FDA OKs COVID Booster for Children Ages 5-11

By Lou Portero - Last Updated: May 26, 2022

The U.S. Food and Drug Administration authorized the use of Pfizer-BioNTech COVID booster shorts in children ages 5-11 years who have completed at least five months of a primary series with the Pfizer vaccine. 

According to the FDA Commissioner Robert M. Califf, “While it has largely been the case that COVID-19 tends to be less severe in children than adults, the omicron wave has seen more kids getting sick with the disease and being hospitalized, and children may also experience longer-term effects, even following initially mild disease,”

The benefit of the Pfizer vaccine has been determined to outweigh the known and potential risk among children in this age group and older. To determine the safety of the single booster dose of the Pfizer-BioNTech COVID-19 Vaccine in this age group, 400 children who had completed the two-dose primary series for at least 5 months received a single booster dose of the Pfizer vaccine. The most common side effects reported were fatigue, fever, chills, muscle or joint pain, as well as pain and swelling at the injection site. 

A third dose of the Pfizer vaccine was needed as data suggest that the vaccine’s effectiveness begins to decline after the second dose of the vaccine across all authorized populations. “Since authorizing the vaccine for children up to 5 years of age in October 2021, emerging data suggest that vaccine effectiveness against COVID-19 wanes after the second dose of the vaccine in all authorized populations”. The director of the FDA’s Center for Biologics Evaluation and Research, Peter Marks, said in a statement. 

The FDA had, in previous research, evaluated the effectiveness of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children in this age group. The research evaluated 67 study participants who received a booster dose 7 to 9 months after completing a two-dose primary series of the Pfizer vaccine. The researchers noted that “the antibody level against the SARS-CoV-2 virus one month after the booster dose was increased compared to before the booster dose”.


Source: US FDA

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January 26, 2023