FDA Authorizes Pfizer COVID-19 Vaccine for Children 5-11 Years

The US Food and Drug Administration (FDA) authorized this Friday the emergency use of the Pfizer-BioNTech vaccine against COVID-19 for children ages 5 to 11. The authorization included input from experts from the independent advisory committee who voted to make the vaccine available to this age group.

As detailed in the FDA on its website, the immune responses of children ages 5 to 11 were comparable to those of people ages 16 to 25. In that study, the vaccine had a 90.7% effectiveness in preventing COVID-19 in children under 12.

The study was conducted in approximately 3,100 children in that age range who received the vaccine and showed no serious side effects in the ongoing study.

“As a mother and a doctor, I know that parents, caregivers, school personnel, and children have been waiting for today’s clearance. Vaccinate younger children against COVID-19 will bring us closer to returning to normality “said the acting FDA commissioner, Janet Woodcock.

The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention (CDC) will meet next week to discuss more clinical recommendations.

The vaccine Pfizer-BioNTech COVID-19 for children 5 to 11 years of age it is given as a primary series of two doses, 3 weeks apart, but it is a lower dose (10 micrograms) than that used for people 12 years of age and older. (30 micrograms).

The document also points out that in the EE.UU., cases of COVID-19 in children from 5 to 11 years old, they represent 39% of the cases in people under 18 years of age. According to CDC, approximately 8,300 cases of COVID-19 in children from 5 to 11 years old they resulted in hospitalization.

“The FDA is committed to making science-guided decisions that the public and the healthcare community can trust. We are confident in the safety, efficacy and manufacturing data behind this authorization. “, he pointed Peter Marks, director of the Center for Biological Evaluation and Research of the FDA.

“As part of our commitment to transparency around our decision-making, which included our public advisory committee meeting earlier this week, today we released documents supporting our decision and additional information detailing our assessment of the data. We hope this information helps build confidence in parents who are deciding whether to vaccinate their children. “, ended.

Continuous security monitoring

The pharmaceutical Pfizer has updated its security monitoring plan to include the evaluation of myocarditis, pericarditis and other similar events in children from 5 to 11 years old. Besides, the FDA and the CDC have multiple systems to continuously monitor vaccine safety COVID-19 and enable rapid detection and investigation of potential security issues.

The document also states that it is mandatory that Pfizer and vaccination providers report any serious adverse events, cases of multisystem inflammatory syndrome and cases of COVID-19 resulting in hospitalization or death in vaccinated persons.