Candidate: COVAXIN™

Category: VAX

Type: Inactivated SARS-CoV-2 vaccine with alum as adjuvant

2021 Status: 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:

● ANTIVIRAL
● VAX
● ANTIBODY
● RNA