Candidate: COVAXIN™

Category: VAX

Type: Whole-virion, inactivated SARS-CoV-2 vaccine manufactured using a Vero Cell manufacturing platform and inactivated with alum as adjuvant

2021 Status: EUA REQUEST TO FDA—Ocugen said November 5 that it submitted to the FDA a request for Emergency Use Authorization of COVAXIN™ (BBV152 in the U.S.) for pediatric use. The submission was based on results of a Phase II/III trial conducted by Ocugen’s partner Bharat Biotech in India with 526 children 2-18 years of age, which bridged immunogenicity data to a large, Phase III safety and efficacy clinical trial in nearly 25,800 adults in India. Among the 526 participants, no serious adverse effects, such as deaths, hospitalizations, myocarditis, pericarditis, Guillain-Barre syndrome, vaccine-induced thrombotic thrombocytopenia or anaphylactic reactions were reported in the study, Ocugen said.

Neutralizing antibody responses against wild-type strain in the pediatric age group of 2-18 years were equivalent to those seen in adults, ages 18+ years, in Bharat Biotech’s large Phase III efficacy and safety trial, Ocugen added.

WHO ADDS COVAXIN TO EUL—The World Health Organization’s technical committee on November 3 approved Bharat Biotech’s request to add COVAXIN to the agency’s Emergency Use Listing (EUL). “Covaxin has been cleared for use in all age groups (18+) over two doses spaced four weeks apart. However, no recommendation has been made for use on children, and available data for use on pregnant women is insufficient to assess safety or efficacy,” the WHO stated.

Ocugen Applies for IND—Ocugen said October 27 that it submitted an IND application with the FDA to evaluate COVAXIN, which will be named BBV152 within U.S. The Phase III trial proposed in the IND is designed to establish whether the immune response experienced by participants in a completed Phase 3 efficacy trial in India is similar to that observed in a demographically representative, healthy adult population in the U.S. who either have not been vaccinated for COVID-19 or who already received two doses of an mRNA vaccine at least six months earlier.

“Cannot Cut Corners”–The World Health Organization said October 18 it was expecting additional information from Bharat Biotech as it continues to assess Bharat Biotech’s request to include COVAXIN in the agency’s Emergency Use Listing (EUL).

“We are aware that many people are waiting for WHO’s recommendation for Covaxin to be included in the #COVID19 Emergency Use Listing, but we cannot cut corners,” the WHO tweeted. “Before recommending a product for emergency use, we must evaluate it thoroughly to make sure it is safe and effective.”

WHO chief scientist Soumya Swaminathan said that the agency’s technical advisory group will meet October 26 to decide on the EUL.

Development-Supply Agreement—Ocugen disclosed in an October 4 regulatory filing that it entered into a development-and-supply agreement through which Bharat Biotech committed to exclusively manufacturing and supplying Ocugen with COVAXIN™ clinical trial materials as well as drug product components and finished drug product “as necessary” for commercial supply of COVAXIN™ following regulatory approval. The value of the agreement was not disclosed.

77.8% Effectiveness Reported—COVAXIN showed 77.8% effectiveness in Phase III data under review by a subject expert committee of the Drugs Controller General of India (DCGI), according to unnamed government sources cited June 22 by India’s ANI news agency. The trial evaluated the vaccine on 25,800 subjects. COVAXIN is one of three COVID-19 vaccines being administered in India.

U.S. Manufacturing Partnership—Ocugen on June 15 announced that it selected Jubilant HollisterStier of Spokane, WA, as its manufacturing partner for COVAXIN to prepare for potential commercial manufacturing of COVAXIN for the U.S. and Canada. The value of the partnership was not disclosed.

FDA Submission, BARDA Talks—Ocugen said May 7 that it submitted to the FDA key information and data as a Master File for agency review prior to a planned emergency use authorization (EUA) application once additional data is received from Bharat Biotech from an ongoing Phase III trial. Ocugen is also in discussions with the U.S. Biomedical Advanced Research and Development Authority (BARDA) regarding potential U.S. government support of COVAXIN.

Ocugen said May 3 that scientists at Indian Council of Medical Research (ICMR)-National Institute of Virology have found that COVAXIN showed potential effectiveness against the Brazil variant of SARS-CoV-2, B.1.128.2. A study conducted by ICMR earlier had also suggested that COVAXIN was effective against the UK variant, B.1.1.7, as well as the Indian double mutant variant, B.1.617. The Brazilian variant includes the E484K mutation that was found in New York.

In the ICMR studies, COVAXIN-vaccinated sera effectively neutralized several SARS-CoV-2 variants (B.1.617 (India, double mutant), B.1.1.7 (United Kingdom), B.1.1.28 (Brazil P2), and heterologous strain) in an in-vitro plaque reduction neutralization assay. The studies suggested that COVAXIN vaccination may be effective against multiple SARS-CoV-2 variants, Ocugen said.

100% Efficacy Reported—Ocugen said April 21 that its partner in developing COVAXIN, Bharat Biotech, shared positive results from a second interim analysis of its Phase III study (NCT04641481) in which COVAXIN showed a vaccine efficacy in mild, moderate, and severe COVID-19 disease of 78%, with efficacy against severe COVID-19 disease alone of 100%.

The Phase III trial enrolled 25,800 participants between 18-91 years of age in India, including 2,433 over the age of 60 and 4,500 with comorbidities. The trial’s primary endpoint was based on the first occurrence of PCR-confirmed symptomatic (mild, moderate, or severe) COVID-19 with onset at least 14 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline.

The second interim analysis was based on accruing more than 87 symptomatic cases of COVID-19, but instead evaluated 127 cases due to a recent surge in cases in India. The trial will be continuing to its pre-planned conclusion, Bharat and Ocugen said.

EUA, 100M U.S. Doses Planned—Ocugen Chairman of the Board, CEO, and Co-founder Shankar Musunuri, PhD, MBA, told Reuters March 15 that his company plans to sell 100 million doses of India’s state-backed COVID-19 vaccine COVAXIN in the U.S. this year. He said Ocugen aims to seek emergency use authorization (EUA) in April from the FDA—with which the company has held initial talks—then launch the Indian-developed vaccine in the U.S. later in the second quarter, initially importing doses before starting production there.

Drugs Controller General of India, V.G. Somani, head of the country’s Central Drugs Standard Control Organisation (CDSCO), removed the “clinical trial mode” emergency authorization status from COVAXIN at the recommendation March 10 of a subject expert committee. The change came a week after Bharat Biotech disclosed positive interim data from its ongoing Phase III trial showing an efficacy of 80.6% for two doses given four weeks apart. Those results, plus the granting of full authorization, are expected to increase uptake of the vaccine.

Ocugen and Bharat Biotech said February 2 that entered into a definitive agreement to co-develop, supply, and commercialize Bharat Biotech’s COVAXIN™, for the U.S market. , Ocugen will have US rights to the vaccine candidate and will be responsible for clinical development, regulatory approval (including Emergency Use Authorization or EUA) and commercialization for the U.S. market. Bharat Biotech will supply initial doses to be used in the U.S. upon Ocugen’s receipt of an EUA. In addition, Bharat Biotech will support the technology transfer for manufacturing in the U.S.

In return for the exclusive license to the U.S. market, Ocugen agreed to share the profits from the sale of COVAXIN in the US market with Bharat Biotech, with Ocugen retaining 45% of the profits.

Ocugen’s Vaccine Scientific Advisory Board and Ocugen management have initiated discussions with the FDA and the Biomedical Advanced Research and Development Authority (BARDA) to develop a regulatory path to EUA and, eventually, biologics license application (BLA) approval in the U.S. for COVAXIN. Ocugen said it was also in active discussions with manufacturers in the US to produce a significant number of doses of COVAXIN to support its U.S. immunization program.

2020 Status: Bharat Biotech joined Ocugen December 22 to announce the companies signed a binding letter of intent (LOI) to co-develop COVAXIN for the United States market. Ocugen will have U.S. rights to COVAXIN and, in collaboration with Bharat Biotech, will oversee clinical development, registration, and commercialization in the U.S. The companies said they will finalize details of their definitive agreement “in the next few weeks.”

Ocugen said it assembled a Vaccine Scientific Advisory Board featuring leading academic and industry experts to evaluate the clinical and regulatory path to approval in the U.S. As of December 22, COVAXIN has been evaluated in approximately 1,000 subjects in Phase I and Phase II clinical trials in India, with promising safety and immunogenicity data. The vaccine candidate is also currently part of a Phase III trial in India involving 26,000 volunteers.

COVAXIN could be launched as early as February 2021, months ahead of schedule, based on the success of late-stage trials that began in November 2020 a senior Indian government scientist told Reuters on November 5. Hyderabad-based Bharat is developing COVAXIN, India’s first home-grown COVID-19 vaccine candidate, with the government-run Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV), from which Bharat obtained a strain of virus for viro-cell culture.

“The vaccine has shown good efficacy,” senior ICMR scientist Rajni Kant, who is also a member of its COVID-19 task force, said at the research council’s New Delhi headquarters. “It is expected that by the beginning of next year, February or March, something would be available.”

COVAXIN was originally expected to reach patients in the second quarter of 2021. Bharat received Drugs Controller General of India (DCGI) approval in July for Phase I and Phase II trials, and later received DCGI approval for Phase III clinical trials in 26,000 participants in over 25 centers across India.

The combined patient population of the Phase I and II trials was initially set at 1,125 participants—375 in Phase I and 750 in Phase II. However, the Phase II population was nearly halved to 380 volunteers. Bharat has not said why, though Gagandeep Kang, professor at Christian Medical College Vellore, told India’s Business Standard in October that the positive immunogenicity data reported in Phase I may have been a reason.

The principal investigator of the Phase I trial, Savita Verma, MBBS, at Post-Graduate Institute of Medical Sciences, Rohtak told India’s Economic Times that no adverse events were reported in subjects vaccinated at the site: “As of now, we know that it is safe.”

Krishna Ella, PhD, Bharat’s chairman & managing director, told India’s Financial Express on July 4 he was confident the company could develop and bring COVAXIN to patients in 2021: “Absolutely you can be confident. Definitely, you will have a vaccine from us, that’s for sure.”

COVAXIN is one of three COVID-19 vaccines Bharat is developing. The other two are being developed with Thomas Jefferson University and the University of Wisconsin-Madison.

COVID-19: 300 Candidates and Counting

To navigate through the >300 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:

FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.

DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data

KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.

TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.

GEN has also tagged the most common treatment types:



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