Liability-Free COVID Vaccine Makers Seek Additional ‘Free Pass’ From FDA

Liability-Free COVID Vaccine Makers Seek Additional ‘Free Pass’ From FDA

The FDA’s “Emergency Use Authorization” allows drugmakers to skip inspections designed to ensure the safety of their manufacturing plants and operations.

By: Jeremy Loffredo

The winner of the race for approval of the first COVID-19 vaccine will get a bonus prize — the ability to pull the switch on vaccine production without having to undergo the standard mandatory safety and compliance inspection of its manufacturing facilities.

Current regulations require that before pharmaceutical companies can take their products to market, their manufacturing plants must pass a compliance inspection by the U.S. Food and Drug Administration (FDA).

The only way a company can bypass the inspection is if the FDA approves the company’s drug for “emergency” use. The FDA’s Emergency Use Authorization is limited to situations “when there are no adequate, approved and available alternatives.”

That’s why drugmakers in the running to produce a COVID-19 vaccine or therapeutic are also racing to be the first to get FDA Emergency Use Authorization — not just because it would allow them to skip the mandatory plant inspections, but also because once the FDA grants the authorization for one vaccine or one therapeutic, no other company can get it.

On Tuesday, Associated Press reported that Pfizer plans to seek emergency use authorization in November, Albert Bourla reportedly told investors he doesn’t know whether Pfizer will be the first company to get that authorization.

Once a drugmaker gets emergency use authorization for a drug or vaccine, the FDA waives the mandatory manufacturing plant inspection, leaving the drug maker solely responsible for certifying the safety of the manufacturing process.

Eli Lilly, which has been working on a COVID therapeutic drug, recently had a run-in with the FDA over problems with one of its manufacturing plants. Reuters reported earlier this month that the FDA had cited “serious quality control problems” at an Eli Lilly plant working on an antibody therapy.

A former associate counsel at the FDA told Reuters the violations were “serious enough and have a significant enough impact on the public health that something needs to be fixed.” If Eli Lilly wins approval of its COVID antibody drug, the company plans to partner with the Gates Foundation to send the drugs to low-and middle-income countries.

So far, no vaccine maker is yet ready to start production of a COVID vaccine, and several that are working on developing vaccines have encountered problems with their clinical trials.

For example, AstraZeneca’s trials were halted after a trial participant developed a neurological disorder consistent with that of transverse myelitis. Transverse myelitis often results in weakness of the limbs, problems emptying the bladder and paralysis. Patients can become severely disabled and there is currently no effective cure.

And in May, as Children’s Health Defense reported, Moderna experienced a 20% “serious” injury rate in one of its COVID vaccine trials:

The vaccine, developed and championed by Anthony Fauci and financed by Bill Gates, used an experimental mRNA technology that the two men hoped would allow rapid deployment to meet President Trump’s ambitious “warp speed” timeline. Dr. Fauci was so confident of his shot’s safety that he waived ferret and primate studies (Moderna suspiciously reported no specific health data from its mouse studies). That appears to have been a mistake.”

Moderna’s COVID vaccine technology has never been approved for use on humans — and the drugmaker’s manufacturing plant has never been inspected by government regulators — but the company is also in the running for FDA’s emergency approval, according to the Associated Press.

Pharmaceutical companies working on COVID-19 vaccines and therapeutics are protected from liability for vaccine injuries under the Public Readiness and Emergency Preparedness Act (PREP Act).

••••

This article Liability-Free COVID Vaccine Makers Seek Additional ‘Free Pass’ From FDA originated on The Defender and has been re-published here on TLB by ‘contribution’ with attribution to the articles author Jeremy Loffredo and the website childrenshealthdefense.org/defender.

Jeremy Loffredo is a reporter for The Defender .

••••

TLB Editors Note: This is World Mercury Project on steroids! TLB highly recommends you click on the image below, visit this great website, and do whatever you can to help see this vital forum succeed … for the sake of our children !!!

Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. CHD is planning many strategies, including legal, in an effort to defend the health of our children and obtain justice for those already injured. Your support is essential to CHD’s successful mission.

••••

••••

Stay tuned to …

••••

The Liberty Beacon Project is now expanding at a near exponential rate, and for this we are grateful and excited! But we must also be practical. For 7 years we have not asked for any donations, and have built this project with our own funds as we grew. We are now experiencing ever increasing growing pains due to the large number of websites and projects we represent. So we have just installed donation buttons on our websites and ask that you consider this when you visit them. Nothing is too small. We thank you for all your support and your considerations … (TLB)

••••

Comment Policy: As a privately owned web site, we reserve the right to remove comments that contain spam, advertising, vulgarity, threats of violence, racism, or personal/abusive attacks on other users. This also applies to trolling, the use of more than one alias, or just intentional mischief. Enforcement of this policy is at the discretion of this websites administrators. Repeat offenders may be blocked or permanently banned without prior warning.

••••

Disclaimer: TLB websites contain copyrighted material the use of which has not always been specifically authorized by the copyright owner. We are making such material available to our readers under the provisions of “fair use” in an effort to advance a better understanding of political, health, economic and social issues. The material on this site is distributed without profit to those who have expressed a prior interest in receiving it for research and educational purposes. If you wish to use copyrighted material for purposes other than “fair use” you must request permission from the copyright owner.

••••

Disclaimer: The information and opinions shared are for informational purposes only including, but not limited to, text, graphics, images and other material are not intended as medical advice or instruction. Nothing mentioned is intended to be a substitute for professional medical advice, diagnosis or treatment.

Be the first to comment

Leave a Reply

Your email address will not be published.


*