FDA requires COVID booster to fight Omicron's BA.4, BA.5 subvariants

US Food and Drug Administration Recommended on Thursday The COVID-19 vaccine maker has redesigned its booster shots from this fall to include components tuned to combat the currently predominant Omicron BA.4 and BA.5 subvariants of the coronavirus.

If approved, the changes mark the first major modification of the COVID vaccine, but the FDA recommends a design that is slightly different from what the company has already tested. Therefore, we have started production, which may delay the deployment. The

FDA also suggested that new shots could be approved before the study testing them in humans was completed. Annual changes to the flu vaccine do not require new trials.

"In a sense, we're chasing the virus like the flu. We have to wait to see how close we can get to the variants that stood out at the time." Infection at Vanderbilt University Medical Center Disease expert Dr. William Schaffner added that the redesigned vaccine can provide better protection than the current one.

The FDA said companies do not need to change the vaccines in the primary vaccination series, and next year "this modified booster vaccine may be introduced. It will be a transitional period. "

The new booster shot will be a bivalent vaccine. That is, the dose targets both the original virus and the Omicron variant. The

decision follows the agency's external advisor's recommendation to redesign the shot this fall to combat the more common version of the coronavirus.

According to the US Centers for Disease Control and Prevention, BA.4 and BA.5 are now estimated to account for more than 50% of infectious diseases in the United States and are predominant in other regions.

The FDA said in a statement Thursday that it hopes the modified vaccine will be available from early to mid-autumn.

Scientists may introduce redesigned boosters to protect against future mutations, even if they are not currently in circulation. It suggests that it can spur a broader immune response.

"COVID has tricked us many times, so it's dangerous to predict the future, especially with COVID-19," Schaffner said.

Pfizer Inc and its partners BioNTech SE and Moderna Inc are testing a modified vaccine version to combat the BA.1 Omicron variant that caused the massive surge last winter.

They state that these vaccines produce a good immune response against BA.1 and recently circulating mutants, but against BA.4 and BA.5. A lower response was seen.

Both companies have already manufactured the BA.1 vaccine and said switching to the BA.4 / BA.5 design on Tuesday could delay adoption.

Pfizer / BioNTech announced a $ 3.2 billion contract on Wednesday to supply more COVID vaccines to the United States, with a significant amount of BA.4 / BA.5 vaccines in October. First week.

Moderna said it would be late October or early November before the newly modified vaccine was ready.

The exact approval process for new shots is not yet clear.

The FDA has instructed manufacturers to begin clinical trials to study the BA.4 / 5 vaccine, but the previous BA to support the approval of modified shots. He said he would evaluate data for .1-based vaccines.