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Modified COVID-19 vaccines can nod from the FDA without repeating full trials



A pharmacist prepares a syringe with the Pfizer-BioNTech COVID-19 vaccine at a COVID-19 vaccination site at NYC Health + Hospitals Metropolitan, Thursday, February 18, 2021 in New York.  (AP Photo / Mary Altaffer)

A pharmacist prepares a syringe with the Pfizer-BioNTech COVID-19 vaccine at a vaccination clinic in New York City. (Mary Altaffer / Associated Press)

The U.S. Food and Drug Administration on Monday released new guidance that streamlines the control process for COVID-19 vaccines modified to target new coronavirus variants.

The recommendations, described in a 24-page document on the FDA’s website, are intended to speed up the review process due to concerns that the new variants – some more contagious, others more able to avoid current vaccines – will undermine efforts at to stop the virus ” spread.

“We know that the country is eager to return to a new normal, and the emergence of the virus variants raises new concerns about the performance of these products,” said Dr. Janet Woodcock, FDA’s acting commissioner, in a statement. “By issuing these guidelines, we want the American public to know that we are using every tool in our toolbox to combat this pandemic, including turning around when the virus adapts.”

The recent emergence of a large number of variants has led to growing concerns that the first generation of vaccines – which were developed based on an early version of the coronavirus – may not be well-equipped to protect people from the mixture of viruses currently is in circulation.

For example, several vaccines have been less effective in South Africa, where a strain known as B.1.135 predominates, than in other parts of the world, where this variant is less widespread.

A vaccine from Johnson & Johnson’s Janssen Biotech unit reduced the risk of moderate to severe cases of COVID-19 by 72% when tested in the United States, but was only 57% effective in South Africa. Similarly, a Novavax vaccine that was almost 90% effective in reducing the risk of all types of COVID-19 in the UK was only 49% effective in South Africa.

Also regarding: A COVID-19 vaccine developed by AstraZeneca and Oxford University was 75% effective in reducing the risk of mild to moderate disease when tested in South Africa before the B.1.351 strain was widespread. But after it took over, the vaccine was no better at preventing mild to moderate disease than placebo.

And in laboratory tests, antibodies generated by humans who had received a vaccine developed by Pfizer and BioNTech did a better job of counteracting a coronavirus variant from the United Kingdom than it did against the South African strain.

Vaccine manufacturers have responded to the threat from new varieties by adjusting their recipes so that the immune system can better recognize them.

The new guide is part of a host of recommendations for vaccine developers, testing and therapy in light of these new variants. It makes it possible to approve modified vaccines under a change to their existing emergency permits, officials said.

The FDA wants companies to submit clinical data showing that the modified version of their vaccine is more effective against new variants than their original vaccine. The agency also asks vaccine manufacturers to test their modified vaccines in people who have never been vaccinated and in people who have been vaccinated before.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said attempts to test the immune response prompted by a tweaked vaccine would likely involve a few hundred individuals and could take about two or three months.

Compare that to a typical clinical phase 3 trial, which may involve tens of thousands of patients and may take several months longer.

Such a rapid vaccine change is the norm for viruses like the flu, said Dr. Diane E. Griffin, a viral immunologist at the Johns Hopkins Bloomberg School of Public Health.

It is possible that modified vaccines could be approved in the future without the need for further clinical trials, the FDA noted. But that is not yet the case.

The agency stressed that the two vaccines currently approved for use in the United States – one manufactured by Pfizer and BioNTech and another developed by Moderna and the National Institutes of Health – are still effective against the mix of variants now circulating in the United States. USA.

That said, “it’s fair to think these companies are considering these changes or thinking they may need to make changes,” Griffin said. “This just helps them know what kind of information the FDA wants and what they don’t need.”

This story originally appeared in the Los Angeles Times.


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