VACCINE WORKS IN KIDS AGED 5 TO 11, PFIZER SAYS
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.