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Debunked: The FDA didn't just 'reissue emergency approval' for Pfizer's Covid-19 vaccine, it granted full approval

There has been some confusion after an FDA document was misread by some people.

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A CLAIM HAS been shared in an Irish Facebook group that the US Food and Drug Administration did not really approve the Pfizer-BioNTech Covid-19 vaccine, but only ‘reissued’ a licence for its emergency use.

It is one of a number of messages shared in response to the announcement made by the Food and Drug Administration (FDA) this week to fully approve the Pfizer vaccine.

A number of social media posts claimed that the Pfizer vaccine wasn’t actually fully approved by the FDA, citing a document posted online by the US drugs regulator.

The FDA has stated several times since, including to The Journal, that the Pfizer Covid-19 vaccine has been fully approved.

Context: Emergency use and full approval

After initial development, medicinal regulators gave approval for the ‘emergency’ use of Covid-19 vaccines, based on strong clinical trial results and the continued threat posed by the novel coronavirus SARS-CoV-2 that causes Covid-19.

Emergency use was granted on the back of two months of safety monitoring data on study participants.

The FDA granted emergency-use authorisation for the Pfizer Covid vaccine in December 2020, and reissued that emergency-use authorisation (EUA) five times since then.

Many anti-vaccine misinformation posts concluded that this emergency authorisation means the vaccines are an “experimental” medicine, despite the rigorous, scientific standards in place for emergency-use authorisation.

Misinformation claims

After the FDA announced on Monday 23 August that it had fully approved the Pfizer Covid-19 vaccine – based on preclinical and clinical data, lab inspections and follow-up data months after vaccination – some claims began appearing online that it hadn’t actually fully approved the Pfizer Covid-19 vaccine.

These claims were mostly made in the US, as it concerns the US drugs regulator, but some similar claims were made here in Ireland.

The following message was posted in an Irish Facebook group about Covid-19 on Tuesday 24 August, which read:

They Are Lying!!!!! The FDA Did Not Approve The Covid-19 Vaccine!!! They Only ‘REISSUED’ The “Emergency Use Authorization” (EUA).
Read Their Own Statement On From Their Site Titled ‘Pfizer-BioNTech COVID-19 Vaccine EUA LOA reissued August 23 2021′.

It included a screenshot: 

FDA Source: FDA

This screenshot is from a document by the US Food & Drug Administration, dated 23 August entitled ‘Pfizer-BioNTech COVID-19 Vaccine EUA LOA reissued August 23 2021′.

The document is a ‘letter of authorisation’, or an ‘LOA’, that the FDA sent to Pfizer.

The contents of the letter concerns two authorisations:

  • That the FDA was fully approving the use of the Pfizer-BioNTech Covid-19 vaccine in people aged 16 and older
  • That the FDA was extending the emergency use authorisation for the Pfizer Covid-19 vaccine for children aged 12-15.

As the document is very technical and uses a lot of medical and legal terminology, those who skim it may incorrectly conclude or believe that the “reissue” was in relation to the emergency use of the Pfizer Covid-19 vaccine in over 16s, rather than emergency use in relation to the 12-15 age group.

Some people could also deliberately take advantage of the complex document and use the word “reissued” out of context to confuse and mislead others.

When asked to clarify whether the vaccine had received full or emergency approval, the FDA confirmed that it had received full approval, and directed The Journal to the FDA statement issued on the subject on 23 August.

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The first line of that statement is: “Today, the US Food and Drug Administration approved the first Covid-19 vaccine.” 

u-s-covid-19-fpizer-vaccine-full-approval People wait in line to receive Pfizer's Covid-19 vaccine at a mobile vaccine clinic in Brooklyn. 23 August. Source: Xinhua News Agency/PA Images

The statement says: “The vaccine also continues to be available under emergency-use authorisation (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.”

The statement also included lengthy details about the FDA’s authorisation process: 20,000 people were involved in the FDA’s monitoring process to confirm that the vaccine is effective; 12,000 people who received either the Pfizer vaccine or a placebo were monitored for follow-up for six months after (as opposed to two months under the emergency-use authorisation); and a rigorous evaluation of incidence of myocarditis and pericarditis was carried out.

The full approval by the FDA of the Pfizer vaccine for people aged 16 and older means that it has now undergone the same rigorous testing and regulatory review as dozens of other long-established vaccines.

Peter Marks PhD, director of FDA’s Center for Biologics Evaluation and Research, said:

“We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of [Pfizer]’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities.”

In conclusion, the US FDA did fully approve the Pfizer Covid-19 vaccine, making it the first Covid-19 vaccine to receive full approval.

Posts that claim the Pfizer vaccine did not receive full FDA approval, despite strong evidence to the contrary, may have the aim of instilling fear in people to continue to deter them from getting vaccinated against Covid-19.

The Journal’s FactCheck is a signatory to the International Fact-Checking Network’s Code of Principles. You can read it here. For information on how FactCheck works, what the verdicts mean, and how you can take part, check out our Reader’s Guide here. You can read about the team of editors and reporters who work on the factchecks here

Have you gotten a message on WhatsApp or Facebook or Twitter about coronavirus that you’re not sure about and want us to check it out? Message or mail us and we’ll look into debunking it. WhatsApp: 085 221 4696 or Email: answers@thejournal.ie

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