Pfizer and its partner BioNTech say their data supports authorization of their COVID-19 vaccine in kids 5 to 11.
The Food and Drug Administration released the companies’ briefing document Friday morning in a prelude to a meeting of expert advisers to the agency scheduled for Tuesday.
The companies studied a 10 microgram vaccine dose in children ages 5 to 11, a third of the dose used for adults and older children. The lower dose was chosen to minimize side effects and because it still prompts a strong immune response, the companies said.
In the main clinical trial conducted by the companies, the vaccine appeared to be more than 90% effective against symptomatic COVID-19
No new safety problems were identified in the companies’ studies. No cases of heart inflammation were observed in the main study, but only a few thousand children were included in the research, so that sort of rare problem wouldn’t necessarily be detected.
The antibody response to the vaccine was comparable to the one seen in people 16 to 25 years old.
Number of COVID-19 Omicron variant cases in Europe as of November 29, 2021, by country
In late-November 2021, the Omicron variant of SARS-CoV-2 (the virus which causes COVID-19) was designated as a variant of concern by the World Health Organization due to fears about a higher transmissibility from the variant and a possible decrease in the effectiveness of vaccines against it.