Fact Check: Recorded Phone Call Does NOT Negate FDA Approval Of Pfizer's Comirnaty COVID-19 Vaccine

Fact Check

  • by: Sarah Thompson
Fact Check: Recorded Phone Call Does NOT Negate FDA  Approval Of Pfizer's Comirnaty COVID-19 Vaccine FDA Approved

Did Pfizer "admit" there is no vaccine approved by the Food & Drug Administration for use in the United States in a recorded phone call? No, that is a misrepresentation. The FDA granted approval on August 23, 2021, of the vaccine known as the Pfizer-BioNTech COVID-19 vaccine, now also marketed under the name Comirnaty.

This vaccine is approved for individuals 16 and older. There are additional emergency use authorizations granted by the FDA for the vaccine to be used for children 12 through 15 years old and for a third dose, or booster dose, in certain individuals.

In a purported recording of a call center phone call -- which may or may not be authentic -- an operator inaccurately told a caller that "there is NO FDA approved vaccine in the USA." A Pfizer media relations associate confirmed to Lead Stories that the vaccine has been granted FDA approval and FDA documents confirm that.

The videotaped recording of a phone call was published in an article by redvoicemedia.com on October 10, 2021. Titled "Biden BUSTED As Pfizer ADMITS There's No Vaccine Approved By FDA In The U.S. In Recorded Call" (archived here), it opened:

Joe Biden and his Regime have stated that Pfizer's COVID vaccine has FDA approval. Someone recently recorded a call of Pfizer saying something completely different.

Users on social media only saw this title, description and thumbnail:

Biden BUSTED As Pfizer ADMITS There's No Vaccine Approved By FDA In The U.S. In Recorded Call

The unusual line of questioning recorded in this call tracks with concerns that have been circulating regarding difficult-to-understand wording of the FDA's Pfizer approval. Some claims focus on the fact that the stock of vaccine currently available in the U.S. was manufactured when the Pfizer-BioNTech COVID-19 vaccine was under provisional approval. The same product has since been approved with the brand name Comirnaty, a product of the same formulation that can be used interchangeably but that the FDA notes is "legally distinct," a semantic distinction, but not a chemical difference.

In an August 24, 2021, interview on Bannon's War Room, Robert Malone, physician and critic of the COVID-19 vaccines, made some assertions about the labeling of these vaccines and legal liability. A fact checking article published by washingtonpost.com included information from Pfizer and the Department of Health and Human Services that clarified that the details Malone had been given from a third-party lawyer were not fully correct: The vaccine under either label carries no liability or compensation differences.

In another example of this misunderstanding, 10 Louisiana state representatives signed a letter to Gov. John Edwards and Dr. Courtney Phillips, the secretary of the state Department of Health, maintaining the available vaccines are not approved by the FDA and cannot legally be mandated. An October 8, 2021, fact check from poynter.org concluded that the FDA had approved that vaccine, which was chemically and biologically identical to Comirnaty.

The 3½-minute-long video appears to show a cell phone on a table recording a speaker call that was being made on a second cell phone. There is no date verification, but this video was uploaded to tv.gab.com on October 9, 2021. The call begins with an automated message identifying this as a call to the "Pfizer Customer Response Center." The "Pfizer First Connect" operator, Cindy, who takes this call, seems surprised by and unprepared for the caller's question:

Yes, I was trying to find out when your COVID vaccine would be available, in the Comirnaty, being sold here in the U.S.

Cindy replies:

OK um -- I don't know if we have that information, it has to be approved first before it became available.

The operator then tries to transfer the caller to the medical information department and repeats that the vaccine would have to be approved first. She restates that the Comirnaty has not been FDA approved. This statement seems to take the caller by surprise. Cindy then reads from her materials but leaves the caller confused:

The licensed Comirnaty vaccine has the same formulation as the authorized vaccine the Pfizer-BioNTech COVID-19 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 affect safety or effectiveness.

The emergency uses of the vaccine have not been approved or licensed by the FDA but have been authorized by the FDA under emergency use authorization to prevent coronavirus disease in individuals 12 years of age and older. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under section 574b1 of the FD&C act unless the declaration is terminated or authorization is revoked sooner.

When the caller asks Cindy to clarify, she is told that nothing has been approved -- it's only approved under the emergency use authorization. It is not possible to verify the full context of her materials, their age or the date the recorded phone call took place, but this has not been the case since August 23, 2021. Lead Stories was able to locate text that Cindy read with nearly identical phrasing in public Pfizer documents (here and here).

Lead Stories contacted Keanna Ghazvini, Pfizer's senior associate global media relations, for clarification. She replied on October 13, 2021, including links to the press releases from August 23, 2021:

I can confirm that our vaccine has been granted FDA approval.

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Lead Stories is working with the CoronaVirusFacts/DatosCoronaVirus Alliance, a coalition of more than 100 fact-checkers who are fighting misinformation related to the COVID-19 pandemic. Learn more about the alliance here.


  Sarah Thompson

Sarah Thompson lives with her family and pets on a small farm in Southeastern Indiana. She founded a Facebook page and a blog called “Exploiting the Niche” in 2017 to help others learn about manipulative tactics and avoid scams on social media. Since then she has collaborated with journalists in the USA, Canada and Australia and since December 2019 she works as a Social Media Authenticity Analyst at Lead Stories.


 

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