Misleading Claims of Vaccine Approval from POLITIFACT


POLITIFACT published an article headlined "Yes, Pfizer’s COVID-19 vaccine is FDA approved" which is not only a false claim, it's refuted by their own argument. 

Deriving from Tik-Tok, a woman stated:

"You guys, the Pfizer vaccine is not approved. They’ve been saying it’s been approved. I have proof, straight from the website where you sign up to get your vaccine, it is not approved for anything beyond the emergency use approval."

POLITIFACT claims this is an outright lie on the meter graphic they use:

Source: Politifact

They premise this conclusion pointing to the FDA's Emergency Use Authorization followed by by stating:

"The FDA granted emergency use authorization to the Pfizer and Moderna vaccines in December 2020 and to the Johnson & Johnson vaccine in February 2021."

However, in the EUA explainer it clearly reads:

Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives.

This is the case with the COVID-19 vaccination which as of September 21st, 2021, has not been approved for children 12 or younger (even under EUA) and is only authorized under the EUA for 12 to 15 year-old adolescents, but not approved.

What POLITIFACT is referring to is Comirnaty, which has been approved for Americans 16 years or older which is the same thing as the Pfizer vaccine (same ingredients/formula) although marketed under a different name.  

Neither Comirnaty nor the Pfizer COVID-19 vaccine has been approved for children under the age of 12 and those 12 to 16 remain under the EUA which is not an approval (see above).

POLTIFACT presents a very misleading premise which insinuates the vaccine is fully approved by pointing to the EUA and then mentioning the vaccine was approved on 8/23/2021 (which is accurate), however, the EUA is not an approval, and the FDA approval is only for those 16 and older.

Granted, there has been confusion regarding the new marketing name, however, "fact checks" such as this can add to that confusion. Additionally, POLITIFACT pointed to several examples on Tik-Tok, some of which appeared more accurately debunked, others were without definition or specificity, and regardless of any of them, POLITIFACT's assessment was simply misleading in presentation, or what they would call "half-true".  

Facts

For absolute clarity, here are the actual facts:

  • Comirnaty and the Pfizer COVID-19, collectively the ("vaccine"), are identical.
  • The vaccine has been approved for those 16 years of age and older.
  • The vaccine has not been approved for children under 12 years of age.
  • The vaccine remains under the EUA for those 12 to 16 years of age.


Summary 

POLITIFACT's fact-check regarding Tik-Tok claims is misleading and disingenuous itself. As such, this is a false fact check, albeit more of what POLITIFACT would call "half-true" in that it is primarily misleading and "needs context". 

Claim: "Yes, Pfizer’s COVID-19 vaccine is FDA approved"

Fact Check Verdict:  PARTIALLY TRUE   MISLEADING  

Claimant:  POLITIFACT