In a much-trumpeted announcement this week the Food and Drug Administration said it was approving for general use the Pfizer COVID-19 vaccine.
Americans have been getting Pfizer shots for months already, under an emergency use authorization.
But an expert in the field says what reports have failed to include is that the vaccine approved by the FDA is not the same as the one that’s already been in use.
It is Dr. Robert Malone who said during an interview on “The Warroom with Steve Bannon” that the vaccines are similar, but not the same.
Bannon asked, is the “authorized” vaccine now ready to be administered to patients?
“It’s absolutely not available,” Malone explained. “The little trick that they’ve done here is that they’ve issued two letters, 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.”
He said, “The product that’s licensed is the BioNTech product which is substantially similar but not necessarily identical. It’s called Comirnaty … and it’s not yet available. They haven’t started manufacturing it or labeling it and that’s the one that the liability waiver will no longer apply.”
He said. “So the one that’s actually licensed is not yet available and when it does become available it will no longer have the liability shield.”
Malone is recognized as knowledgeable, as WND reported earlier on his status as inventor of the mRNA technology behind the COVID-19 vaccines.
He previously warned that Americans don’t have enough information to decide whether or not the benefits of getting the shots outweigh the risks.
Malone – after YouTube deleted a video interview of him discussing the risks of COVID-19 shots – told Fox News’ Tucker Carlson he’s concerned that the government is not being transparent.
“I am of the opinion that people have the right to decide whether to accept vaccines or not, especially since these are experimental vaccines,” Malone said.
“This is a fundamental right having to do with clinical research ethics,” said Malone. “And so, my concern is that I know that there are risks. But we don’t have access to the data, and the data haven’t been captured rigorously enough so that we can accurately assess those risks.
“And therefore … we don’t really have the information that we need to make a reasonable decision.”
In the government’s announcement this week boasting of the FDA approval of the “first COVID-19 vaccine,” it identified that as the “Pfizer-BioNTech COVID-19 Vaccine,” which “will now be marketed as Comirnaty.”
Acting FDA commissioner Janet Woodcock said the FDA “approval” “may now instill additional confidence to get vaccinated.”
The FDA said the vaccine already has been available under the emergency use provisions.
“Comirnaty contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19,” the FDA explains. “The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into – nor does it alter – an individual’s genetic material.
“Comirnaty has the same formulation as the EUA vaccine and is administrated as a series of two doses, three weeks apart.”
The FDA also warned of side effects such as “fatigue, headache, muscle or joint pain, chills, and fever” as well as “myocarditis and pericarditis” and admitted “information is not yet available about potential long-term health outcomes.”
However, a government vaccine information “fact sheet” on the issue specifically lists the shots as two separate objects.
“You are being offered either COMIRNATY (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine to prevent Coronavirus Disease 2019 (COVID-19) caused by SARS-Co-V-2,” the sheet insists.
Multiple times throughout the “fact sheet” the FDA refers to the two separately, despite claims that they have the same formula, and ingredients.
For example, it explains, “This Vaccine Information Fact Sheet for Recipients and Caregivers comprises the Fact Sheet for the authorized Pfizer-BioNTech COVID-19 Vaccine and also includes information about the FDA-licensed vaccine, COMIRNATY (COVID-19 Vaccine, mRNA).”
It separately identifies “COMIRNATY (COVID-19 Vaccine, mRNA)” as the FDA-approved drug made by Pfizer for BioNTech and then the separate “Pfizer-BioNTech COVID-19 Vaccine that is under emergency use authorization.
The government insists, too, that the “COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine,” in fact, “have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series.”
They specifically are addressed differently, with one being “authorized” and the other “approved.” The FDA repeatedly mixes the two, carefully keeping in place the differences between “authorized” and “approved.”
It explains both contain, “mRNA, lipids ((4-hydroxybutyl) azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-Distearoyl-sn-glycero-3-phosphocholine, and cholesterol), potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium
phosphate dihydrate, and sucrose.”
Even in its question-and-answer stage on the fact sheet, it explains what happens if people choose not to get “COMIRNATY (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine.”