Expert panel 'analysing' Covishield data, next meeting on Jan 1: Health Ministry

Hours after the United Kingdom's regulators approved the Oxford-Astrazeneca vaccine, experts examining the vaccine's approval have withheld their nod for its Indian version.

Earlier in the day, the Subject Expert Committee (SEC) within the Central Drugs Standard Control Organisation (CDSCO) met to consider the applications for the Oxford-Serum Institute of India and Bharat Biotech candidate. However, an approval for both the candidates has been withheld. 

"The additional data and information presented by SII and Bharat Biotech Pvt. Ltd. was perused and analysed by the SEC. The analysis of the additional data and information is going on," said the union health ministry.

The expert committee is set to hold a meeting again later this week on January 1, 2021.

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.

The decision to hold the meeting today came 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. The trial in India is a safety and immunogenicity trial, which means that the vaccine candidate would be tested for safety and immune response only. The efficacy data would be based on the UK and Brazil trial results.

At the meeting today, the committee also considered the application for the Pfizer vaccine. Pfizer has asked for more time, the health ministry has said.