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FDA Authorizes Updated COVID Boosters to Target Newest Variants

August 31, 2022 — The FDA on Wednesday granted emergency use approval for Omicron-specific COVID-19 vaccines made by Pfizer/BioNTech and Moderna.

The agency cited data to support the safety and efficacy of these next-generation mRNA vaccines targeting variants of concern.

If you’ve been waiting for a variant-specific booster shot, you might be in luck as early as next week.

The Pfizer EUA is equivalent to the company’s combination booster injection that includes the original COVID-19 vaccine, as well as a vaccine designed to protect against the most recent Omicron variants, BA.4 and BA.5.

The Moderna combination vaccine will contain both the company’s original COVID-19 vaccine and a vaccine to specifically protect against Omicron BA.4 and BA.5 subvariants.

As of Aug. 27, BA.4 and BA.4.6 accounted for about 11% of circulating variants, and BA.5 made up nearly all of the remaining 89%, CDC data shows.

The next step is a review of the scientific data by the CDC’s Advisory Committee on Immunization Practices, which meets Thursday and Friday. The final hurdle to distribution of the new vaccines will be a signing of the CDC recommendations for use by the agency’s director, Rochelle Walensky, MD.

“If you haven’t received a booster dose or if it’s been several months since your last booster dose, now is the time to consider getting one,” said Peter Marks, MD, director of the FDA Center for Biologics Evaluation and Research. during a virtual FDA press conference.

“Even if you haven’t vaccinated your children yet, now is a good time to consider bringing them in to get their vaccination as well,” he said.

“Unfortunately, COVID-19 continues to have devastating effects across the country with nearly 400 deaths and more than 5,000 new hospitalizations per day,” said FDA Commissioner Robert M. Califf, MD. “And yesterday, preliminary CDC data indicated that life expectancy in the US fell again in 2021, largely due to COVID deaths.”

“Unfortunately, only about half of eligible Americans have received their first booster,” he continued. “So this is a remarkable opportunity to improve our life expectancy.”

CDC data indicates that those who are up to date on their vaccines are 13 times less likely to die from COVID compared to those who did not receive the vaccine and 3 times less likely to die from COVID compared to those which instead had only one booster. of two.

“It’s just painful to see people die needlessly when there is some free treatment that would prevent their death,” Califf said, noting that protection from death associated with the COVID-19 vaccines is “much clearer than anything else.” I’ve ever seen.”

Protection now and in the future

Scientific modeling suggests “we’re looking at a possible fall wave peaking around Dec. 1,” Marks said. “By giving the booster now, we will hopefully both master the current plateau we are in — we’re falling off very slowly — and also address this future potential wave that’s looming there.”

Califf noted that the new vaccines have yet another potential long-term benefit, protection against long-term COVID, “which is an increasing concern for young people.”

“I want to make it clear that these updated boosters give us an opportunity to get ahead of the next wave of COVID-19,” Califf said. “And for those who might be wondering, CDC says you may be getting a COVID-19 booster at the same time as your annual flu shot.”

The FDA will continue to investigate how well the new vaccines protect COVID again, Marks said.

And another hope is that these next-generation vaccines will provide stronger protection, Marks said.

“The idea here is not just to increase the antibodies now, but also hopefully give us a longer duration of protection,” he said.

If this is true, Americans may need fewer booster shots in the future.

“Hopefully [this] holds us in the same amount of the whole season.”