The subject expert committee (SEC) of the central drugs standard control organisation (CDSCO) is likely to meet sometime this week to examine Serum Institute of India’s (SII) emergency-use authorisation (EUA) application for Oxford-AstraZeneca’s vaccine against coronavirus disease (Covid-19), according to government sources.
SII, which is manufacturing and testing the Oxford-AstraZeneca coronavirus vaccine in India, last week had submitted additional data to the national drugs regulator that it had sought for its EUA application in its last meeting on December 9.
“The subject expert committee is likely to be convened this week to go through the application. Since Pfizer had also sought a fresh date to present its case on its EUA application of its anti-Covid-19 vaccine, the committee is likely to give them time the same date,” said an official in the government in the know of things, requesting not to be identified.
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The UK Medicines and Healthcare products Regulatory Agency (MHRA) is also considering data for grant of EUA to the Oxford-AstraZeneca vaccine, and its approval for the vaccine candidate will provide an added advantage to receiving the regulatory approval in India.
It is likely that Oxford-AstraZeneca vaccine candidate may be the first anti-Covid-19 vaccine to be granted emergency-use approval in India.
Pfizer may be asked to conduct a small bridging study among the Indian population to know the vaccine candidate’s effect among local population. “Since Pfizer has not conducted a clinical trial in India for its vaccine candidate, the company may be asked to do that first. They could also get a waiver from trials as they already have EUA from other national regulators such as in the US and UK. The ultimate call, however, will be of the experts,” the official added.
CDSCO’s SEC had last convened on December 9 to examine three applications for grant of EUA—SII and Pfizer’s Covid-19 vaccine candidate as well as the Bharat Biotech-Indian Council of Medical Research vaccine candidate.
During the last meeting, the SEC indicated it may wait till MHRA’s assessment was complete and it had decided on whether to clear the vaccine in UK before the data presented by SII was reviewed.
The SEC asked the Hyderabad-based company to present efficacy data, which is likely to take longer to derive since its late stage trials began in mid-November.
Bharat Biotech is yet to reply to the regulator, the official quoted above added.