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12 | MHCE - News www.mhce.us JUNE 2022 EDITION TO ADVERTISE contact kyle.stephens@mhce.us
WWW.MHCE.US Monthly Newsletter | 13 illness in children between 6 months and 2 years old, and 37% effective in children 2 to 5 years old. Regulators previously had set aside three dates for the FDA's outside experts to review the vaccines for young children, beginning with a session on June 8. Those meetings are now canceled. VISIT OUR WEBSITE AT MHCE.US Under the revised schedule, the FDA and its outside experts will discuss the Moderna vaccine for children and adolescents from 6 to 17 years old on June 14. The following day, they will review vaccines for the youngest children, with advisers evaluating the Moderna vaccine for children 6 months through 5 years old and the Pfizer-BioNTech vaccine for children ages 6 months through 4 years old. "The overall data are encouraging such that it is really hard to look at one vaccine apart from the other," according to an official familiar with the process who spoke on the condition of anonymity because that person was not authorized to speak publicly. The official suggested the two vaccines would probably be reviewed side by side. A CDC planning document notes that vaccines are expected to be shipped immediately after being authorized by the FDA. Preordering for doses could begin in late May or early June, but an exact date will be contingent on when the FDA's external advisers meet. The Pfizer-BioNTech vaccine for children younger than 5 is a three-shot regimen tested in nearly 1,700 children. Each dose is one-tenth of the adult dose. The third shot was added in December after it became clear that two shots failed to muster an immune response equivalent to what was generated in young adults in early coronavirus vaccine trials. It is given two months after the second shot. Although that setback was hugely disappointing to parents, the addition of a third shot was seen by many experts as necessary because the omicron variant of the coronavirus had fundamentally changed the pandemic. The two shots that provided robust protection against infection and severe illness early on were markedly less protective against the omicron variant. "Omicron has really thrown a curveball on us — it seems that two doses are not sufficient for adequate efficacy against infection with Omicron, with any vaccine, at any age," Flor Munoz, a pediatric infectious-disease specialist at Baylor College of Medicine, said in an email before the new data was released.
