The Food and Drug Administration authorized the use of the Pfizer-BioNTech COVID-19 vaccine for children aged 5 through 11 on Oct. 29.
The authorization was based on an extensive evaluation process undertaken by the FDA, which saw a third of the original dosage amount reach 90.7% effectiveness in preventing COVID-19 while posing no serious side effects to the 3,100 children involved in the study.
“The FDA is committed to making decisions that are guided by science that the public and healthcare community can trust,” director of the FDA’s Center for Biologics Evaluation and Research Peter Marks said. “We are confident in the safety, effectiveness and manufacturing data behind this authorization.”
According to the Center for Disease Control and Prevention, COVID-19 cases in children aged 5 through 11 comprises approximately 6% of all cases in the United States and 40% of all cases within underaged individuals. In terms of deaths, younger groups take a smaller share at 0.08% of the total number of deaths.
The CDC followed up on the release with the recommendation that children aged 5 through 11 be vaccinated against COVID-19 with the Pfizer vaccine. The recommendation would expand the target group by about 28 million children while allowing vaccinations to begin as soon as possible.
“I think it’s great that the vaccine was approved for those 5 and up, especially since younger kids can finally resume normal activities without worrying about contracting serious COVID,” junior Elaine Pan said. “We should step up the vaccination campaign to better reach out to these people.”
State legislators have provided strong support for strengthening the vaccine mandates for students. While the approval opens up the the prospects of loosening restrictions on masks and social distancing in schools, many schools have opted not to include the younger age group in their vaccine mandate policies.
While some have expressed concern about potential side effects, these claims seem to be inflated. Pfizer Inc. plans to continuously oversee the situation according to their updated safety monitoring plan. In addition, the FDA and CDC have set up their own independent systems for the rapid detection and investigation of potential safety problems.
“As a mother and a physician, I know that parents, caregivers, school staff and children have been waiting for today’s authorization,” Acting FDA Commissioner Janet Woodcock said. “Vaccinating younger children against COVID-19 will bring us closer to a sense of normalcy.”