Indian COVID-19 vaccine lacks efficacy data

India gave emergency approval to Bharat Biotech's Covaxin on Sunday but faced questions after taking steps without publishing efficacy data for the homegrown coronavirus vaccine. The news, announced by India's Drugs Controller General (DCGI), which did not take any questions, was welcomed by Prime Minister Narendra Modi and his ministers as a breakthrough in India's self-reliance. The government has also approved the use of a vaccine developed by AstraZeneca and Oxford University that will be the leading vaccine in India's immunization program until other shots are approved. Covaxin was developed jointly with an Indian government institution and India has joined a small list of countries that have approved their coronavirus shot. Bharat has partnered with drug developer Ocugen Inc to develop it for the US market and Brazil has signed non-binding letters of intent to purchase the shot. The company has said that it is discussing more than 10 countries with Covaxin. Krishna Ala, chairman of Bharat Biotech, said in a statement, "While this vaccine suggests a medical need during this epidemic, our goal is to provide a global reach for the population." "Covaxin has produced excellent safety data with strong immune responses to many viral proteins that persist." Neither the company nor the Central Drugs Standard Control Organization of India will reveal its efficacy results. A source aware of the case told the Reuters news agency that its effectiveness could be more than 60 percent with two doses. China did not publish detailed effective data for an authorized vaccine on Thursday, but its developer has shared interim data. "On what basis was this approval granted when Bharat Biotech has not shown sufficient data to prove safety and efficacy?" Transparency activist Saket Gokhale asked on Twitter. Premature approval Covaxin is fast-tracked like other vaccines in India. The company said it was likely to be launched in the second quarter of 2021 in November, while a government scientist suggested it could be February or March. Opposition politicians and former ministers on Sunday questioned the lack of transparency in approving it. Former Minister Shashi Tharoor asked Health Minister Harsh Vardhan for clarification, "Approval can be premature and dangerous." "Its use should be avoided until the full trial is over. India may meanwhile begin with the AstraZeneca vaccine." Vardhan urged Indians that "stringent protocols" have been followed to ensure the safety and efficacy of both approved vaccines.

Indian COVID-19 vaccine lacks efficacy data

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