Will Vaccine Approval Spur Off-Label Vaccination of Young Children?
(Thursday, August 26, 2021)
Doctors often prescribe FDA-approved drugs to patients who may not be eligible for them based on the labelled claims for the drug, on a case-by-case basis. Such off-label treatment is an important part of patient care in the absence of a specific approved treatment. Now that the Pfizer’s COVID vaccine has been approved, concerned parents may use this option to get their younger school-age children vaccinated, off-label. And it would be legal. Vaccination of all school-going children is the next big milestone for FDA, and it seems that it would be months before children as young as 5 years of age may be eligible to get the vaccination even under an emergency use authorization. Parents are eager to get their children vaccinated and the extremely safe and effective profile of the vaccine in adults so far would embolden parents to get their children vaccinated and not wait for FDA’s decision. This concern prompted the American Academy of Pediatrics to release a cautionary letter to its members to avoid off-label vaccination of children. But that may not be enough. While FDA has done an amazing job of helping develop and approve the first Covid vaccine, it has also seemingly let it be forced to set the scientifically insane goal of authorizing an almost 100% effective vaccine with 0% risk. Every vaccine carries some risk. The exceptionally low risk of the current vaccines is unprecedented. With hundreds of millions of safety vaccinated people worldwide, any delay in making the vaccine available to all those who want would create an underground market for these products. Conventionally, new drugs are first approved for adult populations and then for the pediatric populations once additional safety data is available. But emergency situations require out-of-the-box solutions. FDA has taken a very traditional approach to Covid vaccines making them go through large clinical trials, and extensive data analysis prior to even emergency authorization. Now that we have confirmed that these vaccines are safe and highly effective, it would be prudent for the regulators to take a more aggressive approach to getting the vaccines to all populations. At the minimum an emergency use authorization for children with dose titration information based on the known risk profile of the vaccine and the doses tested in clinical trials, seems reasonable. We saw that the emergency authorization of vaccines led to more than 50% of the population getting vaccinated and curtailing of the pandemic before full approval. A similar emergency use authorization would allow a significant portion of younger populations get legally vaccinated as well. Otherwise, motivated parents would force their pediatricians to vaccinate their children any way and no one would be wiser.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC