vaccine: To get approval in India, vaccines must work in at least...

vaccine: To get approval in India, vaccines must work in at least 50% cases


Mumbai: Companies working on Covid-19 vaccine in India will have to demonstrate that at least half the people who receive it are protected from the infection and that it induces superior antibody and cellular responses to get their vaccine approved.

Vaccines developed outside of India can apply for marketing authorisation based on clinical data generated in trials once they pass the evaluation for safety and effectiveness, according to draft guidelines for Covid-19 vaccine released by the Drugs Controller General of India on Monday.

If necessary, the drug regulator can ask these companies to do additional trials in Indian population to confirm the safety. India’s vaccine guidelines — anticipated for several months now — takes inspiration from the US Food and Drug Administration and World Health Organisation guidelines.

The 39-page document lists several safety protocols that companies have to follow, including developing adaptive trial designs.

“Considering that there is an urgent need of Covid-19 vaccine, the predictive value of the immune response for shortterm and/or longer-term protection from SARS-CoV-2 infection and/or disease may be investigated,” the draft guideline document said.

“Subsequently, after approval of the vaccine, however, the direct evidence of vaccine efficacy in protection from SARS-CoV-2 infection and/or disease must be accessed through appropriate study in post marketing scenario.”

Regulatory approval for vaccines will come through only if companies demonstrate 50% efficacy in the primary endpoint and/or more than 30% efficacy in the secondary end points. This means a vaccine has to either prevent or decrease severity of the disease in at lest 50% of people vaccinated.

The vaccine that will go for approval must elicit superior immune responses compared to no vaccination against Covid-19, the guidelines said. An individual who gets the vaccine should be protected from reinfection for at least a year.


The drug regulator said clinical development programmes for Covid-19 vaccines might get fast-tracked by adaptive and/or seamless clinical trial designs that allow for selection between vaccine candidates and dosing regimens and for more rapid progression through the usual phases of clinical development.

FDA guidelines in the US look at similar parameters to grant an emergency authorisation use (EAU) for vaccines. As the pandemic has been raging on for the last eight months, the EAU route is used to approve certain drugs in India and elsewhere.

Remdesivir and Favipiravir are two such drugs that received emergency approval in India. Officials aware of the development told ET that there could be emergency approval that will come for Covid-19 vaccines, too.

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