Drugmaker Pfizer has again modified the protocol for its late-stage study of its vaccine against the new coronavirus, this time to include more young participants.
The company said Monday that it’s received permission from the Food and Drug Administration to include adolescents aged 12 through 15 in its global COVID-19 vaccine study.
"By doing so, we will be able to better understand the potential safety and efficacy of the vaccine in individuals from more ages and backgrounds," the company said in a statement on its website.
New York-based Pfizer originally planned for 30,000 participants, but in September expanded that to 44,000 people. That increase was made to boost diversity in the trial population, specifically by including 16- and 17-year-old teens, as well as stable patients with some common chronic infections: hepatitis B, hepatitis C and HIV.
Pfizer’s trial also includes significant numbers of Hispanic, Black, Asian and Native American participants, plus many people aged 56 through 85. The diversity is aimed at providing information on how safe and effective the experimental vaccine is in people of different ages and backgrounds.
Until now, children under 16-years-old have not been included in any of the coronavirus vaccine trials underway in America.
The American Academy of Pediatrics reported in late September that children of all ages now make up 10% of all U.S COVID-19 cases, up from 2% in April. Earlier this month, the group wrote to federal health officials urging them to include children in the trials. "Children must be included in vaccine trials to best understand any potential unique immune responses and/or unique safety concerns," the group wrote.
There are currently four coronavirus vaccine candidates in Phase 3/late-stage large-scale studies in the U.S.
Back in early September, the CEO of Pfizer said he believed they should know by the end of October whether their vaccine is safe and effective. The CEO of Moderna, one of Pfizer's competitors, recently said her company should know in November.
The other two Phase 3 trials, from Astrazeneca and Johnson & Johnson, have longer trial timelines.
