FDA grants Pfizer authorization for COVID-19 vaccine for children ages 12 to 15 

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The Food and Drug Administration has approved Emergency Use Authorization for Pfizer's coronavirus vaccine for children ages 12 to 15, making it the first COVID-19 shot available for this age group. 

The approval expands the FDA's Emergency Use Authorization for the vaccine in individuals 16 and older that was issued in December 2020. The Pfizer vaccine continues to require two doses, three weeks apart, for adolescents.

Acting FDA Commissioner Dr. Janet Woodcock called the approval a "significant step in the fight against the COVID-19 pandemic.

"Today's action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic," Woodcock said. "Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations." 

The Centers for Disease Control and Prevention Advisory Committee on Immunization Practices is expected to meet Wednesday, May 12, to vote on the use of the Pfizer vaccine for children ages 12-15.

WHY THIS MATTERS

The Pfizer vaccine is expected to be available to middle and high school students in time for back-to-school this fall, another step in the return of the country to a post-pandemic normal.

Severe illness due to COVID-19 is rare among children, but deaths have been reported. As of May 6, more than 3.85 million children had tested positive for COVID-19 since the onset of the pandemic, representing 14% of the population, according to the American Academy of Pediatrics.

According to the FDA, approximately 1.5 million COVID-19 cases in individuals 11 to 17 years of age were reported to the CDC between March 1, 2020, and April 30, 2021.

THE LARGER TREND

While COVID-19 vaccines from Pfizer, Moderna, and Johnson & Johnson have been available for individuals ages 16 and over under the EUA, the FDA required further study before approving any of the vaccines for individuals under the age of 16.

There are 2,260 participants ages 12 through 15 enrolled in an ongoing randomized, placebo-controlled clinical trial in the U.S. Roughly half of the participants were given the vaccine, while the other half were given a saline placebo.

The side effects that adolescents reported were consistent with those reported by participants ages 16 and up. 

Lasting one to three days, the most commonly reported side effects among adolescents were pain at the injection site, tiredness, headache, chills, muscle pain, fever and joint pain. Participants reported more side effects after the second dose than the first; however, vaccine recipients should expect side effects after either dose.

Researchers also found that the immune response of participants ages 12 to 15 was at least as good as the immune repose of older participants.

An analysis of COVID-19 cases in adolescent participants seven days after receiving the second dose found that the vaccine was 100% effective in preventing COVID-19. 

No COVID-19 cases were found among the 1,005 vaccine recipients, and 16 cases of COVID-19 were found among the 978 participants who received the placebo.

ON THE RECORD

"Having a vaccine authorized for a younger population is a critical step in continuing to lessen the immense public health burden caused by the COVID-19 pandemic," said Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.

"With science guiding our evaluation and decision-making process, the FDA can assure the public and medical community that the available data meet our rigorous standards to support the emergency use of this vaccine in the adolescent population 12 years of age and older."

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