dChan
Anonymous ID: edff12 May 20, 2025, 2:09 p.m. No.23060721   🗄️.is 🔗kun

FDA Says No Licenses for COVID-19 Vaccines for Many Americans Without Trial Data

The new policy 'balances competing values,' agency leaders said.

 

The Food and Drug Administration (FDA) will not approve COVID-19 vaccines for many Americans absent trial data showing that the benefits outweigh the risks, top agency officials said on May 20.

 

FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, head of the FDA's Center for Biologics Evaluation and Research, said that the FDA's new COVID-19 vaccine framework will have two tiers. For people aged 65 or older, and for people who have a risk factor that places them at high risk for severe COVID-19 outcomes, manufacturers will only need to provide proof that a vaccine can trigger antibodies. For everyone else, or those without risk factors, the FDA is requiring data from randomized, controlled trial data showing that a vaccine prevents symptomatic COVID-19 and secondary outcomes such as death.

 

"The FDA can only approve products if it concludes, based on scientific evidence, the benefit to harm balance is favorable. And we simply need more data to have that confidence for younger individuals at low-risk of severe disease," Prasad said in prepared remarks from the FDA's headquarters in Maryland on Tuesday.

 

The trials will not be required every year, but likely every few years, he added later.

 

Some 100 million to 200 million Americans fall under the first tier, the officials estimated in the New England Journal of Medicine article.

 

https://www.ntd.com/fda-says-no-licenses-for-covid-19-vaccines-for-many-americans-without-trial-data_1068351.html

Anonymous ID: edff12 May 20, 2025, 2:30 p.m. No.23060855   🗄️.is 🔗kun   >>0859 >>0893 >>0921

>>23060806

Starting to look like it wasn't Biden.

At least for the purpose of undoing his administration.

They're running with his non compus mentas line,

which is perfect to 25th him and null and void the whole thing.

Anonymous ID: edff12 May 20, 2025, 2:42 p.m. No.23060944   🗄️.is 🔗kun   >>0977

RealRobert🇺🇸

@Real_RobN

And this is,

 

the official results of Arizona Senate audit of the 2020 presidential election

 

• +255,000 early votes with no record, unaccounted for

 

• +23,000 voted by mail after moved from the state/county.

 

• +23,000 double votes

 

• +9,000 more mail in ballots received and recorded than official number of mail in ballots,

 

• +50,000 counterfeit ballots

 

• Dominion rigging systems best friend 🛜

 

• Arrest Katie Hobbs

 

• Arrest Adrian Fontes

 

And

 

On January 6, the United States Congress certified treason—the overthrow of your government at the highest level!”

 

https://x.com/Real_RobN/status/1924935704909643870

Anonymous ID: edff12 May 20, 2025, 2:49 p.m. No.23060980   🗄️.is 🔗kun   >>0998

>>23060938

The questions are only asked as questions for legal reasons.

Do you comprehend?

They're not really questions; they're pointers and markers.

Learn to code.

Study the proofs.

Study the decades to date.

 

Look Sidley Austin as example.

Short code, extremely detailed.

Shall we play a game.

You decode this, and go.

Anonymous ID: edff12 May 20, 2025, 4:10 p.m. No.23061311   🗄️.is 🔗kun

Signature auction:

Roll up, roll up, autopen signatures to the highest bidder.

 

https://x.com/LeadingReport/status/1924937956038459784