FDA authorises Comirnaty^® for emergency use in five to 11 year olds

The US Food and Drug Administration (FDA) authorised the emergency use of the COVID-19 Vaccine Comirnaty^® for the prevention of COVID-19 to include children five through 11 years of age. The authorisation was based on the FDA’s thorough and transparent evaluation of the data that included input from independent advisory committee experts who voted in favour of making the vaccine available to children in this age group.

The effectiveness data to support the emergency use authorisation (EUA) of Comirnaty in children down to five years of age is based on an ongoing randomised, placebo-controlled study that has enrolled approximately 4,700 children five through 11 years of age. Children in the vaccine group received two doses of the vaccine containing 10 micrograms of messenger RNA per dose.

The FDA analysed 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 Comirnaty 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 percent effective in preventing COVID-19. 

Key points for parents and caregivers:

• Immune responses of children five through 11 years of age were comparable to those of individuals 16 through 25 years of age. 
• The vaccine’s safety was studied in approximately 3,100 children ages five through 11 who received the vaccine and no serious side effects have been detected in the ongoing study.
• The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices will meet next week to discuss further clinical recommendations.

The FDA stated that the vaccine for this age group should be administered as a two-dose primary series, three weeks apart, but is a lower dose of 10 micrograms than that used for individuals 12 years of age and older of 30 micrograms. 

“The FDA is committed to making decisions that are guided by science that the public and healthcare community can trust,” commented Dr Peter Marks at the FDA.  “We are confident in the safety, effectiveness and manufacturing data behind this authorisation. 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. We hope this information helps build confidence of parents who are deciding whether to have their children vaccinated,”