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COVID-19 vaccine

From Wikipedia, the free encyclopedia

A US airman receiving a COVID-19 vaccine.
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

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

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

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. As of 14 January 2021, 32.64 million doses of COVID‑19 vaccine had been administered worldwide based on official reports from national health agencies. 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, with about half of the doses purchased by high-income countries comprising only 14% of the world's population.

Background

Prior to COVID‑19, a vaccine for an infectious disease had never been produced in less than several years--and no vaccine existed for preventing a coronavirus infection in humans. 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. 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 and MERS 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. As of 2020, there is no cure or protective vaccine proven to be safe and effective against SARS in humans. There is also no proven vaccine against MERS. 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. As of March 2020, there was one (DNA based) MERS vaccine which completed Phase I clinical trials in humans and three others in progress, all being viral-vectored vaccines: two adenoviral-vectored (ChAdOx1-MERS, BVRS-GamVac) and one MVA-vectored (MVA-MERS-S).

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. 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. 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. As an example, Chinese vaccine developers and the government Chinese Center for Disease Control and Prevention began their efforts in January 2020, 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.

Vaccines by type

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. 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. 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.

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. 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.

COVID‑19 vaccine technology platforms, January 2021
Molecular platform Total number
of candidates
Number of candidates
in human trials
Number authorized in
at least one country
Number of countries
authorized
Inactivated virus 19 5 3 11
Protein subunit 80 4 1 1
Non-replicating 35 4 3 22
RNA-based 36 3 2 30
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".

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 co-formulation of the molecule into lipid nanoparticles which protect the RNA strands and helps their absorption into the cells.

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 and the Moderna COVID-19 vaccine.

Adenovirus vector vaccines

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

As of January 2021, authorized vaccines of this type are the British Oxford–AstraZeneca COVID-19 vaccine, Russian Sputnik V, and Chinese Convidicea. Vaccines in clinical trials include Ad26.COV2.S.

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.

As of January 2021, authorized vaccines of this type are the Chinese CoronaVac and BBIBP-CorV as well as the Indian Covaxin. Vaccines in clinical trials include the Valneva COVID-19 vaccine.

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.

As of January 2021, the only authorized vaccine of this type is the peptide vaccine  [ru]. Vaccines in clinical trials include the Novavax COVID-19 vaccine and RBD-Dimer. 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.

Other types

Additional types of vaccines that are in clinical trials include multiple DNA plasmid vaccines, at least two lentivirus vector vaccines, a virus-like particle, and a vesicular stomatitis virus displaying the SARS-CoV-2 spike protein.

Scientists investigated whether existing vaccines for unrelated conditions could prime the immune system and lessen the severity of COVID‑19 infection. 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.

Formulation

As of September 2020, eleven of the vaccine candidates in clinical development use adjuvants to enhance immunogenicity. 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. 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. 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. 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. The alum adjuvant initiates diverse molecular and cellular mechanisms to enhance immunogenicity, including release of proinflammatory cytokines.

Effectiveness

The effectiveness of a new vaccine is defined by its efficacy. 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. 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. As of 7 January, authorized and approved vaccines have shown efficacies ranging from 62%-90% for the Oxford–AstraZeneca vaccine (various dosage regimens) to 95% for the Pfizer-BioNTech COVID‑19 vaccine. BBV152 has not published efficacy results as of 7 January. With BBIBP-CorV, Sinopharm announced a vaccine's efficacy was 79.34%, which was lower than the 86% announced by the United Arab Emirates (UAE) on 9 December. The UAE based its results on an interim analysis of Phase III trials conducted from July. With CoronaVac, after three delays in releasing results, 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. The efficacy of the Moderna COVID-19 Vaccine is 95.6% for those aged 18 to 64.

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

Development and clinical trials

After a coronavirus was isolated in December 2019, its genetic sequence was published on 11 January 2020, triggering an urgent international response to prepare for an outbreak and hasten development of a preventive vaccine. Since early 2020, COVID-19 vaccine development has been expedited via unprecedented collaboration in the multinational pharmaceutical industry and between governments. 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. 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.

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. 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, with four vaccine candidates entering human evaluation in March (see the table of clinical trials started in 2020, below).

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. 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.

The Pfizer-BioNTech partnership submitted an EUA request to the FDA for the mRNA vaccine BNT162b2 (active ingredient tozinameran) on 20 November 2020. On 2 December 2020, the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) gave temporary regulatory approval for the Pfizer–BioNTech vaccine, 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. As of 21 December, many countries and the European Union 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. 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. A week later, they granted an EUA for mRNA-1273, the Moderna vaccine.

Deployment

COVID-19 vaccination doses administered and % share of population who have been vaccinated, 20 Jan 2021
Location Doses administered (units)
 Total
41,390,000
 United States
15,710,000(3.2%)
 China
15,000,000(0.69%)
 United Kingdom
4,720,000(6.76%)
 Israel
2,800,000(25.60%)
 United Arab Emirates
1,971,521(18.35%)
 Germany
1,220,284(1.43%)
 Italy
1,210,745(1.97%)
 Russia
1,000,000(0.69%)
 Turkey
991,858(1.13%)
 Spain
966,097(1.64%)
 India
674,835(0.03%)
 Canada
651,139(1.51%)
 Mexico
498,122(0.37%)
 Poland
495,164(1.31%)
 France
479,873(0.74%)
 Saudi Arabia
295,530(0.85%)
 Romania
235,239(1.06%)
 Argentina
200,759(0.44%)
 Denmark
177,161(2.88%)
 Sweden
146,775(0.79%)
 Austria
140,232(1.14%)
 Bahrain
122,819(8.06%)
 Belgium
112,293(0.43%)
  Switzerland
110,000(0.76%)
 Portugal
106,000(1.04%)
 Ireland
94,000(1.58%)
 Greece
84,803(0.77%)
 Netherlands
75,000(0.32%)
 Czech Republic
70,680(0.66%)

"Production Statistics". Ourworldindata.org.

As of 18 January 2021, 41.39 million doses of COVID‑19 vaccine had been administered worldwide based on official reports from national health agencies.

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

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." 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. 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. 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.

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

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. 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.

Society and culture

Misinformation

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

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".

Vaccine hesitancy

Some 10% of the public perceives vaccines as unsafe or unnecessary, refusing vaccination – a global health threat called vaccine hesitancy – which increases the risk of further viral spread that could lead to COVID‑19 outbreaks. 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.

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.

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

Vaccine Black Market

In the United States, the vaccine distribution line, while varying by state, has placed healthcare workers and senior citizens as first on the list to get the COVID-19 vaccine, while less essential workers are further down the list. Due to the long process of distribution, certain citizens have seeked to move further up the list to secure themselves a spot on the vaccine distribution list. In response, state governments have imposed large fines and other penalties for violation of federal vaccine distribution guidelines. Because of strict guidelines, a COVID-19 vaccine Black Market has developed with individuals paying a high price for illegal early access to a vaccine.

Table of vaccines

Authorized and approved vaccines

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

Vaccines authorized for emergency use or approved for full use
Vaccine candidates,
developers, and sponsors
Technology Current phase (participants)
design
Completed phase (participants)
Immune response
Authorization
Pfizer-BioNTech COVID-19 vaccine (Comirnaty)
BioNTech, Pfizer, Fosun Pharma
modRNA encapsulated in lipid nanoparticles Phase III (43,448)
Randomized, placebo-controlled.
Positive results from an interim analysis were announced on 18 November 2020 and published on 10 December 2020 reporting an overall efficacy of 95%.
Location(s): Germany, United States
Duration: Jul 2020 – Nov 2020
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.
Duration: May. 2020 –
Moderna COVID-19 vaccine
Moderna, NIAID, BARDA, CEPI
Lipid nanoparticle dispersion containing modRNA Phase III (30,000)
Interventional; randomized, placebo-controlled study for efficacy, safety, and immunogenicity.
Positive results from an interim analysis were announced on 15 November 2020 and published on 30 December 2020 reporting an overall efficacy of 94.1%.
Location(s): United States
Duration: Jul 2020 – Oct 2022
Phase I–II (720)
Dose-dependent neutralizing antibody response on two-dose schedule; undetermined durability.
Location(s): United States
Duration: Mar 2020 – Nov 2021
Oxford–AstraZeneca COVID-19 vaccine
University of Oxford, AstraZeneca, CEPI
Modified chimpanzee adenovirus vector (ChAdOx1) Phase III (30,000)
Interventional; randomized, placebo-controlled study for efficacy, safety, and immunogenicity.
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.
Location(s): Brazil (5,000), United Kingdom, India
Duration: May 2020 – Aug 2021
Phase I–II (543)
Spike-specific antibodies at day 28; neutralizing antibodies after a booster dose at day 56.
Gam-COVID-Vac (Sputnik V)
Gamaleya Research Institute of Epidemiology and Microbiology
Non-replicating viral vector (adenovirus) Phase III (40,000)
Randomized double-blind, placebo-controlled to evaluate efficacy, immunogenicity, and safety
Efficacy is stated at 91.4% based on data analysis of the final control point of clinical trials. Efficacy against severe cases of coronavirus is 100%.
Location(s): Russia, Belarus, India, Venezuela,. UAE
Duration: Aug 2020 – May 2021
Phase I–II (76)
Neutralizing antibody and T cell responses.
Location(s): Russia
Duration: Jun 2020 – Sep 2020
CoronaVac
Sinovac
Inactivated SARS-CoV-2 Phase III (33,620)
Double-blind, randomized, placebo-controlled to evaluate efficacy and safety.
Positive results from an interim analysis of a small sample were announced by Turkey on 24 December 2020, with an efficacy of 91%. Additional results were announced by Indonesia on 11 January, with an overall efficacy of 65.3%. The vaccine was 50.4% effective at preventing symptomatic infections in a Brazilian trial.
Location(s): Brazil (15,000); Chile (3,000); Indonesia (1,620); Turkey (13,000)
Duration: Jul 2020 – Oct 2021 in Brazil; Aug 2020 – Jan 2021 in Indonesia
Phase II (600)
Immunogenicity eliciting 92% seroconversion at lower dose and 98% at higher dose after 14 days
Location(s): China
Duration: May 2020 –
BBIBP-CorV
Sinopharm: Beijing Institute of Biological Products, Wuhan Institute of Biological Products
Inactivated SARS-CoV-2 (vero cells) Phase III (48,000)
Randomized, double-blind, parallel placebo-controlled, to evaluate safety and protective efficacy.
Sinopharm's internal analysis indicated a 79% efficacy.
Location(s): United Arab Emirates, Bahrain, Jordan, Argentina, Morocco, Peru
Duration: Jul 2020 – Jul 2021
Phase I–II (320)
Neutralizing antibodies at day 14 after 2 injections
Location(s): China
Duration: Apr 2020 – Jun 2020
Ad5-nCoV (Convidicea)
CanSino Biologics, Beijing Institute of Biotechnology of the Academy of Military Medical Sciences
Recombinant adenovirus type 5 vector Phase III (40,000)
Global multi-center, randomized, double-blind, placebo-controlled to evaluate efficacy, safety and immunogenicity.
Location(s): China, Argentina, Chile, Mexico, Pakistan, Russia, Saudi Arabia
Duration: Mar. – Dec. 2020, China; Sep. 2020 – Dec. 2021, Pakistan; Sep. 2020 – Nov. 2020, Russia
Phase II (508)
Neutralizing antibody and T cell responses
 [ru]
Vector
Vaccine based on peptide antigens Phase III (40,000)
Randomized double-blind, placebo-controlled to evaluate efficacy, immunogenicity, and safety
Location(s): Russia
Duration: Nov 2020 – Dec 2021
Phase I–II (100)
Simple, blind, placebo-controlled, randomized study of safety, reactogenicity and immunogenicity
Location(s): Russia
Duration: Jul 2020 – Sep 2020
BBV152 (Covaxin)
Bharat Biotech, Indian Council of Medical Research
Inactivated SARS-CoV-2 Phase III (25,800)
Randomised, observer-blinded, placebo-controlled
Location(s): India
Duration: Nov 2020 – Mar 2021
Phase I (375)
Dose-dependent neutralizing antibody response on two-dose schedule. Pending Phase II reports.

Vaccine candidates

COVID‑19 candidate vaccines in Phase I–III trials
Vaccine candidates,
developers, and sponsors
Technology Current phase (participants)
design
Completed phase (participants)
Immune response
Pending authorization
Ad26.COV2.S
Janssen Pharmaceutica (Johnson & Johnson), BIDMC
Non-replicating viral vector (adenovirus serotype 26) Phase III (40,000)
Randomized, double-blinded, placebo-controlled
Temporarily paused on 13 October 2020, due to an unexplained illness in a participant. Johnson & Johnson announced, on 23 October, that they are preparing to resume the trial in the US.
Location(s): United States, Argentina, Brazil, Chile, Colombia, Mexico, Peru, the Philippines, South Africa and Ukraine
Duration: Jul 2020 – 2023
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.
NVX-CoV2373
Novavax, CEPI
SARS-CoV-2 recombinant spike protein nanoparticle with adjuvant Phase III (45,000)
Randomised, observer-blinded, placebo-controlled trial
Location(s): UK, India (15,000); US, Mexico (30,000)
Duration: Sep 2020 – Jan 2021 (UK, India); Dec 2020 – Mar 2021 (US, Mexico)
Phase I–II (131)
IgG and neutralizing antibody response with adjuvant after booster dose.
ZF2001 (RBD-Dimer)
Anhui Zhifei Longcom Biopharmaceutical Co. Ltd.
Recombinant subunit vaccine Phase III (29,000)
Randomized, double-blind, placebo-controlled
Location(s): China, Ecuador, Indonesia, Malaysia, Pakistan, Uzbekistan
Duration: Dec 2020 – Apr 2022
Phase II (900)
Interventional; randomized, double-blind, placebo-controlled
Location(s): Chongqing
Duration: Jun 2020 – Sep 2021
Zorecimeran (CVnCoV)
CureVac, CEPI
Unmodified RNA vaccine Phase III (36,500)
Phase 2b/3: Multicenter efficacy and safety trial in adults
Location(s): Argentina, Belgium, Colombia, Dominican Republic, France, Germany, Mexico, Netherlands, Panama, Peru, Spain
Duration: Nov 2020 – ?
Phase I–II (944)
Phase 1 (284): Partially blind, controlled, dose-escalation to evaluate safety, reactogenicity and immunogenicity.
Phase 2a (660):Partially observer-blind, multicenter, controlled, dose-confirmation.
Location(s): Belgium (P1), Germany (P1), Panama (2a), Peru (2a)
Duration: Jun 2020 – Oct 2021
ZyCoV-D
Cadila Healthcare
DNA plasmid expressing SARS-CoV-2 S protein Phase III (26,000)
Location(s): India
Duration: Jan 2021 – ?
Phase I–II (1,000)
Interventional; randomized, double-blind, placebo-controlled
Location(s): India
Duration: Jul 2020 – Jan 2021
CoVLP
Medicago, GSK
Recombinant, plant-based virus-like particles with AS03 Phase II–III (30,612)
Event-driven, randomized, observer blinded, placebo-controlled
Location(s): Canada
Duration: Nov 2020 – Apr 2022
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)
The Israel Institute for Biological research
Recombinant vesicular stomatitis virus Phase II (1,000)
Location(s): Israel
Duration: Dec 2020 – spring 2021
Phase I (80)
Subjects (18-55 years old) randomly receiving a single administration of IIBR-100 at the low, mid, or high dose of saline or two administrations at a low dose, or saline, 28 days apart.
Location(s): Israel
Duration: Oct – Nov 2020
INO-4800
Inovio, CEPI, Korea National Institute of Health, International Vaccine Institute
DNA plasmid delivered by electroporation Phase I–II (40)
Location(s): United States, South Korea
Duration: Apr–Nov 2020
Preclinical
Pending Phase I report.
Unnamed
Chinese Academy of Medical Sciences
Inactivated SARS-CoV-2 Phase I–II (942)
Randomized, double-blinded, single-center, placebo-controlled
Location(s): Chengdu
Duration: Jun 2020 – Sep 2021
AG0301-COVID‑19
AnGes Inc., AMED
DNA plasmid Phase I–II (30)
Non-randomized, single-center, two doses
Location(s): Osaka
Duration: Jun 2020 – Jul 2021
Lunar-COV19/ARCT-021
Arcturus Therapeutics
mRNA Phase I–II (92)
Randomized, double-blinded
Location(s): Singapore
Duration: Aug 2020 – ?
VLA2001
Valneva
Inactivated SARS-CoV-2 Phase I–II (150)
Randomized, multi-center, double-blinded
Location(s): United Kingdom
Duration: Dec 2020 – Feb 2021
COVID‑19/aAPC
Shenzhen Genoimmune Medical Institute
Lentiviral vector with minigene modifying aAPCs Phase I (100)
Location(s): Shenzhen
Duration: Mar 2020 – 2023
LV-SMENP-DC
Shenzhen Genoimmune Medical Institute
Lentiviral vector with minigene modifying DCs Phase I (100)
Location(s): Shenzhen
Duration: Mar 2020 – 2023
LNP-nCoVsaRNA
MRC clinical trials unit at Imperial College London
mRNA Phase I (105)
Randomized trial, with dose escalation study (15) and expanded safety study (at least 200)
Location(s): United Kingdom
Duration: Jun 2020 – Jul 2021
GRAd-COV2
ReiThera, Lazzaro Spallanzani National Institute for Infectious Diseases
Modified chimpanzee adenovirus vector (GRAd) Phase I (90)
Subjects (two groups: 18-55 and 65-85 years old) randomly receiving one of three escalating doses of GRAd-COV2 or a placebo, then monitored over a 24-week period. 92.5% of subjects who received GRAd-COV2 developed anti-bodies.
Location(s): Rome
Duration: Aug – Dec 2020
GX-19
Genexine consortium, International Vaccine Institute
DNA Phase I (40)
Location(s): Seoul
Duration: Jun 2020 – Jun 2022
SCB-2019
Clover Biopharmaceuticals, GSK, CEPI
Spike protein trimeric subunit with AS03 Phase I (150)
Location(s): Perth
Duration: Jun 2020 – Mar 2021
COVAX-19
Vaxine Pty Ltd
Recombinant protein Phase I (40)
Location(s): Adelaide
Duration: Jun 2020 – Jul 2021
Unnamed
PLA Academy of Military Science, Walvax Biotech
mRNA Phase I (168)
Location(s): China
Duration: Jun 2020 – Dec 2021
HGC019
Gennova Biopharmaceuticals, HDT Biotech Corporation
mRNA Phase I (120)
Location(s): India
Duration: Jan 2021 –
Unnamed
Biological E. Limited, Baylor College of Medicine
Inactivated SARS-CoV-2 using an antigen Phase I–II (360)
Randomized, Parallel Group Trial
Location(s): India
Duration: Nov 2020 – Feb 2021
SARS-CoV-2 Sclamp/V451
UQ, Syneos Health, CEPI, Seqirus
Molecular clamp stabilized spike protein with MF59 Terminated (120)
Randomised, double-blind, placebo-controlled, dose-ranging.
False positive HIV test found among participants.
Location(s): Brisbane
Duration: Jul–Oct 2020
  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.
  3. Serum Institute of India will be producing the ChAdOx1 nCoV-19 vaccine for India and other low and middle income countries.
  4. Oxford name: ChAdOx1 nCoV-19. Manufacturing in Brazil to be carried out by Oswaldo Cruz Foundation.
  5. Latest Phase with published results.
  6. Virus-like particles grown in Nicotiana benthamiana
  7. South Korean Phase I–II in parallel with Phase I in the US

See also

References

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Further reading

Vaccine protocols

External links