FDA panel 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) advisory 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?

Pfizer presented data during the meeting Tuesday showing side effects, like fever, fatigue, headache, and chills, are similar or lower in kids 5 to 11 compared to people 16 to 25 years old. Pfizer says two doses given three weeks apart in kids 5 to 11 show nearly 91 percent effectiveness against symptomatic COVID-19.

An expert from the CDC shared that children have been greatly impacted by the pandemic, saying in total, there have been more than 1.9 million cases of COVID-19 reported in this age group.

“Over the past few months, we are seeing that children 5 to 11 years, shown here again in dark blue, are making up a greater proportion of total cases, representing 10.6 percent of all cases reported to the CDC the week of October 10, 2021," said Dr. Fiona Havers, a medical officer with the CDC.

Health experts have stressed the importance of getting the vaccine into the arms of more school-aged children. ABC Action News spoke to Dr. Michael Teng, an associate professor with USF Health, on what vaccinating this age group will mean for herd immunity.

“This is the group that hasn’t been vaccinated yet," said Teng. "As we’ve moved down in age, we still have lots of kids that are not vaccinated, so we’ve talked about herd immunity for months, but herd immunity means everybody that’s susceptible to the virus, and that includes children.”

The Vaccines and Related Biological Products Advisory Committee voted 17-0 with one doctor abstaining, clearing the way for the FDA to make its decision later this week. The Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) is scheduled to consider the shots early next week.

If that CDC advisory committee grants its 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 two-shot 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.