A Guide to Pfizer/BioNTech’s Pediatric COVID-19 Vaccine for Kids 5-11
As with its adult vaccine, Pfizer/BioNTech was the first to cross the finish line and offer a Food and Drug Administration-authorized COVID-19 vaccine to children ages 5 through 11.
Here, we describe how it’s different from its grown-up cousin and what experts are saying about who should get it.
Quick Summary
Vaccine name: BNT162b2
Design type: mRNA
Dose number: 2 doses of 10 micrograms of modified mRNA, 21 days apart
Population: Children 5 through 11 years of age
Effectiveness: Preliminary 90.7% efficacy in preventing symptomatic COVID-19 a week after receipt of the second dose and a comparable immune response to vaccinated young adults 16 through 25 years of age.
Safety: No serious safety concerns reported, although some rare allergic reactions and rare instances of myocarditis, or inflammation of the heart, are expected. The most common side effects, some of which are less frequent and more mild than in people 12 and up, include temporary injection-site pain, redness or swelling; fatigue; headache; and muscle pain.
Timeline: First doses were administered on Nov. 3, with wider availability expected by the week of Nov. 8.
Storage considerations: Vials are shipped under ultracold freezer temperatures of -130ºF to -76ºF but can be thawed and stored undiluted in a refrigerator for up to 10 weeks.
After months of waiting, the parents and legal guardians of 28 million American elementary school children now have access to a kid-sized version of Pfizer/BioNTech’s COVID-19 mRNA vaccine for their children.
The vaccine contains a third as much mRNA — 10 micrograms instead of 30 — but it is otherwise virtually identical to the adult version, and is also given in two shots three weeks apart.
The FDA granted the pediatric vaccine an emergency use authorization, or EUA, on Oct. 29, after concluding that based on the collective evidence at this time, the known and potential benefits of the vaccine in kids 5 through 11 years old outweigh the known and potential risks. An independent panel of experts advising the agency came to the same determination in a 17-to-0 vote, with one abstention.
The 4,600-child clinical trial, which found the pediatric vaccine to be highly effective in preventing symptomatic COVID-19, did not identify any serious safety concerns. The adult COVID-19 mRNA vaccines, however, are known to very rarely cause inflammation of the heart muscle (myocarditis) or of the surrounding lining (pericarditis), particularly in young men. Myocarditis was therefore the primary risk considered in the evaluation.
An outside group of experts advising the Centers for Disease Control and Prevention then recommended the vaccine for children 5 through 11 on Nov. 2 in a unanimous 14-to-0 vote. The agency endorsed the recommendation the same day, enabling children to be immunized.
Teens 12 through 15 years old are permitted
