June 2022 — MHCE Newsletter

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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.
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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.