SARS‑CoV‑2 (COVID-19)

spaminator

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spaminator

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Moderna study shows immune response in older adults for a combo flu and COVID-19 shot
Author of the article:Associated Press
Associated Press
Carla K. Johnson
Published May 07, 2025 • 2 minute read

A combination shot for flu and COVID-19 using messenger RNA generated antibodies in a study, but U.S. government regulators want to see data on whether the new vaccine protects people from getting sick.


Researchers from vaccine-maker Moderna reported in a study published Wednesday that the new combo shot generated a stronger immune response against COVID-19 and most strains of flu than existing standalone shots in people 50 and older. Side effects were injection site pain, fatigue and headaches. Moderna previously reported a summary of the results from the company-sponsored trial in 8,000 people.

The mRNA technology is used in approved COVID-19 and RSV shots, but has not yet been approved for a flu shot. Moderna believes mRNA could speed up production of flu shots compared with traditional processes that use chicken eggs or giant vats of cells. A combo shot also might improve vaccination rates, the researchers wrote in the study published in the Journal of the American Medical Association.

Dr. Greg Poland, who studies vaccine response at Mayo Clinic and was not involved in the new study, said he’s not convinced that a combo shot would be popular. And while flu comes in seasonal waves, COVID-19 has been spreading throughout the year, Poland said, posing challenges for how to time the shots to keep protection strong.


He’d also like to see data on how well the new shot protected people from infection and hospitalization.

The findings are based on measuring antibodies in participants’ blood after 29 days, an indication of short-term disease protection.

Last week, Moderna pushed its target date for the vaccine’s approval to 2026 after the Food and Drug Administration requested a more direct measure: how much the shot lowered the risk of disease.

“I agree in this case with FDA that efficacy data are important to see,” Poland said.

Health Secretary Robert F. Kennedy Jr. has cast doubt on the safety of mRNA vaccines, but Moderna President Stephen Hoge told investors in an earnings call last week that talks with the FDA were productive and “business as usual.”

Also last week, Novavax said the FDA was asking the company to run a new clinical trial of its protein-based COVID-19 vaccine after the agency grants full approval, sowing uncertainty about other vaccine updates.
 

spaminator

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New Trump vaccine policy limits access to COVID shots
Author of the article:Associated Press
Associated Press
Matthew Perrone And Lauran Neergaard
Published May 20, 2025 • 4 minute read

WASHINGTON — The Trump administration said Tuesday it will limit approval for seasonal COVID-19 shots to seniors and others at high risk pending more data on everyone else — raising questions about whether some people who want a vaccine this fall will be able to get one.


Top officials for the Food and Drug Administration laid out new requirements for access to updated COVID shots, saying they’d continue to use a streamlined approach to make them available to adults 65 and older as well as children and younger adults with at least one high-risk health problem.

But the FDA framework, published Tuesday in the New England Journal of Medicine, urges companies to conduct large, lengthy studies before tweaked vaccines can be approved for healthier people. In the paper and a subsequent online webcast, the FDA’s top vaccine official said still, more than 100 million Americans still should qualify for what he termed a booster under the new guidance.

Dr. Vinay Prasad described the new approach as a “compromise” that will allow vaccinations in high-risk groups while generating new data about whether they still benefit healthier people.


“For many Americans we simply do not know the answer as to whether or not they should be getting the seventh or eighth or ninth or tenth COVID-19 booster,” said Prasad, who joined the FDA earlier this month. He previously spent more than a decade in academia, frequently criticizing the FDA’s handling of drug and vaccine approvals.

It’s unclear what the upcoming changes mean for people who may still want a fall COVID-19 shot but don’t clearly fit into one of the categories.

“Is the pharmacist going to determine if you’re in a high-risk group?” asked Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia. “The only thing that can come of this will make vaccines less insurable and less available.”

The nation’s leading pediatrics group said FDA’s approach will limit options for parents and their children.


“If the vaccine were no longer available or covered by insurance, it will take the choice away from families who wish to protect their children from COVID-19, especially among families already facing barriers to care,” said Dr. Sean O’Leary of the American Academy of Pediatrics.

Provisional data from the Centers for Disease Control and Prevention shows more than 47,000 Americans died from COVID-related causes last year. The virus was the underlying cause for two-thirds of those and it was a contributing factor for the rest. Among them were 231 children whose deaths were deemed COVID-related, 134 of them where the virus was the direct cause — numbers similar to yearly pediatric deaths from the flu.

The new FDA approach is the culmination of a series of recent steps under Health Secretary Robert F. Kennedy Jr. scrutinizing the use of COVID shots and raising major questions about the broader availability of vaccines. It was released two days ahead of the first meeting of FDA’s outside vaccine experts under the Trump administration.


Last week the FDA granted full approval of Novavax’s COVID-19 vaccine but with major restrictions on who can get it — and Tuesday’s guidance mirrors those restrictions. The approval came after Trump appointees overruled FDA scientists’ earlier plans to approve the shot without restrictions.

Pfizer and Moderna, makers of the most commonly used COVID shots, each said they would continue to work with the agency.

For years, federal health officials have told most Americans to expect annual updates to COVID-19 vaccines, similar to the annual flu shot. Just like with flu vaccines, until now the FDA has approved updated COVID shots so long as they show as much immune protection as the previous year’s version.

But FDA’s new guidance appears to be the end of that approach, according to Prasad and FDA Commissioner Marty Makary, who co-authored the journal paper and joined the FDA webcast.


Prasad and Makary criticized the U.S.’s “one-size-fits-all,” contrasting it with some European countries that recommend boosters based on age, risk and other factors.

Prasad said the FDA will ask all manufacturers to do a new clinical trial in healthy people ages 50 to 64, randomly assigning them to get a vaccine or a placebo and tracking outcomes with special attention to severe disease, hospitalization or death. He said such a study might need to be repeated if there’s a large virus mutation rather than the past year’s incremental evolution. Companies are also free to test their vaccines for approval in younger adults and children, Prasad said, adding “this is a free country.”

Since becoming the nation’s top health official in February, Kennedy has filled the FDA and other health agencies with outspoken critics of the government’s handling of COVID shots, particularly their recommendation for young, healthy people. Under federal procedures, the FDA releases new guidance in draft form and allows the public to comment before finalizing its plans. The publication of Tuesday’s policy in a medical journal is highly unusual and could run afoul of federal procedures, according to FDA experts.

Health experts say there are legitimate questions about how much everyone still benefits from yearly COVID vaccination or whether they should be recommended only for people at increased risk.

In June, an influential panel of advisers to the CDC is set to debate which vaccines should be recommended to which groups.

The FDA’s announcement appears to usurp that advisory panel’s job, Offit said. He added that CDC studies have made clear that booster doses do offer protection against mild to moderate illness for four to six months after the shot even in healthy people.
 

spaminator

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RFK Jr. pulls $500 million in funding for vaccine development
Author of the article:Associated Press
Associated Press
Amanda Seitz
Published Aug 05, 2025 • 1 minute read

WASHINGTON — The Department of Health and Human Services will cancel contracts and pull funding for some vaccines that are being developed to fight respiratory viruses like COVID-19 and the flu.


Robert F. Kennedy Jr., the health secretary and a longtime vaccine critic, announced in a statement Tuesday that $500 million worth of vaccine development projects, all using mRNA technology, will be halted.


The projects — 22 of them — are being led by some of the nation’s leading pharmaceutical companies like Pfizer and Moderna to prevent flu, COVID-19 and H5N1 infections.

The mRNA vaccines are credited with slowing the 2020 coronavirus pandemic.

Kennedy said in the Tuesday statement that he wants the health department to move away from mRNA vaccines, calling on the department to start “investing in better solutions.” He provided no details on what those technologies might be.
 

Tecumsehsbones

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RFK Jr. pulls $500 million in funding for vaccine development
Author of the article:Associated Press
Associated Press
Amanda Seitz
Published Aug 05, 2025 • 1 minute read

WASHINGTON — The Department of Health and Human Services will cancel contracts and pull funding for some vaccines that are being developed to fight respiratory viruses like COVID-19 and the flu.


Robert F. Kennedy Jr., the health secretary and a longtime vaccine critic, announced in a statement Tuesday that $500 million worth of vaccine development projects, all using mRNA technology, will be halted.


The projects — 22 of them — are being led by some of the nation’s leading pharmaceutical companies like Pfizer and Moderna to prevent flu, COVID-19 and H5N1 infections.

The mRNA vaccines are credited with slowing the 2020 coronavirus pandemic.

Kennedy said in the Tuesday statement that he wants the health department to move away from mRNA vaccines, calling on the department to start “investing in better solutions.” He provided no details on what those technologies might be.
He's hoping to bring back measles and polio.
 

Ron in Regina

"Voice of the West" Party
Apr 9, 2008
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If you think taking gene altering therapy is progress .
Depends what you’re trying to cure or protect against? Let’s say it was for cystic fibrosis?
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Imagine over the course of a couple generations, those that have the carrier status being able to just get an immunization shot and a booster, & then they can’t pass that shitty disease onto their children?

I’ve been immunized against measles with all of my shots as a child, and I still caught it three times this lifetime so far.

Twice as a child and once as an adult. Ugh…if they had a vaccination that was better than what they’ve had for the last 50 years, I’d try it.
 

Tecumsehsbones

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If you think taking gene altering therapy is progress .
Yep. New tools, new capabilities. Far from perfect to start, like the Carnot-cycle engine. That's a rather primitive idea that kinda took off with improvements and refinements over time.
 

Serryah

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Dec 3, 2008
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He's hoping to bring back measles and polio.

Not to mention how they were looking at mRNA to try and help Alzheimer's and cancers (yes, s, there were several mRNA vaccines being worked on for various types, and IIRC, possibly one that works to mitigate a majority of them by inhibiting the signal for cancer growth in any cell; something like that anyway)
 

petros

The Central Scrutinizer
Nov 21, 2008
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Low Earth Orbit
Not to mention how they were looking at mRNA to try and help Alzheimer's and cancers (yes, s, there were several mRNA vaccines being worked on for various types, and IIRC, possibly one that works to mitigate a majority of them by inhibiting the signal for cancer growth in any cell; something like that anyway)
As long as they are adequately tested and proven safe.
 

pgs

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Nov 29, 2008
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Yep. New tools, new capabilities. Far from perfect to start, like the Carnot-cycle engine. That's a rather primitive idea that kinda took off with improvements and refinements over time.
Like thamaldyhde .
 

pgs

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Nov 29, 2008
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Not to mention how they were looking at mRNA to try and help Alzheimer's and cancers (yes, s, there were several mRNA vaccines being worked on for various types, and IIRC, possibly one that works to mitigate a majority of them by inhibiting the signal for cancer growth in any cell; something like that anyway)
What about the ones that didn’t work ? Never mind ?