Moderna Vaccine Trials Contained ‘Mostly Irrelevant Studies’ and ‘Deceptive Practices’: Veteran Pharma Analyst

Contact Your Elected Officials
The Epoch Times Header

Moderna’s internal documents regarding their COVID vaccine trials, obtained via a Freedom of Information Act request by Judicial Watch, show that most of their studies submitted for approval to the FDA were “irrelevant” and did not follow Good Laboratory Practices (GLP), according to a former pharma executive.

The 700 pages contain a portion of the formal Biologics Licensing Application (BLA) package that a manufacturer is required to submit to the FDA for approval.

Four hundred of these pages were on non-Spikevax products.

The documents have not been made public, but were analyzed by former pharma executive Alexandra Latypova and reviewed by The Epoch Times.

‘Ignore the Cargo, Focus on the Vehicle’

Moderna’s nonclinical program consisted of studies of “irrelevant” and unapproved mRNAs, which are completely different chemical entities from Spikevax, Latypova told The Epoch Times.

“Moderna claimed that the active substance mRNAs of SPIKEVAX does not need to be studied for toxicity and can be replaced with any other mRNA without further testing,” she said.

“The FDA did not push back on this preposterous claim. The company is claiming that the active drug substance of a novel medicine does not need to be tested for toxicity.”

“This is analogous to claiming that a truck carrying food and a truck carrying explosives are the same thing. Ignore the cargo, focus on the vehicle. The claim is preposterous—the mRNAs and LNPs [lipid nanoparticles] separately and together are entirely novel chemical entities, each requiring its own Investigational New Drug [IND] application and data dossier filed with the regulators, and studies with one mRNA are no substitute for all others,” Latypova added.

Latypova has worked in more than 60 pharmaceutical companies, mainly focusing on creating and reviewing clinical trials, many of which were submitted to the FDA.

According to her research, Moderna skipped entire categories of safety and toxicology testing.

The FDA approval document released in January acknowledges that the toxicity test done on the correct mRNA (1273) is non-GLP.

By Enrico Trigoso

Read Full Article on TheEpochTimes.com

The Epoch Times
The Epoch Timeshttps://www.theepochtimes.com/
Tired of biased news? The Epoch Times is truthful, factual news that other media outlets don't report. No spin. No agenda. Just honest journalism like it used to be.

Doxed Democrats Are Getting Fired Left and Left

Not a misprint because a title of “left and...

Hold Up, Feds, Without Federalism, There Is No USA

Federalism is essential to governing the U.S., yet the federal government is undermining it by bribing states to implement unnecessary federal programs.

A Widow Inspires The World

Erika Kirk moved the nation with her speech two days after her husband’s assassination, vowing to continue his mission and grow Turning Point USA.

Both Left and Right Are Making Lists

The right admired Charlie Kirk for his faith and patriotism, while the left opposed him for dismantling their positions and narratives with ease.

Redemption’s playbook: The Senior

The Senior isn’t your usual underdog tale, it’s real, it’s raw, and it flips every cliché on its head with a playbook full of grit and plenty of aftermaths.

Trump Cannot Remove Fed Governor Lisa Cook for Now, Appeals Court Rules

A panel of federal judges on Monday held that President Donald Trump cannot fire Federal Reserve Governor Lisa Cook as of now.

FBI Looking Into Other Possible Charlie Kirk Assassination Accomplices: Deputy Director Bongino

FBI Deputy Dir. Dan Bongino said that the FBI is “looking into” other possible accomplices in the assassination of conservative influencer Charlie Kirk.

Actor Sean Astin, Known for ‘Rudy,’ ‘Lord of the Rings,’ Elected SAG-AFTRA President

Oscar-nominated actor Sean Astin, famed for Samwise in “Lord of the Rings,” has been elected as the new president of SAG-AFTRA.

RFK Jr. Names New Members to CDC Vaccine Advisory Panel

Health Secretary Robert F. Kennedy Jr. named 5 new members to the Advisory Committee on Immunization Practices, which advises the CDC on vaccines.

Trump Signs Memo Targeting Direct-to-Consumer Pharmaceutical Advertising

President Trump signed a memo to ensure drug ads give fair, balanced, and complete information to protect and inform American consumers.

Trump Runs out of Patience With China, Sharpens His Words

President Donald Trump’s recent remarks targeting China and its allies mark a noticeable shift in tone.

Trump Signs Order Renaming Department of Defense as Department of War

President Donald Trump on Sept. 5 signed an executive order renaming the Department of Defense as the Department of War.

Trump Signs Executive Order Targeting Countries That Unlawfully Detain Americans

President Trump signed an EO on targeting the unlawful detention of American citizens around the world and to facilitate the release of hostages.
spot_img

Related Articles