No, regulator did not breach vaccine testing guidelines

What was Claimed

The US medicine regulator breached its own guidelines by failing to test the mRNA COVID-19 vaccine for DNA integration.

Our Verdict

False. The guidelines refer to DNA vaccines, not mRNA vaccines.

One of the US's top health bureaucrats has claimed the country's medicine regulator breached its own guidelines by failing to test mRNA COVID-19 vaccines for DNA integration.

This is false. Experts and the US Food and Drug Administration (FDA) told AAP FactCheck the guidelines relate to DNA vaccines, not mRNA vaccines.

Florida Surgeon General Joseph Ladapo has been campaigning against the use of mRNA COVID-19 vaccines, arguing remaining DNA in the jabs could enter into human cells.

"I am calling for a halt to the use of mRNA COVID-19 vaccines," he said in the January 4 post on his official X account (screenshot here), which has been viewed millions of times and shared to Facebook.

"The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention (CDC) have always played it fast and loose with COVID-19 vaccine safety, but their failure to test for DNA integration with the human genome - as their own guidelines dictate - when the vaccines are known to be contaminated with foreign DNA is intolerable."

Florida Surgeon General Dr Joseph Ladapo's X post.
Vaccine experts say Dr Ladapo's claims are false.

Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA, penned a formal response addressing Dr Ladapo's various claims.

He said the suggestion guidelines were not followed was simply untrue.

"In your letter, you raise questions, citing to the 2007 Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications," he said. "This guidance was developed for DNA vaccines themselves, not for DNA as a contaminant in other vaccines, and is not applicable to the mRNA COVID-19 vaccines."

Kristine Dye, a virologist and molecular/cellular biologist at Florida’s Stetson University, backed up the FDA’s statement.

"Assessing the risk of DNA integration is not a standard part of vaccine approval, as Ladapo claimed, and I do not believe there is any improper procedure here by the FDA," Dr Dye said.

David Gorski, professor of surgery and oncology at Wayne State University and managing editor of the website Science-Based Medicine, told AAP FactCheck there was no merit to Dr Ladapo’s claims "from a scientific viewpoint".

Dr Gorski said he did not believe there was any improper procedure by the FDA. He has previously been critical of Dr Ladapo’s vaccine claims.

As explained by FactCheck.org, the guidelines refer to vaccines in which DNA is the primary ingredient. In mRNA vaccines, DNA is only present in residual amounts, left over from the manufacturing process.

The vaccines are made by using mRNA to create a spike protein that triggers an immune response.

"In order to make the mRNA that is contained in the vaccine, you must start with DNA," Dr Dye said.

During the manufacturing process, the DNA is refined.

Used vials of COVID vaccines (file image)
Florida's top health official is campaigning against vaccines.

"This process does a fantastic job of removing the DNA,” Dr Dye said, noting only trace amounts of DNA would be left and, as multiple health authorities including Australia's Department of Health have noted, the mRNA never enters the nucleus.

Dr Dye said the body also had systems to protect itself against foreign DNA, which were around us every day in the air and food, for example.

"All this DNA that you are constantly exposed to does not integrate into our DNA, so why would this trace, nonsense, residual DNA integrate, but not all the others?"

AAP FactCheck contacted the Florida Department of Health and Dr Ladapo’s office, but did not receive a reply.

As surgeon general, Dr Ladapo is the top health official for the state of Florida.

He is an appointee of Florida Governor Ron DeSantis, whose unsuccessful campaign to be the Republican's presidential nominee was criticised for misleading information on COVID vaccines.

Dr Ladapo has also been criticised for his comments on vaccines.

Work in a vaccine lab (file image)
The FDA says proper procedures were followed during vaccine manufacture.

An FDA spokeswoman told AAP FactCheck Ladapo's claims about DNA integration are "untrue" and "deceptive".

“With over a billion doses of the mRNA vaccines administered and following very careful review of all the available scientific evidence, the FDA has not identified safety concerns related to the sequence of, or amount of, residual DNA," the representative said.

"Perpetuating references to information about residual DNA in COVID-19 vaccines without placing it within the context of the manufacturing process and the known benefits of the vaccine is misleading."

AAP FactCheck has previously debunked claims of the dangers of DNA integration in mRNA vaccines.

The Verdict

The claim the US medicine regulator breached its own guidelines by failing to test the mRNA COVID-19 vaccine for DNA integration is false.

The regulator and experts told AAP FactCheck all proper procedures were followed during the testing process.

Notably, the test in question is for DNA vaccines, not vaccines that may contain residual DNA as a contaminant.

False. The claim is inaccurate.

AAP FactCheck is an accredited member of the International Fact-Checking Network. To keep up with our latest fact checks, follow us on Facebook, Twitter and Instagram.

What is AAPNews?

For the first time, Australian Associated Press is delivering news straight to the consumer.

No ads. No spin. News straight-up.

Not only do you get to enjoy high-quality news delivered straight to your desktop or device, you do so in the knowledge you are supporting media diversity in Australia.

AAP Is Australia’s only independent newswire service, free from political and commercial influence, producing fact-based public interest journalism across a range of topics including politics, courts, sport, finance and entertainment.

What is AAPNews?
The Morning Wire

Wake up to AAPNews’ morning news bulletin delivered straight to your inbox or mobile device, bringing you up to speed with all that has happened overnight at home and abroad, as well as setting you up what the day has in store.

AAPNews Morning Wire
AAPNews Breaking News
Breaking News

Be the first to know when major breaking news happens.


Notifications will be sent to your device whenever a big story breaks, ensuring you are never in the dark when the talking points happen.

Focused Content

Enjoy the best of AAP’s specialised Topics in Focus. AAP has reporters dedicated to bringing you hard news and feature content across a range of specialised topics including Environment, Agriculture, Future Economies, Arts and Refugee Issues.

AAPNews Focussed Content
Subscription Plans

Choose the plan that best fits your needs. AAPNews offers two basic subscriptions, all billed monthly.

Once you sign up, you will have seven days to test out the service before being billed.

AAPNews Full Access Plan
Full Access
AU$10
  • Enjoy all that AAPNews has to offer
  • Access to breaking news notifications and bulletins
  • Includes access to all AAPNews’ specialised topics
Join Now
AAPNews Student Access Plan
Student Access
AU$5
  • Gain access via a verified student email account
  • Enjoy all the benefits of the ‘Full Access’ plan at a reduced rate
  • Subscription renews each month
Join Now
AAPNews Annual Access Plan
Annual Access
AU$99
  • All the benefits of the 'Full Access' subscription at a discounted rate
  • Subscription automatically renews after 12 months
Join Now

AAPNews also offers enterprise deals for businesses so you can provide an AAPNews account for your team, organisation or customers. Click here to contact AAP to sign-up your business today.

SEVEN DAYS FREE
Download the app
Download AAPNews on the App StoreDownload AAPNews on the Google Play Store