Website Peddles Old, Debunked Falsehood About COVID-19 mRNA Vaccines

SciCheck Digest

An executive at the German pharmaceutical company Bayer referred to mRNA vaccines used against COVID-19 as an example of innovation in biotech at the World Health Summit 2021. But a website post takes the executive’s words out of context to falsely claim he said the vaccines are gene therapy.

How safe are the vaccines?

How safe are the vaccines?

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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More than 200 million people in the U.S. have been vaccinated against COVID-19 using messenger RNA vaccines, or mRNA, according to the Centers for Disease Control and Prevention, which has explained that the vaccines cannot alter a person’s DNA.

The mRNA vaccines work by instructing the recipient’s cells on how to make spike proteins, prompting the body to generate an immune response that protects against the virus that causes COVID-19. The messenger RNA — the “m” in mRNA stands for messenger — cannot enter the nucleus of a cell, where DNA is located, and it doesn’t have the enzymes that would let it communicate with or integrate into DNA, Dr. Paul Offit, a vaccine expert at the Children’s Hospital of Philadelphia, explained in a video posted shortly after the vaccines became available.

“It is not possible for messenger RNA to alter DNA,” he said. “The chance of that happening is not small, it’s zero.”

Health departments in several other countries — including the U.K., Canada and Australia — have also explained that mRNA vaccines do not change a person’s DNA. We’ve also written about the false claim that the vaccines are “gene therapy” that can change DNA, as have many others.

But the falsehood persists.

A website called Valuetainment recently posted a version of the false claim that had originally made the rounds months ago, even though fact-checkers had already addressed the claim when it first emerged.

Valuetainment is run by Patrick Bet-David, a businessman who purchased a $4.4 million Florida office in January that houses the website business. Bet-David has discouraged the use of vaccines before. In an appearance on Joe Rogan’s show, he said that he wasn’t going to get a COVID-19 shot, but had received at least 11 vaccines when he was in the Army. “I’ve had plenty of vaccine in myself,” he said, “probably why I’m a little bit off.”

On June 20, Valuetainment posted a story with a headline that said, “mRNA Vaccine Exposed! Bayer Admits COVID-19 Vaccine is Gene Therapy.”

It was based on an Oct. 24 video of Stefan Oelrich, an executive at the German pharmaceutical company Bayer, giving a speech at the World Health Summit 2021.

Toward the end of his talk, Oelrich spoke about public acceptance of health care innovations.

Oelrich, Oct. 24, 2021: We’ve heard a lot about innovation tonight — health for all — it’s certainly imbedding innovation into all facets of the life sciences ecosystem, making use of the current momentum to tackle issues beyond COVID-19. We’ve seen the vaccines as the perfect example during this crisis, but innovations in the field of biotech also radically upend our view on many other diseases, especially [non-communicable diseases]. We can now think of curing many of those disease[s], not just treating symptoms as we think forward. Innovation, and we tend to forget — especially in the rich countries — is also sustainability at a totally different level because those that take the leap to drive innovation in a really meaningful way and invest — and take the risk to invest in [research and development] — will also attain sustainability by creating job security and creating prosperity for those that take the investment. I think this is really important also for these latitudes here.

For us, therefore, we’re really taking that leap — us as company, Bayer, in cell and gene therapy, which to me is one of these examples where really we’re going to make a difference, hopefully, moving forward. Ultimately the mRNA vaccines are an example for that — cell and gene therapy — I always like to say that if we had surveyed two years ago in the public, “would you be willing to take a gene or cell therapy and inject it into your body” — we would have had probably a 95% refusal rate. I think this pandemic has also opened many people’s eyes to innovation in a way that was maybe not possible before.

Valuetainment focused only on the part in bold, and it quoted Oelrich as saying, “Ultimately the mRNA vaccines are an example for that selling gene therapy.” The audio and the context indicate that he said “cell and,” rather than “selling.”

In the context of his speech — which emphasized the value of ingenuity in health care and praised the public’s growing acceptance of new treatments and preventions — it appears he was using the vaccines as an example of new technology that could pave the way for other developments, like the cell and gene therapies that Bayer is working on.

We didn’t hear back from Bayer when we sought clarification on Oelrich’s speech. But the Italian news outlet Open wrote about the claim in November and printed a response from the company that translates into English as this: “It was an obvious slip of the tongue. According to Bayer, mRNA is not a gene therapy in the sense of general understanding.”

The company also has a page on its website explaining how COVID-19 vaccines work and it includes a section debunking the myth that mRNA vaccines can somehow alter DNA.

So, the claim circulating now is just a retread of an already debunked falsehood about the vaccines, which have proven to be both safe and effective.