FDA authorizes booster shot of Pfizer COVID-19 vaccine for children ages 5 to 11

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FDA authorizes booster shot of Pfizer COVID-19 vaccine for children ages 5 to 11

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FDA authorizes booster shot of Pfizer COVID-19 vaccine for children ages 5 to 11.

The U.S. Food and Drug Administration (FDA) on Tuesday granted emergency use authorization for Pfizer-BioNTech’s COVID-19 vaccine for children 5 to 11 years old, according to CNET. A booster shot is given a month later.

Children 12 years and older are already eligible for a third, or booster, shot. Before booster shots start rolling out to younger age groups, they need advice from the U.S. Centers for Disease Control and Prevention (CDC).

The CDC’s independent advisory committee is scheduled to hold a public meeting Thursday, presumably for a vote on whether to recommend a booster shot.

Like the first two doses of the vaccine given to children aged 5 to 11, they received a booster dose of Pfizer’s vaccine that was 1/3 the dose given to children 12 and older.

The FDA said the authorization was based on immune response data from an ongoing randomized trial that supports the October authorization of the primary vaccine for young children.

The trial assessed antibody responses in 67 children who received a booster shot within 7 to 9 months of the second dose.

The researchers evaluated the safety of booster needles in about 400 children. Side effects of the booster for children are similar to common side effects in adults, including pain at the injection site, fatigue, headache, and fever.

“While for the most part, COVID-19 tends to be less severe in children than in adults, in the Omicron wave, there are more children,” FDA Commissioner Dr. Robert M. Califf said in a statement.

After developing the disease and being admitted to the hospital, children may also experience long-term effects, even after the initial mild symptoms.” After last winter’s surge in Omicron, the U.S. About 75% of children have evidence of COVID-19.

A newer, more contagious version of Omicron has driven an increase in COVID-19 cases in recent weeks.

About 1 million people in the U.S. have died from COVID-19 since the pandemic began in early 2020.

Prior to this authorization, the FDA did not meet with an independent advisory committee, which the FDA typically does before authorizing a COVID-19 vaccine or a booster shot for specific age groups.

The FDA said Pfizer’s request for emergency use authorization “did not raise additional questions for committee members” that had not been addressed in other discussions about the COVID-19 vaccine booster. The agency noted that it will provide documents related to the request on its website.

Children under the age of 5 still cannot get the COVID-19 vaccine. The FDA has scheduled three dates next month — June 8, 21 and 22 — for its panel to discuss Moderna and Pfizer’s vaccine authorization requests for infants and younger children.

According to the American Academy of Pediatrics, about 28 percent of children ages 5 to 11 have completed their primary COVID-19 vaccine series (two doses). About 35 percent of children of the same age had already received a dose.

FDA authorizes booster shot of Pfizer COVID-19 vaccine for children ages 5 to 11

(source:internet, reference only)

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