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lite.cnn.com - on gopher - inofficial
ARTICLE VIEW:
FDA approves updated Covid-19 vaccines for limited groups as US cases
continue to rise
By Jamie Gumbrecht, Deidre McPhillips, Brenda Goodman, CNN
Updated:
11:21 PM EDT, Sat August 30, 2025
Source: CNN
The US Food and Drug Administration approved updated Covid-19 vaccines
Wednesday, but for a limited group: adults 65 and older, and younger
people who are at higher risk from Covid-19.
“FDA has now issued marketing authorization for those at higher risk:
Moderna (6+ months), Pfizer (5+), and Novavax (12+). These vaccines are
available for all patients who choose them after consulting with their
doctors,” US Health and Human Services Secretary Robert F. Kennedy
Jr. said in a .
The vaccines have been updated to target coronavirus strains
circulating more recently.
Kennedy said in this post that he had promised “to keep vaccines
available to people who want them, especially the vulnerable,” but
the narrower approval may limit access to Covid-19 shots for people who
were routinely able to get them in the past.
It may be significantly more difficult for infants and young children
to get vaccinated, although they are especially vulnerable to Covid-19.
Last respiratory virus season, there were 48 Covid-19 hospitalizations
for every 100,000 children under 5 – nearly seven times the rate for
older children and more than twice the rate for adults under 50.
Emergency use authorizations for Covid-19 vaccines are rescinded,
Kennedy 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. The FDA had already approved — the
only protein-based, non-mRNA vaccine available in the US — but only
for people 65 and older and those 12 and up who have at least one
underlying condition that puts them at higher risk of severe illness.
“Our health care system is now solidly anti-children and
anti-science. The data are clear: young children–especially
infants–remain highly vulnerable to severe illness and
hospitalization from Covid-19. By restricting access to safe,
evidence-based vaccines, federal leaders are choosing ideology over
science,” Fatima Khan, co-founder of the nonprofit grassroots group
Protect Their Future, which advocates for vaccine access for kids, told
CNN. “Denying children a critical tool to prevent avoidable tragedies
will be a lasting stain on every policymaker who allowed it to
happen.”
FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, director of the
FDA’s Center for Biologics Evaluation and Research, also in May that
there’s not enough evidence that healthy children and adults get
clinically meaningful benefit from regular Covid-19 shots, and they
want to see more placebo-controlled trials, particularly in adults 50
to 64, before recommending the shots for other groups.
A spokesperson for the FDA said in a statement that the decision
“does not affect access to these vaccines. These vaccines remain
available to those who choose them in consultation with their
healthcare provider.”
Many health conditions increase risk with Covid-19, , including lung,
heart and kidney conditions; obesity; cancer; HIV and pregnancy.
And vaccines may be accessible to healthy younger people
“off-label,” Dr. Tina Tan, president of the Infectious Diseases
Society of America, said in a statement. However, she said, the new FDA
decision “completely contradicts the evidence base, severely
undermines trust in science-driven policy and dangerously limits
vaccine access, removing millions of Americans’ choice to be
protected and increasing the risk of severe outcomes from COVID.”
The president of the American Academy of Pediatrics said Wednesday’s
FDA actions could be a barrier to vaccination.
“Any parent who wants their child vaccinated should have access to
this vaccine; today’s unprecedented action from HHS not only prevents
this option for many families, but adds further confusion and stress
for parents trying to make the best choices for their children,” Dr.
Susan Kressly said in a statement. “Parents and pediatricians,
together, make the best decisions to protect children’s long-term
health.”
Approved vaccines are available after they’ve been recommended for
use by the CDC. Kennedy previously that the agency would no longer
recommend Covid-19 vaccines for healthy children or pregnant women. The
CDC’s immunization schedule was updated to reflect that children
would be able to get the vaccines after consulting with a health care
provider, known as “shared decision-making.” For pregnant women,
there is no recommendation.
Last week, the broke from the CDC to recommend Covid-19 shots for
infants and young children. The also reaffirmed support for Covid-19
vaccination during pregnancy,
Covid-19 levels have been on the rise for months in the US, with
transmission increasing in most states, . Surveillance data from
WastewaterSCAN suggests that virus levels are about half of what they
were during the peak of last summer’s surge, but they match the peak
from the summer of 2023 – and epidemiologist Caitlin Rivers noted in
her that there are no signs of slowing yet, so activity will probably
continue to increase in the weeks ahead.
There were about 1.7 Covid hospitalizations for every 100,000 people
during the first week of August, CDC shows, with the highest rates
among seniors and children under 5.
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