone will conduct the applied research which turns promising laboratory experiments into marketable drugs and vaccines. Such research is dauntingly expensive (on average, $3 billion per successful drug) and nearly always fails (only 12 percent of drugs which enter clinical trials ultimately obtain FDA approval),[77] and "governments have neither the money nor the risk tolerance to take over the role of businesses in developing pharmacy-ready medicines".[78][79] The risk of waiving patents for COVID-19 vaccines is that it sets a precedent which may discourage the private sector from future investments in vaccines and other lifesaving technologies, and in turn, future technologies not yet developed will never come to market when the public sector fails to pick up the slack.[71][77][80][81][82][excessive citations] As one financial analyst explained: "It would be intensively counterproductive, in the extreme, because what it would say to the industry is: 'Don't work on anything that we really care about, because if you do, we're just going to take it away from you.'"[83] The "most depressing" worst-case outcome is that pharmaceutical firms give up on saving lives and focus on inventing quality of life treatments which are more profitable and less likely to be expropriated;[84] the most notorious examples of such treatments are Pfizer's Viagra and Allergan's Botox.[85] The "threat of losing developers is real" in the vaccine sector, which had withered away to only a handful of companies by the turn of the 21st century and by 2021 had only recently begun to grow again.[80] However, Peter Bach has argued that whether this risk might be worth it deserves to be frankly debated: "If this action allows for more access and more people to have their lives saved today in 2021 and the consequence is down the road we may not have some new gene therapy for 100 kids, then that's the trade-off worth discussing".[81]

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,[42][44] such as for the AstraZeneca-University of Oxford vaccine candidate, concerning whether there may be[needs update] prioritized distribution first within the UK and to the "highest bidder" – the United States, which made an advance payment of US$1.2 billion to secure 300 million vaccine doses for Americans, even before the AstraZeneca-Oxford vaccine or a Sanofi vaccine was proved safe or effective.[86][87][88] Concerns exist about whether some countries producing vaccines may impose protectionist controls by export restrictions that would stockpile a COVID‑19 vaccine for their own population.[42]

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.[89] Unlike mRNA vaccines, which have to be stored at subzero temperatures, inactivated vaccines from Sinovac and Sinopharm require ordinary refrigeration[90] and may have more appeal in developing countries.[91]

In June, the Serum Institute of India (SII) – a major manufacturer of global vaccines – reached a licensing agreement with AstraZeneca to make 1 billion doses of vaccine for low-and-middle income countries,[92] of which half of the doses would go to India.[93] Similar preferential homeland distribution may exist if a vaccine is manufactured in Australia.[94]

Illegal distribution

In the United States, the vaccine distribution line, while varying by state, has placed healthcare workers and senior citizens high on the list for COVID-19 vaccination, while less essential workers are secondary recipients.[95][96] Due to the long process of distribution,[97] some individuals tried to secure a more favorable position on the vaccination list, such as by bribery or making donations to hospitals.[98][99] In response, state governments imposed large fines and other penalties for violation of federal vaccine distribution guidelines.[100] A COVID-19 vaccine black market enabled some individuals to buy illegal early access to a vaccine.[101]

By mid-February 2021, China had arrested 80 people involved in vaccine contraband, and the Colombian government intercepted a freezer with 70 doses of a Chinese-manufactured vaccine that a traveler brought with her into the airport without any accompanying paperwork.[102]

Vaccine tourism

In the later half of February 2021, it was reported that wealthy and influential people from Canada[103] and European countries flew to the United Arab Emirates to secure early access to the vaccine.[104] The UAE has been promoting Dubai as a vaccine holiday hub for the super-rich, who can pay a hefty amount to skip the queue and get inoculated before the vulnerable ones.[105] Some Canadians who maintained second homes in the United States were able to get vaccines earlier.[106]

As restrictions on vaccine eligibility were lowered in the United States, wealthier individuals from other countries with slower vaccination rates were reportedly travelling to the United States to be vaccinated.[107][108][109] The U.S. state of Alaska announced in April 2021 that it would intentionally offer free vaccinations to tourists at major Alaskan airports starting 1 June 2021.[110] In an effort to guard against vaccine tourism, Greece restricted its eligibility to those with a social security number. However, this had the effect of excluding part of the elderly or immigrant population as well as some Greek citizens who worked abroad before the pandemic.[111]

In Europe, several travel agencies are offering "vaccine vacations".[112] The Maldives are also offering vaccines as part of holiday travel packages.[113][114]

Cost

An effective vaccine for COVID‑19 could save trillions of dollars in global economic impact, according to economists Arnab Acharya and Sanjay Reddy who advocate suspending patent protections for vaccines temporarily and compensating the affected companies.[115] Any price tag in the billions would therefore look small in comparison. 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.[3][4][116] Even with several vaccines on the market, the antigenicity changes in new variants of the virus mean that the billions of dollars could still be invested without success.[6]

Before an effective vaccine was developed, it was clear that 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 billion.[117] Gates also admitted "Ideally, there would be global agreement about who should get the vaccine first, but given how many competing interests there are, this is unlikely to happen".[118] From Phase I clinical trials, 84–90%[8][119] of vaccine candidates fail to make it to final approval during development, and from Phase III, 25.7% fail[119] – the investment by a manufacturer in a vaccine candidate may exceed US$1 billion and end with millions of useless doses given advanced manufacturing agreements.[3][6][116] In the case of the Oxford-AstraZeneca COVID-19 vaccine, 97% of this came from taxpayer money.[120]

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.[121] In December 2020, a Belgian politician briefly published the confidential prices agreed between vaccine producers and the EU:[122]

Manufacturer Vaccine Price per dose[123]
EUR USD
AstraZeneca Oxford–AstraZeneca COVID-19 vaccine €1.78
Johnson & Johnson Janssen COVID-19 vaccine €7.16 US$8.50
Sanofi / GSK Sanofi–GSK COVID-19 vaccine €7.56
R-Pharm Sputnik V €8.43 US$10.00
Sinopharm BBIBP-CorV €8.43 US$10.00
CureVac CureVac COVID-19 vaccine €10.00
Pfizer and BioNTech Pfizer–BioNTech COVID-19 vaccine €12.00
Moderna Moderna COVID-19 vaccine €15.17 US$18.00

Supply chain

Moderna vaccine box packed with insulation and cold packs.

Deploying a COVID‑19 vaccine may require worldwide transport and tracking of 10–19 billion vial doses, an effort readily becoming the largest supply chain challenge in history.[3][124][93] 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.[124][125][126] Globally, supplies critical to vaccine research and development are increasingly scarce due to international competition or national sequestration.[127]

Addressing the worldwide challenge faced by coordinating numerous organizations – the COVAX partnership, global pharmaceutical companies, contract vaccine manufacturers, inter- and intranational transport, vaccine 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."[128]

As an example highlighting the immensity of the challenge, the International Air Transport Association stated that 8,000 Boeing 747 cargo planes, equipped for precision vaccine cold storage, would be needed to transport one dose for the entire population in the more than 200 countries experiencing the COVID‑19 pandemic.[129] GAVI states that "with a fast-moving pandemic, no one is safe, unless everyone is safe."[12]

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.[124][125][130] A major concern is that resources for vaccine distribution in 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.[12][131] In September, the COVAX partnership included 172 countries coordinating plans to optimize the supply chain for a COVID‑19 vaccine,[132] and the United Nations Children's Fund joined with COVAX to prepare the financing and supply chain for vaccinations of children in 92 developing countries.[133][134]

Logistics

Logistics vaccination services assure necessary equipment, staff, and supply of licensed vaccines across international borders.[135] Central logistics include vaccine handling and monitoring, cold chain management, and safety of distribution within the vaccination network.[136] 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.[12][130] Included are logistics tools for vaccine forecasting and needs estimation, in-country vaccine management, potential for wastage, and stock management.[136]

Other logistics factors conducted internationally during distribution of a COVID‑19 vaccine may include:[124][137][138]

  • visibility and traceability by barcodes 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.[139] If the vaccine supply chain fails, the economic and human costs of the pandemic may be extended for years.[126]

Manufacturing capacity

COVID-19 vaccine production by country
Country Doses (millions)
3 Mar 2021[140] 30 Sep 2021[141]
China 141.6 3644
.3
European Union 81.0 1331
.4
India 42.4 920
.7
United States 103.0 647
.5
Russia 10.5 171
.9
Switzerland 5.5 153
.9
South Korea 1.6 103
.8
Thailand - 72
.9
United Kingdom 12.2 66
.0
Argentina - 61
.5
Australia - 24
.1
Cuba - 23
.1
Japan - 21
.7
Kazakhstan - 9
.4
Iran - 2
.5
Belarus - 2
.5
Taiwan - 0
.7
Total 7257
.8
COVID-19 vaccine production by manufacturer, 30 Sep 2021[142]
Manufacturer Doses
(millions)
Country
Sinovac 1987
.7 China
Sinopharm 1531
.3 China
Pfizer 1488
.6 EU, USA
AstraZeneca 1435
.6 India, EU, China, South Korea, UK, USA,
Japan, Thailand, Australia, Argentina
Moderna 411
.5 USA, EU
Gamaleya Research 176
.4 Russia, Kazakhstan, Argentina, Serbia
Johnson & Johnson 90
.0 USA, EU
Bharat Biotech 75
.3 India
Anhui Zhifei [zh] 16 China
CIGB 12
.1 Cuba
Finlay Institute 11
.0 Cuba
CanSino 9
.7 China
Vector 5
.0 Russia
Shifa Pharmed 2
.5 Iran
Chumakov Centre [ru] 1
.5 Russia
RIBSP [ru] 0
.9 Kazakhstan
Medigen 0
.7 Taiwan

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 billion.[93][139][143] 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.[93] 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.[132] Before 2022, 7–10 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.[3][139][93][144][excessive citations]

After joining COVAX in October, China initially stated that it would produce 600 million vaccine doses before the end of 2020.[145] Sinopharm has the capacity to produce 1 billion doses of BBIBP-CorV in 2021,[146] while its Dubai partner G42 Healthcare aimed to produce 100 million doses in 2021 focused on the middle east.[147] Sinovac can produce 2 billion doses of CoronaVac a year,[148] while its Brazilian partner Instituto Butantan planned to produce 100 million doses,[149] and its Indonesian partner Bio Farma planned to produce up to 250 million doses a year.[150] CanSino Biologics is expecting to have a production capacity of 500 million doses of Ad5-nCoV in 2021.[151] ZF2001 is also expected to have a production capacity of one billion doses a year.[152]

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.[93]

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."[153] Preparing for high demand in manufacturing vials, an American glass producer invested $163 million in July for a vial factory.[154] Glass availability for vial manufacturing and contaminant control are issues of concern,[155] indicating higher production costs with lower profit potential for developers amid demands for vaccines to be affordable.[12][93][126]

The RNA vaccines from Moderna and Pfizer-BioNTech are unusually difficult to produce because they rely upon encapsulation of mRNA in lipid nanoparticles, a novel technology which has never been scaled up before for mass production. As of February 2021, this was thought to be the primary bottleneck in the manufacturing of such vaccines.[156]

Vaccines must be handled and transported according to international regulations, be maintained at controlled temperatures that vary across vaccine technologies, and be used for immunization before deterioration in storage.[93][139] The scale of the COVID‑19 vaccine supply chain is expected to be vast to ensure delivery worldwide to vulnerable populations.[3][125] Priorities for preparing facilities for such distribution include temperature-controlled facilities and equipment, optimizing infrastructure, training immunization staff, and rigorous monitoring.[125][128][133] RFID technologies are being implemented to track and authenticate a vaccine dose from the manufacturer along the entire supply chain to the vaccination.[157]

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.[158] 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.[159] The newly built 2,000-square-metre facility will ramp up production to 300 million doses annually. The ingredient will be shipped frozen at −70 °C to Spain's Laboratorios Farmacéuticos Rovi SA for the final stage of manufacturing.[159] Lonza's site in Portsmouth, New Hampshire, aimed to start making vaccine ingredients exclusively for the U.S. by November 2020.[159] Compounding the concerns over massive pre-orders by wealthy countries, manufacturing capacity is also limited by the fact that most vaccines are patented by companies in those countries. India and South Africa proposed a waiver to the TRIPS Agreement which would remove exclusivity agreements as a barrier to setting up new facilities but the measure is being blocked by the G7.[160]

Cold chain

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 stored between −80 and −60 °C (−112 and −76 °F),[161] must be used within five days of thawing,[161] and has a minimum order of 975 doses, making it unlikely to be rolled out in settings other than large, well-equipped hospitals.[162] The Moderna vaccine vials require storage above −40 °C (−40 °F) and between −25 and −15 °C (−13 and 5 °F).[163] Once refrigerated, the Moderna vaccine can be kept between 2 and 8 °C (36 and 46 °F) for up to 30 days.[163]

Vaccines (and adjuvants) are inherently unstable during temperature changes, requiring cold chain management throughout the entire supply chain, typically at temperatures of 2–8 °C (36–46 °F).[138][164] 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 liable to heat, while others should not be frozen at all, and some are stable across temperatures.[164] Freezing damage and inadequate training of personnel in the local vaccination process are major concerns.[165] Sinopharm and Sinovac's vaccines are examples of inactivated vaccines which can be transported using existing cold chain systems at 2–8 °C (36–46 °F).[166][167]

modRNA vaccine technologies in development may be more difficult to manufacture at scale and control degradation, requiring ultracold storage and transport.[126] As examples, Moderna's RNA vaccine candidate requires cold chain management just above freezing temperatures between 2 and 8 °C (36 and 46 °F) with limited storage duration (30 days),[168] but the Pfizer-BioNTech RNA candidate requires storage between −80 and −60 °C (−112 and −76 °F),[161] or colder throughout deployment until vaccination.[169][170] In February 2021, Pfizer and BioNTech asked the U.S. Food and Drug Administration (FDA) to update the emergency use authorization (EUA) to permit the vaccine to be stored at between −25 and −15 °C (−13 and 5 °F) for up to two weeks before use.[171] As of May 2021, Walvax is conducting Phase III trials for its mRNA vaccine which could be stored at room temperature for six months.[172]

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.[3][173] 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.[124][173] 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.[3][133][174]

Air and land transport

Boxes of AstraZeneca's COVID-19 vaccine from India are delivered in Brazil (Jan 2021)

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.[125][129][175] "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.[175]

For the severe reduction in passenger air traffic during 2020, airlines downsized personnel, trimmed destination networks, and put aircraft into long-term storage.[125][175] 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.[133][175]

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[a] and dry ice, but dry ice is only allowed in limited quantities on airplanes as the gases released via 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 3,000 lb (1,400 kg), but it temporarily allowed United Airlines to transport up to 15,000 lb (6,800 kg)—nearly 1 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 Air Lines 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 UPS have installed ultra-cold freezers at air cargo hubs in Europe and North America, and UPS can manufacture 1,200 lb (540 kg) of dry ice per hour.[178]

Security and corruption

Federal police escort COVID-19 vaccine shipment in Brazil (Jan 2021).

Medicines are the world's largest fraud market, worth some $200 billion per year, making the widespread demand for a COVID‑19 vaccine vulnerable to counterfeit, theft, scams, and cyberattacks throughout the supply chain.[130][179] 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".[180] Anticorruption, transparency, and accountability safeguards are being established to reduce and eliminate corruption of COVID‑19 vaccine supplies.[179][181] 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.[179] Tracking system technologies for packaging are being used by manufacturers to trace vaccine vials across the supply chain,[130] and to use digital and biometric tools to assure security for vaccination teams.[157][182] 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.[183] Further, vaccines which require constant freezing temperatures are also susceptible to sabotage.[180]

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".[177]

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.[180]

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".[184] On 21 January 2021, its founder, Johnny Stine, was arrested on a federal warrant charging him with introducing misbranded drugs into interstate commerce.[185]

National infrastructure

The WHO has implemented an "Effective Vaccine Management" system,[186] 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:[135][186]

  • 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

Tailored vaccination strategies

During a pandemic wave, rapid vaccination of those driving virus dissemination (the socially active) and vaccination of those at highest risk (the elderly, often socially less active) are two desirable goals that are at odds in the setting of limited vaccine supply. Postponing a second vaccine dose (the first is more important for avoiding a severe disease course) to allow faster access to the first dose for more persons has been chosen as deployment strategies in some countries.[187] Using a reduced mRNA vaccine dose in the younger, who have a lower disease risk, a stronger immune response to the vaccination but are key drivers of pandemic waves, may allow reaching more persons faster, with vaccination strategy models predicting a significant reduction of nation-wide case load and deaths.[188] On the other side, protection of some groups, e.g. the elderly or the immunosuppressed may require additional booster doses.[189]

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".[190] The declaration is effective in the United States through 1 October 2024.[190]

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.[191] While the purchasing contracts with vaccine manufacturers remain secret, the manufacturers remain liable even for side-effects not known at the time of licensure.[192]

Pfizer has been criticised for demanding far-reaching liability waivers and other guarantees from countries such as Argentina and Brazil, which go beyond what was expected from other countries such as the US (above).[193][194]

See also

Notes

  1. ^ With a steady supply of dry ice, the Pfizer-designed containers can insulate the vaccine for up to 30 days.[176][177]
  1. ^ The table data is automatically updated daily by a bot; see Template:COVID-19 data for more information. Scroll down past the table to find the documentation and the main reference. See also: Category:Automatically updated COVID-19 pandemic table templates.

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