A lower dose of the Pfizer-BioNTech coronavirus vaccine — one-third the amount given to adults and teens — is safe and triggered a robust immune response in children as young as 5 years old, the companies announced early this morning.
Why it matters: The need is urgent: Children now account for more than one in five new cases, and the highly contagious Delta variant has sent more children into hospitals and intensive care units in the past few weeks than at any other time in the pandemic.
Details: The trial included 2,268 participants ages 5 to 11 and used a two-dose regimen of the vaccine administered 21 days apart.
- This trial used a 10-microgram dose — smaller than the 30-microgram dose that has been used for those 12 and older. “The 10 microgram dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age,” Pfizer said in a news release,
- The antibody levels compared well with older people who received the larger dose, demonstrating a “strong immune response in this cohort of children one month after the second dose.”
- “Further, the COVID-19 vaccine was well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age,” the company said.
- In fact, there appeared to be less fever and fewer chills among younger children than in a comparison group of 16- to 25-year-olds, increasing the companies’ confidence they had found the right dose. There were no cases of myocarditis — the heart inflammation condition — in the trial.
What happens from here: The companies still must prepare and submit the data to the Food and Drug Administration, a process they expect to complete by the end of September. Then, the full data — which is not yet published or peer reviewed — will be scrutinized by regulators to ascertain that the vaccine is safe and effective. That could take weeks, or up to a month — so the vaccine could potentially be available for kids 5-11 this fall.