Pfizer Inc. said the COVID-19 shot it developed with BioNTech SE was 90.7 per cent effective against symptomatic cases in children ages 5 to 11, according to a briefing document posted on the Food and Drug Administration’s website.

Outside experts on the FDA’s Vaccines and Related Biological Products Advisory Committee will meet next week 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.

The document was posted on the FDA’s website in advance of the meeting, scheduled for Oct. 26. The efficacy result is based on a trial of about 2,250 kids, according to the document.

Shares of Pfizer were little changed at 9:32 a.m. in New York. 

Pfizer and BioNTech applied for authorization in the younger kids in early October after trial data showed that the lower-dose shot raised antibodies against COVID. The child dose of the companies’ vaccine is one-third of the amount given to adults.  


In the document, 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 side effects were consistent with what has been previously seen with the vaccine.

In the efficacy portion of the trial, 1,305 kids without prior evidence of COVID received two shots, while 663 got placebo injections. Among those who got the vaccine, there were three cases of symptomatic COVID starting a week after the second shot, compared with 16 cases in the placebo group. 

Symptoms were milder in the cases that occurred among vaccinated kids, and none developed fevers, according to the document. Most of the cases occurred in August and September.

Though COVID impacts children less severely than adults, the disease has been a leading cause of death for those aged 5 to 14 this year. As the new school year coincided with a surge in the delta variant, infections among youth have picked up. In August and September, COVID cases among children under the age of 18 surged 419 per cent in the U.S. compared to June and July.

The U.S. expects to be able to begin vaccinating young children before Thanksgiving. Health officials have said they could be ready to vaccinate children of any age in the first quarter of 2022.

A document from FDA’s staff regarding the Pfizer-BioNTech vaccine is expected to be posted later.