Second J&J COVID-19 shot gets expert backing; FDA is looking at lowering
age for Pfizer booster
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[October 16, 2021]
By Julie Steenhuysen and Michael Erman
(Reuters) - Outside advisers to the U.S.
Food and Drug Administration on Friday unanimously recommended the
agency authorize a second shot of Johnson & Johnson's COVID-19 vaccine
for all recipients of the one-dose inoculation.
The agency is also considering lowering the recommended age for booster
shots of the Pfizer/BioNTech vaccine to people as young as 40, FDA
official Dr. Peter Marks told the advisory panel.
The FDA's Vaccines and Related Biological Products Advisory Committee
backed the shots for all J&J recipients aged 18 and older at least two
months after their first dose.
The FDA is not bound to follow the recommendation, but typically does.
After hearing presentations from J&J and FDA scientists, many members of
the advisory panel asked if J&J's single-dose vaccine should actually be
considered a two-dose shot for everyone.
They pointed to the lower levels of virus neutralizing antibodies it
provokes compared to vaccines using messenger RNA (mRNA) technology from
Moderna Inc and Pfizer/BioNTech.
"There is a public health imperative. What we're seeing is this is a
group with overall lower efficacy than we have seen with the mRNA
vaccine, and so there is some urgency to do something," said Dr. Arnold
Monto, an epidemiologist at the University of Michigan's School of
Public Health who chaired the meeting.
The FDA authorized boosters of the Pfizer/BioNTech vaccine last month
for Americans aged 65 and older and those at high risk of severe illness
or occupational exposure to the virus.
Marks, director of the FDA's Center for Biologics Evaluation and
Research, said data from Israel, where Pfizer booster shots have already
been administered broadly, suggests that the vaccine's efficacy is
waning and makes a compelling case for lowering the age for receiving
booster shots to 40.
Concerns about rare cases of heart inflammation in younger men who
receive the Pfizer/BioNTech vaccine also made 40 a good cutoff point for
the additional shots, Marks said.
CONCERNS OVER J&J DATA
Marks raised concerns that the data presented by J&J did not reflect all
of the information on the vaccine's performance.
[to top of second column]
A healthcare clinician prepares a dose of the Johnson & Johnson
vaccine for the coronavirus disease (COVID-19) for a commuter during
the opening of MTA's public vaccination program at the 179th Street
subway station in the Queens borough of New York City, New York,
U.S., May 12, 2021. REUTERS/Shannon Stapleton
"There are some real challenges here. All of the data
do not fully align with this being a vaccine that retains excellent
activity over time, against all forms of disease or even against
severe forms of disease," Marks said.
J&J scientists said their vaccine was more durable than the mRNA
"If the vaccine isn't adequate, it should be boosted and everybody
should get it," said Dr. Eric Rubin, an infectious disease expert at
the Harvard Chan School of Public Health.
After the vote, Rubin said he expects that getting the second J&J
dose later than two months after the first should be safe. While the
data are scarce, he said, "there isn't much to suspect that it's
wrong," adding, "I certainly am supportive of those individuals
getting another dose."
Once the FDA signs off on the second dose, the U.S. Centers for
Disease Control and Prevention will make specific recommendations on
who should get the shots. CDC advisers are scheduled to meet to
discuss the boosters next week.
On Thursday, the panel unanimously backed booster shots of Moderna's
COVID-19 vaccine for Americans aged 65 and older and those at high
risk of severe illness or occupational exposure to the virus.
U.S. health officials have been under pressure to authorize the
additional shots after the White House announced plans in August for
a widespread booster campaign pending approvals from the FDA and the
(Reporting by Manojna Maddipatla in Bengaluru; Editing by Caroline
Humer, and Bill Berkrot)
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