FDA approval is required for COVID-19 vaccine manufacturers to change ingredients in shots

If you thought false claims about COVID-19 vaccines and emergency use authorizations would be over by 2023, think again.

Posts are swirling online saying that the vaccine manufacturers can change a healthy portion of the ingredients without government approval because they are operating under emergency use. 

But this isn’t a real thing.

The problematic claim stems from a video shared by Rochelle "Silk" Richardson.

Richardson and her late sister Lynette "Diamond" Hardaway rose to fame for supporting former President Donald Trump on their "Diamond and Silk" internet show. They also downplayed the pandemic and cast doubt on the effectiveness of COVID-19 vaccines. 

In the video, Richardson speaks with Dr. Sherri Tenpenny, an Ohio-based osteopathic physician who wrote a book called "Saying No to Vaccines." Tenpenny has repeatedly spread COVID-19 vaccine misinformation, including false claims that the shots can cause death and autoimmune disease and disrupt pregnancies.

"And because this is still manufactured under the EUA, under the emergency use, they can change up to 49% of the ingredients of any individual lot-run of those shots, and not have to tell the FDA," Tenpenny says in the Feb. 7 clip.

A screenshot of the video appeared in an Feb. 20 Instagram post, along with text repeating Tenpenny’s claim: "Because the Covid shots are still manufactured under the Emergency Use Authorization, they can change up to 49% of the ingredients without FDA approval."

The Instagram post was flagged as part of Instagram’s efforts to combat false news and misinformation on its News Feed. (Read more about our partnership with Meta, which owns Facebook and Instagram.)

This is wrong. It misrepresents the vaccines’ status, the regulation process and the rules.

The mRNA COVID-19 vaccines aren’t under an emergency use authorization for adults. Both the Pfizer/BioNTech and Moderna vaccines have received full approval by the U.S. Food and Drug Administration. (Pfizer’s is approved for people age 16 and older and Moderna’s is approved for people age 18 and older.) 

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Both are still under an emergency use authorization for younger teens and children, and for the third dose for immunocompromised people. 

Johnson & Johnson’s COVID-19 vaccine is available under emergency use authorization for people age 18 and older "for whom other FDA-authorized or approved COVID-19 vaccines are not accessible or clinically appropriate," the FDA says on its website. The agency has restricted the use of the Johnson & Johnson’s shot because of the threat of rare but serious blood clots.

An emergency use authorization allows drugs or other treatments to be used in a public health emergency when there are no adequate, approved, and available alternatives. This status doesn’t allow manufacturers to alter the vaccines without the FDA’s approval. 

Companies generally can’t change the ingredients or formulation, because every detail is tied to the approval process, said Dr. Paul Offit, a member of the advisory committee to the FDA on COVID-19 vaccines and director of the Vaccine Education Center at Children’s Hospital of Philadelphia. 

"When you license a vaccine you don't just license the product, you also license the process by which the product is made," Offit said. "The company provides detailed instructions for every manufacturing process, which is lengthy. Any change that’s made would have to be monitored and approved. It’s really inhibiting, frankly, because the process is so strict."

PolitiFact reached out to the FDA but did not get a response.

USA Today fact-checked a similar claim in 2021 made by a chiropractor who said the emergency use authorization allows manufacturers to "change the formulas the entire time."

An FDA spokesperson told USA Today that any major changes to a vaccine or drug would require "the submission of data, based on adequate and well-controlled clinical studies demonstrating safety and effectiveness," and that the FDA would have to approve any changes.

An Instagram post claimed, "because the Covid shots are still manufactured under the emergency use authorization, they can change up to 49% of the ingredients without FDA approval."

Manufacturers cannot alter the vaccines’ ingredients without approval, regardless of their status. The FDA has said that any changes to a vaccine would require manufacturers to submit data and have their products reassessed. 

The post also ignores that Moderna and Pfizer-BioNTech’s COVID-19 vaccines are no longer under emergency use authorization for adults.

We rate this claim False.