Will FDA full approval of the Pfizer covid-19 vaccine affect vaccination of kids under 12?
The FDA gave the Pfizer covid-19 vaccine full approval this week for those 16 and older but advises against a workaround for vaccinating those under 12.
Children are heading back to in-person learning across the country and parents worried about their child’s health may be thinking about using a workaround to get their under 12s vaccinated against covid-19. Even though the covid-19 vaccine produced by Pfizer has received full approval for use in those 16 and older, the FDA and health officials advise against attempting to do this as kids respond differently to vaccines than adults.
Pfizer has obtained emergency use authorization for adolescents between 12 and 15 years old and clinical trials are currently underway to determine the efficacy and proper dosage for kids under 12. Results from the trials for children 5 to 11 won’t be ready for until next month when the vaccine-maker expects to seek an emergency use authorization. Those that are even younger will have to wait longer.
Why are vaccines different for children?
A child is not a small adult when it comes to how their bodies will react to a vaccine. Their immune system is different and responds to contagions differently. At the beginning of the covid-19 pandemic, children seemed to be barely affected by the novel virus. However, the Delta variant, which is behind the latest wave of infections, appears to be changing this with younger patients accounting for more and more serious cases.
The immune response of a child reaches maturity sometime after puberty which is why the clinical trials are performed on specific age tiers to account for the physiological changes that occur. Also why there is a specific age-based vaccination schedule for children.
One of the potentially harmful side effect that tends to be more common in young people is developing myocarditis, a rare side effect of the mRNA vaccines that causes inflammation of the heart. The FDA asked Moderna and Pfizer to specifically look for this in children in their clinical trials. Too large of a dose could increase the chance of this happening.
Parents and pediatricians advised against using covid-19 vaccine "off-label"
The American Academy of Pediatrics has called on the FDA to “work aggressively to authorize a covid-19 vaccine for ages 11 and younger.” But at the same time in a statement said it “strongly discourages” the use covid-19 vaccines in children under 12 at this time. The FDA made a similar recommendation and the CDC warned that clinicians that provide the covid-19 vaccine off-label run the risk of losing liability protection for any adverse effect caused and possible forfeiture of payment.
“Off-label” use is where a doctor prescribes an FDA-approved drug for an unapproved treatment of a disease or medical condition. “Ordinarily … when a medical product is approved, physicians often do use off-label prescribing. However, this is a different situation,” Acting FDA Commissioner Janet Woodcock, MD said. “The vaccine is being distributed under a provider agreement by the US government through the CDC, and there are many considerations that would pertain to off-label prescribing for the recipient and so forth.”