COVID-19 in India: Covaxin out of 'clinical trial mode', consent forms no longer required

Over the last few days, homegrown COVID-19 vaccine, Covaxin has emerged as a strong contender in the fight against the pandemic. Data from the third phase trials show an interim vaccine efficacy of 81%. Data from the second phase has been published in well known medical journal The Lancet and pronounced "safe" and immunogenic. Now, the Drugs Controller General of India has amended the licensure of Bharat Biotech's Covaxin, putting in on the same footing as Covishield.

In January this year India had begun inoculating citizens with two COVID-19 vaccines. But while the Serum Institute manufactured Oxford-AstraZeneca vaccine had completed trials and was thus eligible for emergency use authorisation, the situation was somewhat different for Bharat Biotech's Covaxin. As Union Health Minister Dr Harsh Vardhan explained some time ago, the authorisation was "differently conditional – in clinical trial mode".

"All COVAXIN recipients to be tracked, monitored as if they’re in trial. COVAXIN approval is ‘Monitored Approval’ with strict follow-up and rolling review," he had explained in a tweet at the beginning of January.

Now, with the upgradation, vaccine recipients will no longer be required to sign a separate consent form or submit AEFI reports to the vaccination centres before the second dose and after seven days of the second dose.

"Both the COVID-19 vaccines Covaxin and Covishield have the same licensure status. It has already being given to around 19 lakh people. Covaxin has stood the test of time in terms of great safety. Only 311 individuals had minimal side effects. It is the triumph for India's research and development enterprise and science and technology enterprise," NITI Aayog member (Health) Dr V K Paul was quoted as saying on Thursday.

(With inputs from agencies)

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