Govt looks into new vaccine data after Pfizer, Bharat Biotech, SII seek emergency use approval

Govt had sought additional data on the vaccine candidates of companies seeking emergency use authorisation. So far, just one company has submitted this information.

Representational image of Covid vaccine | pixnio

New Delhi: The government Tuesday said the Drugs Controller General of India (DCGI) is going over additional information provided by one of the companies that had applied for emergency use authorisation (EUA) for their Covid-19 vaccine candidate.

So far, Pfizer, Bharat Biotech and Serum Institute of India (SII) have applied for EUA.

Speaking at the ministry’s briefing on Covid-19, Niti Aayog member (Health) V.K. Paul said, “Pfizer hasn’t presented its data yet, the other two companies have presented its data and were asked to furnish more data … So in our knowledge, the new data has been given from one company and that data is being examined.”

In an earlier interaction with the media, he had said that the vaccines are being examined on a “scientific basis” and that “there should be more than reasonable satisfaction about the safety, immunogenicity and effectiveness of the vaccine”.

EUA applications in the pipeline

During the press conference, Paul didn’t specify when the DCGI is likely to complete processing the applications.

“This process is sacrosanct and is driven by the scientific process, norms and SOPs. So let’s see where it takes us and once there is a decision by the regulator and the scientific groups that help take that decision, we will move forward,” he said.

On 4 December, Pfizer, whose vaccine has been authorised in the US, UK and Canada, became the first company to apply for EUA in India. Then on 6 December, Pune-based SII sought authorisation for its Oxford-AstraZeneca Covid-19 vaccine in the country. Bharat Biotech sought authorisation on 7 December.

For now, the Oxford-AstraZeneca and Bharat Biotech vaccines are in the third phase of trials.

SII has completed its phase 3 trial while Bharat Biotech, in a statement issued Tuesday, said it had recruited 13,000 of its target of 26,000 participants.