In a matter of 24 hours, Bharat Biotech was able to convince the expert government panel of its Covid-19 vaccine's efficacy and safety for emergency use, as per minutes of the meeting published online.
In a meeting on January 1, a day before Bharat Biotech received the panel's approval, the committee noted that the 'efficacy' of the vaccine is 'yet to be demonstrated'.
In a matter of 24 hours, Bharat Biotech was able to convince the expert government panel of its Covid-19 vaccine's efficacy and safety for emergency use, as per minutes of the meeting published online.
An expert panel of India's central drug authority on January 2 recommended granting permission for the "restricted" use of Bharat Biotech-developed indigenous Covid-19 vaccine Covaxin in an emergency situation, especially in the context of infection by mutant strains.
However, the company and vaccine have been mired in controversy since the announcement. Experts, scientists and politicians have expressed concern about the hurried approval of the India-made vaccine without Phase III trial or sufficient data.
Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), and became the first Indian vaccine to get the Subject Expert Committee (SEC)'s nod.
The SEC -- panel which recommends the approval or rejection of drugs to the DCGI -- was initially vague about approving the vaccine, according to the minutes of meeting uploaded on Tuesday.
In a meeting on January 1, which discussed the vaccines by Serum Institute and Bharat Biotech, the committee noted that the "efficacy" of the vaccine is "yet to be demonstrated".
The committee suggested that the firm expedite its process for further consideration. "After detailed deliberation, the committee recommended that the firm should try to expedite the recruitment and may perform interim efficacy analysis for further consideration of restricted emergency use approval," it added.
On January 2, the committee noted that the firm requested for consideration of their proposal "in the wake of incidence of new mutated coronavirus infection." The firm, according to the minutes, presented "updated data" and "justification" which were not mentioned in the document.
The SEC noted the firm's pre-existing Phase I and II trial, along with its experiments on "non-human primates" where the vaccine was found to be safe -- things which it had known previously as well.
Based on these considerations, the SEC recommended 'Covaxin' for "restricted use in an emergency situation". "...after detailed deliberation, the committee recommended for grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains."
The panel also advised that Bharat Biotech can continue the on-going Phase III clinical trial and submit data emerging from the trial as and when available.
The SEC had cleared the Serum Institute of India's emergency use authorisation application for the Oxford-AstraZeneca vaccine Covishield on January 1 itself.
Based on a revised factsheet provided by the SII, the committee recommended for"grant of permission for restricted emergency use of the vaccine". Provisions for the use required that the shot for active immunisation in individuals of 18 years or more to prevent the disease and that SII should submit safety, efficacy and immunogenicity data from the ongoing clinical trials in the country and across the globe for review at the earliest.
Also, the Pune-based firm should submit the safety data including the data on adverse events following immunisation (AEFI) and the adverse event of special interest (AESI) with due analysis every 15 days for the first two months and monthly thereafter till the completion of the ongoing clinical trial in the country, according to the recommendations.
Earlier yesterday, the Health Ministry said it is prepared to roll out Covid-19 vaccine within 10 days from date of emergency use authorisation, which was issued on January 3, but noted that the final decision lies with the government.