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lite.cnn.com - on gopher - inofficial
ARTICLE VIEW:
After narrowing Covid-19 vaccine approval, the FDA says healthy people
can still get it. But access might be complicated
By Deidre McPhillips, CNN
Updated:
7:40 PM EDT, Fri August 29, 2025
Source: CNN
Federal officials in the US say that Covid-19 vaccines remain available
to everyone, despite new restrictions on the groups that they’re
approved for. But experts suggest that claim is misleading, as the more
narrow approval may raise significant barriers to access for many
Americans.
On Wednesday, the US Food and Drug Administration approved updated
Covid-19 vaccines specifically for seniors and younger people who have
health conditions that put them at higher risk from Covid-19 – a much
more limited approach than earlier approvals that greenlit the shots
for everyone ages 6 months and older.
FDA Commissioner Dr. Marty Makary said in a on Thursday that “100%
of adults in this country can still get the vaccine if they choose. We
are not limiting availability to anyone.” White House press secretary
Karoline Leavitt also said Thursday that “the FDA decision does not
affect the availability of Covid vaccines for Americans who want them.
We believe in individual choice.”
But for healthy people who do not fall into the specified groups,
experts say that choice may be limited by who can offer the vaccine and
whether insurance covers it.
To get an updated Covid-19 vaccine for the upcoming respiratory virus
season, healthy children and adults younger than 65 will need to get it
prescribed “off-label” – the practice of using a medical product
outside of the terms for which the FDA has explicitly approved it.
This theoretically makes vaccines available but “ignores the
practical barriers the policy created,” said , an infectious disease
specialist with Stanford Health.
“Technical availability and practical accessibility are very
different things,” he said. “The administration replaced
straightforward pharmacy access with a system requiring provider
consultations, navigating insurance uncertainty and finding willing
pharmacies.”
The vast majority of Covid-19 vaccinations have typically happened in ,
but off-label prescribing requires a visit with a physician or other
health care provider.
Some physicians may not be as comfortable prescribing off-label as
others, experts say, and pharmacies may take a more conservative
approach, too.
“In the current environment, where things are turbulent, a bit strict
and very uncertain, pharmacies might not want to put their businesses
at risk of being accused of giving vaccines inappropriately,” said
Dr. William Schaffner, an infectious disease expert at Vanderbilt
University.
Dr. Jerome Adams, who served as US surgeon general during the first
Trump administration, also noted on this week that about 11% of US
adults are uninsured and lack access to a doctor.
“RFK promised – under oath – that anyone who wants a vaccine will
be able to get one. Now he says you can only get one if your doctor
says so. To be frank and objective, unless he’s also giving everyone
access to free healthcare, he seems to be reneging on his promise,”
Adams wrote. “Math doesn’t add up.”
Insurance coverage for off-label prescriptions can also vary,
potentially leaving patients with substantial out-of-pocket costs for a
vaccine that has historically been free, experts say.
“The idea of having people receive the vaccine prescribed off-label
by a physician will work occasionally for some persistent people who
have access to money to pay and a cooperative physician, but it is no
solution for most of us,” said Dr. Kelly Moore, president and CEO of
immunize.org, a nonprofit organization focused on vaccine access.
Claims of universal Covid-19 access are “demonstrably false,” Scott
said, because there are no options available for children under 5 who
don’t have an underlying condition that puts them at higher risk of
severe illness. Emergency use authorizations for Covid-19 vaccines are
rescinded, US Department of Health and Human Services Secretary Robert
F. Kennedy Jr. said Wednesday, which means , , is no longer authorized
for children younger than 5. Moderna’s vaccine is approved for
children as young as 6 months, but only if they have an underlying
condition that puts them at higher risk.
More questions remain, as the independent advisers to the US Centers
for Disease Control and Prevention’s Advisory Committee on
Immunization Practices, or ACIP, still have not weighed in on the
updated Covid-19 vaccines – and their decisions can affect access in
a variety of ways, experts say.
In some states, CDC recommendations are linked to the authority that
pharmacists have to give vaccines.
In some states, pharmacists are forbidden to administer vaccines that
are not recommended by the US Centers for Disease Control and
Prevention’s Advisory Committee on Immunization Practices. CVS said
it will offer shots in most states, but in 16 — Arizona, Colorado,
Florida, Georgia, Kentucky, Louisiana, Maine, Massachusetts, Nevada,
New Mexico, New York, North Carolina, Pennsylvania, Utah, Virginia and
West Virginia — as well as Washington, DC, it may not be able to
offer them due to state policies. But in some of those states, eligible
people with an authorized prescriber’s prescription may still be able
to get them at CVS pharmacies, a spokesperson said.
“The confusion will be at the point of service,” Dr. Georges
Benjamin, executive director of the American Public Health Association,
said at a news briefing Thursday. “There are some pharmacists and
nurse practitioners that, if it’s not on the [CDC vaccine] schedule,
by law, they’re not allowed to give it. So that might be a barrier.
And then there are some physicians who – for a variety of reasons,
cost reasons, etc. – don’t keep it in their office. They’ll write
a prescription, send you to the pharmacist to get it. But then the
question is, can the pharmacist then give it?”
Each state’s board of pharmacy may have to discuss this issue, and
there may end up being 50 different state solutions, Benjamin said. And
some states may require those changes to go through the state
legislature, which may not happen until January.
When it comes to Covid-19 vaccines, the US is “in real uncertain
times,” Schaffner said – but virus trends are much more certain.
“Covid is not going away. We anticipate with full confidence, I’m
afraid, that there will be a substantial winter increase in Covid and
that we will have, as a consequence, hospitalizations, people admitted
to intensive care units and some deaths. There’s no doubt about
it,” he said.
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