India on Sunday granted emergency approval to Bharat Biotech’s COVAXIN but faced questions after taking the step without publishing efficacy data for the homegrown coronavirus vaccine.
The news, announced by the drugs controller general of India (DCGI) who did not take questions, was hailed by Prime Minister Narendra Modi and his ministers as a success in India’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 until other shots are approved.
COVAXIN was jointly developed with a government institute and means India joins a small list of countries to have approved its own coronavirus shot.
Bharat has partnered with drug developer Ocugen Inc to co-develop it for the U.S. 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.
“While this vaccine addresses an unmet medical need during this pandemic, 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% 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.
COVAXIN has been fast-tracked like no other vaccine in India. The company said in November it was likely to be launched in the second quarter of 2021, while a government scientist had suggested it might be February or March.
Opposition lawmakers and former ministers on Sunday questioned the lack of transparency in approving it.
“Approval was premature and could be dangerous,” said opposition lawmaker and former minister Shashi Tharoor, asking Health Minister Harsh Vardhan for an explanation.
“Its use should be avoided till full trials are over. India can start with the AstraZeneca vaccine in the meantime.”
Vardhan urged Indians to trust that “stringent protocols” had been followed to ensure the safety and efficacy of the two approved vaccines.
In the largest such trial in India, Bharat Biotech said it had recruited 23,000 volunteers out of a target of 26,000 for an ongoing Phase III trial of COVAXIN which began in November.
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