U.S. COVID-19 booster debate moves to FDA vaccine advisory committee
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[September 17, 2021]
By Manojna Maddipatla
(Reuters) - The debate over whether
Americans should receive a booster dose of the Pfizer/BioNTech COVID-19
vaccine moves to a panel of independent expert advisers to the U.S. Food
and Drug Administration on Friday.
While U.S. health officials, some other countries and vaccine makers
have said boosters are needed, many scientists and vaccine experts
disagree.
The FDA staff said in documents prepared for the committee this
week that the vaccine Pfizer Inc developed with Germany's BioNTech SE is
still very effective at preventing severe illness and death and that the
evidence is mixed on whether its efficacy declines over time.
Pfizer, which is arguing for broad use of a third shot, submitted data
from an analysis of over 300 participants in its late stage clinical
trial showing that the vaccine's efficacy diminished by around 6% every
two months after the second dose, and that an additional shot boosted
immunity.
The FDA's Vaccines and Related Biological Products Advisory Committee
will also consider data from Israel, which has been administering
booster doses of the Pfizer/BioNTech vaccine.
The effectiveness of the second dose of the vaccine waned six months
after administration, making a booster necessary, Israeli health
officials had said.
It began offering a COVID-19 booster to people as young as age 12 last
month, expanding a campaign that began in July for people over 60.
A new analysis by Israeli scientists published on Wednesday in the New
England Journal of Medicine found that among 1.1 million people age 60
or older who had been fully vaccinated at least 5 months earlier, those
who received a booster were less likely to be infected or become
severely ill than those who did not get the third shot.
The booster debate gained urgency as U.S. COVID-19 hospitalizations and
deaths surged due to the highly transmissible Delta variant of the
virus, mostly among the unvaccinated. But infections among fully
vaccinated people have risen and they can spread the virus on occasion,
mostly to unvaccinated people.
Recent polls have shown most vaccinated Americans want a booster to
enhance their protection.
'LARGER POPULATIONS MAY TAKE LONGER'
Wall Street analysts see the additional shots ultimately getting
approved for a broad population.
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A person receives a dose of the Pfizer-BioNTech vaccine for the
coronavirus disease (COVID-19), at a mobile inoculation site in the
Bronx borough of New York City, New York, U.S., August 18, 2021.
REUTERS/David 'Dee' Delgado
"We expect a potential positive FDA support for
boosters for elderly ahead of Biden's rollout, but larger
populations may take longer for broad support and approval,"
Jefferies analyst Michael Yee said in an email.
Scientists say the strongest evidence for boosters is for older
adults and other high risk populations.
"My guess is we are going to end up with a recommendation for
booster doses for a certain subpopulation, such as adults older than
65," said Bill Moss, executive director of the International Vaccine
Access Center at the Johns Hopkins Bloomberg School of Public
Health.
More than 1.9 million Americans have already gotten a booster dose
after the government authorized them for people with compromised
immune systems, according to the U.S. Centers for Disease Control
and Prevention (CDC).
Eight top health officials in the Biden Administration - including
the heads of the FDA and the CDC - said in August they believe
booster shots will be needed because emerging data shows that
protection against COVID-19 decreases over time.
It is planning a booster campaign for the week of Sept. 20,
contingent on backing by the FDA and CDC.
An FDA decision on a booster will come after the committee
recommendation. Advisers to CDC will meet next Wednesday and
Thursday after which the agency's director, Rochelle Walensky, will
decide whether to follow their advice.
Moderna Inc has also asked for approval of a booster and released
data on Wednesday showing that protection from its vaccine also
wanes over time. That is not expected to be discussed at Friday's
meeting.
(Reporting by Manojna Maddipatla and Ankur Banerjee in Bengaluru;
Editing by Caroline Humer and Bill Berkrot)
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