Bharat Biotech has around 10 million vaccine doses ready, Dr. Savita Verma told NDTV (file)
New Delhi:
Covaxin, the coronavirus vaccine from Hyderabad-based Bharat Biotech, has been recommended for “restricted use in emergency situations of public interest” by a government-appointed panel, which presented its findings to the General Controller of Drugs of India on Saturday night.
The DCGI will take the last call to approve the launch of the vaccine in the country.
The recommendation from the SEC (Committee of Experts in the Field) comes despite the lack of efficacy data, to show how effective the drug is in protecting against the virus.
Covaxin has completed only two of the three phases of clinical trials; the third phase, which tests efficacy, began in November last year. Government data shows that around 25,800 people (between the ages of 18 and 55) have volunteered for the trials.
Interim results from phase I trials showed that the drug induced an immune response and had no serious side effects. Data from the phase II trials showed “tolerable safety results,” suggesting that the antibodies may persist for six to 12 months.
Dr. Savita Verma, a Haryana PGIMS pharmacology professor who is working on the vaccine, told NDTV that about 10 million doses of Covaxin are ready.
The vaccine, given in an accelerated two-dose schedule two weeks apart (instead of four), induced a neutralizing antibody (an immune response) and was well tolerated in all dose groups with no serious vaccine-related adverse events , documents accessed by NDTV.
Approval for the emergency use of a drug, which is what the panel has recommended, is generally granted if there is sufficient evidence to suggest that the drug is safe and effective.
The recommendation comes a day after the panel submitted another drug, Covishield, developed by AstraZeneca and the University of Oxford, and manufactured by the Serum Institute in Pune, for approval.
A third vaccine, developed by US pharmaceutical giant Pfizer, had also applied for emergency authorization for fuses and is currently under review by the panel.
On Saturday, the government conducted a one-day test of the vaccine delivery system to check for potential problems once the vaccine is available. The Health Ministry said drills were carried out in 116 districts, and nearly one lakh of staff received the necessary training.
Health Minister Dr. Harsh Vardhan said this morning that there should be no misconceptions about the safety of the coronavirus vaccines India plans to use. He also reiterated that there was no evidence to suggest that the vaccines could not protect against mutated strains of the virus.
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