PANDEMIC PROTECTION. Syringes with vaccines are prepared at the L.A.
Care and Blue Shield of California Promise Health Plans’ Community
Resource Center, where they were offering members and the public free
flu and COVID-19 vaccines, in Lynwood, California. The U.S. is poised to
make COVID-19 vaccinations more like a yearly flu shot, a major shift in
strategy despite a long list of questions about how to best protect
against a still rapidly mutating virus. The Food and Drug Administration
has asked its scientific advisers to help lay the groundwork for
switching to once-a-year boosters for most Americans — and how and when
to periodically update the recipe of the shots. (AP Photo/Mark J.
From The Asian Reporter, V33, #2 (February 6, 2023), page 12.
FDA’s advisers back plan to simplify COVID-19
By Lauran Neergaard
The Associated Press
The U.S. is poised to make COVID-19 vaccinations more like a yearly
flu shot, a major shift in strategy despite a long list of questions
about how to best protect against a still rapidly mutating virus.
The Food and Drug Administration (FDA) asked its scientific advisers
to help lay the groundwork for switching to once-a-year boosters for
most Americans — and how and when to periodically update the shots’
"This is a consequential meeting to determine if we’ve reached the
point in the pandemic that allows for simplifying the use of current
COVID-19 vaccines," said FDA’s Dr. David Kaslow.
The advisory panel mostly agreed with the FDA’s approach.
COVID-19 vaccines have saved millions of lives and booster doses
continue to help the most vulnerable even as more contagious variants
have popped up. But protection does wane and the shots don’t fend off
milder infections for long.
And people are tired of getting vaccinated. While more than 80% of
the U.S. population has had at least one COVID-19 shot, only 16% of
those eligible for the latest boosters — so-called bivalent doses
updated to better match more recent virus strains — have gotten one.
That makes for tough decisions on how to move forward: Who really
needs another shot, how often, and what kind?
"We’re still protected against severe disease, thank goodness," even
after the latest mutated omicron strains cropped up, noted FDA adviser
Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia.
The first step: The FDA advisory panel voted unanimously that people
should get the same vaccine formula whether they’re receiving their
initial vaccinations or a booster. Today, Americans get one formula
based on the original coronavirus strain that emerged in 2020 for their
first two or three doses — and their latest booster is a combination
shot made by Pfizer or Moderna that adds omicron protection.
The FDA would have to decide how to phase in that change.
But "this isn’t only a convenience thing" to ease confusion about
different kinds of shots, said Dr. Archana Chatterjee, dean of Chicago
Medical School. Since the original coronavirus strain has disappeared,
"moving towards the strains that are circulating is very important."
Who needs another shot and when sparked more debate.
Looking ahead, the FDA said most Americans should do fine if they get
a once-a-year booster targeted to the newest variants in the fall. The
agency asked if some people might need two doses — adults with weakened
immune systems and very young children who’ve never been previously
vaccinated. That’s similar to how youngsters get their first-ever flu
But more data is needed to show exactly who might need two yearly
doses — such as a careful count of who still gets hospitalized with
COVID-19 despite being up-to-date with today’s vaccinations, Offit said.
"Only then can we really best make the decision about who gets
vaccinated with what and when," he said.
Nor is it clear that younger, healthier people would need a COVID-19
booster every year.
"It’s hard to say it’s going to be annual at this point," said
Harvard’s Dr. Eric Rubin.
Fall might not even be the best time to boost, something that would
depend on when infections start rising and how long a booster’s
protection might last, said FDA adviser Dr. Arthur Reingold of the
University of California, Berkeley.
Unlike flu which in the U.S. circulates mostly during late fall and
winter, COVID-19 waves have occurred year-round.
As for the recipe, the FDA’s plan is to call its advisory panel for
another meeting in late May or early June to decide if the vaccine
recipe needs tweaking — including which virus strain to target and
whether it should be a single-strain or multi-strain shot. Pfizer and
Moderna said that would give enough time to produce needed doses by fall
while a third manufacturer, Novavax, urged an earlier start to any
U.S. officials also updated how they’re tracking that the newest
COVID-19 boosters are safe. The Centers for Disease Control and
Prevention spotted a possible warning signal that seniors getting
Pfizer’s updated booster might have a slightly higher risk of stroke.
But FDA safety expert Richard Forshee said data from Medicare and
multiple other health systems — including in other countries — found no
sign of trouble, leading the government to conclude it’s unlikely the
red flag was real.
AP Health Writer Matthew Perrone contributed to this report. The
Associated Press Health and Science Department receives support from the
Howard Hughes Medical Institute’s Science and Educational Media Group.
The AP is solely responsible for all content.
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