FDA to impose strict new vaccine requirements, claiming child covid shot deaths

[mahatmakanejeeves]

Source: Washington Post

FDA to impose strict new vaccine requirements, claiming child covid shot deaths

Vinay Prasad, the nation’s top vaccine regulator, said his team concluded that coronavirus shots were linked to children’s deaths, necessitating a new approach.

November 29, 2025 at 12:05 a.m. EST Today at 12:05 a.m. EST
6 min


Moderna coronavirus vaccines are displayed during a 2021 vaccination campaign in California. (Melina Mara/The Washington Post)

By Dan Diamond and Rachel Roubein

The nation’s top vaccine regulator on Friday laid out a stricter approach for federal vaccine approvals, citing his team’s conclusion that coronavirus vaccines had contributed to the deaths of at least 10 children, according to an internal Food and Drug Administration email obtained by The Washington Post.

Vinay Prasad, an FDA official whose approach to vaccine policy has been championed by Health Secretary Robert F. Kennedy Jr., told agency officials that the FDA will rethink its framework for annual flu shots, examine whether Americans should be receiving multiple vaccines at the same time and require vaccine makers to show far more data to prove the safety and value of their products. For instance, Prasad said that pneumonia vaccine makers must demonstrate that their products reduce pneumonia, rather than just generate antibodies to fight infections.

Prasad also wrote that the new approach means the agency will have strict requirements for authorizing new vaccines for pregnant women. He concluded his lengthy email by maintaining that he was open-minded about next steps. ... “I remain open to vigorous discussions and debate,” Prasad wrote to his team, adding that staff who did not agree with the core principles of his new approach should submit their resignations.

Collectively, Prasad’s plans would transform the FDA’s decades-old process of approving vaccines by compelling pharmaceutical companies to run far larger studies, likely slowing them down, said current and former agency staff and outside public health experts, some of whom spoke on the condition of anonymity to discuss internal FDA operations or comment on a developing situation. The approach could also have a chilling effect on the development of novel vaccines, because manufacturers will need to undertake sweeping new studies when seeking most new approvals — even for expanding the population who can get the shot, they said.

{snip}

By Dan Diamond
Dan Diamond is a White House reporter for The Washington Post, with a focus on policy and public health. His email is [e-mail] and you can reach him on Signal at @dan_diamond.01.follow on X@ddiamond
https://www.washingtonpost.com/people/dan-diamond/

By Rachel Roubein
Rachel Roubein is a national health-care reporter for The Washington Post covering the Food and Drug Administration. Reach her securely on Signal: RachelRoubein.28follow on X@rachel_roubein
https://www.washingtonpost.com/people/rachel-roubein/

Read more: https://www.washingtonpost.com/health/2025/11/29/fda-vaccine-approval-child-covid-deaths/

[lapfog_1]

1. pneumonia vaccine makers must demonstrate that their products reduce pneumonia

rather than just generate antibodies to fight infections.

I bet they will require large double blind human studies...

Think of what this means...

Doctors will give "vaccines" ( some vaccines some saline water ) to a large population and then record who get pneumonia and who does not.

For the people that get pneumonia and were given the saline vaccine... too bad, some of them will DIE needlessly. Just to prove that yes indeed, improved immune response as an outcome of vaccination relates to fewer people dying of pneumonia.

Absolute ghouls. May their eternal souls rot in hell.

[BadgerKid]

2. Presumably same goes for any cancer vaccine.

mRNA vaccines in particular beware. Fortunately, trials in various stages are underway.

[TheRickles]

5. Placebo controls are the standard for testing all new medications (except vaccines). And yes, some people die.

But they've given informed consent, knowing they may get placebo but willing to take a chance so we can all benefit by learning how effective the drug truly is.

[NickB79]

7. That's not what RFK Jr is calling for at all

https://www.pharmexec.com/view/dont-fall-call-placebo-controlled-vaccine-trials

To be clear, placebo-controlled trials can be ethical, even essential, when no vaccine or standard of care exists. For example, testing a vaccine for a novel virus or using a completely new antigen may justify a placebo arm. But that’s not what Secretary Kennedy is advocating. He’s calling for placebo trials even when effective vaccines already exist, where the risk is no longer theoretical, but real and avoidable.

[TheRickles]

9. There's a risk in every placebo-controlled trial.

Avoiding that risk by not using a placebo control means not knowing for sure what the drug in question really accomplishes. It's sometimes a very tough trade-off.

[NickB79]

10. Perhaps you're not understanding this

RFK Jr is calling for placebo-based trials for ALL VACCINES. Not just new ones, but vaccines in common use for 50+ years.

Measles. Chicken pox. Tetanus. Diptheria. Whooping cough. Fucking POLIO. All of them he wants re-done, because he's a fucking conspiracy-theory, anti-vax loon.

That is NOT a tough trade-off. We know exactly what such trials would lead to: thousands of dead and injured children only to reach the same conclusions we already have. And they would have to use young children who haven't been widely exposed to these diseases. We'd literally be testing on infants and toddlers, and accepting that we'd be sending many of them to their tiny little graves.

And some vaccines, such as the flu vaccine, would basically be impossible to trial, because we need to release an updated vaccine annually. By the time the data was compiled, the flu season would be upon us, and it would be too late to release a flu vaccine. It would cause tens of thousands of deaths even in a mild flu season.

[Nasruddin]

16. When do they start on parachutes?

Seems like a double blind study is in order. Maybe people can just glide down.

[llmart]

3. WTeverlovin'F kind of a statement is this?????

“I remain open to vigorous discussions and debate,” Prasad wrote to his team, adding that staff who did not agree with the core principles of his new approach should submit their resignations.

[airplaneman]

17. You beat me to it I was going to post the same thing

[sinkingfeeling]

4. Gee, any studies on how many children died from Covid-19?

[paleotn]

6. An FDA run by complete morons. What could possibly go wrong?

[Orrex]

8. Check out the classic antvax strategy:

If someone dies from Covid, it’s because they had “comorbidities” like diabetes or high blood pressure, or they were overweight or underweight or too old or too young, etc. Literally anything to shift the blame away from the disease that was such an effective political tool.

Fast-forward to now; a statistically infinitesimal number of children are claimed to have died subsequent to the vaccine, so any other possible factors are ignored, to shift blame to the vaccine that’s such an effective political tool.

[NickB79]

11. The same officials saying vaccines cause autism claim 10 children were killed by COVID vaccines?

Is it possible? Yes, I'm sure there's a very small risk of such an outcome from any vaccine. A 1-in-a-million risk means that you'd expect several deaths out of millions of children vaccinated. Do I believe THEM when they make the claim? Nope.

[Ouroborosnek]

12. Can't wait until we have

Science and rational thinking back in our departments and agencies.

[Bayard]

13. What a load of crap!

Show us the proof. Then show us the stats on all the dead kids that didn't get Covid vax'd.

Are there any actual doctors or infectious disease experts left at the FDA?

[pfitz59]

14. their ultimate aim is 'herd immunity'

let 'the strong' survive while 'the weak' are culled. chilling.

[Cirsium]

15. No

Herd immunity does not mean just let people die. It means a sufficient level of immunity in a group has been reached so that a contagious disease cannot spread.

[struggle4progress]

18. By mid-2023 over a million in the US (including over 1600 children) had died of COVID

See: https://www.statista.com/statistics/1191568/reported-deaths-from-covid-by-age-us/

Through September 2025 reports, several hundred per week were typically dying of COVID
See: https://www.cdc.gov/nchs/nvss/vsrr/covid19/

Now we're restricting vaccinations due to an "internal memo" suggesting 10 vaccine deaths?

Huh?

'We're outlawing fire extinguishers because somebody dropped one down a stairwell"

[AllyCat]

19. Jeebus Cripes on a transistor radio , the other thing that kills kids???

COVID!!!

[Grins]

20. So, he's saying the "Trump vaccine" killed children....

The vaccine he demanded and pressured to get created. The one Fox News said should be named after him…?

US News & World Report:

“ The findings of the new FDA review have not been published in a peer-reviewed medical journal, the New York Times reported earlier, adding that the Centers for Disease Control and Prevention's vaccine committee is to meet next week.

Dorit Reiss, professor of law at UC Law San Francisco, who has written on vaccines and law, criticized Prasad for suggesting changes to the approval for respiratory vaccines based on the conclusion of an unpublished investigation by what she said were unknown people.

"It is more problematic given that Dr Prasad's expertise is not in vaccines, but it would be problematic even if he were a vaccine expert," Reiss posted on X.

Prasad, (is) an oncologist…”

Trump has destroyed all faith in all sciences. It will take DECADES to recover from what he and his pathological butt-wipes have done.