FDA authorizes Pfizer and Moderna boosters for all adults
The Food and Drug Administration on Friday authorized
Pfizer-BioNTech and Moderna's Covid-19 boosters for all adults, a move that
will make boosters available to everyone ages 18 and up.
Pfizer requested authorization last week, citing results
from a Phase 3 clinical trial with more than 10,000 participants that found
that the third dose was safe and effective. Moderna requested authorization
Wednesday.
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“The FDA has determined that the currently available data
support expanding the eligibility of a single booster dose of the Moderna and
Pfizer-BioNTech Covid-19 vaccines to individuals 18 years of age and older,”
Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and
Research, said in a statement Friday.
The FDA did not seek the advice of its independent advisory
panel, called the Vaccines and Related Biological Products Advisory Committee,
when reviewing either company's data.
John Grabenstein, a former executive director of medical
affairs for vaccines at Merck, as well as a former immunologist for the Defense
Department, said the FDA did not need to ask its advisory committee to weigh in
at this time.
“This isn’t a matter of antibody response or safety,” he
said. “The FDA can make that decision on its own.”
Dr. Jesse Goodman, a professor of medicine and infectious
diseases at Georgetown University Medical Center, expressed surprise that the
FDA’s decision on Moderna came so quickly, just two days after the company
applied for authorization.
“It is important to be sure the FDA has been able to
thoroughly review data submitted by the sponsors as well as any other relevant
information,” said Goodman, a former chief scientist with the FDA. “So, unless
they previously received and reviewed much of Moderna’s data, if the EUA
request was, as reported, made a few days ago, that could raise concerns.”
Dr. Anthony Fauci, director of the National Institute of
Allergy and Infectious Diseases, said Tuesday that no safety signals linked to
booster shots have emerged thus far, including for younger adults.
The second dose of an mRNA vaccine, from both Pfizer and
Moderna, has been linked to a small but increased risk of myocarditis, or heart
inflammation, particularly in young men.
The onus now shifts to the Centers for Disease Control and
Prevention, whose vaccine advisory committee is scheduled to meet Friday
afternoon to hammer out the final recommendations for the shots.
Typically, CDC signoff is the final step needed before shots
can be administered. In an unusual move, however, a number of states and cities
chose not to wait for the FDA or the CDC to act, instead opting to allow
boosters for all adults in the past week.
Covid cases continue to rise in the United States, and more
than 30 percent of the country has yet to receive a single dose of the vaccine.
"The big question to me is, can we booster ourselves
out of this pandemic?" said Norman Baylor, president and CEO of Biologics
Consulting, a biotech consulting firm, and a former director of the FDA’s
Office of Vaccines Research and Review. "Until we vaccinate those groups
that have not been vaccinated, I’m not sure we can."
Pfizer and Moderna's booster shots are given at least six
months after the completion of the initial two-dose vaccination series.
All adults who were initially vaccinated with the Johnson
& Johnson vaccine are also eligible for a booster shot.
As of Thursday, more than 31 million people in the U.S. have
received a booster shot, according to the CDC.
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