FDA Expands Pfizer’s Covid-19 Vaccine to Kids Age 12 and Older

Children and teens age 12 and older are now able to get the Pfizer-BioNTech Covid-19 vaccine. 

On Monday afternoon, the U.S. Food and Drug Administration amended its December 11, 2020, emergency-use authorization to include younger ages (initially the vaccine was approved for ages 16 and up). 

According to the release, the Centers for Disease Control and Prevention received reports of about 1.5 million Covid-19 cases in children aged 11–17 from March 1, 2020 to April 30, 2021. Although young people typically have milder cases, the FDA has approved the vaccine because “the known and potential benefits of this vaccine in individuals 12 years of age and older outweigh the known and potential risks, supporting the vaccine’s use in this population.” The vaccine will be doled out to this age group in the same way as adults: two doses at least three weeks apart. 

“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 Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a statement. “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.”

The Pfizer vaccine, which started the process to get full FDA approval last week, was the first emergency use authorization in the U.S. At the time, the decision to approve the vaccine was based on the results of a trial of 44,000 people aged 12 and older. 

Today’s expansion is based on a trial that included 2,260 participants, aged 12–15 years. In the trial, 1,131 participants received the vaccine and the rest were given a placebo. According to the FDA, reactions to the vaccine injection were similar to adults—i.e., tiredness, headache, chills, muscle pain, fever, injection-site pain for one-to-three days—although, the adolescents typically had stronger reactions to the second dose than the first.

According to the FDA, the vaccine was 100-percent effective in preventing Covid-19. 

Of course, the FDA’s news isn’t exactly a surprise. On May 3, news outlets began reporting that the vaccine would be approved for adolescents soon. 

Last week, in anticipation of the FDA’s approval of Pfizer’s vaccine for adolescents, the Texas Department of State Health Services began encouraging pediatric health care providers to sign up for the state’s Covid-19 Vaccine Program. 

“Vaccinating adolescents will bring us closer to ending the pandemic and getting back to normal,” said DSHS Commissioner John Hellerstedt in a May 7 statement. “Starting the enrollment process now will enable pediatric providers to start vaccinating their patients soon after the FDA expands the Pfizer vaccine’s EUA.”

Because the Pfizer vaccine’s approval is an emergency-use authorization—which means the FDA’s decided the threat of Covid-19 is strong enough that the vaccine’s potential benefits outweighed the risks—Pfizer will continue its safety monitoring and reporting to national authorities.

So far, Johnson & Johnson and Moderna’s vaccines are not approved for younger age groups.   

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