Pfizer said the COVID shot it’s developed with BioNTech SE was 90.7% effective against symptomatic cases in young kids ages 5 to 11, according to a briefing document posted on the Food and Drug Administration website.
Pfizer posted the document in advance of a key hearing scheduled for Oct. 26 where an advisory panel will debate whether the vaccine should be cleared for young children. The efficacy result is based on a trial of about 2,250 children, according to the briefing documents.
Outside experts on the FDA’s Vaccines and Related Biological Products Advisory Committee will meet to evaluate Pfizer and BioNTech’s application for emergency authorization of their COVID vaccine in young children. If the panel votes to recommend clearance and the FDA agrees, it could pave the way for a COVID vaccine for young kids to be available by the beginning of November.
Pfizer and BioNTech applied for emergency authorization for their vaccine in the younger kids in early October after trial data showed that the lower-dose shot raised antibodies against the COVID. The child dose of the vaccine is one-third of the adult dose.
In its briefing documents, Pfizer also released new safety data from an additional 2,250 children enrolled in the trial as part of an expansion of the study requested by U.S. regulators. The data found no new safety problems and the side effects seen were consistent with what has been previously seen with the vaccine.
FDA’s staff document is expected to be posted later.
More health care and Big Pharma coverage from Fortune:
- What you need to know about the Delta Plus COVID variant and the danger it poses
- Should kids under 12 get the COVID vaccine? What parents should know
- Intrivo launches new at-home rapid test for COVID amid U.S. supply shortage
- COVID-19 vaccine makers could inoculate the world by the end of 2022, says J&J CEO Alex Gorsky
- Got the J&J vaccine? Here’s what you need to know about boosters
Subscribe to Fortune Daily to get essential business stories straight to your inbox each morning.