COVID-19 Vaccine: FDA Sets Deadline to Redesign COVID Shots for Use This Fall

The Food and Drug Administration (FDA) said the U.S. has until June to decide whether the public needs new COVID-19 shots to target different virus variants.

Health officials are preparing for another possible surge in the coming fall while deliberating whether vaccine makers need to change existing COVID shots to target different virus variants.

Dr. Peter Marks, who heads the FDA office responsible for vaccine safety and efficacy, told the agency's advisory committee Wednesday that a decision needs to be made by June to have shots available in the fall, CNBC reported.

Marks said the U.S. could face another wave of infection in the fall as the virus will continue to evolve as immunity from the current vaccines wanes.

Robert Johnson, a Biomedical Advanced Research and Development Authority senior official, said at the meeting that the biggest challenge in updating the new COVID shots would be coordinating across the vaccine makers.

According to virologist Trevor Bedford at the Fred Hutchinson Cancer Research Center, COVID has mutated two to 10 times faster than the flu. Bedford noted that he expects the spike protein, which the COVID virus uses to invade human cells, to keep evolving.

New COVID-19 Shots

Leading U.S. scientists and physicians expressed concern that the FDA and the Centers for Disease Control and Prevention (CDC) are moving too fast to approve the COVID-19 vaccine's fourth dose.

According to another CNBC report, a little public debate gives the vaccine makers too huge a role in setting the pace with which the doses are distributed across the country.

Last week, top U.S. public health agencies endorsed a fourth COVID shot for older adults without holding a public meeting, which drew scrutiny from leading vaccine experts.

The FDA authorized a second booster shot for people age 50 and older last week. The CDC has quickly supported the authorization hours later based on data from Israel that rolled out fourth doses a few months ago.

According to a senior federal official, new COVID-19 shots could cost the federal government about $5 billion to $12 billion.

Congress has slashed the administration's new COVID budget request around in half, with the official saying that it might leave enough to cover that cost.

A National Institutes of Health new study analyzed how Moderna's vaccine works if revised to target three different variants, alone or in combination.

COVID-19 Vaccine Makers

Pfizer noted that it aims to have an Omicron-specific COVID-19 vaccine ready by March. According to Nature Briefing, it will be the first revision of its mRNA vaccine Comirnaty if it gains approval.

Rick Malley, CSO and scientific founder of vaccine developer Affinivax, argued that by the time an Omicron variant vaccine could be made, there might be some other variant that has emerged with a different antigenic profile.

Pfizer, Moderna, and other vaccine makers are doing clinical trials on Omicron-based shots. However, Jerry Weir, head of FDA's division of viral products, said the companies are not currently coordinating on their new vaccine formulas.

Dr. Paul Offit, an FDA committee member, noted that the CDC needs to take the lead when it comes to deciding when the vaccines are no longer effective against severe illness.

This article is owned by Latin Post.

Written by: Mary Webber

WATCH: 3 Doses of Pfizer Vaccine May Be Needed to Protect Against Omicron COVID Variant - From BBC News