Deployment of COVID-19 vaccines

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COVID-19 vaccination doses administered per 100 people. See date on map.
Health officials distribute the Moderna COVID‑19 vaccine to frontline health workers and first responders in Baltimore County, Maryland (Dec 2020).

As of 3 May 2021, 1.18 billion COVID-19 vaccine doses had been administered worldwide based on official reports from national health agencies collated by Our World in Data.[1]

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

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).[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] 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 plan 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] For example, successful COVID‑19 vaccines would likely be allocated first 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]

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.[8][10][12] WHO Director General Tedros Adhanom referred to subsequent inequities in the distribution as "a catastrophic moral failure".[14] A March 2021 survey of 77 epidemiologists concluded that mutations would render existing vaccines ineffective within one year — a window which wealthy nations were on pace to meet.[15] Conversely, an Economist Intelligence Unit report from earlier in the year estimated that a similar level of herd immunity would not be achieved globally until 2024.[14]

Distribution[edit]

[show all]
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COVID-19 vaccine distribution by location
(as of 3 May 2021[a])[16]
Location Vaccinated[b] % of pop.[c]
  World[d] 904,549,284 7.8%
 China[e] 275,338,000 --
 United States 147,047,012 44.0%
 India 126,704,151 9.2%
 EU 109,537,497 24.6%
 United Kingdom 34,505,380 50.8%
 Brazil 29,421,191 13.8%
 Germany 23,492,053 28.0%
 France 15,782,608 23.2%
 Italy 14,593,168 24.1%
 Turkey 13,800,405 16.4%
 Canada 12,696,698 33.6%
 Mexico 12,572,997 9.8%
 Indonesia 12,469,406 4.6%
 Russia 12,431,003 8.5%
 Spain 11,763,360 25.2%
 United Arab Emirates[e] 10,634,693 --
 Saudi Arabia[e] 9,557,948 --
 Poland 8,917,338 23.6%
 Chile 8,112,125 42.4%
 Argentina 7,025,492 15.5%
 Bangladesh 5,819,656 3.5%
 Israel 5,403,739 62.4%
 Netherlands[e] 5,265,860 --
 Morocco 5,055,239 13.7%
 Hungary 4,073,149 42.2%
 Colombia 3,412,223 6.7%
 South Korea 3,396,864 6.6%
 Romania 3,336,830 17.4%
 Belgium 3,070,545 26.5%
 Portugal 2,513,836 24.6%
 Sweden 2,511,121 24.9%
 Japan 2,493,961 2.0%
 Austria 2,341,905 26.0%
 Australia[e] 2,254,074 --
 Czech Republic 2,195,779 20.5%
 Greece 2,170,847 20.8%
 Pakistan 2,100,000 0.9%
 Nepal 2,091,511 7.2%
 Serbia 2,028,302 29.8%
 Switzerland 1,703,819 19.7%
 Finland 1,694,744 30.6%
 Philippines 1,689,829 1.6%
 Cambodia 1,422,722 8.5%
 Singapore 1,364,124 23.3%
 Denmark 1,350,867 23.3%
 Norway 1,343,500 24.8%
 Kazakhstan 1,293,379 6.9%
 Nigeria 1,229,733 0.6%
 Dominican Republic 1,185,502 10.9%
 Peru 1,176,645 3.2%
 Uruguay 1,165,904 33.6%
 Ireland 1,159,083 23.6%
 Slovakia 1,115,253 20.4%
 Thailand 1,099,460 1.6%
 Qatar 1,017,019 35.3%
 Myanmar 1,000,000 1.8%
 Kuwait[e] 1,000,000 --
 Azerbaijan 975,208 9.6%
 Hong Kong 952,119 12.7%
 Mongolia 947,529 28.9%
 Sri Lanka 928,107 4.3%
 Malaysia 898,094 2.8%
 Iran 858,296 1.0%
 Kenya 853,081 1.6%
 Ghana 849,527 2.7%
 El Salvador 839,870 12.9%
 Ecuador 791,651 4.5%
 Ukraine 755,101 1.7%
 Bahrain 717,024 42.1%
 Croatia 708,137 17.2%
 Jordan 699,328 6.8%
 Lithuania 691,403 25.4%
 Egypt 660,000 0.6%
 Bolivia 614,600 5.3%
 Bulgaria 608,428 8.8%
 Uzbekistan 600,369 1.8%
 Costa Rica 538,682 10.6%
 Vietnam 506,435 0.5%
 Panama 496,449 11.5%
 Albania[e] 494,028 --
 Bhutan 480,498 62.3%
 Angola 456,349 1.4%
 Zimbabwe 430,068 2.9%
 Ethiopia[e] 430,000 --
 Slovenia 427,449 20.6%
 Senegal 413,031 2.5%
 Rwanda 350,131 2.7%
 Estonia 339,651 25.6%
 Uganda 339,607 0.7%
 South Africa 318,670 0.5%
 Tunisia 305,484 2.6%
 Iraq 298,377 0.7%
 Maldives 296,961 54.9%
 Malawi 296,127 1.6%
 Lebanon 294,945 4.3%
 Latvia 263,964 14.0%
 Oman 253,000 5.0%
 Venezuela 250,000 0.9%
 Belarus 244,000 2.6%
 Afghanistan 240,000 0.6%
 Malta 231,511 52.4%
 Cyprus 176,082 20.1%
 New Zealand 172,564 3.6%
 Palestine 170,109 3.3%
 Guatemala 169,369 0.9%
 Ivory Coast 163,176 0.6%
 Togo 160,000 1.9%
 Luxembourg 140,495 22.4%
 Sudan 140,227 0.3%
 Jamaica 135,473 4.6%
 Nicaragua 135,130 2.0%
 Moldova 130,218 3.2%
 Laos 126,072 1.7%
 Guyana 124,000 15.8%
 Somalia 117,567 0.7%
 Mauritius 117,323 9.2%
 Iceland 109,409 32.1%
 Guinea 95,312 0.7%
 Paraguay 92,926 1.3%
 Algeria[e] 75,000 --
 Barbados 74,608 26.0%
 Curaçao 72,861 44.4%
 Macau 70,655 10.9%
 Seychelles 67,680 68.8%
 Equatorial Guinea 64,646 4.6%
 Bosnia and Herzegovina 63,376 1.9%
 North Macedonia 61,603 3.0%
 Northern Cyprus 60,642 15.9%
 Taiwan[e] 58,252 --
 Mozambique 57,305 0.2%
 Isle of Man 56,849 66.9%
 Fiji 56,000 6.2%
 Sierra Leone 55,083 0.7%
 Honduras 55,000 0.6%
 Aruba 54,306 50.9%
 Jersey 52,405 51.9%
 Mali 49,903 0.2%
 Botswana 47,160 2.0%
 Georgia 45,338 1.1%
 Trinidad and Tobago 42,455 3.0%
 Belize 42,100 10.6%
 Montenegro 40,215 6.4%
 Suriname 39,953 6.8%
 Gibraltar 37,504 111.3%
 Cayman Islands 35,774 54.4%
 Eswatini 34,897 3.0%
 Guernsey 32,969 49.2%
 Bermuda 32,129 51.6%
 Zambia 32,034 0.2%
 Antigua and Barbuda 29,754 30.4%
 Kyrgyzstan 27,000 0.4%
 Bahamas 25,692 6.5%
 Saint Lucia[e] 24,426 --
 Kosovo 22,096 1.1%
 Andorra 21,733 28.1%
 Gambia 20,922 0.9%
 San Marino 20,269 59.7%
 Namibia 18,837 0.7%
 Dominica 18,498 25.7%
 Lesotho 16,000 0.8%
 Turks and Caicos Islands 15,039 38.8%
 Faroe Islands 14,458 29.6%
 Congo 14,297 0.3%
 Saint Vincent and the Grenadines[e] 13,852 --
 Monaco 12,758 32.5%
 Grenada 12,666 11.3%
 Saint Kitts and Nevis 11,848 22.3%
 Brunei 10,715 2.5%
 Djibouti 10,246 1.0%
 São Tomé and Príncipe 9,724 4.4%
 Greenland 8,867 15.6%
 Liechtenstein 8,044 21.1%
 Mauritania 7,038 0.1%
 Gabon 6,895 0.3%
 Anguilla 6,115 40.8%
 Samoa[e] 5,880 --
 Tonga 5,367 5.1%
 Solomon Islands 4,890 0.7%
 Saint Helena 3,563 58.7%
 Papua New Guinea 2,900 0.0%
 Falkland Islands 2,632 75.6%
 East Timor 2,629 0.2%
 Syria 2,500 0.0%
 Cape Verde 2,184 0.4%
 DR Congo 1,700 0.0%
 Montserrat 1,293 25.9%
 Niger 1,366 0.0%
 South Sudan 947 0.0%
 Libya 750 0.0%
 Nauru 700 6.5%
 Armenia 565 0.0%
 Cameroon 400 0.0%
 F.S. Micronesia[17] 20,945 20.2%
 Marshall Islands[17] 14,790 25.3%
 Palau[17] 12,655 70.7%
 Vatican City[18][19] 22 2.7%

Sources

Notes

  1. ^ Latest available data as of this date. Individual country reporting frequency varies.
  2. ^ Number of unique individuals who have received at least one dose of a COVID-19 vaccine (unless noted otherwise).
  3. ^ Includes those who are partially vaccinated with a single dose. May include vaccination of non-citizen workers, which can push totals beyond 100% of the local population.
  4. ^ Some countries are not yet reporting first-dose counts. Total dose counts for these countries are not included in the World total.
  5. ^ a b c d e f g h i j k l m This country's data reflects total doses administered, not the first shot only.

Phased distribution[edit]

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.[20]

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.[21] 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.[22] However, states control the final plans for prioritization, distribution, and logistics of vaccinating everyone as supply becomes available.[23]

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.[24][25]

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.[26]

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.[27][28][29][30] 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.[31]

Mixed series[edit]

The use of the different vaccines in a two shot regimen is not recommended or deliberately employed by any vaccinating nation; 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.[32] 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.[33]

Equitable access[edit]

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]

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.[36][37]

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][39][40] CEPI, which was created to monitor fair distribution of infectious disease vaccines to low- and middle-income countries,[41][42] has recommended considering manufacturing capacity, financing and purchasing, and releasing vaccine developers from liability.[10] Despite opposition from some vaccine manufacturers,[42][43] 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.[42]

International groups, such as the Centre for Artistic Activism and Universities Allied for Essential Medicines, advocate for equitable access.[44][45] 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[41][42] and to prioritize healthcare workers, vulnerable populations, and children.[4][5][43] The first polio vaccine was never patented; similar treatment of an effective COVID‑19 vaccine could enable fair distribution.[46]

Negotiations at the World Trade Organization (WTO) to waive patent rights have been blocked due to resistance by the US, Switzerland, Norway, and the EU.[47] Initially one observer considered the US position unlikely to change,[48] but as of April 2021 the US administration is discussing the merits of waiving the patent rights.[49] However, some question if patent waiver proposals formulated for easy-to-copy small molecule drugs can be applied to more complex biologics like vaccines.[50][51] Although Moderna has stated that it will not seek enforcement of its patents during the pandemic,[52] 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.[50] 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.[53] Without access to the original vaccine manufacturer's know-how, reverse engineering the process is difficult and expensive with no guarantee of success.[50][54] Even if a third party succeeds, they must actually prove it. 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.[54] 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,[55] which may be too long to have any net impact on global public health.[51] 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."[56] 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. Some conclude that voluntary technology transfers are the superior option for producing more doses[50][51]—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[52]—and others describe patent waiver proposals as "more symbolic than practical".[57] 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.[58] 400 non-profit organizations and 115 members of the European Commission signed a letter urging the United States and Europe to side with the WTO members in the global south.[59] Several have pointed out that the larger issue at stake in the vaccine patent waiver debate is who will control the broader technology of RNA therapeutics.[52][60][61][62] 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.[61] 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.[62][63]

By mid-March 2021, 67 countries, mostly in Africa and the Middle East, had not yet reported any vaccinations.[64] 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.[65] 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.[66]

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.[67][68] 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.[69] 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.[69]

Sovereignty[edit]

Favored distribution of vaccines within one or a few select countries, called "vaccine sovereignty", is a criticism of some of the vaccine development partnerships,[41][43] 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 billion to secure 300 million vaccine doses for Americans, even before the AstraZeneca-Oxford vaccine or a Sanofi vaccine was proved safe or effective.[70][71][72] 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.[41]

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.[73] Unlike mRNA vaccines, which have to be stored at subzero temperatures, inactivated vaccines from Sinovac and Sinopharm require ordinary refrigeration[74] and may have more appeal in developing countries.[75]

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,[76] of which half of the doses would go to India.[77] Similar preferential homeland distribution may exist if a vaccine is manufactured in Australia.[78]

Illegal distribution[edit]

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.[79][80] Due to the long process of distribution,[81] some individuals tried to secure a more favorable position on the vaccination list, such as by bribery or making donations to hospitals.[82][83] In response, state governments imposed large fines and other penalties for violation of federal vaccine distribution guidelines.[84] A COVID-19 vaccine black market enabled some individuals to buy illegal early access to a vaccine.[85]

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.[86]

Vaccine tourism[edit]

In the later half of February 2021, it was reported that wealthy and influential people from Canada[87] and European countries flew to the United Arab Emirates to secure early access to the vaccine.[88] 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.[89] Some Canadians who maintained second homes in the United States were able to get vaccines earlier.[90]

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.[91][92][93] The U.S. state of Alaska announced in April 2021 that it would intentionally offer free vaccinations to tourists at major Alaskan airports starting June 1, 2021.[94] 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.[95]

In Europe, several travel agencies are offering "vaccine vacations".[96] The Maldives are also offering vaccines as part of holiday travel packages.[97][98]

Cost[edit]

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.[99] 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][100] 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.[101] 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".[102] From Phase I clinical trials, 84–90%[8][103] of vaccine candidates fail to make it to final approval during development, and from Phase III, 25.7% fail[103] – 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][100] In the case of the Oxford-AstraZeneca COVID-19 vaccine, 97% of this came from taxpayer money.[104]

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.[105] In December 2020, a Belgian politician briefly published the confidential prices agreed between vaccine producers and the EU:[106]

Manufacturer Vaccine Price per dose[107]
EUR USD
AstraZeneca Oxford–AstraZeneca COVID-19 vaccine €1.78
Johnson & Johnson Johnson & Johnson 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
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[edit]

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][108][77] 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.[108][109][110] Globally, supplies critical to vaccine research and development are increasingly scarce due to international competition or national sequestration.[111]

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."[112]

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.[113] 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.[108][109][114] 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][115] In September, the COVAX partnership included 172 countries coordinating plans to optimize the supply chain for a COVID‑19 vaccine,[116] 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.[117][118]

Logistics[edit]

Logistics vaccination services assure necessary equipment, staff, and supply of licensed vaccines across international borders.[119] Central logistics include vaccine handling and monitoring, cold chain management, and safety of distribution within the vaccination network.[120] 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][114] Included are logistics tools for vaccine forecasting and needs estimation, in-country vaccine management, potential for wastage, and stock management.[120]

Other logistics factors conducted internationally during distribution of a COVID‑19 vaccine may include:[108][121][122]

  • 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.[123] If the vaccine supply chain fails, the economic and human costs of the pandemic may be extended for years.[110]

Manufacturing capacity[edit]

COVID-19 vaccine production by country (as at 3 March 2021)[124]
Country Doses (millions)
China 141.6
United States 103
Germany/Belgium 70.5
India 42.4
United Kingdom 12.2
Netherlands/Belgium 10.5
Russia 10.5
Switzerland 5.5
South Korea 1.6
South Africa 1.1
Brazil 0.2

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.[77][123][125] 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.[77] 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.[116] 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][123][77][126]

After joining COVAX in October, China initially stated that it would produce 600 million vaccine doses before the end of 2020 and another one billion doses in 2021.[127] Sinopharm said it has the capacity to produce 1 billion doses of BBIBP-CorV in 2021,[128] while its Dubai partner G42 Healthcare aimed to produce up to 100 million doses in 2021 focused on the middle east.[129] Sinovac aimed to complete a second production line by February 2021 to increase production of CoronaVac to 1 billion doses a year,[128] while its Brazilian partner Instituto Butantan planned to produce 100 million doses,[130] and its Indonesian partner Bio Farma planned to produce up to 250 million doses a year.[131] CanSino Biologics's Ad5-nCoV is also expecting to have a production capacity of 500 million doses in 2021.[132]

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.[77]

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."[133] Preparing for high demand in manufacturing vials, an American glass producer invested $163 million in July for a vial factory.[134] Glass availability for vial manufacturing and contaminant control are issues of concern,[135] indicating higher production costs with lower profit potential for developers amid demands for vaccines to be affordable.[12][77][110]

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.[136]

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.[77][123] The scale of the COVID‑19 vaccine supply chain is expected to be vast to ensure delivery worldwide to vulnerable populations.[3][109] Priorities for preparing facilities for such distribution include temperature-controlled facilities and equipment, optimizing infrastructure, training immunization staff, and rigorous monitoring.[109][112][117] RFID technologies are being implemented to track and authenticate a vaccine dose from the manufacturer along the entire supply chain to the vaccination.[137]

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.[138] 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.[139] 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.[139] Lonza's site in Portsmouth, New Hampshire, aimed to start making vaccine ingredients exclusively for the U.S. by November 2020.[139] 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.[140]

Cold chain[edit]

See also: ULT freezer
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),[141] must be used within five days of thawing,[141] and has a minimum order of 975 doses, making it unlikely to be rolled out in settings other than large, well-equipped hospitals.[142] The Moderna vaccine vials require storage above −40 °C (−40 °F) and between −25 and −15 °C (−13 and 5 °F).[143] Once refrigerated, the Moderna vaccine can be kept between 2 and 8 °C (36 and 46 °F) for up to 30 days.[143]

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).[122][144] 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.[144] Freezing damage and inadequate training of personnel in the local vaccination process are major concerns.[145] 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.[144] Sinopharm and Sinovac's vaccines are examples of inactivated vaccines in Phase III testing which can be transported using existing cold chain systems at 2–8 °C (36–46 °F).[146][147]

modRNA vaccine technologies in development may be more difficult to manufacture at scale and control degradation, requiring ultracold storage and transport.[110] 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),[148] but the Pfizer-BioNTech RNA candidate requires storage between −80 and −60 °C (−112 and −76 °F),[141] or colder throughout deployment until vaccination.[149][150] 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.[151]

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][152] 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.[108][152] 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][117][153]

Air and land transport[edit]

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.[109][113][154] "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.[154]

For the severe reduction in passenger air traffic during 2020, airlines downsized personnel, trimmed destination networks, and put aircraft into long-term storage.[109][154] 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.[117][154]

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.[157]

Security and corruption[edit]

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.[114][158] 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".[159] Anticorruption, transparency, and accountability safeguards are being established to reduce and eliminate corruption of COVID‑19 vaccine supplies.[158][160] 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.[158] Tracking system technologies for packaging are being used by manufacturers to trace vaccine vials across the supply chain,[114] and to use digital and biometric tools to assure security for vaccination teams.[137][161] 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.[162] Further, vaccines which require constant freezing temperatures are also susceptible to sabotage.[159]

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".[156]

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.[159]

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".[163] On 21 January 2021, its founder, Johnny Stine, was arrested on a federal warrant charging him with introducing misbranded drugs into interstate commerce.[164]

National infrastructure[edit]

The WHO has implemented an "Effective Vaccine Management" system,[165] 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:[119][165]

  • 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[edit]

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".[166] The declaration is effective in the United States through 1 October 2024.[166]

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.[167] While the purchasing contracts with vaccine manufacturers remain secret, the manufacturers remain liable even for side-effects not known at the time of licensure.[168]

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).[169][170]

See also[edit]

Vaccine deployment by country/territory[edit]

Africa
Asia
Europe
North America
Oceania
South America

Notes[edit]

  1. ^ With a steady supply of dry ice, the Pfizer-designed containers can insulate the vaccine for up to 30 days.[155][156]

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