Pfizer and BioNTech are requesting FDA authorization to expand their COVID-19 vaccine to children as young as 12, claiming recently-released trial results demonstrate the immunizations’ safety. Currently, the Pfizer-BioNTech vaccine, BNT162b2, is being administered in the US under an FDA emergency use authorization (EUA) for people aged 16 or above.
In fact, that already makes it the only COVID-19 vaccine currently in deployment in the US which is authorized for people under the age of 18. Both Moderna’s COVID-19 vaccine, and Johnson & Johnson’s Janssen COVID-19 vaccine, are authorized only for those 18 or above.
Pfizer and BioNTech announced a new set of Phase 3 trial results for their vaccine at the end of March, which focused on its efficacy among younger cohorts. The latest study looked at participants aged 12-15 years: across a total of 2,260 adolescents, vaccinated participants who received the pharma companies’ BNT162b2 drug showed 100-percent efficacy and “robust antibody response.” Side-effects were similar to those encountered among older recipients, the vaccine being “well tolerated” generally.
At the time, the two pharma companies said that the next step was to apply for an amendment to the existing EUA from the FDA. That’s now been applied for, it was confirmed today.
“The companies look forward to working closely with the U.S. Food and Drug Administration (FDA) and other worldwide regulatory authorities as part of the companies’ efforts to expand emergency or conditional authorization of their COVID-19 vaccine in 12- to 15-year-olds as quickly as possible,” Pfizer and BioNTech said in a statement.
Just how susceptible to coronavirus young people are has been a topic of great controversy during the ongoing pandemic, particularly amid pressures to reopen schools and colleges. Adding to the complexity is the potential for children to act as agents of community spread, carrying COVID-19 and infecting others, even if they themselves don’t show the same extent of reaction as older people might.
The US CDC recently announced new protocols for schools, potentially reducing the recommended minimum distance that young people should be kept at from six feet to three feet. However, the Centers for Disease Control and Prevention pointed out, COVID-19 does not affect every person under 18 in the same way. Indeed, while younger children might be relatively low-risk when in small groups, the same may not hold true for the sort of age groups that Pfizer is looking to expand its vaccine to now.