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