Trump U.S. FDA’s new approach to covid vaccines could have been way worse

[TallGuyJohninBKK]

 

Older adults can continue getting covid boosters, but not everyone who wants them can

 

May 22,2022

 

...

The framework, unveiled on Tuesday in a New England Journal of Medicine article co-authored by FDA commissioner Marty Makary and center director Vinay Prasad, is decidedly better than my worst fears. It preserves vaccine access for people most vulnerable to covid-19. However, it takes away the freedom of other groups to choose to protect themselves and raises questions about how available these shots will be going forward.

 

The most important part of the FDA’s announcement is that the agency is expected to continue approving boosters for people 65 and older based on immune response data. This is terrific news; it means manufacturers won’t have to conduct time- and resource-intensive randomized controlled trials when new variants arise. This alleviates my concern that there will be long delays that will leave the most vulnerable Americans unprotected.

Older adults should also be able to continue getting covid boosters. This is a group that clearly benefits from added protection. The Centers for Disease Control and Prevention reports that adults 65 and older now account for 68 percent of all covid-associated hospitalizations and, between September 2023 and August 2024, nearly 90 percent of all deaths.
 

(more)

Washington Post

https://archive.ph/jXGQo

[Yellowtail]

Poor lefty, I know how much you love wearing masks, getting shots, and compelling others to do the same. 

 

 

[TallGuyJohninBKK]

The FDA’s New Covid Vaccine Policy Is Clear as Mud

Healthy agency leaders’ promises of transparency and choice fall short in first big test

 

May 22, 2025

 

...

"Here’s what we know: The FDA is adopting a risk-based strategy for approving new Covid vaccines that will limit their use to people 65 and older or anyone with a health condition that puts them at risk for severe disease — a group Prasad and Makary estimate accounts for about 100 million Americans. The new policy keeps the current standards for greenlighting vaccines, meaning pharmaceutical companies need only to produce data showing theirs prompts people to produce antibodies against the virus.

 

For healthy adults and children, new vaccines, including boosters updated to match circulating strains of the virus, seem to be on ice. FDA officials will require drug manufacturers to run studies proving their vaccines are better than a placebo in preventing symptomatic infections in people ages 50 to 64 — a group Prasad said was chosen because health agencies around the world express the most disagreement over the benefits of vaccination for the demographic. They said companies can choose to pursue studies that demonstrate their drugs effects in other groups. The future of pediatric Covid vaccines seems particularly foggy, since updated shots also function as the primary series for unvaccinated children.

While billed as “a balance of regulatory flexibility and a commitment to gold-standard science,” the policy seems designed to put the vaccines out of reach.

(more)

Bloomberg News

https://archive.ph/a2bqs

[Yellowtail]

The left is still obsessed with covid, and they call MAGA a cult. 

 

morons

[TallGuyJohninBKK]

FDA advisory panel debates COVID vaccine recipe as questions swirl about fall shots

May 22, 2025

 

WASHINGTON (AP) — Government advisers are meeting Thursday to decide if COVID-19 vaccines need updating to improve protection this fall and winter — even as a new Trump administration policy has thrown into question who may be eligible for a shot.

 

...the FDA said routine approval of COVID-19 boosters will be limited to seniors and to younger people who are at high risk of severe infection. Manufacturers will need to do new studies to show whether seasonal shots still benefit healthy people younger than 65.

 

That raises big implications for next fall’s vaccination campaign, with uncertainty over whether healthy people still could get a vaccine even if it’s not recommended for them — or whether insurers will keep paying for the shots for everyone. Nor is it clear what the policy means for babies who have never been vaccinated.

 

(more)

 

https://apnews.com/article/fda-vaccines-covid-boosters-kennedy-244bdc80f825f953782d35f68798d885

 

 

[Yellowtail]

Poor lefty, his whole world is covid...

[TallGuyJohninBKK]

Now is the relative quiet season in the U.S. for COVID, with the infection peaks usually coming around the end of the year each year, with weekly COVID deaths in the U.S. peaking at more than 1,000 per week last January (as shown below).

 

And yet, the latest reports from the CDC say that COVID deaths in the U.S. (those where COVID is the underlying or contributing cause) even now in the quiet season are running more than 350 people each and every week.

 

That's a lot of COVID deaths for a disease and threat that the resident anti-vaxers here like to dismiss and claim is a non-serious infection.

 

 

* the three gray colored columns at the right of the above chart reflect incomplete data, and thus are colored differently to reflect that.

 

https://covid.cdc.gov/covid-data-tracker/#trends_weeklydeaths_select_00

 

 

 

 

[Yellowtail]

We've got to shut down the schools and churches !

[ronnie50]

Was out today in Bangkok at a big shopping center. I'd say around 40% of Thais were wearing masks given the recent spike in new infections from the new variant. As far as I know, the only vaccine available is the same one from last year (XP.1). Dunno if it offers any protection from the new variant. Apparently WHO is meeting this month and next to agree the make-up of the next batch of shots. 

[Yellowtail]

4 minutes ago, ronnie50 said:

Was out today in Bangkok at a big shopping center. I'd say around 40% of Thais were wearing masks given the recent spike in new infections from the new variant. As far as I know, the only vaccine available is the same one from last year (XP.1). Dunno if it offers any protection from the new variant. Apparently WHO is meeting this month and next to agree the make-up of the next batch of shots. 

I had covid two weeks ago. No big deal. 

[ronnie50]

18 minutes ago, TallGuyJohninBKK said:

And yet, the latest reports from the CDC say that COVID deaths in the U.S. (those where COVID is the underlying or contributing cause) even now in the quiet season are running more than 350 people each and every week.

 

That's a lot of COVID deaths for a disease and threat that the resident anti-vaxers here like to dismiss and claim is a non-serious infection.

They like to ignore the fact that more Americans died from, or as a complication of Covid, in a 2 year period than all the Americans that died in every war since Independence. Facts these days are ignored in general it seems.

[TallGuyJohninBKK]

15 minutes ago, ronnie50 said:

Was out today in Bangkok at a big shopping center. I'd say around 40% of Thais were wearing masks given the recent spike in new infections from the new variant. As far as I know, the only vaccine available is the same one from last year (XP.1). Dunno if it offers any protection from the new variant. Apparently WHO is meeting this month and next to agree the make-up of the next batch of shots. 

 

The WHO advisory group already met and announced in recent days their recommendations for updating COVID vaccines....

 

May 16, 2025

 

"The World Health Organization (WHO) Technical Advisory Group on COVID-19 vaccine composition, after meeting earlier this month, today released its recommendations for updated vaccines, which say the current monovalent JN.1 or KP.2 strains are still appropriate, but monovalent LP.8.1 is a suitable alternative.

 

Over the last 2 years, after examining the latest data on virus changes and response to current vaccines, the group has been weighing in on strain recommendations twice a year, once in the spring and once in December.

 

The WHO’s latest recommendations come ahead of a meeting of the Food and Drug Administration (FDA) vaccine advisory group on May 22, which will discuss the make-up of COVID vaccines for use in United States during the fall and winter months. Current US vaccines include the KP.2 antigen. Also, the WHO recommendations come as a few countries in Asia report rising COVID activity."

 

(more)

 

https://www.cidrap.umn.edu/covid-19/who-advisers-say-current-strains-ok-covid-vaccine-production

 

 

 

 

[Yellowtail]

1 minute ago, ronnie50 said:

They like to ignore the fact that more Americans died from, or as a complication of Covid, in a 2 year period than all the Americans that died in every war since Independence. Facts these days are ignored in general it seems.

To put that into perspective, 350 a week is about one-fifth the number of people dying from Fentanyl poisoning, and about 2% of the number of babies aborted.  

[TallGuyJohninBKK]

9 minutes ago, ronnie50 said:

They like to ignore the fact that more Americans died from, or as a complication of Covid, in a 2 year period than all the Americans that died in every war since Independence. Facts these days are ignored in general it seems.

 

 

Officially reported U.S. COVID deaths -- 11,216 thus far in 2025, and 1.23 million cumulative since the start of the COVID pandemic:

 

 

 

https://www.cdc.gov/nchs/nvss/vsrr/covid19/index.htm

 

 

[blaze master]

Hahaha no one cares about covid anymore. In fact they haven't cared for many years now. 

 

Cue post telling me how important it is for zzzzzzzzzzzzzz

 

No one cares.

[TallGuyJohninBKK]

 

The Thai Travel Clinic at Mahidol University near Victory Monument in BKK has the JN.1 version of the Pfizer vaccine available for a fee, according to their website:

 

 

 

[Yellowtail]

8 minutes ago, TallGuyJohninBKK said:

 

 

U.S. COVID deaths -- 11,216 thus far in 2025, and 1.23 million cumulative since the start of the COVID pandemic:

 

 

 

https://www.cdc.gov/nchs/nvss/vsrr/covid19/index.htm

 

 

So about ten times as many people this year have died of pneumonia or the flu, as died of covid. 

[dinsdale]

25 minutes ago, ronnie50 said:

Was out today in Bangkok at a big shopping center. I'd say around 40% of Thais were wearing masks given the recent spike in new infections from the new variant. As far as I know, the only vaccine available is the same one from last year (XP.1). Dunno if it offers any protection from the new variant. Apparently WHO is meeting this month and next to agree the make-up of the next batch of shots. 

If you are not in a vulnerable group why would you want a jab of the mRNA juice for what is essentially a non-severe viral infection for the vast majority. This has been the reality for several years now. Even in the height of the pandemic it's highly questionable that healthy people needed to be jabbed.

[blaze master]

Just now, Yellowtail said:

So about ten times as many people this year have died of pneumonia or the flu, as died of covid. 

 

You won't even get a reasonable response to this fact.

[Yellowtail]

Just now, blaze master said:

 

You won't even get a reasonable response to this fact.

About 35 times as many babies have been aborted, and about three times as many deaths from Fentanyl poisoning so far this year than from covid. 

[TallGuyJohninBKK]

12 minutes ago, Yellowtail said:

So about ten times as many people this year have died of pneumonia or the flu, as died of covid. 

 

As usual, you're throwing out unsourced and unsubstantiated claims that aren't supported by the facts:

 

The CDC estimates there have been 26,000 U.S. flu deaths thus far this season vs. 11,216 COVID deaths since January.  This year, as shown below, was a very bad season for flu deaths compared to recent years.

 

Want to avoid dying from the flu (and COVID)... Get vaccinated!

 

CDC on this year's flu cycle:

 

"This season is classified as a high severity season overall and for all age groups (children, adults, older adults) and is the first high severity season since 2017-2018.

 

CDC continues to recommend that everyone ages 6 months and older get an annual flu vaccine as long as influenza viruses are circulating.^1"

 

 

https://www.cdc.gov/fluview/surveillance/2025-week-17.html

[Yellowtail]

Just now, TallGuyJohninBKK said:

 

As usual, you're throwing out unsourced and unsubstantiated claims that aren't supported by the facts:

 

The CDC estimates there have been 26,000 U.S. flu deaths thus far this season vs. 11,216 COVID deaths since January.

 

Want to avoid dying from the flu... Get vaccinated!

 

CDC on this year's flu cycle:

 

"This season is classified as a high severity season overall and for all age groups (children, adults, older adults) and is the first high severity season since 2017-2018.

 

CDC continues to recommend that everyone ages 6 months and older get an annual flu vaccine as long as influenza viruses are circulating.^1"

 

 

https://www.cdc.gov/fluview/surveillance/2025-week-17.html#:~:text=CDC estimates that there have been at,deaths from flu so far this season.

 

 

 

Poor lefty, I used the numbers on the chart you posted. 

 

Go git you some more masks and shots. 

[Yellowtail]

It is interesting how (per lefty's newest chart) almost no one died from the flu from 2020-2022. I wonder why that was? 

[still kicking]

53 minutes ago, Yellowtail said:

We've got to shut down the schools and churches !

Only for posters like you

[Yellowtail]

Remember how most everyone on the left seemed to have 5-10 friends and family members that died from covid, but people on the right did not seem to know anyone? 

 

Maybe that's why Trump won, all those old leftists dying from covid. 

[Yellowtail]

2 minutes ago, still kicking said:

Only for posters like you

How're your eyes? Better I hope. 

[still kicking]

2 minutes ago, Yellowtail said:

How're your eyes? Better I hope. 

My eyes are good enough to read your rubbish 

[Yellowtail]

Just now, still kicking said:

My eyes are good enough to read your rubbish 

I'm glad to hear that. 

[TallGuyJohninBKK]

Noted epidemiologist Katelyn Jetelina, author of the widely read Your Local Epidemiologist blog, has the following column explaining how two Trump Admin political appointees (Marty Makary and Vinay Prasad) with no expertise in vaccine matters totally bypassed both the FDA and CDC's own expert vaccine advisory panels in putting forward the FDA's new COVID vaccines policy... And why that's a problem.

 

Covid-19 vaccines, what just happened at the FDA, and why it matters

This is not how vaccine policy should be made.

May 21,2025

 

"...beneath the surface, this move is deeply troubling. It bypasses the scientific systems built to answer these questions, replacing the public process in health policy with the opinions of two political appointees with chips on their shoulders.

 

...

Yet, here we are. This decision was made without a [FDA advisory group] VRBPAC vote. No [CDC advisory group] ACIP meeting. No new data. No transparency or public discussion. Two FDA appointees decided the Covid-19 vaccine policy needed to change.

 

Why that’s a big problem

 

This matters for several reasons:

1. It undermines the evidence-based process.
   Makary and Prasad—neither of whom is a vaccinologist or has experience leading vaccine policymaking—circumvented the rigorous, transparent system in place. This was neither collaborative nor grounded in new evidence. There was no urgent reason to bypass that process. VRBPAC meets this Thursday, just two days after this announcement.

(more)

 

https://yourlocalepidemiologist.substack.com/p/covid-19-vaccines-what-just-happened

 

 

 

[blaze master]

Knock knock....who's there

Covid

Covid who ? 

Ya exactly no one cares.