Pfizer COVID Vaccine for Children Under 5 Could Be Ready This Month

Updated 4 p.m. Tuesday

The last age group of the population unable to get a COVID-19 vaccine may soon be able to do so — and much earlier than anticipated.

Pfizer-BioNTech on Tuesday filed a submission for emergency use authorization to the Food and Drug Administration for a vaccine regimen designed for use in children age 6 months to 5 years.

“Having a safe and effective vaccine available for children in this age group is a priority for the agency and we’re committed to a timely review of the data,” said acting FDA Commissioner Janet Woodcock.

The FDA announced a Feb. 15 meeting of its advisory committee to discuss the request for an emergency use authorization.

Clinical trials last fall showed that the low doses of the vaccine generated protection in children up to 2 years old but failed to do so in kids age 2-5. The companies announced in December they’d add a third dose to its trials, which would delay the submission to the FDA.

Emergency use authorization could allow children to begin a two-dose regimen, which would prepare children between 2 and 5 years old to receive a third shot when the data demonstrates it’s effective.

“By now they probably have more information on whether the two shots provided any protection at all,” said Dr. Bob Wachter, chair of the UCSF Department of Medicine.

“It seems likely the third shot will be necessary … but you can’t get shot #3 until you’ve [had] shots 1 and 2,” he wrote in an email Monday night.

The FDA authorized the companies’ vaccine for children age 5 through 11 last October, but use among children remains significantly lower than the overall population. According to data from the Centers for Disease Control and Prevention, only 21.6% of children 5-11 are fully vaccinated.

“The key question is whether the parents of younger children will get their kids vaccinated,” said Dr. Celine Gounder, clinical assistant professor at NYU Langone Health. “Parents are relatively more hesitant to get their young children vaccinated than themselves.”

Gounder predicted vaccination rates for the younger group of children would mirror that of the group already authorized for the doses.

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