FDA expected to approve use of Pfizer’s COVID vaccine for 12- to 15-year-olds by next week

The U.S. Food and Drug Administration will authorize the use of Pfizer’s COVID-19 vaccine for those ages 12 to 15 by next week, well in advance of the start of the new school year, several media outlets are reporting.

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In March, Pfizer reported to the FDA that clinical trial results showed no cases of COVID-19 among the 2,260 U.S. volunteers ages 12 to 15 who received the company’s vaccine. Eighteen cases were confirmed among those volunteers who received a placebo.

Volunteers produced strong antibody responses and had similar side effects to those experienced by volunteers in the 16- to 25-year-old age group, the company said.

The FDA’s approval will actually be an amendment to Pfizer’s existing emergency use authorization that was granted in December.

When the agency grants approval for use of the vaccine for those 12 to 15 years old, the Centers for Disease Control and Prevention’s vaccine advisory panel will most likely meet within 24 hours to review the company’s clinical trial data and make recommendations for the vaccine’s use in the age group.

While the FDA has not commented publicly on the authorization to administer the vaccine to those 12 to 15 years old, The New York Times, The Washington Post and The Associated Press all cite unnamed government officials who have said the vaccine is expected to be approved for use for 12- to 15-year-olds by the end of this week or the beginning of next week.

According to the AP, the federal official quoted in its reporting, speaking on the condition of anonymity to preview the FDA’s action, said the agency was expected to approve and expand its emergency use authorization for Pfizer’s two-dose vaccine by early next week, and also said the agency is expected to approve Pfizer’s use by even younger children sometime this fall.

Moderna, one of the three companies that have FDA authorization for COVID-19 vaccines, is also conducting clinical trials of its vaccine on volunteers ages 12-17. Results are expected in June.

According to the FDA, both Pfizer and Moderna are being allowed to begin trials in the U.S. on children aged 11 and younger.

Pfizer and its partner in the development of the COVID-19 vaccine, BioNTech, announced that clinical trials were continuing and that it was testing preferred dosing levels for three age groups — between 6 months and 2 years old, 2 to 5 years old, and 5 to 11. The companies will evaluate test results on children ages 5 to 11 first, before moving to the younger age groups.

BioNTech co-founder and chief medical officer Dr. Ozlem Tureci said last week that because results from trials on children from 5 to 11 would be done first, it’s likely that younger children would not get the vaccine until the end of the year.

“We expect the data at the end of the summer or autumn of this year. We will then file it with the regulators and, depending on how fast they react, by the end of the year we might get approval to also immunize younger children,” Tureci said.

As of this week, Pfizer has administered more than 131 million doses of its vaccine in the United States. The vaccine is given in two doses, 21 days apart.

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