Contributor to mRNA and Former HHS Official Criticize FDA on Approval of COVID Vaccine Saying Premature, Followed by Lies, Still Has Immunity

MRNA And Former HHS Official
Dr. Robert W. Malone, a virologist and Dr. Paul E. Alexander, former Trump administration official at the U.S. Department of Health and Human Services, have both claimed, FDA approval for Pfizer’s COVID vaccine is premature.

CORRECTION, NOV 11, 2021, 12:54 PM: An earlier version of this story referred to Dr. Robert W. Malone and the ‘creator’ or ‘inventor’ of mRNA technology, which is incorrect. Apparently, while Malone had claimed in his self described biographies on his website (now removed) and elsewhere, that he is or was the inventor, it has come to our attention the claim couldn’t possibly be true as it was first identified in 1961, when Malone was an infant. While Malone contributed early evidence that mRNA could be delivered and produce proteins in cells, the development of the mRNA vaccines was due to the work of hundreds of researchers, of which Malone is one.

WASHINGTON, D.C. – Two prominent doctors are being criticized for spreading misleading information about COVID vaccines and the recent FDA approval of the Pfizer injection. Dr. Robert W. Malone, a virologist, and contributor to the discovery of messenger RNA, and Dr. Paul E. Alexander, former Trump administration official at the U.S. Department of Health and Human Services, have both claimed, on video, that the current approval from the FDA for Pfizer’s COVID vaccine, is a smoke-screen and actually applied to a “legally distinct” product called “COMIRNATY” which will be available at a future date, potentially years from now, effectively biding more time for it to be further tested, but being marketed, in name, as the current Pfizer product available under emergency use.

Both doctors are speaking out in interviews to advise the public that from what they believe, and from what they have read on publicly available documentation and information from the FDA, in their professional opinions, the currently available vaccine being produced by Pfizer, the multinational pharmaceutical and biotechnology corporation, remains under emergency use declaration (EUD) and continues to have immunity from liability, even with the recent approval.

Their opinions come, at least partly, from an interesting footnote in the fine print section within the FDA’s fact-sheet on the approval of what has been known as the ‘Pfizer-BioNTech COVID-19 Vaccine,’ published on August 23, 2021. The foot-note states that the approval is for a similar, yet “legally distinct” product called “COMIRNATY®” which is how both products will be marketed going forward.

“The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.”

The distinction appears in several areas where official information is available, such as below at the website setup by BioNTech and Pfizer which is intended for use only by U.S. healthcare professionals.

 BioNTech and Pfizer
BioNTech and Pfizer website which is intended only for U.S. healthcare professionals.

The claims, which are said to be an elaborate vaccine conspiracy theory, are being aggressively debunked as false by the usual players observed in fact-checking circles such as USA Today, which calls the claim “bunk” while not mentioning the “similarity” but “distinctiveness” of the two products, as well as The Washington Post, which does reference those differences citing them as “differences in manufacturing sites or approved suppliers.”

While one legal publisher, JD Supra, cites the two products as identical,” the FDA’s footnote remains confusing to some. The legal publisher also makes clear that since the government invoked the PREP Act during their creation, both the old version and new version of the products, regardless of name, will be granted immunity from liability so while the FDA states it has given its “full authorization,” that might not necessarily be the “full authorization” the general public has come to expect from FDA approvals.

For instance, one of the roles of the FDA is to ensure the public is aware or made aware of any risk’s associated with a product. Some social media users have compared the release of this approval to cigarettes, which are widely known and accepted to cause cancer, which is why cigarette manufacturers are required through the Tobacco Control Act (regulation of the manufacture, distribution, and marketing of tobacco products) to include specific labeling with certain health warning requirements. Cigarettes and other tobacco products are not FDA approved, they are regulated. With Pfizer-BioNTech’s COVID-19 Vaccine, or now, COMIRNATY, it too includes such warnings which are listed under “WARNINGS AND PRECAUTIONS” including “myocarditis” (inflammation of the heart muscle) and “pericarditis” (inflammation of the pericardium, a sac-like structure with two thin layers of tissue that surround the heart), as well as “ADVERSE REACTIONS”.

Package Insert

A video call with the FDA did not include any mention of the distinctiveness of the available version or the newer to-be-produced product, and recommended physicians continue to use the product which is already “on the shelves” of suppliers. The FDA also said that they are requiring the manufactures of the new COMIRNATY continue to study longer term effects of the vaccine and specifically on two of the side effects, myocarditis and pericarditis.

The FDA is requiring the company to conduct post marketing studies to further assess the risks of myocarditis and pericarditis following vaccination with Comirnaty including the evaluation of long-term outcomes among individuals who develop myocarditis. In addition, the company is committed to conducting additional post marketing safety studies including conducting a pregnancy registry to study and evaluate pregnancy and infant outcomes after vaccination during pregnancy.

FDA, United States Food and Drug Administration

Despite the information released by the FDA, Dr. Robert W. Malone, M.D., M.S., a virologist, and contributor to the discovery of messenger RNA, says the media is not doing their job while on the video podcast show “War Room” hosted by Steve Bannon and suggested the media is spinning the news without digging into the release further, or as further as they should be.

“The little trick that they have done here. They have issued two separate letters for two separate vaccines. The Pfizer vaccine which is what is currently available is still under emergency use authorization, and it still has the liability shield. Once again, the mainstream media has lied to you, I’m sorry to say that, I know it’s a shock. The product that’s licensed is the BioEnTech product, which is substantially similar but not necessarily identical, it’s called COMIRNATY. It’s not yet available, they have not started manufacturing it or labeling it, that’s the one that the liability waiver will no longer apply to. The one that is actually licensed is not yet available and when it does come to be available it will no longer have the liability shield. In the interim, the one that does have the liability shield is the Pfizer product, and that’s what is currently available and its still under emergency use authorization. So that’s no change, the press has just not done their work and figured out what’s actually going on here.

Dr. Robert W. Malone, a virologist, and contributor to the discovery of mRNA vaccines.

Additionally, Dr. Paul E. Alexander, former Trump administration official at the U.S. Department of Health and Human Services, called the vaccine a catastrophic failure during an interview on The Stew Peters Show published August 27, 2021.

The vaccines are not working, and to even propose a booster shot when you can’t even get the second shot sorted out and we have all these break-through infections is a catastrophic failure and the FDA did a disservice to the public because they have just issued an approval for a vaccine which is unavailable but extended emergency use for an available unapproved vaccine; this is the most wrong sided upside down thing. I think the FDA tried a trick on the American public here.

Dr. Paul E. Alexander, former Trump administration official at the U.S. Department of Health and Human Services

According to a recent press release, an individual may be offered one of two vaccines, either COMIRNATY® (COVID-19 Vaccine, mRNA) or the EUA-authorized ‘Pfizer-BioNTech COVID-19 Vaccine’ to prevent coronavirus disease 2019 caused by SARS-CoV-2. A separate release instructs vaccination providers to report adverse events to VAERS (The Vaccine Adverse Event Reporting System) and such reports should include the words “Pfizer-BioNTech COVID-19 Vaccine EUA” in the description section. For whatever reason, it is not suggested to be reported as COMIRNATY.

Editors Note: This story contains opinions by experts in their field accompanied by video statements for transparency and responsibility in reporting. We must remind the reader that nothing should supersede the advice received from one’s own medical physician based on their specific circumstances.

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