FDA approves vaccine in children aged 5 to 11

The US Food and Drug Administration (FDA) has amended the emergency use authorization of the Pfizer/BioNTech vaccine to include children aged 5 to 11 years.

Following the recommendation of the recommendation of Vaccines and Related Biological Products Advisory Committee this past Tuesday, the US Food and Drug Administration has expanded the emergency use authorization of the Pfizer/BioNTech vaccine to include children aged 5 to 11 years with a 2 dose primary season with a 10 µg dose. The Advisory Committee on Immunization Practices will meet next week to discuss any further recommendations.

Study of the vaccine found that the immune response in children aged 5 to 11 years was similar to that seen in people aged 16 to 25 years and was 90.7% and was 90.7% effective at preventing a COVID-1i infection. The most common side effects included injection site pain, fatigue, headache, chills, fever, and nausea. They were typically mild to moderate in severity and occurred within 2 days of receiving a dose and subsided in 1 day or so. As has been seen with older recipients, side effects were more common following the second dose.

An increased risk of myocarditis has been found via safety surveillance systems after receiving the vaccine, especially the second dose, but the risk is highest among males aged 12 to 17 years. However, a benefit-risk analysis in this new age group confirmed that the benefits outweigh the risk.

On the expansion, editor-in-chief of Contemporary Pediatrics Tina Q. Tan, MD, FAAP, FIDSA, FPIDS, said, "I think that it is great news that COVID-19 vaccine will be available for use in children 5 – 11 years of age. This will allow us to provide protection against COVID-19 to a population of children that are at risk for infection and the possible complications and hospitalizations associated with COVID-19 infection. The clinical trials showed that the lower dose of vaccine was very immunogenic and safe in this age group. The complications that have been reported with mRNA vaccines (eg myocarditis) are very rare complications that were only observed after millions of doses of the vaccines were given. This demonstrates that the vaccine safety monitoring system that is in place here in the United States works very well in recognizing the occurrence of these very rare complications."

Reference

1. US Food and Drug Administration. FDA authorizes Pfizer-BioNTech COVID-19 vaccine for emergency use in children 5 through 11 years of age. Published October 29, 2021. Accessed October 29, 2021. https://www.fda.gov/news-events/press-announcements/fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use-children-5-through-11-years-age

This article was originally published on Contemporary Pediatrics®.