Covaxin: What was the rush to approve India's homegrown vaccine?

How can a coronavirus vaccine be cleared for emergency use by millions of vulnerable people in a "clinical trial" mode?

No idea, says Dr Gagandeep Kang, one of India's best-known vaccine experts. "Either you are doing a clinical trial or not". Clinical trials - a three-phased process - determine whether the vaccine induces good immune responses and whether it causes any unacceptable side-effects.

On Sunday, India's drug regulator gave emergency approval of a locally produced coronavirus vaccine, called Covaxin, before the completion of trials. The government-backed vaccine has been developed by Bharat Biotech, a 24-year-old vaccine maker, which has a portfolio of 16 vaccines and exports to 123 countries.

The regulator said the vaccine had been approved for "restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, especially in the context of infection by mutant strains". (The regulator also approved the global AstraZeneca Oxford jab, which is also being produced in India.)

This, despite the fact that the key third phase of Covaxin's clinical trials - the vaccine is given to thousands of people and tested for efficacy and safety - was underway.

Assurances by the regulator that the vaccine is "safe and provides a robust immune response" have not placated most scientists and health experts. All India Drug Action Network, a watchdog, said it was "baffled to understand the scientific logic" to approve "an incompletely studied vaccine".

Bharat Biotech says it has a stockpile of 20 million doses of Covaxin, and is aiming to make 700 million doses out of its four facilities in two cities by the end of the year. "Our vaccine is 200% safe," says Dr Krishna Ella, chairman of the firm.

Dr Ella has defended the approval. For one, he said, Indian clinical trial laws allowed "accelerated" authorisation for use of drugs after the second phase of trials for "unmet medical needs of serious and life-threatening diseases in the country". The fact that his vaccine was based on an inactivated form of coronavirus - a reliable and time-tested platform - also helped.

Studies on monkeys and hamsters had shown that Covaxin provided ample protection against the infection, Dr Ella said. Nearly 24,000 of the 26,000 volunteers had already participated in the ongoing third phase trials, and the firm was expected to have the efficacy data for the vaccine by February, he added.

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