Could
This Be the Reason COVID Jabs Are Being Pushed for Kids?
September 28, 2021
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.
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