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Covaxin approved for emergency use without release of efficacy data

Jan 06, 2021 11:23 IST

Coronavirus vaccines have finally arrived in India as two vaccines are given emergency use approvals in India, the Oxford-Astrazeneca vaccine (Covishield) and Bharat Biotech's Covaxin. However, there are accusations that data on phase 3 trials of Covaxin hasn't been revealed and therefore, the vaccines' efficacy is under question. Is this comparable to any other country that has allowed for emergency use of covid vaccines? What is the downside when something like this happens? How should this process be followed to ensure there is no vaccine hesitancy, despite the obvious hurry to inoculate people across the world? BOOM Explains. Dr Anant Bhan, Researcher, Global Health, Bioethics & Health Policy, says that most countries that have approved vaccines have efficacy data available with the regulators and subsequently published for everyone to see, including for Oxford-Astrazeneca. The Health Secretary recently said that the two conditions under which they would approve emergency use for vaccines would be either a foreign regulator giving permission along with bridging data which Covishield is probably applying for and other is local efficacy data, which is what Covaxin is applying for. None of the data is in public domain. Murali Neelakantan, Former Global General Counsel at Cipla & Glenmark, says that recent precedent regarding drug regulation approvals is different than earlier. In 2020, the regulators have been willing to approving drugs for COVID-19 with haven't shown efficacy. There is a long list of conditions under which a drug or a vaccine can be given emergency use authorisation. We don't have any of the same protocols in India as other countries do. Watch BOOM's Govindraj Ethiraj interview Dr Anant Bhan and Murali Neelakantan on the legality of approving these vaccines, the need for public data on vaccines and required emergency use authorisation protocol for Covid vaccines.