Opposition politicians and former ministers warn approval could be premature and risky after the government ramps up Covaxin.
India granted emergency approval to Bharat Biotech’s Covaxin on Sunday, but faced questions after taking the plunge without releasing efficacy data for the local coronavirus vaccine.
The news, announced by the Controller General of Drugs of India (DCGI) who did not answer questions, was hailed by Prime Minister Narendra Modi and his ministers as a success in the independence campaign of the India.
The government has 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 India is joining a small list of countries that have approved its own coronavirus vaccine.
Bharat partnered with drug developer Ocugen Inc to co-develop it for the US market, and Brazil signed non-binding letters of intent to purchase the vaccine.
The company said it was in discussions with more than 10 countries over Covaxin.
“As this vaccine addresses an unmet medical need during this pandemic, our goal is to provide global access to the populations who need it most,” Bharat Biotech President Krishna Ella said in a statement.
“Covaxin has generated excellent safety data with robust immune responses to several viral proteins that persist.”
Neither the company nor India’s Central Drugs Standards Control Organization will reveal its effectiveness results.
A source with knowledge of the matter told Reuters news agency that it could be over 60% effective with two doses.
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 given when Bharat Biotech has NOT shown sufficient data to prove safety and efficacy?” transparency activist Saket Gokhale asked on Twitter.
Gokhale has filed a request under India’s Right to Know Act, asking the government for safety data and other data for the two vaccines approved on Sunday.
Covaxin has been accelerated 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 had suggested it might be February or March.
Opposition politicians and former ministers on Sunday questioned the lack of transparency in his endorsement.
“The approval was premature and could be dangerous,” former minister Shashi Tharoor said, asking Health Minister Harsh Vardhan for an explanation.
“Its use should be avoided until the end of full testing. India can start with the AstraZeneca vaccine in the meantime. “
Vardhan urged Indians to believe that “strict protocols” were followed to ensure the safety and effectiveness 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.