Introduction
Introduction Statistics Contact Development Disclaimer Help
.-') _ .-') _
( OO ) ) ( OO ) )
.-----. ,--./ ,--,' ,--./ ,--,'
' .--./ | \ | |\ | \ | |\
| |('-. | \| | )| \| | )
/_) |OO )| . |/ | . |/
|| |`-'| | |\ | | |\ |
(_' '--'\ | | \ | | | \ |
`-----' `--' `--' `--' `--'
lite.cnn.com - on gopher - inofficial
ARTICLE VIEW:
Top FDA vaccine official rejected broad use of Covid-19 shots,
documents show
By Sarah Owermohle, Brenda Goodman, CNN
Updated:
12:31 PM EDT, Thu July 3, 2025
Source: CNN
The US Food and Drug Administration’s top vaccine official overrode
agency experts in May to recommend against the broad use of two
Covid-19 vaccines, newly released documents show.
Dr. Vinay Prasad, director of the agency’s Center for Biologics
Evaluation and Research, said in two memos that he disagreed with
reviewers’ conclusions about the vaccines’ safety and about the
ongoing threat of the virus that causes Covid-19, particularly for
young and healthy people.
Prasad’s decisions are in line with broader Trump administration
efforts, under the leadership of US Health and Human Services Secretary
Robert F. Kennedy Jr., to restrict availability of coronavirus
vaccinations. Kennedy said in May that the shots will for healthy
children and pregnant people; the FDA said earlier that month that it
but only for older people and those in higher-risk groups.
In a memo that week, Prasad had rejected a recommendation from about 30
FDA scientists to approve that vaccine, Novavax’s Nuvaxovid, for
people 12 and older. He cited limited data and “a diminishing risk”
of severe Covid-19 infection and safety concerns.
He cited similar safety concerns in a May 30 document, entitled
“override memo,” regarding wide recommended use of Moderna’s
latest version of its mRNA vaccine, mNexspike. The company had applied
for approval of the updated version in people 12 and older.
Prasad wrote that despite the totality of data submitted by Moderna, he
was unable to conclude that the manufacturer had improved the shot’s
safety or conclusively addressed concerns about risks of myocarditis,
or heart inflammation, in teenage and young men.
Earlier that week, the FDA had advised Moderna and another maker of
mRNA Covid-19 vaccines, Pfizer, to to include warnings about this rare
condition.
“Novavax is focused on ensuring that vaccination for COVID-19 is
available to those who are at highest risk and who choose to be
vaccinated,” the company said in a statement Wednesday. “We believe
it is important that consumers have choice in selecting the vaccine
that is right for them.”
Moderna declined to comment for this story.
“The idea that Dr. Prasad ‘overruled’ FDA scientists is a
distortion of the facts,” HHS spokesperson Andrew Nixon said
Wednesday in a statement to CNN. “He evaluated the totality of the
evidence and made a judgment rooted in gold standard science. That’s
not political – it’s what principled leadership looks like.”
Experts see ‘major overreach’
Dr. Daniel Griffin, an infectious disease specialist at Columbia
University, said the memos reflect wider talking points among health
officials.
“They seem obsessed with myocarditis, and they made a decision on
that which they just have a fixed ideology that they keep looking for
confirmation bias on,” he said. “And the data there, I think, is
really clear. Early on, we saw, let’s say, 20 to 65 [cases] per
million doses when we were giving the initial [vaccine] doses three to
four weeks apart. … We really, actually haven’t seen very much
since it was spaced out. And what we have seen is that now everyone is
getting Covid – it’s really kind of a question of how often per
year – and the risk of ending up with myocarditis being unvaccinated
is tenfold higher than if you’re protected by a vaccine. So their
their argument of restricting access to the vaccines to protect us
against myocarditis is flawed. They’re increasing our chance tenfold
by restricting our access.”
The memos also mark a break from typical agency responsibilities,
Griffin said.
“The role of the FDA is to make a decision based upon the safety and
efficacy of a product, whether or not it should be licensed or not. But
as far as restricting access, as far as providing guidance on who
should specifically get a vaccination, that has fallen to the [US
Centers for Disease Control and Prevention] and a number of
professional societies for decades. So I think most of us would view
this as a major overreach of the of the responsibility of the FDA. The
FDA is is not supposed to have the power to restrict access to safe and
effective products.”
Dr. Peter Marks, who was director of CBER before Prasad, said in a text
message Wednesday that “In the past, the center Director override
memos were rare and only done after very careful consideration – and
usually after consultation with other center directors. During the
nearly decade that I was at FDA, there were only a few that I authored
– certainly less than one a year on average during my tenure at CBER
– and that included all the various types of decisions that could be
overridden.”
Dr. Peter Lurie, a former FDA associate commissioner who’s now
president and executive director of the Center for Science in the
Public Interest, said overrides like Prasad’s tend to err on the side
of being less restrictive – making a product available when reviewers
are more cautious. He’s never seen one restrict the use of a product
that reviewers have deemed safe and effective.
“It’s very hard to escape the conclusion that antipathy towards
these Covid vaccines is playing a significant role in this extremely
rare override,” he said. “I think the concern remains that, yes,
they were making policy decisions that should have been reserved for
the CDC.”
Prasad’s memos were first reported by the New York Times.
Prasad questioned approval process
Prasad assumed his role as CBER director on May 8, a little over a
month after Marks said he had been due to Kennedy’s vaccine strategy.
More recently, FDA Commissioner Dr. Marty Makary also elevated Prasad
to be the agency’s chief medical and scientific officer.
Prasad is a hematologist-oncologist and outspoken critic of what he’s
argued as groupthink in medicine. The former University of California
San Francisco professor became a prominent voice during the pandemic
for challenging Covid-era mandates but has also questioned the drug
approval process and developers’ reliance on secondary results, or
surrogate endpoints, in clinical trials.
Prasad has called previous FDA commissioners — under both Democratic
and Republican administrations — “” who have not required enough
randomized clinical trial data in approval decisions.
Biotech stocks tumbled in the hours after his announcement as CBER
director, with some industry analysts calling Prasad an to lead the
department overseeing vaccines and biologic products.
He seemed to nod to those concerns in a May 20 town hall with Makary,
suggesting a flexible approach that speeds up drug approvals.
“We have to, and we will, always embrace surrogate endpoints for
people who have very concerning diseases, very rare conditions, few
treatment options,” he told FDA staff at the agency’s Maryland
campus. “We have an obligation at FDA to expedite those products to
those patients who desperately want them. We also have an obligation to
check on the back end and make sure that we’re actually achieving
what we thought we were.”
Prasad also signaled his approach to Covid-19 vaccines during that town
hall.
“The risk of severe disease and hospitalization, thank goodness, has
fallen among the American people. The efficacy of repeat doses … of
these vaccines to further reduce severe disease and symptomatic illness
is uncertain, and there are important safety considerations whose
long-term impact is not fully known,” he said. “We will continue to
monitor those closely.”
<- back to index
You are viewing proxied material from codevoid.de. The copyright of proxied material belongs to its original authors. Any comments or complaints in relation to proxied material should be directed to the original authors of the content concerned. Please see the disclaimer for more details.