August 31, 2022 – The U.S. Food and Drug Administration (FDA) on Wednesday granted emergency use authorization for the Omicron COVID-19 vaccines produced by Pfizer/BioNTech and Moderna.
The agency cited data to support the safety and efficacy of this next generation of mRNA Vaccines Target variables of concern.
If you’ve been waiting to get a different booster dose, you may be out of luck as early as next week.
Pfizer EUA is compatible with the company’s combination booster vaccine that includes the original COVID-19 vaccine as well as Serum Designed to protect against the latest Omicron versions, BA.4 and BA.5.
Moderna’s combination vaccine will contain the company’s original COVID-19 vaccine and a vaccine to specifically protect against Omicron BA.4 and BA.5 sub variants.
As of August 27, BA.4 and BA.4.6 accounted for about 11% of the circulating variants, and BA.5 for nearly all of the remaining 89%, according to CDC data.
The next step will be a review of the scientific data by the Centers for Disease Control and Prevention’s Immunization Practices Advisory Committee, which is scheduled to meet on Thursday and Friday. The final hurdle before distributing the new vaccines will be approval of the CDC’s recommendations for use by agency director Rochelle Wallinsky, MD.
Peter Marks, MD, director of the Food and Drug Administration’s Center for Evaluation and Research in Biology, said during the period of an FDA virtual press conference.
“Also, if you haven’t vaccinated your children yet, now is the time to think about taking them to get vaccinated as well,” he said.
“Unfortunately, COVID-19 continues to cause severe consequences across the country with nearly 400 deaths and more than 5,000 new hospitalizations every day,” said Robert M. Califf, Commissioner of the Food and Drug Administration. “CDC provisional data only yesterday indicated that life expectancy in the United States is declining again in 2021, due in large part to COVID deaths.
“Unfortunately, only about half of eligible Americans received their first booster dose,” he continued. “So this is a great opportunity to improve life expectancy.”
Centers for Disease Control and Prevention (CDC) data shows that those who see their vaccines are 13 times less likely to die from COVID than those who didn’t get vaccinated, and they are three times less likely to die from COVID than those who got just one booster dose Instead of that. of two.
“It hurts to see people die needlessly when there is free treatment that prevents their death,” Califf said, noting that the protection from death associated with COVID-19 vaccines is “much more obvious than anything I’ve seen in my life.”
Protection now and in the future
Scientific modeling indicates that “we are looking at a possible fall wave that will peak on December 1,” Marks said. “By giving the booster now, we hope to control the current plateau that we are in – we are declining very slowly – and also address this potential future wave looming.”
Califf noted that the new vaccines have another potential long-term benefit, long-term protection from COVID, “which is a major concern for increasingly young people.”
“I want to make it clear that these updated reinforcements present us with an opportunity to move forward with the next wave of COVID-19,” Califf said. “And for those who may be wondering, the CDC says you may get a booster dose of COVID-19 at the same time you take your annual flu shot.”
Marks said the Food and Drug Administration will continue to study how effective new vaccines are at protecting COVID again.
Another hope, Marks said, is that next-generation vaccines will provide stronger protection.
“The idea here is not only to increase the antibodies for now, but also to hopefully give us a longer protection period,” he said.
If true, Americans may need fewer booster shots in the future.
“or not [this] He carries us quite a bit the whole season.”