Aug. 31, 2022 – The FDA on Wednesday granted emergency use authorization to Omicron-specific COVID-19 vaccines made by Pfizer/BioNTech and Moderna.
The agency cited data to support the safety and efficacy of this next generation of mRNA vaccines targeted toward variants of concern.
If you’ve been waiting to get a variant-specific booster shot, you may be in luck as early as next week.
The Pfizer EUA corresponds to the company’s combination booster shot 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 firm’s original COVID-19 vaccine and a vaccine to protect specifically 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 almost all the remaining 89%, CDC data show.
The next step will be a review of the scientific data by the CDC’s Advisory Committee on Immunization Practices, which is set to meet Thursday and Friday. The final hurdle before distribution of the new vaccines will be a sign-off on CDC recommendations for use by agency Director Rochelle Walensky, MD.
“If you’ve not yet received a booster dose or it’s been several months since your last booster dose, now is the time to consider getting one,” Peter Marks, MD, director, FDA Center for Biologics Evaluation and Research, said during a virtual FDA news conference.
“Also, if you’ve not yet vaccinated your children, now is a great time to consider taking them along to receive their vaccination as well,” he said.
“Unfortunately, COVID-19 continues to cause devastating consequences throughout the country with nearly 400 deaths and over 5,000 new hospitalizations every day,” FDA Commissioner Robert M. Califf, MD, said. “And just yesterday provisional CDC data indicated that US life expectancy fell again in 2021, In large part due to COVID deaths.”
“Regrettably 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 indicate that those who are up to date on their vaccines are 13 times less likely to die from COVID compared to those who have not received the vaccine and are 3 times less likely to die from COVID compared to those who only had one booster instead of two.
“It’s just painful to see people dying unnecessarily when there’s a free treatment that would prevent their death,” said Califf, noting that protection against death associated with the COVID-19 vaccines “is much more clear than anything I’ve ever seen.”
Protection Now and In the Future
Scientific modeling suggests “that we are looking at a possible fall wave with a peak around Dec. 1,” Marks said. “By giving the booster now, we will hopefully both control the current plateau that we’re in — we’re dropping off very slowly — as well as address this future potential wave that looms out there.”
Califf noted that the new vaccines have another potential long-term benefit, protection against long COVID, “which for young people is increasingly a major concern.”
“I want to make clear that these updated boosters present us with an opportunity to get ahead of the next wave of COVID-19,” Califf said. “And for those who may be wondering, CDC says you may get a COVID-19 booster at the same time as your annual flu shot.”
The FDA will continue to study how well the new vaccines protect again COVID going forward, 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 right now, but also to hopefully give us a longer duration of protection,” he said.
If this holds true, then Americans might need fewer booster shots in the future.
“Hopefully [this] holds us for as much of the entire season.”
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