Last updated September 17, 2020
In this latest update, we have included new information about the Sinovac, University of Oxford/AstraZeneca/IQVIA, Pfizer/BioNTech, and Novavax vaccines.
This vaccine tracker is a compilation of the active vaccine candidates that are being studied for coronavirus 2019 (COVID-19)
. This tracker will update periodically and will have the latest news and information.
Continue to check out the tracker and refer it as a resource.
The results of Moderna’s phase 1 trial of the mRNA-1273 vaccine against the novel coronavirus (COVID-19) were published
in The New England Journal of Medicine
, where investigators determined the vaccine induced protective responses in all 45 adult participants who received doses of 25 μg, 100 μg, or 250 μg throughout March and April 2020.
Only 25 days had passed from the time Chinese authorities shared the genetic sequence of COVID-19 to the time Moderna completed its first clinical batch of mRNA-1273, the company
The US Food and Drug Administration (FDA) granted Fast Track designation
to Moderna for their vaccine and they completed enrollment of a phase 2 trial at the end of May. This phase will enroll 600 patients in 2 cohorts, those aged 18-55 years and those aged over 55 years, and patients will receive a placebo, a 50 μg or a 250 μg dose at 2 vaccination sessions with a one-year planned follow-up period.
A phase 3 trial involving 30,000 volunteers is receiving funding from BARDA and Operation Warp Speed. Participants in the study will receive either an injection of 100 μg mRA-1273 on Days 1 and 29 or placebo.
On August 5, the company decided to modify their phase 3 protocol to include people living with HIV in the study.
On August 11, the US government announced it has purchased 100 million doses of mRNA-1273, which the company will manufacture while it is undergoing its clinical trials.
On August 26, it was reported that new interim data from the phase 1 assessment of investigative coronavirus 2019 (COVID-19) vaccine candidate mRNA-1273 showed the two-dose vaccine has tolerance across age groups and capability in inducing neutralizing antibodies in the upper-half range of convalescent serum across observed age strata.
The phase 1 trial, sponsored by the National Institutes of Health, enrolled 120 healthy adults aged ≥18 years old. For the sake of observing immunogenicity, safety, and tolerability across age groups, participants were stratified by ages 18-55 (n = 45), 56-70 (20) for two-dose administration of 25 and 100 mcg mRNA-1273, and all ages (35) for one-dose 50 mcg.
On August 28, the company confirmed it was engaged in discussions with the Ministry of Health, Labour and Welfare of Japan (MHLW) to potentially purchase 40 million or more doses of mRNA-1273.
Wuhan Institute of Biological Products; China National Pharmaceutical Group (Sinopharm)
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.
On August 10, it was reported a phase 3 clinical trial of their COVID-19 vaccine was started in Bahrain.
0n 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."
On August 20, it was reported Peru had approved a phase 3 clinical trial.
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. Notaby
, there are plans to enroll 9000 patients in the health care industry for that study.
On 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.
On August 31, according to Reuters the company received emergency use approval for its vaccine under a program in China to vaccinate high-risk groups.
On September 7, it was reported by Reuters had vaccinated 90% of its employees and their family member 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.
The University of Oxford; AstraZeneca; IQVIA
Previously known as ChAdOx1, The University of Oxford and the Oxford Vaccine Group are working toward a chimpanzee adenovirus vaccine vector known now as AZD1222.
In a phase 1/2 trial of 1,090 healthy adult volunteers aged 18-55 years, investigators will administer two treatment arms with a single dose of the vaccine or a meningococcal vaccine. A third cohort will receive AZD1222 plus a booster shot after 4 weeks, while a fourth arm will receive either the vaccine or a meningococcal vaccine plus 1 g acetaminophen every 6 hours for 24 hours.
This trial is currently recruiting, but an article in The Lancet
said that the vaccine candidate had an acceptable safety profile. A pre-print paper
said that the vaccine candidate showed an immune response in mice and pigs.
BARDA is contributing
$1 million for the development, production and delivery of the vaccine starting in September as well as a phase 3 trial including 30,000 participants. This also includes a pediatric trial, according to the plans. Operation Warp Speed is also contributing funds for phase 3.
On August 12, it was reported that Mexico and Argentina will manufacture the vaccine for Latin America. The countries will make 150 million to 250 million initial doses.
On August 19, the Australian government announced it had reached a deal with AstraZeneca for its Covid-19 vaccine, which the country will supply free of charge to its population.
On August 31, the company announced it had entered a phase 3 trial in the United States. Trial centers across the US are recruiting up to 30000 adults. Prospective participants must be at least 18 years or over, can be from diverse racial, ethnic, and geographic groups who are healthy or have stable underlying medical conditions, including those living with HIV, and who are at increased risk of infection from the SARS-CoV-2 virus.
On September 8, the vaccine studies were put on hold due to a suspected serious adverse event reaction in a UK-based participant. An AstraZeneca spokesperson said in a statement that the investigation’s pause is the result of a routine action required to occur “whenever there is a potentially unexplained illness in one of the trials.” As such, the company is now looking to expedite the review of the single event to “minimize any potential impact on the trial timeline.”
September 12: They resumed clinical trials
for coronavirus 2019 (COVID-19) candidate vaccine AZD1222 in the UK following sign-off from independent reviewers that it would be safe to do so.
Pfizer and BioNTech said in a joint press release
that their phase 1/2 trial in Germany saw their vaccine approved by the Paul-Ehrlich-Institut after testing it in 200 healthy adult participants. The Pfizer CEO said a vaccine could be available in the fall of 2020, and their most promising candidate is a modified mRNA-based vaccine called BNT162b1.
That vaccine was tested at 10 μg, 30 μg and 100 μg and the investigators wrote in a non-peer reviewed paper
that the highest doses saw adverse events, so participants did not receive a second dose. The authors believe that the well-tolerated dose could be between 10 μg and 30 μg.
BNT162b1 has received FDA Fast Track designation – as well as another vaccine candidate called BNT162b2—and the CEO told media
they may be ready for regulatory approval by the end of the year 2020.
On August 5, Pfizer Canada and BioNTech SE announced an agreement with the Government of Canada to supply their BNT162 mRNA-based vaccine candidate, subject to clinical success and Health Canada approval.
On August 20, Pfizer released this statement: “Assuming clinical success, Pfizer and BioNTech are on track to seek regulatory review of BNT162b2 as early as October 2020 and, if regulatory authorization or approval is obtained, currently plan to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021.” To read more about this news go here
September 14: Pfizer and BioNTech reported
they were planning to expand the enrollment of their phase 3 trial from 30,000 to 44,000 participants.The trial expansion is intended to include adolescents as young as 16 years of age and people living with HIV, Hepatitis C, or Hepatitis B infection, as well as provide additional safety and efficacy data.
Bacillus Calmette-Guerin (BCG) live-attenuated vaccine
University of Melbourne and Murdoch Children’s Research Institute; Radboud University Medical Center; Faustman Lab at Massachusetts General Hospital
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.
Adjuvant recombinant vaccine candidate
Anhui Zhifei Longcom Biopharmaceutical, Institute of Microbiology of the Chinese Academy of Sciences
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.
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.
On August 12, it was reported they begun conducting phase 3 trials in Saudi Arabia, after completing the first two phases of the human trials in China.
On August 17, China had awarded CanSino a patent for their vaccine.
Johnson & Johnson (Janssen)
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.
On August 18, Brazil approved human trials for this vaccine.
On September 2, it was reported Janssen had agreed in principle to supply Canada with up to 38 million doses.
Beijing Institute of Biological Products; China National Pharmaceutical Group (Sinopharm)
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
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
On August 19, it was reported the vaccine showed defense and resistance efficacy against the Covid-19 virus in two primates.
Gamaleya Research Institute, Acellena Contract Drug Research and Development
The investigation into Gam-COVID-Vac is supported by the Health Ministry of the Russian Federation. The phase 1
study is active with 18 volunteers and will assess the non-replicating viral vector vaccine candidate as a solution for intramuscular administration. A second stage of the Phase 1 trial will involve 20 volunteers vaccinated 5 days later, and all patients will have a follow-up period of 6 months.
The phase 2
trial will monitor 18 patients’ reaction to the vaccine for 5 days, followed by an additional 20 volunteers receiving the vaccine. The second stage will include a booster vaccine and follow up will last 180 days.
On August 11, it was announced a Russian healthcare regulator had approved the first vaccine for COVID-19, according to an announcement from President Vladimir Putin.
The vaccine was not previously assessed in any phase 3 testing—raising global agency concerns that the country is skipping very necessary stages of safety and efficacy research prior to administering the vaccine to at-risk populations.
Self-amplifying RNA vaccine
Imperial College London
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.
Arcturus Therapeutics and Duke-NUS Medical School
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.
On 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.
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.
Novavax announced in August its vaccine candidate, was well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. This comes from phase 1 data from its phase 1/2 randomized, observer-blinded, placebo-controlled trial. The investigational vaccine was delivered using its saponin-based Matrix-M adjuvant, which has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.
September 15: The company announced an amendment to its existing agreement with Serum Institute of India Private Limited (SIIPL) under which SIIPL will also manufacture the antigen component of NVX‑CoV2373. With this agreement, Novavax increases its manufacturing capacity of its vaccine to over two billion doses annually, when all planned capacity has been brought online by mid-2021.
adjuvanted recombinant protein-based vaccine
Sanofi and GSK
On September 3, Sanofi and GSK announced the start of a phase 1/2 clinical trial for their adjuvanted COVID-19 vaccine.
The phase 1/2 clinical trial is designed to evaluate the safety, tolerability and immune response, and is enrolling 440 Americans across 11 sites in the US.
The companies anticipate first results in early December 2020, and plan initiation of a phase 3 trial that same month. If these data are sufficient for licensure application, they will request regulatory approval in the first half of 2021.
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