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 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.
[to top of second column] |
 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.
"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 vaccines.
"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 CDC.
(Reporting by Manojna Maddipatla in Bengaluru;
Editing by Caroline Humer, and Bill Berkrot)
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