Manufacturers need FDA’s approval to alter COVID-19 vaccines
CLAIM: Up to 49% of the ingredients in COVID-19 vaccines can be changed without the approval of the Federal Drug Administration because they are still manufactured under emergency use authorization.
AP’S ASSESSMENT: False. As part of the emergency use authorization process for vaccines, the FDA stipulates in letters to manufacturers that “no changes will be implemented to the description of the product, manufacturing process, facilities, or equipment without notification to and concurrence by FDA.” Regardless, the first two doses of the Pfizer and Moderna vaccines are FDA approved for adults and some children, and are no longer under emergency use authorizations.
THE FACTS: Erroneous claims about the FDA’s approval process for COVID-19 vaccines are spreading on social media following comments made by an anti-vaccine doctor on an online show featuring conservative commentary.
During an early February episode of “Chit Chat Live,” hosted by political commentator Rochelle “Silk” Richardson, Dr. Sherri Tenpenny stated that emergency use authorizations let drug manufacturers change up to half of the ingredients in COVID-19 vaccines without approval.
“Because this is still manufactured under the EUA, under the emergency use, they can change up to 49% of the ingredients in any individual lot run of those shots and not have to tell the FDA,” the Ohio-based osteopathic physician said.
Social media posts sharing Tenpenny’s claim have received thousands of likes and shares. Neither Richardson nor Tenpenny immediately responded to emails from The Associated Press.
An emergency use authorization, or EUA, allows for the use of unapproved medical products, or unapproved uses of approved medical products, during public health crises. The first two doses of Pfizer and Moderna’s COVID-19 vaccines are no longer under EUAs for certain age groups, having been approved by the FDA. For Pfizer, that applies to individuals 12 and older and for Moderna, individuals 18 and older. EUAs still apply to COVID-19 vaccines produced by Johnson & Johnson and Novavax.
But even if a vaccine is available only under an EUA, manufacturers must receive FDA approval before making changes to the product.
“The information circulating on social media that asserts manufacturers of COVID-19 vaccines can change up to 49% of the ingredients in their products without FDA approval is completely false,” FDA spokesperson Abby Capobianco wrote in an email to The Associated Press. “No changes can be made to COVID-19 vaccines used under Emergency Use Authorization (EUA) without prior evaluation and authorization from FDA.”
As stipulated in the U.S. Code’s Federal Food, Drug, and Cosmetic Act, EUAs come with certain conditions. Vaccine manufacturers, for example, are issued a letter of authorization upon receiving an EUA that details the process for making changes to their product — in this case, the COVID-19 vaccines. It states: “No changes will be implemented to the description of the product, manufacturing process, facilities, or equipment without notification to and concurrence by the FDA.”
Letters containing this language that were issued to Pfizer, Moderna, Johnson & Johnson and Novavax for their COVID-19 vaccines are publicly available on the FDA’s website.
Aaron Lottes, an associate professor of engineering practice at Purdue University who researches regulatory science, confirmed that these requirements mean that the COVID-19 vaccines, even those available under an EUA, cannot be adjusted at will.
“I do not agree with the claim that up to 49% of the ingredients can be changed without FDA approval,” he wrote in an email.
This is part of AP’s effort to address widely shared misinformation, including work with outside companies and organizations to add factual context to misleading content that is circulating online. Learn more about fact-checking at AP.