CEO says Pfizer will submit data on COVID-19 vaccine trial in 5- to 11-year-olds within days, with U.S. daily death toll still above 2,000
New York City healthcare workers face a deadline for mandatory vaccination
The chief executive of Pfizer Inc. said the company is expecting to submit data from late-stage trials of its COVID-19 vaccine in 5- to 11-year-old children to the U.S. Food and Drug Administration within days, raising hopes that another key patient group will soon be eligible for shots.
Albert Bourla said on ABC’s “This Week” on Sunday that if the FDA authorizes the vaccine’s use for this demographic, Pfizer PFE, -0.84% and German partner BioNTech BNTX, -7.91% will be ready to produce a vaccine aimed at children.
“It is a different formulation,” Bourla said. “It’s one-third of the dose that we are giving to the rest of the population.”
Last week, the two companies said a study found that the lower dose was safe and effective in younger children. The news comes as children have returned to in-person classrooms with only those 12 and older eligible for vaccination.
Separately, Pfizer said Monday that it is starting a Phase 2/3 trial involving 2,660 healthy adults aged 18 and older of its investigational novel oral antiviral candidate to treat adults living in a household with someone who has tested positive for and has symptoms of COVID-19. The candidate is called PF007321332 and is co-administered with a low dose of ritonavir to prevent infection.
“If successful, we believe this therapy could help stop the virus early — before it has had a chance to replicate extensively — potentially preventing symptomatic disease in those who have been exposed and inhibiting the onset of infection in others,” said Mikael Dolsten, Pfizer’s chief scientific officer and president of worldwide research and development.