FDA Sounds Alarm Over Use Of Pfizer COVID Vaccine Off-Label In Children Below 12

The US Food and Drug Administration (FDA) has finalized the full approval of Pfizer/BioNTech COVID-19 vaccine for individuals aged 16 and older. However, the use of the vaccine off-label in children aged 11 and under remains unauthorized. Off-label is the use of an approved product in a patient in a way that it wasn't approved for.

According to the American Academy of Pediatrics, administration of the vaccine in the 11 and below age group has been strongly discouraged. The US FDA also gave a warning against this practice saying this “would not be appropriate”.

The Pfizer vaccine has no current approval for use in children under 12 as the appropriate dosage for this age group has yet to be studied. It cites the dosage for adults is much higher compared for doses being tested for children younger than 12.

“The clinical trials for the COVID-19 vaccine in children ages 11 years old and younger are underway, and we need to see the data from those studies before we give this vaccine to younger children,” said AAP President Lee Savio Beers, MD, FAAP.

The AAP has asked the FDA to aggressively work on the approval for younger adolescents citing concerns on the rapid spread of the Delta variant among unvaccinated people. Beers called on the eligible to avail of the vaccine to help reduce the spread of the concerning variant to those who are too young to get a jab.

“While we wait for a vaccine to be authorized for younger children, it’s important that everyone who is eligible now gets the vaccine.” Beers explained.

At the same time, Dr. Yvonne Maldonado, chair of the AAP Committee on Infectious Diseases, has urged physicians to wait until clinical trials are complete. "We do not want individual physicians to be calculating doses and dosing schedules one-by-one for younger children based on the experience with the vaccine in older patients," she said in a statement.

But while the FDA is considering full approval of the vaccine for those between 12 and 15 years of age, it is available for emergency use authorization with the AAP strongly recommending that all adolescents in this age group get vaccinated as soon as possible.

Beers said the data from clinical trials and experience with the vaccine over the past four months in this age group show that it is safe and very effective.

Pfizer expects to have its vaccine authorized for younger ages by the end of September or shortly after. Meanwhile, Moderna and Johnson & Johnson are also working on clinical studies of their vaccines in children. As it is, the FDA has asked both Pfizer and Moderna to double the number of their clinical trials in children aged 5 to 11.

Based on reports from the AAP, 8.5 million or 34% of adolescents aged 12 to 17 have already received full inoculation doses against COVID-19 with 180,000 new cases reported among adolescents and children as of last week.