Pfizer reports vaccine works for children 5 to 11, ready to seek FDA approval

Pfizer reported Monday that company data show its Covid-19 vaccine to be safe and effective in children ages 5 to 11. It and the German company BioNTech, the co-developer, plan to apply to the Food and Drug Administration by the end of the month for approval to administer to that age group. If the authorization goes as smoothly as it did for adults and teenagers, elementary school students could begin to be vaccinated by the end of October, the Los Angeles Times reported.

Although children are at lower risk of severe illness or death than adults, more than 5 million children in the U.S. have tested positive for Covid-19 since the pandemic began and at least 460 have died, according to the American Academy of Pediatrics.

Children’s cases have risen sharply since the return to school this fall amid the more contagious delta variant. Delta has sent more children into hospitals and intensive care units in the past month than at any other time in the pandemic, the New York Times reported.

In Pfizer’s limited trial of 2,268 children, two-thirds of the children ages 5 to 11 received a vaccine that was a third of the amount given to teenagers and adults, yet they developed coronavirus antibodies that were just as strong after a second dose, Dr. Bill Gruber, a Pfizer senior vice president, told the Associated Press. The other one-third were injected with two doses of saltwater placebo.

The FDA’s full approval of the Pfizer-BioNTech vaccine last month did not apply to children ages 12 to 15. They continue to receive the vaccine under an emergency use authorization.

About 54% of vaccinated Americans have received the Pfizer-BioNTech vaccine, with the rest receiving Moderna’s vaccine, which uses similar technology. Moderna is also studying extending the use of its vaccine to elementary-school-age children.

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