FDA authorizes updated COVID booster shots for kids as young as 5
By Jamie Gumbrecht, CNN
The US Food and Drug Administration on Wednesday gave emergency use authorization to updated Covid-19 boosters for children as young as 5.
Like the boosters that became available for people 12 and older in September, these bivalent boosters target the original coronavirus strain as well as the Omicron BA.4/BA.5 subvariants.
"Since children have gone back to school in person and people are resuming pre-pandemic behaviors and activities, there is the potential for increased risk of exposure to the virus that causes COVID-19. Vaccination remains the most effective measure to prevent the severe consequences of COVID-19, including hospitalization and death," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a news release Wednesday.
"While it has largely been the case that COVID-19 tends to be less severe in children than adults, as the various waves of COVID-19 have occurred, more children have gotten sick with the disease and have been hospitalized. Children may also experience long-term effects, even following initially mild disease," Marks said. "We encourage parents to consider primary vaccination for children and follow-up with an updated booster dose when eligible."
The shots for younger children must be recommended by the US Centers for Disease Control and Prevention before they can be administered.
However, Pfizer said its doses will be shipped immediately. "Pfizer has the capacity to ship up to 6 million pediatric doses in the first 7 calendar days following receipt of EUA approval, without any impact to distribution output of the doses for individuals 12 years and old," a spokesperson told CNN.
The updated Pfizer/BioNTech booster received authorization for use in children ages 5 to 11 and will be given as a 10-microgram dose. Pfizer's updated booster was previously authorized for people 12 and older.
"This milestone is important to be able to provide access to variant-adapted vaccines to a broader population," Dr. Ugur Sahin, co-founder of BioNTech, said in a company statement. "In addition, we have started a clinical trial to evaluate the adapted vaccine based on the BA.4 and BA.5 subvariants in children six months through 11 years of age aiming to offer all age groups the opportunity to immunize against Omicron variants and subvariants."
The FDA also authorized Moderna's updated boosters for people ages 6 to 11 and 12 to 17. Moderna's updated booster was previously authorized for people 18 and older.
About 13 million to 15 million people in the US have gotten the updated Covid-19 boosters since September 1, according to White House Covid-19 Response Coordinator Dr. Ashish Jha.
An analysis published this month found that if more people in the United States get their booster by the end of the year, about 90,000 Covid-19 deaths could be prevented this fall and winter.
But if booster vaccinations continue at their current pace, the nation could see a peak of more than 1,000 Covid-19 deaths per day this winter, according to the study by The Commonwealth Fund.
There are now more than 400 daily Covid-19 deaths, on average, in the United States.