August 31, 2022 – The FDA on Wednesday granted emergency use authorization for Omicron-specific COVID-19 vaccines manufactured by Pfizer/BioNTech and Moderna.
The agency cited data demonstrating the safety and efficacy of this next-generation mRNA vaccine 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.
Pfizer’s EUA corresponds to the company’s combined booster vaccine, which includes the original COVID-19 vaccine plus a vaccine designed to protect against the latest Omicron variants BA.4 and BA.5.
Moderna’s combination vaccine will contain both the company’s original COVID-19 vaccine and a vaccine specifically protecting 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 accounted for almost all of 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 scheduled to meet on Thursday and Friday. The final hurdle before the new vaccines can be distributed will be approval of the CDC’s recommendations for use by the agency’s director, Dr. Rochelle Walensky, his.
“If you haven’t received a booster dose yet, or it’s been several months since your last booster dose, now is the time to get 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 think about taking them to get their vaccinations,” he said.
“Unfortunately, COVID-19 continues to wreak havoc across the country with nearly 400 deaths and over 5,000 new hospital admissions per day,” said FDA Commissioner Robert M. Califf, MD. “And just yesterday, preliminary CDC data showed that U.S. life expectancy fell again in 2021, in large part due to COVID deaths.”
“Unfortunately, only about half of eligible Americans got their first booster shot,” he continued. “So this is a remarkable opportunity to improve our life expectancy.”
CDC data shows those who are up to date on their vaccines are 13 times less likely to die from COVID than those who did not receive the vaccine and 3 times less likely to dying from COVID than those who instead received only one booster shot out of two.
“It’s just painful to see people dying needlessly when there is free treatment that would prevent their deaths,” Califf said, noting that the protections from death related to the COVID-19 vaccines are “much clearer is than anything I’ve ever seen”.
Protection now and in the future
Scientific models suggest “we are looking at a possible fall wave peaking around December 1st,” Marks said. “By giving the booster now, hopefully we’ll both control the current plateau we’re in – we’re declining very slowly – as well as address that future potential wave that’s looming out there.”
Califf noted the new vaccines have another potential long-term benefit, protection from long-term COVID, “which is becoming a major concern for young people.”
“I want to make it clear that these updated boosters give us an opportunity to stay one step ahead of the next wave of COVID-19,” Califf said. “And for those wondering, CDC says you may receive a COVID-19 booster at the same time as your annual flu shot.”
The FDA will continue to evaluate how well the new vaccines protect against COVID going forward, Marks said.
And another hope is that these next-generation vaccines offer stronger protection, Marks said.
“The idea here is not only to increase antibodies now, but hopefully give us a longer duration of protection,” he said.
If true, Americans may need fewer booster shots in the future.
“Hopefully [this] keeps us for so much of the entire season.”