COVID-19 Vaccine for Children Ages 5 to 11 Receives Final Approval

An FDA Advisory Panel votes 17-0 to recommend the Pfizer vaccine for kids 5-11.

The Centers for Disease Control and Prevention now recommends children ages 5-11 be vaccinated against COVID-19 with the Pfizer-BioNTech pediatric vaccine.

This announcement follows a Food and Drug Administration panel granted emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine for kids ages 5 to 11 after finding a 90.7% efficacy rate, according to a Pfizer press release.

Pfizer’s randomized, controlled trial included 4,500 children between the ages 5-11 who received two vaccine shots spread between 21 days. The study ran from July through August before Pfizer-BioNTech requested Emergency Use Authorization (EUA) on Oct. 6. The results are strong: the trial, which gave doses that are two-thirds less than the adult dose, “showed a favorable safety profile, robust immune responses and a vaccine efficacy rate of 90.7%,” the press release says. Pfizer also found the lower dose to be effective while attempting to subside side effects. Last Tuesday, the FDA’s Vaccines and Related Biological Products Advisory Committee unanimously voted 17-0 with one abstention, according to the press release, and on Friday, the FDA announced the authorization of emergency use of the Pfizer vaccine in kids 5-11. In Michigan, there have been 142,554 cases and 20 reported deaths from COVID-19 for 10- to 19-year-olds, as well as 54,091 cases and zero reported deaths for children younger than 10 years old, according to state data. As booster shots and mask mandates struggle to combat the higher transmission rate brought by the Delta variant, the COVID-19 vaccine is possibly days away from being available for elementary- and middle school-aged children. Children with more than one underlying condition, such as obesity, chronic lung disease and neurological disorders, accounted for more than two-thirds of COVID-19 hospitalizations. In the United States, nearly 4 million 5- to 11-years-olds have contracted the virus as of Oct. 15, the FDA says. The CDC has reported more than 700 COVID-19 deaths in the United States younger than 18. Of that number, 146 deaths were among ages 5-11, according to the FDA. If approved for EUA, Pfizer doses for 5- to 11-year-olds — packaged in smaller needles — will be distributed to pediatricians’ offices, pharmacies, hospitals and “school- and community-based sites,” according to a Biden Administration plan.


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