Pharmacist LaChandra McGowan prepares a dose of the Pfizer COVID-19 vaccine at a DePaul Community Health-operated clinic in New Orleans in August. Soon, children ages 5-11 could be eligible for Pfizer shots.
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Mario Tama / Getty Images
Pharmacist LaChandra McGowan prepares a dose of the Pfizer COVID-19 vaccine at a DePaul Community Health-operated clinic in New Orleans in August. Soon, children ages 5-11 could be eligible for Pfizer shots.
Mario Tama / Getty Images
Pfizer and its partner BioNTech say their data supports the approval of their COVID-19 vaccine in children aged 5-11.
The Food and Drug Administration published the briefing document of the companies Friday morning as a prelude to a specialist consultant meeting of the agency planned for Tuesday.
The companies studied a vaccine dose of 10 micrograms in children aged 5 to 11 years, a third of the dose used for adults and older children. The lower dose was chosen to minimize side effects and because it still elicits a strong immune response, the companies said.
In the main clinical study conducted by the companies, the vaccine appeared to be greater than 90% against symptomatic COVID-19. to be effective
No new security issues 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 study, so a rare problem would not necessarily be detected.
The antibody response to the vaccine was similar to that seen in subjects aged 16-25 years.
The FDA is preparing its own analysis, which is expected to be published on Friday.
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Reference: www.npr.org
