Pfizer Inc and BioNTech SE said on Monday their COVID-19 vaccine induced a robust immune response in 5 to 11 year olds, and they plan to ask for regulatory authorization as soon as possible to use the shot in children in that age range in the United States, Europe and elsewhere.
The companies said their two-dose vaccine generated an immune response in the 5-to-11 year olds in a Phase II/III clinical trial that matched what was previously 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 percent 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 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency,” Bourla added.
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. A rapid authorization could help mitigate a potential surge of cases this fall, with schools already open nationwide.
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 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.
FDA acting Commissioner Janet Woodcock said that once the agency receives the application, its process for determining if the vaccine is safe and effective for children in the younger age group includes verifying the manufacturing processes for the lower concentrations of the shots and any study of its safety.
“We’ll look at the clinical data and make sure that children responded to the vaccine the way we would expect,” Woodcock said during an appearance on former Biden administration official Andy Slavitt’s podcast.
Pfizer shares fell 1.3% to $43.28 before the bell on Monday amid broader market weakness.
