US agency authorizes Pfizer bivalent booster for children ages 5 to 11

The Food and Drug Administration (FDA), an agency similar to Anvisa in the United States, granted this Wednesday (12) emergency use authorization for updated Covid-19 booster doses for children aged 5 to 11 years.

Booster immunization had already been authorized for people aged 12 and over in September. The so-called bivalent vaccines target the original strain of the coronavirus, in addition to Ômicron BA.4/BA.5 subvariants.

“As children have returned 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 serious consequences of the disease, including hospitalization and death,” Peter Marks, director of the FDA’s Center for Biological Assessment and Research, said in a press release Wednesday.

“While it has largely been the case that Covid-19 tends to be less severe in children than in adults, as the various waves of Covid-19 have occurred, more children have become sick and have been hospitalized. Children can also experience long-term effects, even after initially mild illness,” said Marks. “We encourage parents to consider primary vaccination for children and follow-up with an updated booster dose when eligible.”

Doses for younger children must be recommended by the US Centers for Disease Control and Prevention (CDC) before they are administered.

However, Pfizer said its doses will ship immediately. “Pfizer is able to ship up to 6 million pediatric doses within the first 7 calendar days after receiving approval, with no impact on dose distribution for individuals 12 years and older,” a spokesperson told CNN .

The updated Pfizer/BioNTech booster has been authorized for use in children ages 5 to 11 and will be administered at a dose of 10 micrograms. Updated booster was also previously authorized for people aged 12 and over.

“This milestone is important for providing access to variant-adapted vaccines to a wider population,” said Ugur Sahin, co-founder of BioNTech, in a company statement. “In addition, we have initiated a clinical trial to evaluate the adapted vaccine based on the BA.4 and BA.5 subvariants in children aged six months to 11 years with the aim of offering all age groups the opportunity to immunize against variants. and Omicron subvariants”.

THE FDA also authorized Moderna’s updated boosters for 6-11 year olds and 12-17 year olds. . Moderna’s upgraded booster was previously authorized for people aged 18 and over.

Some 13 million to 15 million people in the U.S. have received the updated Covid-19 boosters as of Sept. 1, according to White House Covid-19 Response Coordinator Ashish Jha.

An analysis published this month pointed out that if more people in the US get their booster by the end of the year, about 90,000 Covid-19 deaths could be averted this fall and winter.

However, if booster vaccinations continue at the current pace, the country could see a peak of more than 1,000 Covid-19 deaths a day this winter, according to the study by The Commonwealth Fund.

Currently, there are more than 400 daily deaths from Covid-19, on average, in the United States.