Fact check: False claim that COVID-19 vaccine ingredients and formulas have changed since rollout

The claim: COVID-19 vaccine ingredients and formulations changed since vaccine rollout

Over the last nine months, 212 million Americans have received at least one dose of the Pfizer-BioNTech, Moderna or Johnson & Johnson COVID-19 vaccines, each of which helps the body recognize and attack the deadly virus.

A recent study published in August in the journal Health Affairs estimates these life-saving shots may have prevented 3 million new infectious cases and almost 140,000 COVID-19-related deaths in the early months of 2021.

But online, claims casting doubt on the vaccines' safety and effectiveness persist; one of the latest asserts the vaccines' ingredients and formulas have changed since their initial national rollout.

"The emergency use authorization allows (vaccine) manufacturers to put in and change the formulas the entire time," says Bryan Ardis, a Tennessee-based chiropractor, in a TikTok video shared to Instagram on Sept. 12. "It's only once the approval process from the FDA steps in that they're not allowed to change it legally anymore."

Ardis claims this has been the case with Pfizer and Moderna's COVID-19 vaccines, both of which he alleges contain ingredients potentially different than the original shots deployed that are unknown to the public.

"One of the reasons people ask why ... is it that I got the shots early on for COVID-19 but I didn’t get sick and why are we seeing all these other issues and I’m telling them, they’re actually changing the (vaccine) lots all the time," he says.

These statements were made during an interview with Rick Rene, host of an online show and podcast that advertises itself as "Empowering Christian Patriots with Truth."

The TikTok video has been viewed over 5,000 times on Instagram. The original Sept. 1 Facebook video, which the TikTok video appears to be clipped from, garnered less than 3,000 views and only 169 interactions, according to CrowdTangle, a social media insights tool.

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While an emergency use authorization, or EUA, merely permits a drug or other treatment to be used during a public health emergency, like the COVID-19 pandemic, it's not a standard full FDA approval.

But that doesn't mean it gives vaccine manufacturers free rein to switch up or adjust their vaccines once released to the public, the regulatory agency and a health expert told USA TODAY. And contrary to Ardis' assertion, there's no evidence any of the three COVID-19 vaccines contain unknown or different ingredients.

USA TODAY reached out to Ardis and Rene for comment.

Alterations require FDA re-approval

Once a COVID-19 vaccine has been granted EUA or is formally licensed and distributed for human use – as with Pfizer's COVID-19 vaccine, Comirnaty – there really is no changing its ingredients or formulation, said Dr. Paul Offit, director of the Vaccine Education Center at the Children's Hospital of Philadelphia and a member of the FDA's COVID-19 vaccine advisory panel.

"Every lot has to be exactly the same as the next lot, exactly the same," he told USA TODAY, explaining this consistency is baked into the vaccine's approval process, which also involves how it's manufactured.

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Any modification or addition to a vaccine needed for whatever reason would require vaccine developers to have their product reassessed by the FDA.

"If a company ever decides to make a change ... they have to essentially get a new license," Offit said.

In an emailed statement, an FDA spokesperson told USA TODAY any major changes made to a vaccine or drug require "the submission of data, based on adequate and well-controlled clinical studies demonstrating safety and effectiveness." The FDA must then approve any such changes.

Same ingredients since initial vaccine rollout

And there's no evidence to suggest the COVID-19 vaccines currently in use in the U.S. have switched up their formulations.

Recent fact sheets containing ingredient lists for Pfizer and Moderna's two-dose vaccine, as well as J&J's single shot, are publicly available on the FDA's website. Aside from exact dosages listed for Pfizer's Comirnaty, USA TODAY found no differences in terms of ingredients between the earliest and most recent fact sheets.

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In emails to USA TODAY, Pfizer spokesperson Keanna Ghazvini and J&J spokesperson Richard Ferreira both confirmed the formulas and ingredients contained in their companies' COVID-19 vaccines have remained unchanged since their EUA issuance. USA TODAY reached out to Moderna for comment.

Our rating: False

Based on our research, we rate FALSE the claim that COVID-19 vaccine ingredients and formulations changed since the vaccine rollout. COVID-19 vaccines cannot be continually changed or modified without FDA approval. There is no evidence that the ingredients and formula of the Pfizer-BioNTech, Moderna or J&J vaccines have changed since their rollout.

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This article originally appeared on USA TODAY: Fact check: No change in COVID-19 vaccines' formulas since rollout