Serum Institute, Bharat Biotech Vaccines Not Cleared For Emergency Use

Due to lack of relevant data, the authorization for emergency use has not been granted to Serum Institute of India (SII) and Bharat Biotech’s Covid-19 vaccines.

Bharat Biotech had on Monday applied to the Drugs Controller General of India (DCGI) seeking emergency use authorisation for its Covid-19 vaccine Covaxin. The Pune-based SII had applied to the central drug regulator for emergency use authorisation of Astra Zeneca-Oxford’s coronavirus vaccine.

Drugs Controller General of India (DCGI) Seeking emergency took suggestion from Subject Expert Committee (SEC) on vaccine approval for the company.

While there have been different news saying that the rejection news on the vaccine approval is fake and it takes the government to hold several meetings before it can come to any decision over the vaccine approval for emergency use.

“The media report about the rejection of Serum Institute and Bharat Biotech’s emergency use authorisation of vaccine is fake,” The Union Ministry of Health and Family Welfare said in a tweet.

According to Indian rules for accelerated approval of vaccines, a company can be granted a license if regulators are satisfied with the risk-benefit ratio.