A subject expert committee (SEC) for examining Serum Institute's application for Covishield, the Indian version of the Oxford-AstraZeneca candidate is meeting on Wednesday, according to government sources. The SEC has the mandate to examine the data submitted by the vaccine developer and make recommendations to the DCGI, who makes the final decision for the accelerated approval in India.
Recommendations from the SEC are expected later in the day, sources say.
The decision to hold the meeting comes shortly after the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK granted emergency approval to the Oxford-Astrazeneca vaccine. Earlier in December, the SEC had asked Serum Institute of India for additional data for its application to be considered further. The SEC had asked for updated safety data of the Phase II/III clinical trial in the country, immunogenicity data from the clinical trial in the UK and India, and the outcome of the assessment of UK- MHRA for grant of EUA.
In the first trials of the Oxford vaccine, the shots were found to be 62 per cent effective overall. One group accidentally given a half-dose first was 90 per cent protected, early results had shown. In India, in the phase 2/3 trials conducted by Serum Institute of India and ICMR, two full doses were given to 1,600 participants. However, the results of the interim analysis with the two full dose regimen in India have not yet been published yet.
