With the full FDA approve of the Pfizer vaccine now called Comirnaty, there is a faint hope that more Americans will step forward to get vaccinated to stop the horrible spread of the virus now ravaging the country. With K-12 students reentering schools this also raised the possibility of soon vaccinating children.
Once a drug or vaccine has been FDA-approved, doctors have the leeway to prescribe it “off label” — that is, for a use for which it wasn’t specifically approved. After rigorous clinical trials, the FDA authorized the Pfizer-BioNTech vaccine for emergency use in people 16 and up in December 2020 and in adolescents ages 12 to 15 in May 2021. Significant data does not yet exist for children under the age of 12 yet.
Trials in children between the ages of 5 and 11 should be completed in September 2021, Pfizer Chief Executive Albert Bourla told NBC News anchor Lester Holt. Trial data for even younger children should be landing soon after that. That however leaves children unvaccinated as the Delta variant spreads through the school systems.
The American Academy of Pediatrics acknowledged that August 23rd’s regulatory action “means it is legally permissible for physicians to administer the vaccine off-label for children aged 11 and younger, who currently have no available vaccine.” But the organization said in a statement that it “strongly discourages that practice.” FDA officials were also quick to discourage prescribing of the vaccine for younger children.
This is a deeply stressful time for parents of younger children, given that COVID-19 has largely now become a scourge of the unvaccinated. And it’s nerve-wracking to send those unvaccinated children out into school where they’ll be exposed to other people indoors for long periods of time. The best advice for parents is to wait for the FDA give a definite green light.