Sunday, December 4, 2022
Home HEALTH FDA approves Pfizer booster for children ages 12 to 15

FDA approves Pfizer booster for children ages 12 to 15

The Food and Drug Administration has lowered the age requirement for the Pfizer booster in an effort to protect more people from COVID-19 infections as omicron cases rise.

The third shot can now be given to anyone over the age of 12, the FDA announced Monday, approving emergency use authorization for the booster. Previously, it was approved for ages 16 and up.

The federal agency also reduced the waiting period between Pfizer’s second and third injections to five months, instead of six, to speed up the process.

And “certain” immunocompromised children, particularly those who have undergone a solid organ transplant, between the ages of 5 and 11 may also receive a third dose of the Pfizer vaccine.

“Throughout the pandemic, as the virus that causes COVID-19 has continually evolved, the need for the FDA to adapt quickly has meant using the best available science to make informed decisions with health and safety in mind. of the American public,” Acting FDA Commissioner Janet Woodcock said in a statement.

“With the current wave of the omicron variant, it is critical that we continue to take effective, life-saving preventive measures such as primary and booster vaccinations, wearing of masks, and social distancing to effectively fight COVID-19.”

During the week of December. From February 22 to 28, an average of 378 children under the age of 17 were hospitalized daily with COVID, according to a Centers for Disease Control and Prevention study released Thursday. That’s a 66% increase from the previous week and 10% more than the previous peak in early September.

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Pfizer CEO Albert Bourla called the FDA approval “critical to help us finally defeat this pandemic.”

“We continue to believe that the widespread use of boosters is essential to preserve a high level of protection against this disease and reduce the rate of hospitalizations,” he said in a statement.

At least 78% of people in the United States who are eligible for the vaccine have received at least one injection, according to the CDC. About 66% of eligible citizens are fully vaccinated, not including the booster.

The FDA said Monday that it studied “real-world data” from Israel, where more than 6,300 children between the ages of 12 and 15 received the booster within five months of their second injection. No safety issues arose from these data, and no new cases of myocarditis or pericarditis were reported.

The news comes just as students head back to school after winter break, despite calls to return to virtual learning as omicron cases skyrocket.

“Based on the FDA’s evaluation of currently available data, a booster dose of currently licensed vaccines may help provide better protection against delta and omicron variants,” said Peter Marks, director of the FDA Center for Biological Evaluation and Research. the FDA, in a statement. statements. “In particular, the omicron variant appears to be slightly more resistant to the levels of antibodies produced in response to primary series doses of current vaccines.”

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