By Dr. Mercola
A little-known incentive for tailoring vaccines for children could be a big financial boost for COVID vaccine manufacturers.
Historically, children’s vaccines have taken years of studies before they come to market — exactly opposite what’s happening with the COVID shots. And, in case anyone questions the motives for that (beyond federal health officials encouraging it) the FDA itself may hold the answer.
“The carrot” is that a special provision “allows companies to qualify for an additional six months of marketing exclusivity — in other words, their patents — if they do the studies in children as requested by the FDA.
“The FDA has interpreted the provision so that the six months of exclusivity isn’t added only to the drug that was studied in the pediatric population, but also to any of the drug company’s formulations, dosage forms, and indications that contain the same active part of a molecule (moiety) and have existing marketing exclusivity or patent life,” the FDA says on its website.
While the initial exclusivity was supposed to end in 2007, it was made permanent in 2012. In 2020 it was confirmed that pediatric exclusivity applied to biologics, which the COVID vaccines are. In February 2021 the FDA confirmed in a memo on applications for the exclusivity that it, indeed, applies to vaccines.