EXCLUSIVE: FDA Refuses to Provide Key COVID-19 Vaccine Safety Analyses

Contact Your Elected Officials
The Epoch Times Header

U.S. drug regulators are refusing to provide key analyses of a COVID-19 vaccine safety database, claiming that the factual findings cannot be separated by internal discussions protected by law.

The Epoch Times asked the Food and Drug Administration (FDA) in July for all analyses performed by the agency for the COVID-19 vaccines using a method called Empirical Bayesian data mining, which involves comparing the adverse events recorded after a specific COVID-19 vaccine with those recorded after vaccination with non-COVID-19 vaccines.

According to operating procedures laid out by the agency and its partner in January 2021 and February 2022, the FDA would perform data mining “at least biweekly” to identify adverse events “reported more frequently than expected following vaccination with COVID-19 vaccines.” The agency would perform the mining on data from the Vaccine Adverse Event Reporting System (VAERS).

In a recent response, the FDA records office told The Epoch Times that it would not provide any of the analyses, even in redacted form.

The agency cited an exemption to the Freedom of Information Act that lets the government withhold inter-agency and intra-agency memorandums and letters “that would not be available by law to a party other than an agency in litigation with the agency.”

The agency also pointed to the Code of Federal Regulations, which says that “all communications within the Executive Branch of the Federal government which are in written form or which are subsequently reduced to writing may be withheld from public disclosure except that factual information which is reasonably segregable in accordance with the rule established in § 20.22 is available for public disclosure.”

It’s not clear why the FDA could not produce copies of the analyses with non-factual information redacted. The Epoch Times has appealed the determination by the records office. The FDA declined to comment, citing the appeal.

‘Unacceptable’

Kim Witczak, co-founder of Woodymatters, a nonprofit that advocates for a stronger FDA and drug safety system, said the agency’s refusal to provide the analyses was not acceptable.

By Zachary Stieber

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.

Trump’s Proposal For NATO To Stop Buying Russian Oil & Start Tariffing China Is Unrealistic

Trump proposed on social media that NATO stop buying Russian oil and start tariffing China 50-100% as part of his plan for ending the Ukrainian Conflict.

The Choices We Make

Death and disagreement are inevitable. Love and hate are choices. We will all die. Before we do, what choices will we make?

Elon Musk Speaks at Unite the Kingdom Rally

Tommy Robinson held rally, with Elon Musk appearing virtually, calling attention to leftist politicians who allow foreign immigrants to invade England.

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.

ABC Halts ‘Jimmy Kimmel Live’ Indefinitely After Charlie Kirk Remarks

ABC has indefinitely pulled “Jimmy Kimmel Live” after the host’s remarks about Charlie Kirk’s assassination drew criticism from the FCC chairman.

ABC Reporter Apologizes for Calling Texts From Kirk’s Alleged Murderer ‘Very Touching’

ABC reporter apologized after describing text messages between Charlie Kirk’s alleged murderer and the man’s boyfriend as “very touching.”

Federal Reserve Cuts Interest Rates for First Time in 2025

The Federal Reserve cut interest rates for the first time this year following its two-day policy meeting that concluded on Sept. 17.

Driver Rams Car Into FBI Pittsburgh Gate in Potential Act of Terror, Official Says

Driver crashes car into FBI Pittsburgh office gate in a suspected targeted attack the agency says may be an act of terror against the bureau.

Rubio Says US Visa Revocations Underway After Charlie Kirk Death Celebrations

SoS Marco Rubio said foreign nationals who made celebratory comments over Charlie Kirk’s assassination will have their U.S. visas revoked.

Trump Supports Designating Antifa a Terrorist Organization

President Trump said he would support designating the antifa movement a terrorist organization in the wake of Charlie Kirk’s assassination last week.

US Conducts Strike on Another Drug Boat From Venezuela: Trump

Three people were killed in a U.S. strike on a Venezuelan drug boat, President Donald Trump announced on Sept. 15.

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.
spot_img

Related Articles

Popular Categories

MAGA Business Central