As we slowly inch toward yet another fall and winter living with the COVID-19 pandemic, many of the public health measures used to mitigate its spread over the past few years have completely been abandoned.
But we will have an updated booster shot.
The Food and Drug Administration on Wednesday authorized Moderna and Pfizer’s new booster shots, which were tailored to tackle Omicron B.A.5, currently the dominant subvariant of Omicron. The Moderna booster will be available to people over the age of 18, while the Pfizer booster will be available to people 12 and over, as long as they haven’t had a booster shot in the last two months.
“As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent COVID-19 vaccine to provide better protection against currently circulating variants,” Dr. Robert Califf, the FDA commissioner, said in a statement.
The FDA notably authorized the new boosters without evidence from human trials, which is similar to how it evaluates updated flu vaccines, NBC News reported. (The effectiveness of flu vaccines can vary wildly from season to season.)
Pfizer said last week that pre-clinical data showed “a strong neutralizing antibody response” against all of the currently circulating Omicron subvariants, as well as the original strain of the virus. Moderna, which already had an updated booster authorized in the UK, also said last week that its new booster had a “superior neutralizing antibody response” against Omicron compared to a regular booster dose.
The FDA authorized the booster using data from the original shot, which was proven to be safe in both clinical and real-world studies, and justified the decision by saying the companies used the same process to manufacture both vaccines.
“We are confident in the evidence supporting these authorizations,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in the FDA’s statement. “The public can be assured that a great deal of care has been taken by the FDA to ensure that these bivalent COVID-19 vaccines meet our rigorous safety, effectiveness and manufacturing quality standards for emergency use authorization.”
Americans have been less and less likely to keep up with their COVID-19 vaccinations, according to CDC data. While nearly 80 percent of Americans have received at least one shot and two-thirds received both primary doses, fewer than half got a first booster dose and just a third of all eligible Americans got a second booster shot, the data showed.
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