Pfizer-BioNTech say COVID-19 vaccine safe, protective in kids aged 5-11

Pfizer Inc. and BioNTech said on Monday their COVID-19 vaccine induced a robust immune response in five- to 11-year-olds, and they plan to ask for authorization to use the vaccine in children in that age range in the United States, Europe and elsewhere as soon as possible.

The companies said the vaccine generated an immune response in the five- to 11-year-olds in their Phase II/III clinical trial that matched what they had previously observed in 16- to 25-year-olds. The safety profile was also generally comparable to the older age group, they said.

"Since July, pediatric cases of COVID-19 have risen by about 240 per cent in the U.S. — underscoring the public health need for vaccination," Pfizer chief executive Albert Bourla said in a news release.

"These trial results provide a strong foundation for seeking authorization of our vaccine for children five to 11 years old, and we plan to submit them to the FDA and other regulators with urgency."

The news release from Pfizer makes no specific mention of when the company might seek approval from Canadian regulators.

COVID-19 hospitalizations and deaths have surged in the United States in recent months due to the highly contagious delta variant. Pediatric cases are also up, particularly as children under 12 are all unvaccinated, but there is no indication that, beyond being more transmissive, the delta virus is more dangerous in kids.

A rapid authorization could help mitigate a potential surge of cases in the fall, especially with schools already open nationwide.