Pfizer, the pharma major has withdrawn their application of seeking Emergency Use Authorisation (EUA) of their COVID-19 vaccine in India. On Wednesday, a meeting of the Subject Expert Committee (SEC) under the drug regulator was conducted where Pfizer had presented its case.

The company’s spokesperson said that in the process of undertaking the Emergency Use Authorisation of its COVID-19 vaccine, Pfizer had participated in the SEC meeting of the Drug Regulatory Authority of India on 3rd February. Based on the discussions that happened at the meeting and their understanding of additional information that would be required by the regulator, the company has decided to withdraw their application for this time.

As per the government sources, as Pfizer was trying to seek a clinical trial waiver for its vaccine, the SEC did not consider their proposal and asserted on a related study that should be conducted on Indian population.

A source further said that it is proven that the Pfizer vaccine is safe. But, the purpose of the experts is to understand the vaccine’s immunogenicity and that’s the reason they want a bridging study on Indian population. The source said in a statement that they will resubmit their application. Pfizer will continue to involve the authority and resubmit the approval request with added information as it will become available in the near future.

The company spokesperson also said that they are “committed to make its vaccine available soon for use by the Government in India. It will pursue the obligatory pathway for emergency use authorization which will enable the availability of its vaccine for any future deployment.

Source: ET Healthworld