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Fact Check-Media reports have not lied about Pfizer-BioNTech’s FDA approval

Update Dec. 21, 2021: Additional legal detail has been added in four new paragraphs at the end of the check. Paragraph eight has been updated to reflect recent developments; a summary paragraph has been removed for length and a grammatical error in paragraph four has been corrected.

News reports did not mislead the public that the Pfizer-BioNTech COVID-19 vaccine was approved by the U.S. Food and Drug Administration (FDA), despite contrary claims on social media.

Various documents have been said to prove that the FDA did not approve any vaccine (here , here) and some users have criticised those who believed media reports and did not “bother to fact check the news” (here).

These claims are misleading. Reuters reported on Aug. 23 that the FDA had granted full approval to the Pfizer-BioNTech COVID-19 vaccine for use in people aged 16 and older. It would be marketed under the name Comirnaty (here).

The FDA states that Comirnaty has the same formulation as the EUA-approved (Emergency Use Authorization) Pfizer vaccine and is interchangeable for the purposes of administration (here). Its website says: “Providers can use doses distributed under EUA to administer the vaccination series as if the doses were the licensed vaccine. For purposes of administration, doses distributed under the EUA are interchangeable with the licensed dose” (bit.ly/3ej9cvP).

The FDA letter approving the vaccine can be read (here) alongside the updated FDA vaccine information sheet (here).

Emily Smith, assistant professor at the Milken Institute School of Public Health at George Washington University (here), told Reuters in an email that Comirnaty is identical to the Pfizer-BioNTech vaccine.

“With full FDA approval, the company can officially give the Pfizer-BioNTech COVID-19 vaccine a brand name, and that name is Comirnaty. So, people getting the vaccine can feel confident that it is both safe and effective”, Smith wrote.

The FDA told Reuters via email that one point of continuity is that the Pfizer-BioNTech COVID-19 vaccine would still be covered by the EUA for children aged 12 to 15 years old and for third doses to immunocompromised individuals aged 12 and older. On December 16, 2021, Pfizer and BioNTech said they had filed for full approval of their vaccine for 12 to 15 year olds (here).

Following media coverage of the FDA’s August announcement, some social users questioned whether the approved vaccine Comirnaty would still be covered under the Public Readiness and Emergency Preparedness (PREP) Act of 2005 that provides liability immunity for medical countermeasures related to the novel coronavirus.

When queried over this point, a spokesperson for the U.S. Department of Health and Human Services directed Reuters via email to a published Q&A about the PREP Act. Section 4 (here) states that a "covered countermeasure" may be an unapproved drug or biological product used under an EUA or an approved drug or biological product.

Renée Gentry, director of the Vaccine Injury Litigation Clinic at the George Washington University Law School, told Reuters by email, “The Countermeasures Program (CICP) offers complete immunity from liability. My understanding is that so long as the Covid vaccines are designated a pandemic response they’ll be under the CICP regardless of EUA or FDA approved.”

Meanwhile, the FDA’s statement that vaccine doses distributed under the EUA and doses that are licensed can be used interchangeably was raised in a legal challenge against the U.S. military vaccine mandate (here, 12 NOV 21, US District Court for the Northern District of Florida, pages 12-15 - Google Docs). While it was an issue given consideration by a Florida judge, the injunction motion was nonetheless denied (here).

VERDICT

Missing context. Media reports were correct about the FDA’s approval of the Pfizer-BioNTech COVID-19 vaccine and did not mislead people. Comirnaty is identical to the Pfizer-BioNTech vaccine in formulation and can be used interchangeably for the purposes of administration in the U.S. for those aged 16 years old and above, according to the FDA.

This article was produced by the Reuters Fact Check team. Read more about our fact-checking work here .

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