COVID-19 vaccine

A COVID‑19 vaccine is a vaccine intended to provide acquired immunity against severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2), the virus causing Coronavirus disease 2019 (COVID‑19). Prior to the COVID‑19 pandemic, work to develop a vaccine against coronavirus diseases like severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS) established knowledge about the structure and function of coronaviruses; this knowledge enabled accelerated development of various vaccine technologies during early 2020.

For vaccine development and distribution, see Development of COVID-19 vaccines and Deployment of COVID-19 vaccines.

Map of countries by approval status
  Approved for general use, mass vaccination underway
  EUA (or equivalent) granted, mass vaccination underway
  EUA granted, limited vaccination
  Approved for general use, mass vaccination planned
  EUA granted, mass vaccination planned
  EUA pending
Percentage of population that has been vaccinated against COVID-19 worldwide, as of February 6, 2021.
  Over 30%
  10-29%
  Less than 10% or no data
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As of February 2021, 66 vaccine candidates are in clinical research, including 17 in Phase I trials, 23 in Phase I–II trials, 6 in Phase II trials, and 20 in Phase III trials.[1] Trials for four other candidates were terminated.[1] In Phase III trials, several COVID‑19 vaccines demonstrate efficacy as high as 95% in preventing symptomatic COVID‑19 infections. As of February 2021, ten vaccines are authorized by at least one national regulatory authority for public use: two RNA vaccines (the Pfizer–BioNTech vaccine and the Moderna vaccine), four conventional inactivated vaccines (BBIBP-CorV from Sinopharm, BBV152 from Bharat Biotech, CoronaVac from Sinovac, and WIBP from Sinopharm), three viral vector vaccines (Sputnik V from the Gamaleya Research Institute, the Oxford–AstraZeneca vaccine, and Ad5-nCoV from CanSino Biologics), and one peptide vaccine (EpiVacCorona from the Vector Institute).[1]

Many countries have implemented phased distribution plans that prioritize those at highest risk of complications, such as the elderly, and those at high risk of exposure and transmission, such as healthcare workers.[2] As of 5 February 2021, 123.54 million doses of COVID‑19 vaccine have been administered worldwide based on official reports from national health agencies.[3] Pfizer, Moderna, and AstraZeneca predicted a manufacturing capacity of 5.3 billion doses in 2021, which could be used to vaccinate about 3 billion people (as the vaccines require two doses for a protective effect against COVID‑19). By December, more than 10 billion vaccine doses had been preordered by countries,[4] with about half of the doses purchased by high-income countries comprising 14% of the world's population.[5]

Background
A US airman receiving a COVID-19 vaccine.

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

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

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

Planning and development

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

There have been several unique challenges with COVID-19 vaccine development. The rapid development and urgency of producing a vaccine for the COVID‑19 pandemic may increase the risks and failure rate of delivering a safe, effective vaccine.[25][26][27] Additionally, research at universities is obstructed by physical distancing and closing of laboratories.[28][29]

Vaccines must progress through several phases of clinical trials to test for safety, immunogenicity, effectiveness, dose levels and adverse effects of the candidate vaccine.[30][31] Vaccine developers have to invest resources internationally to find enough participants for Phase II–III clinical trials when the virus has proved to be a "moving target" of changing transmission rate across and within countries, forcing companies to compete for trial participants;[32] clinical trial organizers may encounter people unwilling to be vaccinated due to vaccine hesitancy[33] or disbelieving the science of the vaccine technology and its ability to prevent infection.[34] Even as new vaccines are developed during the COVID‑19 pandemic, licensure of COVID‑19 vaccine candidates requires submission of a full dossier of information on development and manufacturing quality.[35][36][37]

Organizations

Internationally, the Access to COVID-19 Tools Accelerator is a G20 and World Health Organization initiative announced in April 2020.[38][39] It is a cross-discipline support structure to enable partners to share resources and knowledge. It comprises four pillars, each managed by two to three collaborating partners: Vaccines (also called "COVAX"), Diagnostics, Therapeutics, and Health Systems Connector.[40] The WHO's April 2020 "R&D Blueprint (for the) novel Coronavirus" documented a "large, international, multi-site, individually randomized controlled clinical trial" to allow "the concurrent evaluation of the benefits and risks of each promising candidate vaccine within 3–6 months of it being made available for the trial." The WHO vaccine coalition will prioritize which vaccines should go into Phase II and III clinical trials, and determine harmonized Phase III protocols for all vaccines achieving the pivotal trial stage.[41]

National governments have also been involved in vaccine development. Canada announced funding for 96 research vaccine research projects at Canadian companies and universities, with plans to establish a "vaccine bank" that could be used if another coronavirus outbreak occurs,[42] and to support clinical trials and develop manufacturing and supply chains for vaccines.[43] China provided low-rate loans to a vaccine developer through its central bank and "quickly made land available for the company" to build production plants.[44] Three Chinese vaccine companies and research institutes are supported by the government for financing research, conducting clinical trials, and manufacturing.[45] Great Britain formed a COVID‑19 vaccine task force in April 2020 to stimulate local efforts for accelerated development of a vaccine through collaborations of industry, universities, and government agencies. It encompassed every phase of development from research to manufacturing.[46] In the United States, the Biomedical Advanced Research and Development Authority (BARDA), a federal agency funding disease-fighting technology, announced investments to support American COVID‑19 vaccine development and manufacture of the most promising candidates.[47][48] In May 2020, the government announced funding for a fast-track program called Operation Warp Speed.[49][50]

Large pharmaceutical companies with experience in making vaccines at scale, including Johnson & Johnson, AstraZeneca, and GlaxoSmithKline (GSK), formed alliances with biotechnology companies, governments, and universities to accelerate progression to an effective vaccine.[51][52]

History
This section is an excerpt from History of COVID-19 vaccine development[edit]
COVID‑19 vaccine research samples in NIAID lab freezer. (30 January 2020)

After a coronavirus was isolated in December 2019,[53] its genetic sequence was published on 11 January 2020, triggering an urgent international response to prepare for an outbreak and hasten development of a preventive COVID-19 vaccine.[54][55][56] Since early 2020, vaccine development has been expedited via unprecedented collaboration in the multinational pharmaceutical industry and between governments.[57] By June 2020, tens of billions of dollars were invested by corporations, governments, international health organizations, and university research groups to develop dozens of vaccine candidates and prepare for global vaccination programs to immunize against COVID‑19 infection.[55][58][59][60] According to the Coalition for Epidemic Preparedness Innovations (CEPI), the geographic distribution of COVID‑19 vaccine development puts North American entities having about 40% of the activity compared to 30% in Asia and Australia, 26% in Europe, and a few projects in South America and Africa.[54][57]

In February 2020, the WHO said it did not expect a vaccine against severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2), the causative virus, to become available in less than 18 months.[61] The rapidly growing infection rate of COVID‑19 worldwide during early 2020 stimulated international alliances and government efforts to urgently organize resources to make multiple vaccines on shortened timelines,[62] with four vaccine candidates entering human evaluation in March (see the table of clinical trials started in 2020, below).[54][63]

On 24 June 2020, China approved the CanSino vaccine for limited use in the military and two inactivated virus vaccines for emergency use in high-risk occupations.[64] On 11 August 2020, Russia announced the approval of its Sputnik V vaccine for emergency use, though one month later only small amounts of the vaccine had been distributed for use outside of the phase 3 trial.[65]

The Pfizer-BioNTech partnership submitted an EUA request to the FDA for the mRNA vaccine BNT162b2 (active ingredient tozinameran) on 20 November 2020.[66][67] On 2 December 2020, the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) gave temporary regulatory approval for the Pfizer–BioNTech vaccine,[68][69] becoming the first country to approve this vaccine and the first country in the Western world to approve the use of any COVID‑19 vaccine.[70][71][72] As of 21 December, many countries and the European Union[73] have authorized or approved the Pfizer-BioNTech COVID‑19 vaccine. Bahrain and the United Arab Emirates granted emergency marketing authorization for BBIBP-CorV, manufactured by Sinopharm.[74][75] On 11 December 2020, the United States Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID‑19 vaccine.[76] A week later, they granted an EUA for mRNA-1273, the Moderna vaccine.[77][78][79]

Vaccine types
Conceptual diagram showing three vaccine types for forming SARS‑CoV‑2 proteins to prompt an immune response: (1) RNA vaccine, (2) subunit vaccine, (3) viral vector vaccine

As of January 2021, nine different technology platforms – with the technology of numerous candidates remaining undefined – are under research and development to create an effective vaccine against COVID‑19.[1][80] Most of the platforms of vaccine candidates in clinical trials are focused on the coronavirus spike protein and its variants as the primary antigen of COVID‑19 infection.[80] Platforms being developed in 2020 involved nucleic acid technologies (nucleoside-modified messenger RNA and DNA), non-replicating viral vectors, peptides, recombinant proteins, live attenuated viruses, and inactivated viruses.[6][80][81][82]

Many vaccine technologies being developed for COVID‑19 are not like vaccines already in use to prevent influenza, but rather are using "next-generation" strategies for precision on COVID‑19 infection mechanisms.[80][81][82] Vaccine platforms in development may improve flexibility for antigen manipulation and effectiveness for targeting mechanisms of COVID‑19 infection in susceptible population subgroups, such as healthcare workers, the elderly, children, pregnant women, and people with existing weakened immune systems.[80][81]

COVID‑19 vaccine technology platforms, January 2021[1]
Molecular platform[lower-roman 1] Total number
of candidates		 Number of candidates
in human trials		 Number authorized in
at least one country		 Number of countries
authorized
Non-replicating viral vector 35 4 3 32
RNA-based 36 3 2 32
Inactivated virus 19 5 3 14
Protein subunit 80 4 1 2
DNA-based 23 2 0 0
Virus-like particle 19 1 0 0
Replicating viral vector 23 0 0 0
Live attenuated virus 4 0 0 0
  1. Technologies for dozens of candidates are unannounced or "unknown".[1]

RNA vaccines
Diagram of the operation of an RNA vaccine. Messenger RNA contained in the vaccine enters cells and is translated into foreign proteins, which trigger an immune response.

An RNA vaccine contains RNA which, when introduced into a tissue, acts as messenger RNA (mRNA) to cause the cells to build the foreign protein and stimulate an adaptive immune response which teaches the body how to identify and destroy the corresponding pathogen or cancer cells. RNA vaccines often, but not always, use nucleoside-modified messenger RNA. The delivery of mRNA is achieved by a coformulation of the molecule into lipid nanoparticles which protect the RNA strands and help their absorption into the cells.[83][84][85][86]

RNA vaccines were the first COVID-19 vaccines to be authorized in the United States and the European Union. As of January 2021, authorized vaccines of this type are the Pfizer-BioNTech COVID‑19 vaccine[87][88][89] and the Moderna COVID-19 vaccine.[90][91]

Adenovirus vector vaccines

These vaccines are examples of non-replicating viral vectors, using an adenovirus shell containing DNA that encodes a SARS‑CoV‑2 protein.[92] The viral vector-based vaccines against COVID-19 are non-replicating, meaning that they do not make new virus particles, but rather produce only the antigen which elicits a systemic immune response.[92]

As of January 2021, authorized vaccines of this type are the British Oxford–AstraZeneca COVID-19 vaccine,[93][94][95] Russian Sputnik V,[96] and Chinese Convidicea. Vaccines in clinical trials include Johnson & Johnson's Ad26.COV2.S.[97][98]

Inactivated virus vaccines

Inactivated vaccines consist of virus particles that have been grown in culture and then are killed using a method such as heat or formaldehyde to lose disease producing capacity, while still stimulating an immune response.[99]

As of January 2021, authorized vaccines of this type are the Chinese CoronaVac[100][101][102] and BBIBP-CorV[103] as well as the Indian Covaxin. Vaccines in clinical trials include the Valneva COVID-19 vaccine.[104][105]

Subunit vaccines

Subunit vaccines present one or more antigens without introducing whole pathogen particles. The antigens involved are often protein subunits, but can be any molecule that is a fragment of the pathogen.[106]

As of January 2021, the only authorized vaccine of this type is the peptide vaccine EpiVacCorona.[107] Vaccines in clinical trials include the Novavax COVID-19 vaccine[108] and RBD-Dimer.[1] The V451 vaccine was previously in clinical trials, which were terminated because it was found that the vaccine may potentially cause incorrect results for subsequent HIV testing.[109][110]

Other types

Additional types of vaccines that are in clinical trials include multiple DNA plasmid vaccines,[111][112][113][114][115][116] at least two lentivirus vector vaccines,[117][118] a virus-like particle,[119] and a vesicular stomatitis virus displaying the SARS‑CoV‑2 spike protein.[120]

Scientists investigated whether existing vaccines for unrelated conditions could prime the immune system and lessen the severity of COVID‑19 infection.[121] There is experimental evidence that the BCG vaccine for tuberculosis has non-specific effects on the immune system, but no evidence that this vaccine is effective against COVID‑19.[122]

Trial and authorization status

Phase I trials test primarily for safety and preliminary dosing in a few dozen healthy subjects, while Phase II trials – following success in Phase I – evaluate immunogenicity, dose levels (efficacy based on biomarkers) and adverse effects of the candidate vaccine, typically in hundreds of people.[30][31] A Phase I–II trial consists of preliminary safety and immunogenicity testing, is typically randomized, placebo-controlled, while determining more precise, effective doses.[31] Phase III trials typically involve more participants at multiple sites, include a control group, and test effectiveness of the vaccine to prevent the disease (an "interventional" or "pivotal" trial), while monitoring for adverse effects at the optimal dose.[30][31] Definition of vaccine safety, efficacy, and clinical endpoints in a Phase III trial may vary between the trials of different companies, such as defining the degree of side effects, infection or amount of transmission, and whether the vaccine prevents moderate or severe COVID‑19 infection.[32][123][124]

A clinical trial design in progress may be modified as an "adaptive design" if accumulating data in the trial provide early insights about positive or negative efficacy of the treatment.[125][126] Adaptive designs within ongoing Phase II–III clinical trials on candidate vaccines may shorten trial durations and use fewer subjects, possibly expediting decisions for early termination or success, avoiding duplication of research efforts, and enhancing coordination of design changes for the Solidarity trial across its international locations.[125][127]

List of authorized and approved vaccines

National regulatory authorities have granted emergency use authorizations for nine vaccines. Three of those have been approved for emergency or full use by WHO-recognized stringent regulatory authorities (SRAs).

Vaccines authorized for emergency use or approved for full use
Vaccine, developers/sponsors Country of Origin Technology Current phase (participants) Completed phase[lower-alpha 1] (participants) Authorization
BBIBP-CorV[103]
Sinopharm: Beijing Institute of Biological Products, Wuhan Institute of Biological Products		 China Inactivated SARS‑CoV‑2 vaccine (vero cells) Phase III (48,000)
Randomized, double-blind, parallel placebo-controlled, to evaluate safety and protective efficacy.
Sinopharm's internal analysis indicated a 79% efficacy.[128]
Jul 2020 – Jul 2021, United Arab Emirates, Bahrain, Jordan,[129] Argentina,[130] Morocco,[131] Peru[132]		 Phase I–II (320)
Neutralizing antibodies at day 14 after two injections[133]
Apr 2020 – Jun 2020, China
Sputnik V COVID-19 vaccine
Gamaleya Research Institute of Epidemiology and Microbiology		 Russia Adenovirus vector vaccine (recombinant adenovirus type 5 and 26 vector) Phase III (40,000)
Randomized double-blind, placebo-controlled to evaluate efficacy, immunogenicity, and safety.[149]
Interim analysis from the trial was published in The Lancet, indicating 91.6% efficacy without unusual side effects.[150]
Aug 2020 – May 2021, Russia, Belarus,[151] India,[152][153] Venezuela,[154][155] UAE[156] 		Phase I–II (76)
Neutralizing antibody and T cell responses.[157]
Jun 2020[157] – Sep 2020, Russia
Pfizer–BioNTech COVID-19 vaccine (Comirnaty)[87][88][89]
BioNTech, Pfizer		 United States, Germany RNA vaccine (modRNA encapsulated in lipid nanoparticles) Phase III (43,448)
Randomized, placebo-controlled.
Positive results from an interim analysis were announced on 18 November 2020[184] and published on 10 December 2020 reporting an overall efficacy of 95%.[185][186]
Jul 2020 – Nov 2020,[187][188] Germany, United States 		Phase I–II (45)
Strong RBD-binding IgG and neutralizing antibody response peaked 7 days after a booster dose, robust CD4+ and CD8+ T cell responses, undetermined durability.[189]
May 2020 – ?
Moderna COVID-19 vaccine[90][91]
Moderna, NIAID, BARDA, CEPI		 United States RNA vaccine (modRNA encapsulated in lipid nanoparticles) Phase III (30,000)
Interventional; randomized, placebo-controlled study for efficacy, safety, and immunogenicity.
Positive results from an interim analysis were announced on 15 November 2020[236] and published on 30 December 2020 reporting an overall efficacy of 94%.[237]
Jul 2020 – Oct 2022, United States		 Phase I–II (720)[238][239]
Dose-dependent neutralizing antibody response on two-dose schedule; undetermined durability.[240][241][242]
Mar 2020 – Nov 2021, United States
Oxford–AstraZeneca COVID-19 vaccine[lower-alpha 3][lower-alpha 4][93][94][95]
University of Oxford, AstraZeneca, CEPI		 United Kingdom Adenovirus vector vaccine (modified chimpanzee adenovirus vector, ChAdOx1) Phase III (30,000)
Interventional; randomized, placebo-controlled study for efficacy, safety, and immunogenicity.[262]
Positive results from an interim analysis of four ongoing trials were announced on 23 November 2020, and published on 8 December 2020. Overall efficacy was 70%, ranging from 62% to 90% with different dosing regimens, with a peer-reviewed safety profile.[263]
May 2020 – Aug 2021, Brazil (5,000),[264] United Kingdom, India[265]		 Phase I–II (543)
Spike-specific antibodies at day 28; neutralizing antibodies after a booster dose at day 56.[266]
EpiVacCorona[107]
Vector Institute		 Russia Peptide vaccine[107] Phase III (40,000)
Randomized double-blind, placebo-controlled to evaluate efficacy, immunogenicity, and safety
Nov 2020 – Dec 2021, Russia[290] 		Phase I–II (100)
Simple, blind, placebo-controlled, randomized study of safety, reactogenicity and immunogenicity[107]
Jul 2020[107] – Sep 2020,[291] Russia
CoronaVac[100][101][102]
Sinovac		 China Inactivated SARS‑CoV‑2 vaccine Phase III (33,620)
Double-blind, randomized, placebo-controlled to evaluate efficacy and safety.
Positive results from an interim analysis of a small sample were announced by Turkey on 24 December 2020, with an efficacy of 91%.[296] Additional results were announced by Indonesia on 11 January, with an overall efficacy of 65%.[297] The vaccine was 50% effective at preventing symptomatic infections in a Brazilian trial.[298]
Jul 2020 – Oct 2021, Brazil (15,000);[299] Aug 2020 – Jan 2021, Indonesia (1,620); Chile (3,000);[300] Turkey (13,000)[301] 		Phase II (600)
Immunogenicity eliciting 92% seroconversion at lower dose and 98% at higher dose after 14 days[302]
May 2020 – July 2020, China
Ad5-nCoV (Convidicea)
CanSino Biologics, Beijing Institute of Biotechnology of the Academy of Military Medical Sciences		 China Adenovirus vector vaccine (recombinant adenovirus type 5 vector) Phase III (40,000)
Global multi-center, randomized, double-blind, placebo-controlled to evaluate efficacy, safety and immunogenicity.

In February 2021, interim analysis from global trials showed an efficacy of 65.7% against moderate cases of COVID-19 and 90.98% efficacy against severe cases.[310]
Mar–Dec 2020, China; Sep 2020 – Dec 2021, Pakistan; Sep 2020 – Nov 2020, Russia,[311] China, Argentina, Chile;[312] Mexico;[313] Pakistan;[314] Saudi Arabia[315][316]

Phase II (508)
Neutralizing antibody and T cell responses[317]
BBV152 (Covaxin)
Bharat Biotech, Indian Council of Medical Research		 India Inactivated SARS‑CoV‑2 vaccine Phase III (25,800)
Randomised, observer-blinded, placebo-controlled[320]
Nov 2020 – Mar 2021, India[321]		 Phase I (375)
Dose-dependent neutralizing antibody response on two-dose schedule. Pending Phase II reports.[322]

Vaccine candidates
COVID‑19 candidate vaccines in Phase I–III trials[1][323][324]
Vaccine candidates,
developers, and sponsors		 Country of Origin Technology Current phase (participants)
design		 Completed phase[lower-alpha 5] (participants)
Immune response		 Pending authorization
Ad26.COV2.S[97][98]
Janssen Pharmaceutica (Johnson & Johnson), BIDMC		 Netherlands, United States Adenovirus vector vaccine (adenovirus serotype 26) Phase III (40,000)
Randomized, double-blinded, placebo-controlled
Positive results from an interim analysis were announced on 29 January 2021.[325]
Jul 2020 – 2023, United States, Argentina, Brazil, Chile, Colombia, Mexico, Peru, the Philippines, South Africa, Ukraine 		Phase I–II (1,045)
Neutralizing-antibody titers against wild-type virus were detected in 90% or more of all participants on day 29 after the first vaccine dose and reached 100% by day 57 with a further increase in titers, regardless of vaccine dose or age group. Titers remained stable until at least day 71.[326]
Emergency (4)
NVX-CoV2373[108]
Novavax, CEPI		 United States Subunit vaccine (SARS‑CoV‑2 recombinant spike protein nanoparticle with adjuvant) Phase III (45,000)
Randomised, observer-blinded, placebo-controlled trial[330]
Sep 2020 – Jan 2021, UK (15,000); Dec 2020 – Mar 2021, US, Mexico, (30,000)[331] 		Phase I–II (131)
IgG and neutralizing antibody response with adjuvant after booster dose.[332]
Emergency (2)
ZF2001 (RBD-Dimer)[1]
Anhui Zhifei Longcom Biopharmaceutical Co. Ltd.		 China Subunit vaccine (recombinant) Phase III (29,000)
Randomized, double-blind, placebo-controlled[334]
Dec 2020 – Apr 2022, China, Ecuador, Indonesia, Malaysia, Pakistan, Uzbekistan[335][336] 		Phase II (900)
Interventional; randomized, double-blind, placebo-controlled[337]
Jun 2020 – Sep 2021, Chongqing
Zorecimeran (CVnCoV)
CureVac, CEPI		 Germany RNA vaccine (unmodified RNA)[338] Phase III (36,500)[339]
Phase 2b/3: Multicenter efficacy and safety trial in adults
Nov 2020 – ?, Argentina, Belgium, Colombia, Dominican Republic, France, Germany, Mexico, Netherlands, Panama, Peru, Spain		 Phase I–II (944)[340][341]
Phase I (284): Partially blind, controlled, dose-escalation to evaluate safety, reactogenicity and immunogenicity.
Phase IIa (660):Partially observer-blind, multicenter, controlled, dose-confirmation.
Jun 2020 – Oct 2021, Belgium (phase I), Germany (phase I), Panama (phase IIa), Peru (phase IIa)
ZyCoV-D[111]
Cadila Healthcare		 India DNA vaccine (plasmid expressing SARS‑CoV‑2 S protein) Phase III (26,000)[342]
Jan 2021 – ?, India[343]		 Phase I–II (1,000)
Interventional; randomized, double-blind, placebo-controlled[344][345]
Jul 2020 – Jan 2021, India
CoVLP[119]
Medicago, GSK		 Canada Virus-like particles[lower-alpha 6] (recombinant, plant-based with AS03) Phase II–III (30,612)
Event-driven, randomized, observer blinded, placebo-controlled[347]
Nov 2020 – Apr 2022, Canada 		Phase I (180)
Neutralizing antibodies at day 42 after the first injection (day 21 after the second injection) were at levels 10x that of COVID-19 survivors.
IIBR-100 (Brilife)[120]
The Israel Institute for Biological research		 Israel Vesicular stomatitis vector vaccine (recombinant) Phase II (1,000)[348]
Dec 2020 – spring 2021, Israel		 Phase I (80)[120]
Subjects (18–55 years old) randomly receiving a single administration of IIBR-100 at the low, mid, or high dose, or saline, or two administrations at a low dose, or saline, 28 days apart.
Oct–Nov 2020, Israel
FINLAY-FR-2 (SOBERANA 02)
Instituto Finlay de Vacunas		 Conjugate vaccine Phase II (910)[349]
Allocation: Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Study design: Parallel.
Jan–Mar 2021, Cuba		 Phase I (40)[350]
Allocation: Non-randomized controlled trial. Masking: Open. Control group: Uncontrolled. Study design: Adaptive, sequential
Nov 2020 – Jan 2021, Cuba
INO-4800[lower-alpha 7][112][113]
Inovio, CEPI, Korea National Institute of Health, International Vaccine Institute		 DNA vaccine (plasmid delivered by electroporation) Phase I–II (40)
Apr–Nov 2020, United States, South Korea		 Preclinical
Pending Phase I report.
Unnamed[351]
Chinese Academy of Medical Sciences		 Inactivated SARS‑CoV‑2 vaccine Phase I–II (942)
Randomized, double-blinded, single-center, placebo-controlled
Jun 2020 – Sep 2021, Chengdu		 Preclinical
AG0301-COVID‑19[114]
AnGes Inc.,[352] AMED		 DNA vaccine (plasmid) Phase I–II (30)
Non-randomized, single-center, two doses
Jun 2020 – Jul 2021, Osaka		 Preclinical
Lunar-COV19/ARCT-021[353][354]
Arcturus Therapeutics		 RNA vaccine Phase I–II (92)
Randomized, double-blinded
Aug 2020 – ?, Singapore		 Preclinical
VLA2001[104][105]
Valneva		 Inactivated SARS‑CoV‑2 vaccine Phase I–II (150)
Randomized, multi-center, double-blinded
Dec 2020 – Feb 2021, United Kingdom		 Preclinical
COVID‑19/aAPC[117]
Shenzhen Genoimmune Medical Institute[355]		 Lentiviral vector vaccine (with minigene modifying aAPCs) Phase I (100)
Mar 2020 – 2023, Shenzhen		 Preclinical
LV-SMENP-DC[118]
Shenzhen Genoimmune Medical Institute[355]		 Lentiviral vector vaccine (with minigene modifying DCs) Phase I (100)
Mar 2020 – 2023, Shenzhen		 Preclinical
LNP-nCoVsaRNA[356]
MRC clinical trials unit at Imperial College London		 RNA vaccine Phase I (105)
Randomized trial, with dose escalation study (15) and expanded safety study (at least 200)
Jun 2020 – Jul 2021, United Kingdom		 Preclinical
GRAd-COV2[357][358]
ReiThera, Lazzaro Spallanzani National Institute for Infectious Diseases		 Adenovirus vector vaccine (modified chimpanzee adenovirus vector, GRAd) Phase I (90)[359]
Subjects (two groups: 18–55 and 65–85 years old) randomly receiving one of three escalating doses of GRAd-COV2 or a placebo, then monitored over a 24-week period. 93% of subjects who received GRAd-COV2 developed anti-bodies.
Aug–Dec 2020, Rome		 Preclinical
GX-19[115][116]
Genexine consortium,[360] International Vaccine Institute		 DNA vaccine Phase I (40)
Jun 2020 – Jun 2022, Seoul		 Preclinical
SCB-2019[361][362]
Clover Biopharmaceuticals,[363] GSK, CEPI		 Subunit vaccine (Spike protein trimeric subunit with AS03) Phase I (150)
Jun 2020 – Mar 2021, Perth		 Preclinical
COVAX-19[364]
Vaxine Pty Ltd[365]		 Subunit vaccine (recombinant protein) Phase I (40)
Jun 2020 – Jul 2021, Adelaide		 Preclinical
Unnamed[366]
PLA Academy of Military Science, Walvax Biotech[367]		 RNA vaccine Phase I (168)
Jun 2020 – Dec 2021, China		 Preclinical
HGC019[368]
Gennova Biopharmaceuticals, HDT Biotech Corporation[369]		 RNA vaccine Phase I (120)[370]
Jan 2021 – ?, India		 Preclinical
Bangavax [371][372] Globe Biotech Ltd of Bangladesh RNA vaccine Phase I (100)[371][373]
Randomized, Parallel Group Trial
Feb 2021 – Feb 2022,[374] Bangladesh		 Preclinical
Unnamed[375]
Biological E. Limited, Baylor College of Medicine[376]		 Inactivated SARS‑CoV‑2 vaccine (using an antigen) Phase I–II (360)[377]
Randomized, Parallel Group Trial
Nov 2020 – Feb 2021, India		 Preclinical
Nano Covax[378]
Nanogen Pharmaceutical Biotechnology JSC		 Recombinant spike protein[379] Phase I (60)[378]
Dec 2020 – Jan 2021, Vietnam		 Preclinical
Tested on mice, hamsters, and monkeys. Approved for human clinical trials by the Vietnam Ministry of Health.[379]
PTX-COVID19-B[380]
Providence Therapeutics		 RNA vaccine Phase I (60)[380]
Jan 2021 – May 2021, Canada		 Preclinical
SARS-CoV-2 Sclamp/V451[109][110]
UQ, Syneos Health, CEPI, Seqirus		 Subunit vaccine (molecular clamp stabilized spike protein with MF59) Terminated (120)
Randomised, double-blind, placebo-controlled, dose-ranging.
False positive HIV test found among participants.
Jul–Oct 2020, Brisbane
V590[381] and V591/MV-SARS-CoV-2[382] Merck & Co. (Themis BIOscience), Institut Pasteur, University of Pittsburgh’s Center for Vaccine Research (CVR), CEPI Terminated
In phase I, immune responses were inferior to those seen following natural infection and those reported for other SARS-CoV-2/COVID-19 vaccines.[383]
  1. Latest phase with published results.
  2. US authorization also includes the three sovereign nations in the Compact of Free Association: Palau, the Marshall Islands, and Micronesia.[216][217]
  3. Serum Institute of India will be producing the ChAdOx1 nCoV-19 vaccine for India[259] and other low and middle income countries.[260]
  4. Oxford name: ChAdOx1 nCoV-19. Manufacturing in Brazil to be carried out by Oswaldo Cruz Foundation.[261]
  5. Latest Phase with published results.
  6. Virus-like particles grown in Nicotiana benthamiana[346]
  7. South Korean Phase I–II in parallel with Phase I in the US

Efficacy
Cumulative incidence curves for symptomatic COVID‑19 infections after the first dose of the Pfizer–BioNTech vaccine (tozinameran) or placebo in a double-blind clinical trial. (red: placebo; blue: tozinameran)[384]

The effectiveness of a new vaccine is defined by its efficacy.[188] In the case of COVID‑19, a vaccine efficacy of 67% may be enough to slow the pandemic, but this assumes that the vaccine confers sterilizing immunity, which is necessary to prevent transmission. Vaccine efficacy reflects disease prevention, a poor indicator of transmissibility of SARS‑CoV‑2 since asymptomatic people can be highly infectious.[385] The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) set a cutoff of 50% as the efficacy required to approve a COVID‑19 vaccine.[386][387] As of 7 January, authorized and approved vaccines have shown efficacies ranging from 62–90% for the Oxford–AstraZeneca vaccine (various dosage regimens) to 95% for the Pfizer-BioNTech COVID‑19 vaccine.[388][389] BBV152 has not published efficacy results as of 7 January.[390] With BBIBP-CorV, Sinopharm announced a vaccine's efficacy was 79%, which was lower than the 86% announced by the United Arab Emirates (UAE) on 9 December. The UAE based its results on an interim analysis of Phase III trials conducted from July.[391] With CoronaVac, after three delays in releasing results,[392] Instituto Butantan announced in January 2021 that the vaccine was 78% effective in mild cases and 100% effective against severe and moderate infections based on 220 COVID‑19 cases from 13,000 volunteers. Butantan declined to elaborate how the efficacy rate was calculated.[393] The efficacy of the Moderna COVID-19 Vaccine is 96% for those aged 18 to 64.[394] The Novavax vaccine was found to be 89% effective in the UK.[395]

At the University of Oxford, researchers have as of early February 2021 begun enrolling volunteers in an 820 person trial to evaluate the efficacy of combining two different vaccines, a mix and match approach, as opposed to using two doses of the same vaccine. The ultimate goal of the study will be find whether the mix and match method is just as or more effective than the currently used practice. The study will utilize the shot developed by Pfizer and BioNTech with the University of Oxford and AstraZeneca shot, two vaccines which rely on different methods to deliver information to the cells of the recipient. Ugur Sahin has voiced his opposition to the trial in December, stating that a study "“will use up doses that people who need them could profit from, I am not happy about this,” though Pfizer and AstraZeneca have supported the trals.[396]

SARS-CoV-2 variants
Main article: Variants of SARS-CoV-2
See also: 501.V2 variant § Vaccine evasion

In mid-December 2020, a new SARS‑CoV‑2 variant (VOC-202012/01) was identified in the UK.[397] While preliminary data indicates that this variant showed an estimated increase in reproductive number (R) by 0.4 or greater and increased transmissibility of up to 70%, there is as yet no evidence for lower vaccine effectiveness.[398]

A South African variant (501.V2) has also emerged, which is believed to be more contagious.[399]

Early results suggest that both the Pfizer and Moderna vaccines protect against the UK variant.[400] However they are less effective against the South Africa variant, with Moderna reporting that the current vaccine produced only one-sixth of the antibodies in response to the South African variant compared with the original virus. They have launched a trial of a new vaccine to tackle the South African variant.[401]

On 4 February 2021, researchers at the University of Oxford released a study detailing the efficacy of the AstraZeneca vaccine against the British variant of the virus, finding the vaccine to be 75% effective from a study of around 256 participants' blood samples. These findings are only preliminary and have yet to be peer reviewed by other scientists.[402][403]

Formulation

As of September 2020, eleven of the vaccine candidates in clinical development use adjuvants to enhance immunogenicity.[80] An immunological adjuvant is a substance formulated with a vaccine to elevate the immune response to an antigen, such as the COVID‑19 virus or influenza virus.[404] Specifically, an adjuvant may be used in formulating a COVID‑19 vaccine candidate to boost its immunogenicity and efficacy to reduce or prevent COVID‑19 infection in vaccinated individuals.[404][405] Adjuvants used in COVID‑19 vaccine formulation may be particularly effective for technologies using the inactivated COVID‑19 virus and recombinant protein-based or vector-based vaccines.[405] Aluminum salts, known as "alum", were the first adjuvant used for licensed vaccines, and are the adjuvant of choice in some 80% of adjuvanted vaccines.[405] The alum adjuvant initiates diverse molecular and cellular mechanisms to enhance immunogenicity, including release of proinflammatory cytokines.[404][405]

Deployment
[show all]
[collapse]
COVID-19 vaccine distribution by location
(as of 8 February[lower-alpha 1])[406]
Location Vaccinated[lower-alpha 2] % of pop.[lower-alpha 3]
   World[lower-alpha 4]101,574,9991.3%
 United States31,579,1009.4%
 China31,200,0002.2%
 United Kingdom12,014,28817.7%
 EU11,776,9972.7%
 India6,259,0080.4%
 United Arab Emirates4,063,86841.1%
 Brazil3,534,0041.7%
 Israel3,480,45340.2%
 Turkey[lower-alpha 5]2,610,496--
 Germany2,287,1962.7%
 France1,866,0912.8%
 Italy1,425,1792.4%
 Spain1,305,2512.8%
 Poland1,206,2123.2%
 Canada[lower-alpha 5]1,042,171--
 Russia[lower-alpha 5]1,000,000--
 Indonesia784,3180.3%
 Romania656,1773.4%
 Mexico637,0980.5%
 Chile603,5883.2%
 Serbia[lower-alpha 5]544,209--
 Morocco[lower-alpha 5]463,966--
 Saudi Arabia[lower-alpha 5]443,153--
 Netherlands[lower-alpha 5]414,198--
 Switzerland[lower-alpha 5]368,252--
 Belgium328,6232.8%
 Argentina319,3160.7%
 Greece318,0973.1%
 Portugal290,3022.9%
 Hungary289,0423.0%
 Sweden286,8532.8%
 Czech Republic256,4402.4%
 Austria210,2392.3%
 Denmark197,7103.4%
 Bahrain191,40611.3%
 Slovakia179,9953.3%
 Singapore175,0003.0%
 Finland170,3353.1%
 Sri Lanka[lower-alpha 5]160,148--
 Norway160,0763.0%
 Nepal[lower-alpha 5]158,487--
 Ireland152,2003.1%
 Lithuania78,6222.9%
 Croatia59,5931.5%
 Slovenia54,5892.6%
 Costa Rica45,8630.9%
 Bulgaria39,6460.6%
 Seychelles37,58938.2%
 Estonia35,9052.7%
 Kuwait[lower-alpha 5]35,000--
 Malta28,8376.5%
 Oman24,7730.5%
 Cyprus22,8132.6%
 Latvia17,7940.9%
 Gibraltar13,49940.1%
 Luxembourg13,2562.1%
 Iceland12,6603.7%
 Jersey11,70711.6%
 Northern Cyprus[lower-alpha 5]11,000--
 Isle of Man9,06310.7%
 Cayman Islands7,81111.9%
 Panama[lower-alpha 5]6,420--
 Ecuador6,2280.0%
 Guernsey6,1519.2%
 Bermuda[lower-alpha 5]4,897--
 Faroe Islands4,0518.3%
 Myanmar[lower-alpha 5]3,800--
 Bolivia[lower-alpha 5]3,560--
 Maldives[lower-alpha 5]3,204--
 Greenland2,5844.6%
 Monaco[lower-alpha 5]2,400--
 Egypt[lower-alpha 5]1,315--
 Andorra1,0361.3%
 Liechtenstein[lower-alpha 5]833--
 Bangladesh5670.0%
 Saint Helena[lower-alpha 5]107--
 Algeria[lower-alpha 5]30--
 Marshall Islands[407]4,6287.9%
 F.S. Micronesia[407]7,5507.2%
 Palau[407]3,10917.4%

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. Percentage of population that has received at least one dose of a COVID-19 vaccine.
  4. Some countries are not yet reporting first-dose counts. Total dose counts for these countries are not included in the World total.
  5. Data based on total doses administered, not first shot only.
These paragraphs are an excerpt from Deployment of COVID-19 vaccines[edit]

As of 8 February 2021, 134.65 million COVID‑19 vaccine doses had been administered worldwide based on official reports from national health agencies.[408]

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).[409] Individual countries producing a vaccine may be persuaded to favor the highest bidder for manufacturing or provide first-service to their own country.[410][411][412][413] Experts emphasize that licensed vaccines should be available and affordable for people at the frontline of healthcare and having the greatest need.[410][411][413] In April, it was reported that the UK agreed to work with 20 other countries and global organizations including France, Germany and Italy to find a vaccine and to share the results and that UK citizens would not get preferential access to any new COVID‑19 vaccines developed by taxpayer-funded UK universities.[414] 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.[413]

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."[415] 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.[409][416][417][418] 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.[419][420] 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.[415][417][419]

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".[421] The declaration is effective in the United States through 1 October 2024.[421]

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.[422] While the purchasing contracts with vaccine manufacturers remain secret, they do not contain liability exemptions even for side-effects not known at the time of licensure.[423]

Society and culture

Access

Nations pledged to buy doses of COVID-19 vaccine before the doses were available. Though high-income nations represent only 14% of the global population, as of 15 November 2020, they had contracted to buy 51% of all pre-sold doses. Some high-income nations bought more doses than would be necessary to vaccinate their entire populations.[424]

On 18 January 2021, WHO Director-General Tedros Adhanom Ghebreyesus warned of problems with equitable distribution: "More than 39 million doses of vaccine have now been administered in at least 49 higher-income countries. Just 25 doses have been given in one lowest-income country. Not 25 million; not 25 thousand; just 25."[425]

The Chinese Sinopharm's COVID-19 vaccine was authorized for emergency use by Bahrain and the United Arab Emirates in December 2020.[426] [427] The vaccine was widely being used in the UAE, despite pending approval from the World Health Organization. In February 2021, a report revealed that the UAE was running a pay-to-access vaccination programme to “bring tourism into the area”. The Arab country was offering access to BBIBP-CorV only to a few elite foreign tourists, making it a selling point of tourism despite a global scarcity of doses.[428]

Misinformation
Anti-vaccination activists and other people spread a variety of rumors, including overblown claims about side effects, a story about COVID-19 being spread by childhood vaccines, misrepresentations about how the immune system works, and when and how COVID-19 vaccines are made.

Vaccine hesitancy

Some 10% of the public perceives vaccines as unsafe or unnecessary, refusing vaccination – a global health threat called vaccine hesitancy[429] – which increases the risk of further viral spread that could lead to COVID‑19 outbreaks.[430] In mid-2020, estimates from two surveys were that 67% or 80% of people in the U.S. would accept a new vaccination against COVID‑19, with wide disparity by education level, employment status, race, and geography.[431]

A poll conducted by National Geographic and Morning Consult demonstrated a gender gap on willingness to take a COVID‑19 vaccine in the U.S., with 69% of men polled saying they would take the vaccine, compared to only 51% of women. The poll also showed a positive correlation between education level and willingness to take the vaccine.[432]

In an effort to demonstrate the vaccine's safety, prominent politicians have received it on camera, with others pledging to do so.[433][434][435]

See also

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Further reading

Vaccine protocols
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