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COVAXIN FAILS TO GET U.S. NOD, BUT INDIA ISN’T WORRIED

It will have no bearing on India’s vaccine plan, says the government, as every country has its own benchmark for such approvals. Health experts, meanwhile, urge the Centre not to vaccinate those who have recovered from Covid-19.

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COVAXIN FAILS TO GET U.S. NOD, BUT INDIA ISN’T WORRIED

As India reported less than 1 lakh new Covid cases for the fourth day on Friday, the Indian Public Health Association and health experts of Covid task force have written to Prime Minister Narendra Modi, advising that there is no need to vaccinate people who had recovered from Covid-19 infection.

According to the statement released by the Union Health Ministry at 8 am on Friday, 91,702 new Covid 19 cases were detected across the country, declining India›s active caseload further to 11,21,671 cases.

The open report by IPHA and CTF said that unplanned vaccination can promote mutant strains of Covid-19. It said that there is no need to vaccinate people who had documented Covid-19 infection. These people may be vaccinated after generating evidence that vaccines are beneficial after natural infection.

“Vaccinating the vulnerable and those at risk, instead of mass population-wide inoculation including children, should be the aim at present,” the report stated.

Meanwhile, raising doubts over the efficacy of Covaxin, Bharat Biotech’s India-made Covid-19 vaccine was not given the emergency use approval in the United States by that country›s top public health regulator—the Food and Drug Administration (FDA).

Rejecting Covaxin’s application, the FDA sought more data on the clinical trials for the vaccine, the complete extent of which is still lacking. The FDA rejection would normally indicate a delay in Covaxin›s launch in the US, but Bharat Biotech›s US partner Ocugen Inc—which is co-developing Covaxin with Bharat Biotech for the US market—said that it would instead push for a full US approval of Covaxin without pursuing an emergency use authorisation.

Reacting to the FDA’s rejection, the government on Friday said that it respects the decision taken by the authority but it will not have any bearing on India›s vaccine plan. Emphasising that every country has its own benchmark for such approval, Dr V.K. Paul, Member Health, NITI Aayog, said: “We are happy as we have gone through their safety data.”

A vaccine manufactured in India may not be equally effective in Argentina, Dr Paul said, citing the example of the Rotavirus for children. The nutrition level, the gut flora of the population make a difference in the effect of the Rotavirus. “This may lead to some differences especially in countries where science is strong, and our manufacturing is strong,” Dr Paul said.

“Every country has a different regulatory system. The scientific framework might be the same but nuances change depending on the context. They have their own parameters which we respect. Our regulatory authorities too have separate parameters. When our vaccine makers make vaccines for our children, the nutritional status, the genetic background are taken into account to find out whether the vaccine will be fully effective. If one vaccine is effective on our children, it may not work in Argentina. That is a different cohort of people,” Dr Paul said.

Bharat Biotech’s application before the World Health Organization for emergency use approval is also pending.

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