TUESDAY, MAY 24 , 2022. THE WASHINGTON POST EZ RE A
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 three-shot
Pfizer-BioNTech regimen and
two doses of the Moderna pediat-
ric vaccines succeeded on that
measure, although the signifi-
cance of that benchmark has
shifted with the arrival of the
omicron variant.
The companies also measured
cases of symptomatic illness in
the study population, and Pfizer
and BioNTech said the 80 per-
cent efficacy finding was prelimi-
nary and based on 10 cases of
covid-19 in the study population
as of the end of April. Once 21
cases have occurred, the compa-
nies will conduct a more formal
analysis of efficacy.
David Benkeser, a biostatisti-
cian at Emory University’s Roll-
ins School of Public Health, said
that the updated data would
probably be ready before a
decision would need to be made
and that he wouldn’t be sur-
prised if the efficacy number
declines somewhat as more cas-
es 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.
If Pfizer’s efficacy data holds
up, it could pose a conundrum
for public health officials, physi-
cians and parents. If both vac-
cines 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 sec-
ond shot in the initial series.
In either case, the hope is that
children will be fully vaccinated
in advance of a potential surge in
the fall.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.
While the adult trials recruit-
ed tens of thousands of volun-
teers and waited to see whether
vaccinated people were better
protected, the children’s vaccine
trials were primarily designed to
measure immune responses us-
ing blood tests.because the omicron variant of
the coronavirus had fundamen-
tally changed the pandemic. The
two shots that provided robust
protection against infection and
severe illness early in the health
crisis were markedly less protec-
tive against the omicron variant.
“Omicron has really thrown a
curveball on us — it seems that
two doses are not sufficient for
adequate efficacy against infec-
tion with Omicron, with anyis 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 vac-
cine trials.
Although that setback in the
trial of two doses was hugely
disappointing to parents, the
addition of a third shot was seen
by many experts as necessaryIf the FDA advisory committee
reviewed the Moderna shot June
8 and the Pfizer-BioNTech vac-
cine two weeks later, “we would
say we don’t know which is
better,” Patel said. “I might say,
‘Wait two weeks’ ” until the panel
reviews the Pfizer-BioNTech vac-
cine.
“The more confusing it is for
doctors to explain, the less likely
people are to get their children
vaccinated,” Patel said.
Nimmi Rajagopal, a family
medicine doctor at Cook County
Health in Chicago and mother of
a 3-year-old son, agreed. She said
she believes there is “value to all
the information coming out at
once. It’s confusing enough al-
ready.”
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 Pfizer-BioNTech vaccine al-
ready is authorized for that age
group.
The following day, they will
review vaccines for the youngest
children, with advisers evaluat-
ing the Moderna vaccine for
children 6 months through 5
years old and the Pfizer-BioN-
Tech vaccine for children 6
months through 4 years old.
A CDC planning document
notes that vaccines are expected
to be shipped immediately after
being authorized by the FDA.
Preordering for doses could be-
gin in late May or early June, but
an exact date will be contingent
on when the FDA’s external ad-
visers meet.
So far, the Pfizer-BioNTech
data is available only through a
news release with few details
and a top-line efficacy number
that could change. The compa-
nies are seeking authorization
for a regimen with a two-month
gap between the second and
third doses, but it is not yet clear
how closely the study data reflect
that. The average gap in the trial
could have been longer for many
participants who may have been
first vaccinated last year — and a
longer interval could account for
some of the protection, because a
longer time gap is thought to
help with the immune memory
response.
The Pfizer-BioNTech vaccine
for children younger than 5 is a
three-shot regimen tested in
nearly 1,700 children. Each shotwho should get the shots, with a
final recommendation coming
from the agency’s director, Ro-
chelle Walensky, shortly after-
ward. The vaccines would be
available almost immediately.
Pfizer and BioNTech said they
plan to finish filing data, which
has not been peer reviewed, with
the FDA this week. The compa-
nies warned that the efficacy
number was fluid because re-
sults are still arriving.
“This is incredibly exciting
data!” Kawsar Talaat, a pediatri-
cian and vaccine expert at Johns
Hopkins Bloomberg School of
Public Health, wrote in an email.
“I also think that it reinforces
what we’ve seen in adults as well.
For the Omicron variant, a third
dose is necessary for optimal
protection.”
The FDA is already reviewing
the pediatric vaccine from Mod-
erna, a two-shot regimen that
was 51 percent effective in pre-
venting illness in children be-
tween 6 months and 2 years old,
and 37 percent effective in chil-
dren 2 to 5 years old.
Regulators previously had set
aside three possible dates for the
FDA’s outside experts to debate
pediatric vaccines. The earliest,
June 8, presumably was for Mod-
erna, whose review is further
along. Those meetings have been
canceled. Now, the June 15 meet-
ing sets up a head-to-head com-
parison of efficacy and safety for
Moderna’s two-shot regimen and
Pfizer-BioNTech’s three-shot vac-
cine for the youngest children.
“The overall data are encour-
aging such that it is really hard to
look at one vaccine apart from
the other,” according to an offi-
cial familiar with the process
who spoke on the condition of
anonymity because they were
not authorized to speak publicly.
Some parents reacted angrily,
saying the FDA should move
ahead with the June 8 meeting to
consider the Moderna vaccine.
Fatima Khan, co-founder of Pro-
tect Their Future, a group of
physicians and parents who have
been pushing the FDA to acceler-
ate pediatric vaccines, said: “It’s
so disappointing. I think what is
really frustrating here, from the
very beginning, we have been
saying, ‘Let’s follow the science.
Let’s review ASAP and have the
same urgency you have had with
the adults’ vaccines.’ ”
In a statement, the group
noted that Peter Marks, director
of the FDA’s Center for Biologics
Evaluation and Research, said
the agency would not delay the
review of the Moderna vaccine to
allow Pfizer-BioNTech to catch
up.
But Marks also has said sev-
eral times it might be preferable
to review both vaccines at the
same time with the FDA’s outside
advisers. He has said he would
consider doing that if it would
not cause more than a week’s
delay in authorizing the Moder-
na vaccine.
In a statement Monday, the
FDA defended its plan. The agen-
cy said putting both vaccines
before the committee “is the best
approach to ensure the most
informed recommendations
from our external advisers and
allow the most optimal decision-
making by FDA experts because
they will have the comprehen-
sive analyses for both vaccines in
the youngest patient populations
before them.”
Kavita Patel, a primary care
doctor at Mary’s Center, which
has clinics in the District and
Maryland, said she thinks a si-
multaneous review of the two
vaccines “gives providers a lot of
benefit.” That’s because, she said,
“the most common question we
will get from early vaccine recipi-
ents is which one is better. We
will say, ‘This is what the data
show.’ ”
VIRUS FROM A
Pfizer vaccine is 8 0 percent e≠ective in children, data shows
ELAINE THOMPSON/ASSOCIATED PRESS
Amy McCoy at her day care in Washington state. Children under 5 are the last group in the country waiting for a coronavirus vaccine.CONNECT WITH US
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