Posts Spread False Claim About Moderna Patent Application

SciCheck Digest

The mRNA COVID-19 vaccines — like many other vaccines — can contain small amounts of DNA left over from the manufacturing process. There’s no evidence this residual DNA causes “turbo cancer,” or very aggressive cancer. Nor did Moderna admit that “mRNA Jabs Cause Turbo-Cancer,” contrary to an online article that misconstrues a line from a patent application.

More than half a billion doses of COVID-19 vaccines have now been administered in the U.S. and only a few, very rare, safety concerns have emerged. The vast majority of people experience only minor, temporary side effects such as pain at the injection site, fatigue, headache, or muscle pain — or no side effects at all. As the Centers for Disease Control and Prevention has said, these vaccines “have undergone and will continue to undergo the most intensive safety monitoring in U.S. history.”

A small number of severe allergic reactions known as anaphylaxis, which are expected with any vaccine, have occurred with the authorized and approved COVID-19 vaccines. Fortunately, these reactions are rare, typically occur within minutes of inoculation and can be treated. Approximately 5 per million people vaccinated have experienced anaphylaxis after a COVID-19 vaccine, according to the CDC.

To make sure serious allergic reactions can be identified and treated, all people receiving a vaccine should be observed for 15 minutes after getting a shot, and anyone who has experienced anaphylaxis or had any kind of immediate allergic reaction to any vaccine or injection in the past should be monitored for a half hour. People who have had a serious allergic reaction to a previous dose or one of the vaccine ingredients should not be immunized. Also, those who shouldn’t receive one type of COVID-19 vaccine should be monitored for 30 minutes after receiving a different type of vaccine.

There is evidence that the Pfizer/BioNTech and Moderna mRNA vaccines may rarely cause inflammation of the heart muscle (myocarditis) or of the surrounding lining (pericarditis), particularly in male adolescents and young adults.

Based on data collected through August 2021, the reporting rates of either condition in the U.S. are highest in males 16 to 17 years old after the second dose (105.9 cases per million doses of the Pfizer/BioNTech vaccine), followed by 12- to 15-year-old males (70.7 cases per million). The rate for 18- to 24-year-old males was 52.4 cases and 56.3 cases per million doses of Pfizer/BioNTech and Moderna vaccines, respectively.

Health officials have emphasized that vaccine-related myocarditis and pericarditis cases are rare and the benefits of vaccination still outweigh the risks. Early evidence suggests these myocarditis cases are less severe than typical ones. The CDC has also noted that most patients who were treated “responded well to medicine and rest and felt better quickly.”

The Johnson & Johnson vaccine has been linked to an increased risk of rare blood clots combined with low levels of blood platelets, especially in women ages 30 to 49. Early symptoms of the condition, which is known as thrombosis with thrombocytopenia syndrome, or TTS, can appear as late as three weeks after vaccination and include severe or persistent headaches or blurred vision, leg swelling, and easy bruising or tiny blood spots under the skin outside of the injection site.

According to the CDC, TTS has occurred in around 4 people per million doses administered. As of early April, the syndrome has been confirmed in 60 cases, including nine deaths, after more than 18.6 million doses of the J&J vaccine. Although TTS remains rare, because of the availability of mRNA vaccines, which are not associated with this serious side effect, the FDA on May 5 limited authorized use of the J&J vaccine to adults who either couldn’t get one of the other authorized or approved COVID-19 vaccines because of medical or access reasons, or only wanted a J&J vaccine for protection against the disease. Several months earlier, on Dec. 16, 2021, the CDC had recommended the Pfizer/BioNTech and Moderna shots over J&J’s.

The J&J vaccine has also been linked to an increased risk of Guillain-Barré Syndrome, a rare disorder in which the immune system attacks nerve cells. Most people who develop GBS fully recover, although some have permanent nerve damage and the condition can be fatal.

Safety surveillance data suggest that compared with the mRNA vaccines, which have not been linked to GBS, the J&J vaccine is associated with 15.5 additional GBS cases per million doses of vaccine in the three weeks following vaccination. Most reported cases following J&J vaccination have occurred in men 50 years old and older.

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Vaccines can contain trace amounts of materials left over from their manufacturing process. One of these materials is DNA, which can remain in both mRNA vaccines and a variety of older vaccines. This DNA is expected and considered safe, and there are purification and quality control steps meant to ensure it is present within regulatory limits.

We have covered unsubstantiated claims that residual DNA in mRNA COVID-19 vaccines is considered “adulteration” or integrates into people’s DNA and causes cancer. Representatives from regulatory agencies and various academic experts told us there isn’t reason to believe the small amounts of residual DNA in the mRNA vaccines would integrate into a person’s cellular DNA and cause cancer. And legal experts told us that the residual DNA would not be considered adulteration.

(For more about residual DNA in mRNA vaccines, read our article “COVID-19 Vaccines Have Not Been Shown to Alter DNA, Cause Cancer.”)

In a twist on these claims, recent social media posts shared a headline falsely stating that “Moderna Admits mRNA Jabs Cause Turbo-Cancer” and referencing the residual DNA found in vaccine vials. The headline is from an article published by the People’s Voice, a website with a history of spreading misinformation and publishing false headlines.

As we also have written previously, there isn’t reason to believe the mRNA vaccines cause very aggressive cancer, or “turbo cancer.”

The new false claim, that Moderna has admitted the mRNA vaccines cause turbo cancer, stems from misleading statements made by Dr. Robert Malone, who has spread COVID-19 misinformation in the past. Malone made his remarks during a Nov. 13 event held and livestreamed by Rep. Marjorie Taylor Greene.

Malone referred to a short section in a Moderna patent application, published in 2019. The patent application is related to RNA vaccines, but the comments Malone highlighted are about DNA vaccines, which remain experimental in the U.S.

In its description of DNA vaccines, the Moderna patent application mentioned some theoretical cancer-related concerns as an example of a drawback of the technology: “With this technique, however, comes potential problems, including the possibility of insertional mutagenesis, which could lead to the activation of oncogenes or the inhibition of tumor suppressor genes.”

Insertional mutagenesis is a phenomenon in which foreign DNA integrates into a genome, causing changes. The concern the patent application references is that the DNA could integrate in precisely the wrong place in a cell’s DNA and turn on a gene that could contribute to cancer or turn off a gene that helps protect cells from becoming cancerous.

“FDA says they’re not aware of any concerns, but Moderna in its own patent lays out exactly the same concerns that exist about DNA and insertional mutagenesis and genotoxicity,” Malone said.

But the concerns mentioned in the patent application were about vaccines using DNA as their main ingredient, not residual DNA left over in other types of vaccines. DNA vaccines rely on getting DNA into the nucleus of a cell, where it is transcribed into mRNA, which is used to make protein. The messenger RNA, or mRNA, vaccines work by introducing mRNA into the body of a cell, where it serves as instructions for making protein.

With residual DNA, scientists from the U.S. Food and Drug Administration have written that they consider the primary cancer-related concern to be the introduction of DNA encoding an activated cancer-causing gene. There is no residual DNA encoding cancer-causing genes in the mRNA COVID-19 vaccines.

The patent application also makes clear that even for DNA vaccines, the concern is theoretical. What the line quoted from the patent application does not spell out is that this “potential” concern has not been demonstrated to be a real safety problem, even for DNA vaccines.

In a 2020 review paper on mRNA vaccines, FDA scientists nodded to the theoretical concerns about insertional mutagenesis from DNA vaccines, while making clear they did not consider this risk to have been borne out.

In listing advantages of mRNA vaccines over DNA vaccines, they referred to the absence of the “perceived” risk of DNA integrating into a person’s own DNA. They went on to explain that this was a concern with DNA vaccines in the past, but experiments have shown that the rate of integration was low, “thus lessening the concern for integration.”

In a response sent to us for our prior article on residual DNA in the mRNA COVID-19 vaccines, an FDA spokesperson did in fact make reference to past concerns about DNA integration and cancer, while expressing confidence in the mRNA vaccines.

The FDA email said that “with regard to the mRNA vaccines, while concerns have been raised previously as theoretical issues, available scientific evidence supports the conclusion that the minute amounts of residual DNA do not cause cancer or changes to a person’s genetic code.”

Editor’s note: SciCheck’s articles providing accurate health information and correcting health misinformation are made possible by a grant from the Robert Wood Johnson Foundation. The foundation has no control over FactCheck.org’s editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation.

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