An FDA review states that the benefits of Pfizer's COVID-19 vaccine in kids ages 5 to 11 outweigh the potential risks, The Washington Post reported.
The FDA noted in its review, released Oct. 22, that there could be a risk of more pediatric hospitalizations from myocarditis, a rare inflammatory heart condition, caused by the vaccine than COVID-19 in a scenario of low levels of COVID-19 transmission, but said "the overall benefits of the vaccine may still outweigh the risks under this lowest incidence scenario."
Vaccine-related myocarditis tends to resolve in a few days, unlike COVID-19 infections, the Post reported.
The FDA's vaccine advisory panel is set to meet Oct. 26 to discuss recommending authorization for Pfizer's shot in kids 5 to 11. The CDC's advisory panel will then meet Nov. 2 and Nov. 3 to vote on recommending authorization for the age group. Authorization would expand COVID-19 vaccine eligibility to about 28 million children.
A study released Oct. 22 by the FDA said Pfzier's vaccine was nearly 91 percent effective at preventing symptomatic infections in children ages 5 to 11. The children indicated equal levels of protection against the delta variant as they did against the original virus strain.
The U.S. detailed a plan Oct. 20 for vaccinating children in the age group. The government said it will make the vaccines available at more than 25,00 pediatricians' offices and other primary care sites, more than 100 children's hospitals and health systems, tens of thousands of pharmacies, hundreds of school and community-based clinics and hundreds of community health centers and rural health clinics.
HHS also said it plans to launch a national campaign to educate parents and guardians about vaccinations and how they can protect children and the community.