BackAfter Serum, Bharat Biotech seeks emergency use authorisation for its Covid vaccine
Bharat Biotech is the third company after Pfizer, Serum to seek emergency use authorisation nod for Covid vaccine in IndiaThe Hyderabad-based vaccine maker is currently conducting a Phase-3 clinical trial to determine the efficacy of its vaccine, involving 26,000 participants across more than two dozen sites
PremiumBharat Biotech International Ltd on Monday applied to the Drug Controller General of India V. G. Somani for restricted emergency use for its Covid-19 vaccine Covaxin, a senior government official told Mint.
“Bharat Biotech today applied for the restricted emergency use of their vaccine. The SEC (Subject Expert Committee) may look at the proposal this week itself along with applications from Serum and Pfizer, and a decision on this will be taken in two weeks," the official said, on condition of anonymity.
While it was not clear which data the company has submitted, the company had begun its Phase 3 efficacy trial only in mid-November and participants who have been screened and found eligible receive two intramuscular injections 28 days apart.
With none of the participants expected to receive both doses in the country’s largest efficacy trial, Bharat Biotech may have submitted data from its Phase 1 and 2 trials, after observing that the vaccine’s efficacy is robust.
As per clinical trial regulations, a company can apply for an accelerated approval process if it observes “remarkable efficacy" with a defined dose in the Phase 2 clinical trial and there is an unmet medical need of serious and life threatening disease in the country.
The Hyderabad-based vaccine maker’s application for emergency use authorisation is the third in as many days, following Pfizer on Saturday and Serum Institute of India on Sunday.
“Bharat Biotech today applied for the restricted emergency use of their vaccine. The SEC (Subject Expert Committee) may look at the proposal this week itself along with applications from Serum and Pfizer, and a decision on this will be taken in two weeks," the official said, on condition of anonymity.
Bharat Biotech’s vaccine is the first indigenously developed vaccine, which has sought an emergency application. Serum Institute’s vaccine was originally developed by the University of Oxford and British firm AstraZeneca plc, and the Pune-based firm is conducting 1,600-participant phase 3 trial for the vaccine that it will be contract manufacturing for India and other low- and middle-income countries.
In contrast, Bharat Biotech is conducting a Phase-3 clinical trial to determine the efficacy of its vaccine, which will involve 26,000 participants across more than two dozen sites in the country.
Interestingly, the trial, the country’s largest efficacy trial, had only begun in mid-November and participants who have been screened and found eligible receive two intramuscular injections 28 days apart.
Also, of the 26 sites that are conducting trials, six of them are yet to receive approval from their respective institutional ethics committees (IEC). As per clinical trial norms, every site has an IEC which is tasked with ensuring that trial protocols are followed and safety of participants is ensured.
The company is spending around ₹150 crore on the phase 3 trials and another ₹120-150 crore in setting up a new facility that will be operational by December.
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