June 2022 — MHCE Newsletter

14 | MHCE - News www.mhce.us JUNE 2022 EDITION
While the adult trials recruited tens of thousands of
volunteers and waited to see if vaccinated people were
better protected, the children's vaccine trials were primarily
designed to measure immune responses using blood tests.
The criteria for success was whether a vaccine provoked
a comparable immune response to what was seen among
young adults in trials conducted before the widespread
emergence of variants. Both the Pfizer-BioNTech and
Moderna pediatric vaccines succeeded on that measure,
although the significance of that benchmark has shifted
with the emergence of the omicron variant.
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The companies also measured cases of symptomatic illness
in the population, and Pfizer and BioNTech said the 80%
efficacy finding was preliminary and based on 10 cases of
COVID-19 in the study population as of the end of April.
Once 21 cases have occurred, the companies will conduct a
more formal analysis of efficacy.
David Benkeser, a biostatistician at Emory University's
Rollins School of Public Health, said the updated data
would probably be ready before a decision would need to
be made, and that he wouldn't be surprised if the efficacy
number declined somewhat as more cases occur.
"Even still, it appears the data are so far pointing towards
a safe and effective vaccine for young children," Benkeser
wrote in an email.
Moderna's two-shot vaccine regimen was about 51%
effective in children 6 months to 2 years old, and 37%
effective in children 2 to 5 years old.
If Pfizer's efficacy data holds up, it could pose a conundrum
for public health officials, physicians and parents. If
both vaccines are cleared by the FDA, the CDC advisory
committee could weigh whether one vaccine should be
recommended over the other.
Moderna is studying a booster given six months after the
last shot.
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In either case, the hope is that children will be fully
vaccinated in advance of a potential surge in the fall.
On Sunday, before the Pfizer announcement, White House
coronavirus response coordinator Ashish Jha predicted on
ABC News' "This Week" that children could have access
to a shot "in the next few weeks" and that action would be
taken on the Moderna vaccine as soon as regulators were
finished with their review.