The COVID-19 Live Vaccine Tracker

Article

Here is a compilation of the COVID-19 vaccine candidates that have achieved FDA Emergency Use Authorization, other approvals, and are in phases 1-3.

Updated January 5, 2021

In this latest update, we have included new information about several vaccines and added new sections regarding authorizations and approvals.

This vaccine tracker is a compilation of the active vaccine candidates that are being studied for coronavirus 2019 (COVID-19). This tracker will be updated periodically and will have the latest news and information.

Achieved FDA Emergency Use Authorization

The following vaccines have been granted an Emergency Use Authorization from the Food and Drug Administration (FDA).

Vaccine Name: BNT162

Company: Pfizer, BioNTech

Emergency Use Authorization: This was granted on December 11, 2020.It was approved for the prevention of coronavirus 2019 (COVID-19) in the United States.

The vaccine is authorized for persons aged 18 years and older.

Vaccine Name: mRNA-1273

Company: Moderna

Emergency Use Authorization: This was granted on December 18, 2020. It was approved for the prevention of coronavirus 2019 (COVID-19) in the United States.

The vaccine is authorized for persons aged 18 years and older.

Other Approvals and Authorizations

These vaccines have been approved in countries outside of the United States.

Vaccine Name: AZD1222

Company: The University of Oxford; AstraZeneca; IQVIA

Approval: The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) announced on December 30, 2020 that it had provided an emergency authorization of the AstraZeneca and Oxford COVID-19 vaccine, AZD1222, for individuals 18 years and older.

The company is expected to file for an Emergency Use Authorization with the FDA in January.

Vaccine Name: Gam-COVID-Vac

Company: Gamaleya Research Institute, Acellena Contract Drug Research and Development

Approval: This vaccine was approved on August 11, 2020 in Russia. At the time of its approval, this vaccine had not been scrutinized in phase 3 trial data. It has not been authorized in the United States.

Phase 3

Vaccine Name: NVX-CoV2373

Company: Novavax

Update: The company announced on December 28 it has initiated a phase 3 clinical trial, PREVENT-19, for its investigational COVID-19 vaccine, NVX-CoV2373.

The trial will be conducted in the United States and Mexico to evaluate the efficacy, safety, and immunogenicity of the vaccine candidate.

Vaccine Name: Inactivated Vaccine

Company: Wuhan Institute of Biological Products; China National Pharmaceutical Group (Sinopharm)

Update: Sinopharm and the Wuhan Institute of Virology is receiving funding from the Ministry of Science and Technology in China to develop an inactivated vaccine candidate. A phase 1/2 clinical trial of individuals ages 6 and up is underway, with a China National Biotec Group press release saying that it presented a strong antibody response.

Sinopharm initiated a phase 3 trial to evaluate their vaccine candidate in the United Arab Emirates. The country has authorized as many as 15,000 participants aged 18 to 60 years to enroll.

August 10: It was reported a phase 3 clinical trial of their COVID-19 vaccine was started in Bahrain.

August 13: A new study appeared JAMA and the authors wrote: "In this interim report of the phase 1 and phase 2 trials of an inactivated COVID-19 vaccine, patients had a low rate of adverse reactions and demonstrated immunogenicity; the study is ongoing.has been reported."

August 20: It was reported Peru had approved a phase 3 clinical trial.

October 15: it was reported that Sinpharm was offering their COVID-19 vaccines to Chinese students who were planning to go abroad, but it was also reported the program was said to be suspended.

Vaccine Name: CoronaVac

Company: Sinovac

Update: PiCoVacc, now known as CoronaVac, has shown partial and complete protection in macaques against COVID-19, according to a paper published in the journal Science. Investigators said in mice, rats, and nonhuman primates, the antibodies neutralized 10 representative SARS-CoV-2 strains. The vaccine was administered in 3 doses of 3 or 6 μg per dose.

Investigators moved forward with a phase 1/2 trial which demonstrated no serious adverse events, according to a company press release. The June statement also reported a positive immune response.

A phase 3 trial is underway in Brazil in conjunction with Instituto Butantan. There are plans to enroll 9000 patients in the health care industry for that study.

August 11: It was reported a phase 3 trial was being launched in Indonesia. They also reported that in a phase 2 study the vaccine appeared to be safe and induced detectable antibody-based immune responses.

August 31: According to Reuters the company received emergency use approval for its vaccine under a program in China to vaccinate high-risk groups.

September 7: It was reported by Reuters that Sinovac had vaccinated 90% of its employees and their family members under the country's emergency use program.

September 10: The company reported positive data from its Phase I/II clinical trial. Their vaccine showed it was safe and showed an immune response. The vaccine was well tolerated across low, medium, and high dosages and there were no reports of any serious adverse events.

September 23: The company announced it had been approved to begin a phase1/2 trial for adolescents and children in China. This investigational vaccine is already in phase 1/I2 clinical trial for adults.

This new trial is a randomized, double-blinded, and placebo-controlled trial among adolescents and children between the ages of 3-17 years old was approved by the Ethics Committee of the Hebei Provincial CDC.

November 10: Brazil has suspended Sinovac's phase 3 trial for its COVID-19 vaccine due to the appearance of a serious adverse event.

However, the Chinese company said in a statement that they believed the adverse event was not related to the vaccine.

Phase 2/3

Vaccine Name: Bacillus Calmette-Guerin (BCG) live-attenuated vaccine

Company: University of Melbourne and Murdoch Children’s Research Institute; Radboud University Medical Center; Faustman Lab at Massachusetts General Hospital

Update: A paper in March 2020 indicated that countries with pediatric Bacillus Calmette-Guerin (BCG) vaccination programs were faring better in combating the coronavirus compared to countries that did not have such a program. The paper was not peer reviewed.

BCG is intended to prevent tuberculosis in high-risk patients, but is known to help boost the immune system in fighting similar infections, such as leprosy or buruli ulcer disease, according to the World Health Organization.

Phase 3 trials in Australia and the Netherlands are both currently recruiting to assess how BCG vaccines impact health care workers’ ability to prevent the virus. And Massachusetts General Hospital is evaluating BCG’s role in type 1 diabetes and is working to secure funding to examine its effects on COVID-19 in health care workers.

Phase 2

Vaccine Name: Adjuvant recombinant vaccine candidate

Company: Anhui Zhifei Longcom Biopharmaceutical, Institute of Microbiology of the Chinese Academy of Sciences

Update: Results from a phase 1 study of an RBD-Dimer vaccine that began in June are expected in September, according to media reports.

A subsequent phase 2 clinical trial is actively recruiting and will enroll 900 subjects. They will be randomly divided into groups that will receive either: 2 doses of a low-dose vaccine, 2 doses of a high-dose vaccine, 2 doses of placebo, 3 doses of low-dose vaccine, 3 doses of high-dose vaccine, or 3 doses of placebo.

November 7: The Ministry of Innovative Development of Uzbekistan announced that the country would participate in vaccine trials with Anhui Zhifei Longcom Biopharmaceutical.

Vaccine Name: Ad5-nCoV

Company: CanSino Biologics

Update: This adenovirus type 5 vector vaccine candidate has made its way through a phase 1 trial that included 108 adult participants that received low, medium, and high doses of the vaccine. Results published in The Lancet described significantly increased antibodies by day 14 post-vaccination with a peak at 28 days post-vaccination. T-cell response peaked at 14 days post-vaccination, the study authors wrote. Side effects included pain, fever, fatigue, headache, and muscle pain present in a majority of patients.

A phase 2 trial saw immune responses at all dose levels for most participants. Reuters reported in June that China’s Central Military Commission was approved to use Ad5-nCoV for a 1-year period. It will also undergo human testing in Canada.

August 12: It was reported they begun conducting phase 3 trials in Saudi Arabia, after completing the first 2 phases of the human trials in China.

August 17: China had awarded CanSino a patent for their vaccine.

September 21: It was reported a phase 3 clinical trial was launched in Russia.

November 3: Mexico received the first doses of the Chinese pharmaceutical company's vaccine for a late stage-trial on between 10,000 and 15,000 volunteers, according to a Reuters report.

Phase 1/2

Vaccine Name: Ad26.COV2.S

Company: Johnson & Johnson (Janssen)

Update: Johnson & Johnson announced that its drug development wing, Janssen Pharmaceutical, has reached an agreement with the US Biomedical Advanced Research and Development Authority (BARDA) for the large scale manufacturing and delivery of 100 million doses of Ad26.COV2.S, an adenovirus based SARS-CoV-2 investigational vaccine.

The major vaccine candidates are adenovirus or messenger RNA based. Janssen is evaluating both 1- and 2-dose regimens of the adenovirus vector investigational vaccine.

According to J&J, the vaccine “will be provided at a global not-for-profit basis for emergency pandemic use.” The government also has the option to purchase an additional 200 million doses under a subsequent agreement.

August 18: Brazil approved human trials for this vaccine.

September 2: It was reported Janssen had agreed in principle to supply Canada with up to 38 million doses.

September 23: the company has launched the multinational phase 3 ENSEMBLE trial for its SARS-CoV-2 vaccine candidate and looking to enroll up to 60000 participants.

October 12: J&J paused their clinical trials due to an unexplained illness in a vaccine participant.

“We have temporarily paused further dosing in all our COVID-19 vaccine candidate clinical trials, including the phase 3 ENSEMBLE trial,” the company said in a statement.

The company did not offer any more information about the illness. “We must respect this participant’s privacy. We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information.”

October 23:The company announced it was preparing to resume recruitment in the Phase 3 ENSEMBLE trial of its investigational Janssen COVID-19 vaccine in the United States after a temporary pause.

The independent Data Safety and Monitoring Board (DSMB) overseeing the ENSEMBLE study has recommended resuming trial recruitment. Following consultation with the U.S. Food and Drug Administration (FDA), preparations to resume the trial in the United States, including submissions for approval by the Institutional Review Boards, are now underway. Discussions with other regulators around the world to resume the clinical trial program are progressing.

Vaccine Name: BBIBP-CorV

Company: Beijing Institute of Biological Products; China National Pharmaceutical Group (Sinopharm)

Update: This is the second of Sinopharm’s inactivated COVID-19 vaccine candidates. Study authors wrote in Cell that 2 doses of this candidate induced high levels of antibodies in animal models, including macaques, and seemed to be safe.

A post on a Chinese social media platform in May from the company indicated the vaccine could be ready for the market by the end of 2020 or early 2021, Reuters reported.

October 15: According to a study published in The Lancet, the vaccine was reported to be safe and well tolerated.

Vaccine Name: GX-19

Company: Genexine

Update: GX-19 is a DNA vaccine candidate from South Korean-based biotechnology company Genexine, 1 of 3 companies supported by the Korean government.

Their phase 1 trial is currently recruiting as many as 210 healthy participants that will receive either the vaccine or placebo. The company plans to complete their phase 1 trial within 3 months in order to move to a phase 2 trial involving multiple countries in the second half of 2020, they said in a press release.

August 19: It was reported the vaccine showed defense and resistance efficacy against the Covid-19 virus in two primates.

Vaccine Name: Self-amplifying RNA vaccine

Company: Imperial College London

Update: The British government pledged £22.5 million to help fund 2 rounds of a self-amplifying RNA vaccine against COVID-19 in April and May.

The investigators’ Phase 1 trial is actively recruiting about 300 healthy volunteers aged 18-75 years for a trial that will last 12 months. An efficacy trial planned for October will involve about 6,000 volunteers.

In June, Imperial College London announced a partnership with VacEquity Global Health designed to “accelerate global distribution,” especially to low- and middle-income countries, “and support new research.” They believe they will be ready to produce tens of millions of vaccines by 2021 stemming from this partnership, the statement continued.

October 16: Imperial reported it had agreed to a pioneering research and education collaboration with Indonesia to advance vaccine development and help tackle COVID-19.

Vaccine Name: ARCT-021

Company: Arcturus Therapeutics and Duke-NUS Medical School

Update: The Singapore Health Sciences Authority approved a COVID-19 vaccine candidate that uses self-replicating RNA and nanoparticle non-viral delivery systems, created by Arcturus Therapeutics and Duke-NUS Medical School, a leading Singapore medical school. A company statement said they plan to initiate human dosing of LUNAR-COV19 as soon as possible in up to 108 adults at various dosages.

Preclinical data showed that antibody levels increased over 50 days at LUNAR-COV19 dose levels of 0.2, 2.0, and 10 µg in animal models, the statement continued.

August 18: it was reported that Arcturus Therapeutics had executed a definitive supply agreement with the Israeli Ministry of Health, to supply its vaccine candidate to the country. Delivery to Israel of the vaccine is contingent upon achievement of near term clinical and regulatory milestones.

November 9: Based on interim Phase 1/2 results, a single 7.5 µg dose of ARCT-021, along with prime-boost regimens are selected to advance into later stage global clinical trials

Seroconversion in majority of participants receiving doses in the range of 5 µg to 7.5 µg; Geometric Mean Titer (GMT) levels for neutralizing antibodies in the range of convalescent plasma

Dose-dependent anti-spike IgG titers increased over time through approximately day 43; T cell reactivity to spike protein peptides, including receptor binding domain (RBD) observed

Favorable safety and tolerability profile in both younger (ages 21-55) and older (ages 56-80) subjects; no moderate or severe fevers

Singapore Economic Development Board (EDB) financial commitment includes $45 million up front to fund manufacture of ARCT-021 and up to an additional $175 million in vaccine purchases

Vaccine Name: ZyCoV-D

Company: Zydus Cadila

Update: India-based Zydus Cadila is investigating a plasmid DNA vaccine candidate against COVID-19. ZyCoV-D was found to induce a strong immune response in animals like mice, rats, guinea pigs and rabbits in a preclinical phase, the company said in a statement.

They added that their first human dosing would commence with a trial of 1,000 patients in mid-July.

The company said it will begin phase 2 clinical trials beginning on August 6.

Vaccine Name: Inactivated Vaccine

Company: Wuhan Institute of Biological Products; China National Pharmaceutical Group (Sinopharm)

Update: Sinopharm and the Wuhan Institute of Virology is receiving funding from the Ministry of Science and Technology in China to develop an inactivated vaccine candidate. A phase 1/2 clinical trial of individuals ages 6 and up is underway, with a China National Biotec Group press release saying that it presented a strong antibody response.

Sinopharm initiated a phase 3 trial to evaluate their vaccine candidate in the United Arab Emirates. The country has authorized as many as 15,000 participants aged 18 to 60 years to enroll.

August 10: It was reported a phase 3 clinical trial of their COVID-19 vaccine was started in Bahrain.

August 13: A new study appeared JAMA and the authors wrote: "In this interim report of the phase 1 and phase 2 trials of an inactivated COVID-19 vaccine, patients had a low rate of adverse reactions and demonstrated immunogenicity; the study is ongoing.has been reported."

August 20: It was reported Peru had approved a phase 3 clinical trial.

October 15: it was reported that Sinpharm was offering their COVID-19 vaccines to Chinese students who were planning to go abroad, but it was also reported the program was said to be suspended.

Vaccine Name: CoronaVac

Company: Sinovac

Update: PiCoVacc, now known as CoronaVac, has shown partial and complete protection in macaques against COVID-19, according to a paper published in the journal Science. Investigators said in mice, rats, and nonhuman primates, the antibodies neutralized 10 representative SARS-CoV-2 strains. The vaccine was administered in 3 doses of 3 or 6 μg per dose.

Investigators moved forward with a phase 1/2 trial which demonstrated no serious adverse events, according to a company press release. The June statement also reported a positive immune response.

A phase 3 trial is underway in Brazil in conjunction with Instituto Butantan. There are plans to enroll 9000 patients in the health care industry for that study.

August 11: It was reported a phase 3 trial was being launched in Indonesia. They also reported that in a phase 2 study the vaccine appeared to be safe and induced detectable antibody-based immune responses.

August 31: According to Reuters the company received emergency use approval for its vaccine under a program in China to vaccinate high-risk groups.

September 7: It was reported by Reuters that Sinovac had vaccinated 90% of its employees and their family members under the country's emergency use program.

September 10: The company reported positive data from its Phase I/II clinical trial. Their vaccine showed it was safe and showed an immune response. The vaccine was well tolerated across low, medium, and high dosages and there were no reports of any serious adverse events.

September 23: The company announced it had been approved to begin a phase1/2 trial for adolescents and children in China. This investigational vaccine is already in phase 1/I2 clinical trial for adults.

This new trial is a randomized, double-blinded, and placebo-controlled trial among adolescents and children between the ages of 3-17 years old was approved by the Ethics Committee of the Hebei Provincial CDC.

November 10: Brazil has suspended Sinovac's phase 3 trial for its COVID-19 vaccine due to the appearance of a serious adverse event.

However, the Chinese company said in a statement that they believed the adverse event was not related to the vaccine.

Vaccine Name: Ad5-nCoV

Company: CanSino Biologics

Update: This adenovirus type 5 vector vaccine candidate has made its way through a phase 1 trial that included 108 adult participants that received low, medium, and high doses of the vaccine. Results published in The Lancet described significantly increased antibodies by day 14 post-vaccination with a peak at 28 days post-vaccination. T-cell response peaked at 14 days post-vaccination, the study authors wrote. Side effects included pain, fever, fatigue, headache, and muscle pain present in a majority of patients.

A phase 2 trial saw immune responses at all dose levels for most participants. Reuters reported in June that China’s Central Military Commission was approved to use Ad5-nCoV for a 1-year period. It will also undergo human testing in Canada.

August 12: It was reported they begun conducting phase 3 trials in Saudi Arabia, after completing the first 2 phases of the human trials in China.

August 17: China had awarded CanSino a patent for their vaccine.

September 21: It was reported a phase 3 clinical trial was launched in Russia.

November 3: Mexico received the first doses of the Chinese pharmaceutical company's vaccine for a late stage-trial on between 10,000 and 15,000 volunteers, according to a Reuters report.

Vaccine Name: VXA-CoV2-1

Company: Vaxart

Update: Vaxart announced it has given its first participant its investigational, oral COVID-19 tablet vaccine, VXA-CoV2-1.

The company has entered a phase 1, open-label, dose-ranging trial and is expecting to finish in November of this year. The trial is going to examine the safety and immunogenicity of 2 doses of VXA-CoV2-1 in up to 48 healthy adult volunteers aged 18 to 54 years old.

All participants will be receiving the low or high dose of the VXA-CoV2-1 oral tablet at days 1 and 29. Safety, reactogenicity and immunogenicity assessments will be performed at set times during the active phase

Vaccine Name: UB-612

Company: Covaxx

Update: As of December 2020, the company reported a phase 1 trial in Taiwan was wrapping up, and the vaccine is expected to begin trials in Brazil and the United States in 2021.

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