India’s approval of homegrown virus vaccine criticised over lack of data

India’s approval of homegrown virus vaccine criticised over lack of data

India drug regulator approves AstraZeneca Oxford vaccine

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.

CRITICISM

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