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.
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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.
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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 to receive the adult shot, also under an EUA, and that vaccine has full FDA approval in people 16 years of age and older.
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The Pfizer/BioNTech COVID-19 vaccines are currently the only ones any Americans below the age of 18 are authorized to receive as standard first or second shots, and are likely to remain the sole choice for at least several months.
Fellow mRNA vaccine maker Moderna has released positive results from its clinical trials in 12- to 17-year-olds and in 6- to 11-year-olds, and has submitted the results of the older age group to the FDA for authorization.
But the company announced that the agency said on Oct. 29 that it would potentially need until January 2022 to conduct its review to “evaluate recent international analyses of the risk of myocarditis.”
Several Nordic countries say they have observed an elevated risk of myocarditis in recipients of the Moderna vaccine compared with Pfizer/BioNTech’s and have restricted the former’s use in younger people. Moderna says the FDA has not seen such a pattern, but that it would wait to file an EUA request for its pediatric vaccine while the agency reviews the one for teens.
Moderna has used more mRNA in its vaccines than Pfizer, with teens receiving the full adult dose of 100 micrograms per shot, and younger children a 50-microgram dose.
In April, Johnson & Johnson expanded one of its ongoing clinical trials to include teenagers ages 12 to 17, but is not yet testing its viral vector vaccine in kids below the age of 12.
Pfizer has said that it expects initial data from its clinical trials testing an even lower 3 microgram dose in two other groups of younger children — those 2 to 5 years old and babies 6 months of age to 2 years old — as soon as the end of 2021 or early 2022.
Pfizer/BioNTech 5-11 years Q&A
How is the children’s vaccine different from the adult version?
The biggest difference between the two vaccines is the amount of messenger RNA, or mRNA, in each shot. The mRNA provides the instructions to cells to make the spike protein of SARS-CoV-2, the coronavirus that causes COVID-19, thereby triggering the body to mount a protective immune response against the virus.
