New Delhi: The Subject Expert Committee set up by the CDSCO, the Drugs Controller General of India, will on Wednesday afternoon examine the data submitted by three companies studying the Emergency Use Authorisation (EUA) for Covid-19 vaccine by Bharat Biotech, Pfizer and Serum Institute of India.
The first process will be the presentation of data that will reflect the safety profile of the vaccine candidate. “From quality to efficacy of the vaccine all aspects would be studied in two hours,” said an official not wanting to be named.
The onus to show proven clinical evidence is on the vaccine developing company. The Subject Expert Committee will have a series of questions and there is a considerable back and forth expected. If satisfied, the SEC would put the file on the regulator’s table and the power to grant the emergency use authorisation lies solely with the DCGI.
There could be a scenario where the vaccine developing company would be given a query form and asked to submit more information. There is also a possibility of allowing emergency use but on a conditional basis. The vaccine developing company could be asked to get healthy people receiving the vaccine to sign an informed consent form. It is also likely that the company would only be asked to supply to the government.
In the case of Pfizer, which does not want bridging studies, they would be asked to justify the reason for the same. “They can be given restricted use authorisation after being asked to start bridging studies side by side,” said a highly placed government source.
It is expected that one meeting of the SEC will suffice to study the data submitted, interim phase 3 in the case of Bharat Biotech. The vaccine roll out will be possible as soon as the approvals come through and as soon as the companies are in a position to supply doses to the government.
An official privy to the application form submitted by Pfizer has said that there is no question of granting them indemnity. It has been reliably learnt that Pfizer wants the Government of India to grant them indemnity , a legal protection it got in the UK.
“Every batch was studied and assessed so the UK government relented, we are not in a position to do so,” any official said.