No need for lengthy trials for retooled vaccines: FDA

 No need for lengthy trials for retooled vaccines: FDA

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•WASHINGTON • The US Food and Drug Administration (FDA) said vaccine developers would not need to conduct lengthy randomised controlled trials for vaccines that have been adapted to protect against coronavirus variants.

The recommendation, which calls for small trials more like those required for annual flu vaccines, would greatly accelerate the review process at a time when scientists are increasingly anxious about how the variants might slow or reverse progress made against the virus.

The guidance was part of a slate of new documents that the agency released on Monday, including others addressing how antibody treatments and diagnostic tests might need to be retooled to respond to the virus variants.

Together, they amounted to the US government’s most detailed acknowledgement of the threat that the variants pose to existing vaccines, treatments and tests for the coronavirus, and came weeks after the FDA’s acting commissioner, Dr Janet Woodcock, said the agency was developing a plan.

Most of the vaccine makers with authorised vaccines or candidates in late-stage trials have already announced plans to adjust their products to address the variants.

Despite recent indications that some variants – particularly the B1351 – make the currently authorised vaccines less effective, the shots still offer protection and appear to greatly reduce the severity of the disease, preventing hospitalisations and death.

An updated Covid-19 vaccine can skip the months-long process of a randomised clinical trial that would compare it with a placebo, the agency said. But a tweaked vaccine will still need to undergo some testing.

NYTIMES

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