FDA Authorizes Pfizer COVID Vaccine for Children Ages 5-11

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A 5-year-old girl being vaccinated in North Carolina, in September.
A 5-year-old girl being vaccinated in North Carolina, in September.Credit: Shawn Rocco/Reuters

The Food and Drug Administration authorized Friday the Pfizer-BioNTech COVID-19 vaccine for emergency use in children ages 5 to 11.

In the United States, about 28 million children are now eligible to receive one-third of the adult dose, with two jabs three weeks apart.

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An advisory panel to the U.S. Centers for Disease Control and Prevention will meet next week to make a recommendation on the administration of the vaccine. The CDC director will make the final call. Vaccinations could start as early as Wednesday.

Pfizer and BioNTech said their vaccine showed 90.7 percent efficacy against the coronavirus in a clinical trial of children aged 5 to 11.

Only a few other countries, including China, Cuba and the United Arab Emirates, have so far cleared COVID-19 vaccines for children in this age group and younger.

The FDA authorized a 10-microgram dose of Pfizer's vaccine in young children, lower than the 30 micrograms in the original vaccine for those ages 12 and older.

The companies expect data from a clinical trial in children ages 2 to 4 years by year-end.

Pfizer's vaccine was the first to be authorized for emergency use in the United States in December last year for those aged 16 and older. It gained clearance for the 12 to 15 age group in May and was granted full U.S. approval in August.

Will Israel follow suit?

If vaccinations for younger children are approved in the United States, and then in Israel, about 1 million more Israelis could potentially be vaccinated – about 11 percent of the population.

Director of Public Health Dr. Sharon Alroy-Preis told Israel's Channel 12 News channel on Tuesday that if the FDA approves the vaccines for this age group, she expects the vaccination campaign in Israel will begin within the next few weeks.

An opinion poll conducted at the beginning of the month by Liora Shmueli of Bar Ilan University, found that among 894 parents of Israeli children aged 5 to 11, 57 percent expressed willingness to vaccinate their kids against the coronavirus this coming winter if the vaccine is approved and available.

While children becoming seriously ill or dying from COVID-19 is relatively rare compared with adults, some develop complications, and infections in unvaccinated kids have risen due to the easily transmitted Delta variant of the coronavirus.

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