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NEW DELHI: India granted Bharat Biotech’s COVAXIN emergency approval on Sunday (January 3), but faced questions after taking the plunge without releasing efficacy data for the homegrown coronavirus vaccine.
The news, announced by India’s Drug Controller General (DCGI), who did not answer questions, was hailed by Prime Minister Narendra Modi and his ministers as a success in boosting India’s self-reliance.
The government also approved the use of a vaccine developed by AstraZeneca and the University of Oxford, which will be the main vaccine in India’s immunization program until other vaccines are approved.
COVAXIN was jointly developed with a government institute and means that India joins a small list of countries that have approved their own coronavirus vaccine.
Bharat has partnered with drug developer Ocugen Inc to jointly develop it for the US market, and Brazil has signed non-binding letters of intent to purchase the injection.
The company has said that it is in talks 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 most,” Bharat Biotech President 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 the Indian Central Medicines Standards Control Organization disclosed their efficacy results. A source with knowledge of the matter told Reuters that its effectiveness could be more than 60 percent with two doses.
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China also did not release detailed efficacy data for a vaccine it authorized on Thursday, but its developer has shared interim data.
“On what basis was this approval granted when Bharat Biotech has NOT shown enough data to demonstrate safety and 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 data and other data for the two vaccines approved on Sunday.
REVIEW
COVAXIN has been sped up like no other vaccine in India. The company said in November that it would likely launch in the second quarter of 2021, while a government scientist suggested it could be February or March.
Opposition lawmakers and former ministers on Sunday questioned the lack of transparency in its approval.
“The approval was premature and could be dangerous,” said opposition lawmaker and former minister Shashi Tharoor, asking for an explanation from Health Minister Harsh Vardhan.
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“Its use should be avoided until full trials are completed. India can start AstraZeneca vaccine in the meantime.”
Vardhan urged the Indians to trust that “strict protocols” have been followed to ensure the safety and efficacy of the two approved vaccines.
In the largest trial of its kind 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 that began in November.
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