April 27, 2022 – Pfizer and BioNTech have applied to the FDA for authorization of their COVID-19 booster shot for children ages 5-11, according to an update from Pfizer.
The companies submitted data that showed the low-dose booster shot is safe for children 5-11 and could protect them against the Omicron variant. The companies also said a third shot could counter waning immunity about 6 months after the second dose.
“Over time, immunity to the vaccine wanes, and we know that happens in children as well,” Yvonne Maldonado, MD, a pediatric infectious diseases researcher at Stanford University, told NPR.
Maldonado advises the American Academy of Pediatrics and has also helped to test the vaccine for Pfizer.
“The data right now really support vaccine and boosters in particular to maintain immunity,” she said.
Earlier this month, Pfizer released data from a small study of blood samples from 30 kids ages 5-11, which showed a significant increase in antibody levels against the Omicron variant after a third dose.
At the same time, experts have argued that the primary vaccines are still protecting most people, including children, from severe illness.
“It may be that over time, those two doses don’t protect against serious illness, in which case one could reasonably receive a third dose,” Paul Offit, MD, an infectious diseases doctor and director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told NPR.
Offit is also an adviser to the FDA. He said that without evidence that a third dose boosts protection against serious illness, “I don’t see a clear reason to give a third dose now.”
To move forward, the authorization will need to be reviewed by the FDA and CDC, according to CNBC, which could potentially include reviews by their independent advisory panels. In January, the FDA authorized Pfizer booster doses for children 12-15 without calling a meeting of its outside expert panel.
About 28% of children ages 5-11 have been fully vaccinated with the first two shots, according to the latest CDC data. About 59% of children 12-17 are fully vaccinated, and about 24% have received booster shots.
Pfizer and BioNTech also plan to submit their data to the European Medicines Agency and other regulatory groups worldwide in coming weeks, the companies said.