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Government Contracts With COVID Vaccine Makers Let Federal Agencies Bypass Normal Regulatory Process: FOIA Docs

By Brenda Baletti, Ph.D. | The Defender | June 30, 2023

A little-known federal agency called BARDA dedicated to countering “health security threats” was responsible for conducting the quality review of every COVID-19 vaccine dose administered in the U.S., Sasha Latypova reported on her Substack.

But BARDA, the Biomedical Advanced Research and Development Authority, which has a “militarized” purpose according to Latypova, is not subject to the same regulations as typical pharmaceutical manufacturers, distributors or regulatory agencies.

Distribution through BARDA was part of the “bait and switch” the federal government subjected the American people to with the COVID-19 vaccines, Latypova — a former pharmaceutical industry executive who now exposes fraud in COVID-19 countermeasures — told The Defender in an interview.

“The public was told these vaccines are made by Pfizer and Moderna and rigorously approved by the FDA.” That, she said, would mean that the “consumer protections we expect from pharmaceutical products, medical devices and even food — which are huge and extensive — we expect them to be in place.”

But in fact, countermeasures contracts made available through Freedom of Information Act (FOIA) requests by various parties and U.S. Securities and Exchange Commission disclosures show the U.S. Department of Defense (DOD) and BARDA contracts with the pharmaceutical companies were structured such that these protections weren’t required, according to Latypova.

The contracts also specified that manufacturers and federal agencies were protected by the Public Readiness and Emergency Preparedness (PREP) Act, which shields “covered persons” — such as pharmaceutical companies, or the DOD/BARDA — from liability for injuries sustained from “countermeasures,” such as vaccines and medications administered during a public health emergency.

Latypova posted a video of a November 2022 presentation during which BARDA’s then-director of Regulatory and Quality Affairs (RQA) Tremel Faison bragged that before the U.S. government could purchase and release any COVID-19 product, the RQA team had to perform a review and acceptance.

“I thought it was very strange, given that this is technically the FDA’s [U.S. Food and Drug Administration] job,” Latypova wrote, so she investigated BARDA.

BARDA is housed within the U.S. Department of Health and Human Services, but its purpose is “to develop medical countermeasures that address the public health and medical consequences of chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases.”

BARDA now functions as part of the Office of the Assistant Secretary for Pandemic Preparedness and Response, elevated by the Biden administration in 2022 to coordinate the nation’s response to health emergencies.

BARDA reports that it has 77 products on the market.

This is concerning, Latypova said, because typically pharmaceutical products are subject to regulations that govern the clinical trial and manufacturing process and then the licensed pharmacy distribution system monitors for consumer safety.

They are subject to “cGxP” regulations, a suite of “current good practice” processes and procedures with the “x” standing in for a variety of life sciences areas, including manufacturing, laboratory, clinical and distribution.

Those regulations create tight control over pharmaceutical products ensuring, for example, that labeling is accurate, dosage is accurate, there are no impurities, and the active ingredients are active and present in the proper amounts.

The regulations also establish supply chain regulations so the products are tracked during transportation and distribution and are traceable, and they protect consumers from drugs being counterfeit, stolen, contaminated or otherwise harmful.

According to Latypova, the fact that BARDA receives and quality checks the vaccines means the vaccines and COVID-19 countermeasures are subject to different protocols than typical FDA-approved or FDA-authorized products.

According to BARDA’s Standard Operating Procedure (SOP) documents outlining its procedures for receiving and inspecting medical countermeasure products, which Children’s Health Defense obtained through a FOIA request, materials ordered by BARDA have their own process of approval.

Products are shipped from the manufacturer to BARDA. Prior to delivery, BARDA receives the lot number and a certification from the producer that says the product meets its established specifications and contains other technical information such as lot number, etc.

BARDA’s RQA team then receives sealed trucks, makes sure documentation is in order and temperature control is maintained, watches the unloading, and “conducts a cursory examination of obvious physical damage.”

BARDA does not test or verify the contents of the vials it receives. It simply accepts the claims in the manufacturers’ paperwork.

And the products from BARDA, according to the SOP, go into storage at a Strategic National Stockpile site, which, unlike typical pharmaceutical storage sites, is also not subject to regulations.

Pharmacy distribution is licensed on a state-by-state basis. Those regulations are typically extensive as seen, for example, in the Pharmacy Lawbook for the state of California that Latypova posted.

It was previously known that the FDA exempted COVID-19 countermeasures from many of these requirements, justifying that exemption based on the public health emergency.

In May, the FDA extended that exemption beyond the May 11 end of the COVID-19 public health emergency.

But the BARDA documents reveal how limited the oversight provided for the receipt and inspection of countermeasures is in practice.

Brenda Baletti Ph.D. is a reporter for The Defender. She wrote and taught about capitalism and politics for 10 years in the writing program at Duke University. She holds a Ph.D. in human geography from the University of North Carolina at Chapel Hill and a master’s from the University of Texas at Austin.

This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.

July 2, 2023 - Posted by aletho | Deception | COVID-19 Vaccine, United States