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FDA wants COVID boosters to target Omicron BA.4, BA.5 subvariants

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US Food and Drug Administration will redesign booster shots from this fall to fight the now dominantOmicron BA.4 and BA.5 on Thursday. Recommended to include tuned components. Subvariant of coronavirus.

If approved, the changes indicate the first major modification of the COVID vaccine, as the FDA recommends a design that is slightly different from what the company has already tested and started manufacturing. , May delay deployment.

The FDA does not require completion of new studies testing human BA.4 / BA.5 shots for approval, as well as how annual changes in influenza vaccines are handled. A senior government official told Reuters.

OMICRON COVID-19 VARIANT gives infected people a little immunity: Researcher

"In a sense, I We are chasing the virus. As with the flu, we have to wait for how close we can get to the prominent variants at the time, "said an infectious disease expert at the Vanderbild University Medical Center." Dr. William Schaffner said. The redesigned vaccine may provide better protection than the current one.

Medical syringes and FDA logo displayed in the background are seen in this illustration photo taken in Krakow, Poland on December 2, 2021. 

Medical syringe and FDA displayed in the background The logo will be displayed This illustration is a photo taken in Krakow, Poland on December 2, 2021.  (Jakub Porzycki / NurPhoto via Getty Images)

The FDA does not require companies to change their primary vaccination series vaccines. Next year will be "a transitional period in which this modified booster vaccine may be introduced."

The new booster shot will be a bivalent vaccine that targets both the original virus and the Omicron variant. The

decision follows a recommendation from the agency's external advisor to change the vaccine design this fall to combat the more common version of the coronavirus.

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

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

Scientists say that redesigned boosters could spur a broader immune response that could protect against possible future mutations. Suggests.

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

Country-specific strategies

Regulators in other countries are new based on the BA.1 Omicron variant, which caused a massive surge last winter. We are seriously considering the use of boosters. , Dr. Peter Markes, FDA Chief Executive Officer, said in an interview.

"Some people may want a vaccine sooner. It (vaccine) will be available sooner," Marks said after a meeting of international regulatory agencies on Thursday. rice field.

World Health Organization advisers prefer BA.1-based boosters, arguing that variants are more pronounced and may generate a broader response than the recently circulating subvariants. did.

Pfizer Inc and its partners BioNTech SE and Moderna Inc are testing aversion of the vaccine modified to combat the BA.1 Omicron variant.

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.

New Omicron variants currently account for about 20% of US infectious diseases

Moderna before the improved vaccine is ready He said it would be late October or early November.

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

Marks stated that data from the new trials are important for assessing the continued efficacy of boosters against new mutations that may occur.