On Friday October 29th, the US Food and Drug Administration (FDA) authorized the emergency use of the Pfizer-BioNTech Covid-19 Vaccine for the prevention of Covid-19 to include children 5 through 11 years of age. The authorization was based on the FDA’s thorough and transparent evaluation of the data that included input from independent advisory committee experts who overwhelmingly voted in favor of making the vaccine available to children in this age group.
According to Reuters, the vaccine will not be immediately available as the Centers for Disease Control and Prevention (CDC) still needs to advise on how the shot should be administered. A group of outside advisers will discuss the plan on November 2nd and decide the next steps.
Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards
Janet Woodcock, Acting FDA Commissioner
The Pfizer-BioNTech Covid-19 Vaccine for children 5 through 11 years of age is administered as a two-dose primary series, 3 weeks apart, but is a lower dose (10 micrograms) than that used for individuals 12 years of age and older (30 micrograms).
In the US, Covid-19 cases in children 5 through 11 years of age make up 39% of cases in individuals younger than 18 years of age. According to the CDC, approximately 8,300 Covid-19 cases in children 5 through 11 years of age resulted in hospitalization. As of October 17th, 691 deaths from Covid-19 have been reported in the US in individuals under 18, with 146 deaths in the 5 through 11 years age group.
As part of our commitment to transparency around our decision-making, which included our public advisory committee meeting earlier this week, we have posted documents today supporting our decision and additional information detailing our evaluation of the data will be posted soon
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research
The FDA has determined this Pfizer vaccine has met the criteria for emergency use authorization. Based on the totality of scientific evidence available, the known and potential benefits of the Pfizer-BioNTech COVID-19 vaccine in individuals down to 5 years of age outweigh the known and potential risks.
The effectiveness data to support the Emergency Use Authorization (EUA) in children down to 5 years of age is based on an ongoing randomized, placebo-controlled study that has enrolled approximately 4,700 children 5 through 11 years of age. The study is being conducted in the US, Finland, Poland and Spain. Children in the vaccine group received two doses of the Pfizer-BioNTech COVID-19 Vaccine containing 10 micrograms of messenger RNA per dose.
The FDA analyzed data that compared the immune response of 264 participants from this study to 253 participants 16 through 25 years of age who had two higher doses of the vaccine in a previous study which determined the vaccine to be effective in preventing Covid-19. The immune responses of the younger age participants were comparable to the older participants.
The FDA also conducted a preliminary analysis of cases of Covid-19 occurring seven days after the second dose. In this analysis, among participants without evidence of prior infection with SARS-CoV-2, 3 cases of COVID-19 occurred among 1,305 vaccine recipients and 16 cases of Covid-19 occurred among 663 placebo recipients; the vaccine was 90.7% effective in preventing Covid-19.
