FDA authorizes updated booster doses for Covid-19 for children up to 5 years old

CNN
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The U.S. Food and Drug Administration on Wednesday granted emergency use authorization to update Covid-19 boosters for children up to 5 years old.

Like the boosters that became available to people 12 and older in September, these bivalent boosters target the original coronavirus strain as well as the Omicron BA.4/BA.5 sub variants.

“As children have gone back to school by themselves and people have resumed pre-pandemic behaviors and activities, there is the potential for increased risk of exposure to the virus that causes COVID-19,” said Dr. Peter Marks, director of the FDA’s Center for Biology Assessment and Research, in a news release on Wednesday. Vaccination remains the most effective measure to prevent severe consequences of COVID-19, including hospitalization and death.

While it has largely been the case that COVID-19 tends to be less severe in children than in adults, as different waves of COVID-19 have occurred, more children have fallen ill and been hospitalized. Children may also experience long-term effects, even after initially mild illness,” Marks said. “We encourage parents to consider the initial vaccination of children and to follow up with an updated booster dose when they are eligible.”

The US Centers for Disease Control and Prevention should recommend the injection to younger children before it is given.

However, Pfizer said its doses will be shipped immediately. “Pfizer has the ability to ship up to 6 million doses to children in the first 7 calendar days after receiving EUA approval, with no impact on dosing for individuals 12 and over,” a Pfizer spokesperson told CNN.

The updated Pfizer/BioNTech booster has received authorization for use in children 5 to 11 years of age and will be given as a 10 mcg dose. Pfizer’s Updated Booster is pre-licensed for people 12 years of age or older.

“This achievement is important to be able to provide access to diverse adaptive vaccines for a wider 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 from six months to 11 years of age with the aim of allowing all age groups to be immunized against Omicron variants and subvariants.”

The FDA has also approved Moderna Enhancers for people ages 6 to 11 and 12 to 17 years old.

About 13 million to 15 million people in the United States have received 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 got a booster dose by the end of the year, about 90,000 deaths from COVID-19 could be prevented in the 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.

Originally published at San Jose News Bulletin