Montreal Gazette



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 regulatory authorizat­ion as soon as possible to use the shot in children.

The companies said their two-dose vaccine generated an immune response in a clinical trial that matched what had been observed in 16-to-25 year olds. The safety profile was also generally comparable to the older age group, they added.

“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 CEO Albert Bourla said.

The Pfizer/biontech vaccine already has won U.S. regulatory authorizat­ion for people age 12 and up, including full Food and Drug Administra­tion approval last month for ages 16 and up.

Top U.S. health officials believe regulators could make a decision on whether the shot is safe and effective in younger children within three weeks of the companies submitting a request for authorizat­ion, two sources told Reuters this month.

COVID-19 hospitaliz­ations and deaths have surged in the United States in recent months due to the highly contagious Delta variant, especially in areas with low vaccinatio­n rates even as U.S. President Joe Biden implores vaccine holdouts to get their shots. Pediatric cases are also up, particular­ly as children under 12 are all unvaccinat­ed, but there is no indication that, beyond being more transmissi­ble, the Delta virus is more dangerous in kids.

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