Bharat Biotech’s COVAXIN approval faces criticism over lack of data

Some industry experts and opposition lawmakers have questioned the approval without publishing efficacy data

India on Sunday granted emergency approval to Bharat Biotech’s COVAXIN but faced questions from industry experts and opposition lawmakers after taking the step without publishing efficacy data for the homegrown coronavirus vaccine.

The news, announced by the Drugs Controller General of India (DCGI), was hailed by Prime Minister Narendra Modi and his ministers as a success in the country’s self-reliance push.

The government also approved the use of a vaccine developed by AstraZeneca and Oxford University which will be the lead vaccine in India’s immunisation programme.

COVAXIN was jointly developed with a government institute and means India joins a small list of countries to have approved their coronavirus vaccines.

Bharat Biotech has partnered with drug developer Ocugen Inc to co-develop it for the US market, and Brazil has signed non-binding letters of intent to buy the shot.

The company has said it is in discussions with more than 10 countries about COVAXIN.

“Our goal is to provide global access to populations that need it the most,” Bharat Biotech Chairman Krishna Ella said in a statement.

“COVAXIN has generated excellent safety data with robust immune responses to multiple viral proteins that persist.”

Neither the company nor India’s Central Drugs Standards Control Organisation would reveal its efficacy results. A source with knowledge of the matter told Reuters its effectiveness could be more than 60 per cent with two doses.

China also did not publish detailed efficacy data for a vaccine it authorised on Thursday but its developer has shared interim data.

“On what basis was this approval given when Bharat Biotech has NOT shown enough data proving safety & efficacy?” transparency activist Saket Gokhale asked on Twitter.

Gokhale has filed a request under India’s right-to-information law asking the government for safety and other data for the two vaccines approved on Sunday.

Serum Institute of India (SII), the local maker of the AstraZeneca shot that will be branded COVISHIELD in the country, also took a dig at the Bharat Biotech vaccine.

Reuters