FDA considers EUA for 5 to 11 year olds

October 26, 2021
FDA considers EUA for 5 to 11 year olds

There were no reports of myocarditis/pericarditis or anaphylaxis, and no participant deaths.

FDA Briefing Document, EUA amendment request for Pfizer-BioNTech COVID-19 Vaccine for use in children ages 5 through 11.
  • The FDA advisory panel will consider emergency use authorization for the Pfizer COVID-19 vaccine.
  • If the FDA approves EUA, then the CDC would also have to approve and issue guidance before the vaccine becomes available for children.
  • Overall, the briefing document points to the vaccine keeping children less susceptible and less sick due to COVID-19, with the added benefit of potentially blunting the spread of the virus – but the sample size was small, and the Associated Press posted this important context: "The FDA review affirmed results from Pfizer posted earlier in the day showing the two-dose shot was nearly 91% effective at preventing symptomatic infection in young children. Researchers calculated the figure based on 16 COVID-19 cases in youngsters given dummy shots versus three cases among vaccinated children. There were no severe illnesses reported among any of the youngsters, but the vaccinated ones had much milder symptoms than their unvaccinated counterparts."
  • Why This Matters: This would be the first COVID-19 vaccine approved for use in the U.S. for children as young as 5.

Here's a link to the FDA meeting on October 26

Here's a link to the brief

Interesting highlights – attributed to the brief:

As of October 17, 2021, 691 deaths from COVID-19 have been reported in the United States in individuals less than 18 years of age, with 146 deaths in the 5-11 year age group.

While the overall incidence of myocarditis following COVID-19 infection is low, persons with COVID-19 have a nearly 16-fold increase in risk for myocarditis, compared to individuals without COVID-19.

While children and adolescents appear less susceptible to SARS-CoV-2 infection and generally have a milder COVID-19 disease course as compared with adults, adolescents and adults have similar SARS-CoV-2 viral loads in their nasopharynx, so adolescents may play a role in community transmission.

Remdesivir is the only product currently approved by the FDA for treatment of COVID-19 requiring hospitalization, and its approved use is limited to individuals 12 years of age and older.

FDA says Pfizer COVID vaccine looks effective for young kids

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by Jenna Lee,