Vaccines Adapted for Variants Will Not Need Lengthy Testing, F.D.A. Says - The New York Times

The Food and Drug Administration said on Monday that vaccine developers would not need to conduct lengthy randomized controlled trials for vaccines that have been adapted to protect against concerning coronavirus variants.

The guidance was part of a slate of new documents 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.

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

Moderna has already begun developing a new version of its vaccine that could be used as a booster shot against a virus variant that originated in South Africa, known as B.1.351, which seems to dampen the effectiveness of the existing vaccines.

An updated Covid-19 vaccine can skip the monthslong process of a randomized clinical trial that would compare it with a placebo, the agency said.

acknowledged that many questions remained unanswered, such as what type of data would trigger the need for an adapted vaccine and who would make that decision.

The newly tweaked Covid-19 vaccines would be authorized under an amendment to the emergency authorization granted to the original vaccine, regulators said