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Indian approval of homemade vaccine criticizing Reuters lack of data

© Reuters. File Photo: Medic administers COVAXIN, an experimental COVID-19 vaccine backed by the Government of India, to healthcare professionals during a study in Ahmedabad.

Krishna N. Das

New Delhi (Reuters)-India gave urgent approval to Bharat Biotech’s COVAXIN on Sunday, but faced questions after taking steps without disclosing efficacy data for its homemade coronavirus vaccine.

The news released by India’s Drug Controller General (DCGI), who did not ask questions, was welcomed by Prime Minister Narendra Modi and his Minister as a success in promoting India’s independence.

The government has also approved the use of a vaccine developed by AstraZeneca (NASDAQ :) and the University of Oxford. This will be the main vaccine in India’s vaccination program until other shots are approved.

COVAXIN was developed in collaboration with a government agency, meaning that India has joined the list of a few countries to approve its own coronavirus shots.

Bharat has partnered with drug developer Ocugen (NASDAQ :) Inc to co-develop for the US market and Brazil has signed a non-binding agreement to purchase this shot.

The company says it is in talks with more than 10 countries about COVAXIN.

“This vaccine addresses the unmet medical needs during this pandemic, but our goal is to provide global access to those who need it most,” said Barrat Biotech Chairman. Krishnaela said in a statement.

“COVAXIN has generated excellent safety data with a strong immune response to persistent viral proteins.”

Neither the company nor India’s Central Pharmaceutical Standards Administration have revealed the results of its effectiveness. Sources aware of the problem told Reuters that its effectiveness could be more than 60% with two doses.

China has also not released detailed efficacy data for the vaccine approved Thursday, but its developers share interim data.

“What was the rationale for this approval when Bharat Biotech did not provide sufficient data to prove its safety and efficacy?” Transparency activist Saket Gokhale asked on Twitter.

Gokhale has submitted a request to the government for the safety and other data of the two vaccines approved on Sunday under Indian Information Rights Act.

Criticism

COVAXIN, unlike other vaccines in India, is rapidly becoming widespread. The company said it was likely to launch in the second quarter of 2021 in November, but government scientists suggested it could be in February or March.

Opposition lawmakers and former ministers on Sunday questioned the lack of transparency in approving it.

“Approval is premature and can be dangerous,” opposition lawmaker and former minister Shashi Tharoor asked Health Minister Harsh Vardhan for clarification.

“It should be avoided until the full trial is complete. India can start with the AstraZeneca vaccine in the meantime.”

Vardhan urged Indians to trust that they are following “strict protocols” to ensure the safety and efficacy of the two approved vaccines.

In India’s largest such trial, Bharat Biotech said it had recruited 23,000 volunteers from a target of 26,000 for the ongoing Phase III trial of COVAXIN, which began in November.

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Indian approval of homemade vaccine criticizing Reuters lack of data

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