FDA panel unanimously votes to recommend Pfizer vaccine for kids as young as 5

Pfizer Children Vaccines
Posted at 8:13 AM, Oct 26, 2021

On Tuesday, a key Food and Drug Administration (FDA) panel voted to formally recommend that children as young as 5 be authorized to receive Pfizer's COVID-19 vaccine under emergency use authorization.

The committee was posed with the following question:

Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 Vaccine when administered as a 2-dose series outweigh its risks for use in children 5-11 years of age?

The Vaccines and Related Biological Products Advisory Committee voted 17-0 with one doctor abstaining, clearing the way for the full FDA authorization later this week. The Centers for Disease Control and Prevention (CDC) is scheduled to consider the shots early next week.

If the CDC grants approval next week, agency director Dr. Rochelle Walensky would need to personally sign off on the shots before they become widely available.

Officials estimate that the vaccines — a smaller dose of the COVID-19 vaccine already available for adults — could be available to children as early as the first or second week in November.

Last week, the White House said that if and when Pfizer's vaccine receives emergency use authorization, it would begin shipping 15 million vaccine doses to clinics around the country for immediate distribution.

Biden Administration officials say the country currently has enough doses on hand to vaccinate every child aged between 5 and 11 that lives in the U.S. The White House says that it will primarily lean on primary care doctors and pharmacies to distribute the vaccines but noted that it is also working with some school boards to offer doses in schools.

Pfizer's COVID-19 vaccine has been fully approved by the FDA for everyone aged 16 and up. The shots are also available for adolescents between the age of 12 and 15 on an emergency use basis.

On Monday, Moderna released data that showed its COVID-19 vaccine was safe and effective for use in children aged 6 to 11. Moderna now plans to submit the data from the study to the FDA, the European Medicines Agency and other global regulators.