A little-known incentive for tailoring vaccines for children could be a big financial boost for COVID vaccine manufacturers.<\/p>\n
Historically, children\u2019s vaccines have taken years of studies before they come to market \u2014 exactly opposite what\u2019s 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.<\/p>\n
\u201cThe carrot\u201d is that a special provision \u201callows companies to qualify for an additional six months of marketing exclusivity \u2014 in other words, their patents \u2014 if they do the studies in children as requested by the FDA.<\/p>\n
\u201cThe 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,\u201d the FDA says on its website.<\/p>\n
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.<\/p>\n
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SOURCES:<\/p>\n
US FDA May 4, 2016<\/a><\/p>\n US FDA April 29, 2020<\/a><\/p>\n MOFO Life Sciences September 9, 2020<\/a><\/p>\n FDA February 9, 2021<\/a><\/p>\n","protected":false},"excerpt":{"rendered":" A little-known incentive for tailoring vaccines for children could be a big financial boost for COVID vaccine manufacturers. Historically, children\u2019s vaccines have taken years of studies before they come to market \u2014 exactly opposite what\u2019s happening with the COVID shots. … Continue reading