FDA Will ‘Streamline’ Authorizations of COVID-19 Vaccines Revamped for New Strains

A “streamlined” process for authorizing COVID-19 vaccines modified to address significant new coronavirus strains is in the works to enable the FDA to quickly react to significant viral mutations, said Center for Biologics Evaluation and Research (CBER) Director Peter Marks.

Marks said that the FDA will not require large-scale phase 3 clinical trials if vaccines must be rejiggered to retain protection against deadly viral strains but will ask for small-sized trials that confirm a reworked vaccine still generates an immune response. Speaking to the American Medical Association late last week, the CBER chief said that the agency “would intend to be pretty nimble with this,” especially given the speed at which variants can spread.

It appears that Pfizer/BioNTech’s and Moderna’s vaccines both protect against the highly contagious UK and South African strains, though the latter appears to render them less effective. The companies aren’t completely reworking their existing vaccines to increase their effectiveness but are developing booster shots to try and make up for the lost efficacy against the South African mutation.

Novavax’s and Johnson & Johnson’s vaccine candidates also proved less effective in fighting the South African variant, demonstrating 60 percent and 57 percent effectiveness against it, respectively.

The two variants have generated concerns around the world that the coronavirus could mutate significantly and often enough to evade vaccines and force frequent changes to coronavirus vaccines similar to how flu shots must be reworked each year.

If a revamp is warranted, it likely wouldn’t take long for Pfizer/BioNTech and Moderna, whose vaccines use mRNA technology that allows for faster updates. BioNTech CEO Uğur Şahin previously projected that the Pfizer/BioNTech vaccine could be updated in approximately six weeks. However, these reworked vaccines would still need to be manufactured en masse and distributed.

While some have called for administering as many initial shots of authorized vaccines as possible in order to ramp up vaccinations across the U.S., including the Biden administration, Marks shunned that idea. The CBER chief noted that the length of protection conveyed by a single dose is not known and that the positive data that led to authorization is for the two-dose regimen. — James Miessler