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SciCheck Digest

Federal officials authorized two mRNA vaccines for COVID-19 after they were determined to be safe and effective against symptomatic illness in clinical trials. But a Texas doctor, in a widely shared video, falsely claims the vaccines don’t provide protection and that they’re actually “experimental gene therapy.”




Full Story

In a video shared widely on social media, a Texas doctor known for his political activism — and whose vitamin sales prompted a warning by federal officials — is peddling a host of false claims to try to discourage people from getting vaccinated against COVID-19.

Dr. Steven Hotze implores viewers to “just say no” to the vaccines, after a long, error-filled pitch that baselessly alleges that the mRNA vaccines aren’t actually vaccines at all. 

As we’ve explained in previous SciCheck stories, two vaccines currently approved in the U.S., from Pfizer/BioNTech and Moderna, are designed using modified messenger RNA. The mRNA provides instructions for cells to make spike proteins that then trigger an immune response against the spike protein of the SARS-CoV-2 virus, which causes COVID-19. (See “A Guide to Pfizer/BioNTech’s COVID-19 Vaccine” and “A Guide to Moderna’s COVID-19 Vaccine.”) 

Hotze is a conservative activist who unsuccessfully challenged COVID-19 public health measures in Texas last year and who made unproven allegations about voter fraud ahead of the 2020 election. In December, the Food and Drug Administration and Federal Trade Commission sent Hotze a letter warning him to stop selling his line of vitamins by using misleading suggestions that they could treat or prevent COVID-19.

His video focusing on mRNA vaccines was published on his website Feb. 26. The link to that post has been shared more than 10,000 times on Facebook, according to CrowdTangle analytics data. The video has also been viewed tens of thousands of times across various posts on Facebook and Instagram.

We reached out to Hotze about some of his claims in the video and didn’t hear back. We’ll break down a few of his assertions here.

False Claims About Vaccine Efficacy, Definition

Hotze tells his viewers: “If you are immune to a disease, you can be exposed to it without becoming infected. The so-called COVID-19 vaccine does not provide any individual who receives the vaccine with immunity to COVID-19, nor does it prevent the spread of the disease. It does not meet the CDC’s own definition of a vaccine. That’s why it’s a deceptive trade practice under 15 US Code Section 41 of the Federal Trade Commission for pharmaceutical companies who are producing this experimental gene therapy to claim that it’s a vaccine.”

The vaccines have demonstrated in clinical trials to be highly effective in preventing symptomatic COVID-19 disease, as we’ve detailed. The Pfizer and Moderna trials enrolled more than 30,000 people each and found an efficacy in preventing symptomatic disease of at least 94% after the second dose. So his claim that the vaccines don’t “provide any individual who receives the vaccine with immunity to COVID-19″ is wrong.

As we’ve explained before, it’s currently unclear how much the vaccines will limit transmission of the virus, SARS-CoV-2. In other words, while the vaccines were shown to prevent someone from developing symptoms of COVID-19, they may not prevent a person from carrying the virus. But there’s a good chance they will help curb transmission to some degree: Experts say with other vaccines, a vaccinated person, even if infected with the virus, often sheds less virus, therefore making them less contagious.

Hotze’s remark that mRNA vaccines don’t “meet the CDC’s own definition of a vaccine” also holds no weight.

He points out that the Centers for Disease Control and Prevention website defines a vaccine as a “product that stimulates a person’s immune system to produce immunity to a specific disease, protecting the person from that disease.” That’s correct. But that definition is also consistent with the FDA’s decision to issue emergency use authorizations for the Moderna and Pfizer/BioNTech vaccines because of their demonstrated efficacy in trials.

“Clearly, Moderna and Pfizer’s vaccines are ‘product[s] that stimulate a person’s immune system to produce immunity to a specific disease,’ i.e., COVID-19, and they have a protective effect,” Jacob Sherkow, a University of Illinois law professor whose research focuses in part on the legal implications of advanced biotechnologies, told us in an email. Sherkow noted that it’s not entirely clear what the legal effects of the CDC’s website definition are, since “[i]t’s not a formal administrative rule or even a guidance … it’s just a generic definition of a vaccine.”

Hotze’s argument that the mRNA vaccines are a “deceptive trade practice” also doesn’t make sense. While he cites “15 US Code Section 41 of the Federal Trade Commission,” it appears he’s referring to 15 U.S. Code § 45 — since section 41 just deals with the establishment of the FTC.

“The only thing § 45 of the FTC Act does, here, is give FTC authority to police ‘deceptive acts or practices in or affecting commerce,’” Sherkow said. “It doesn’t define what a deceptive act is.”

Sherkow said the definition of a “deceptive practice” rests on many years’ worth of case law: “In general, those arise when three conditions are met: there is a representation or omission that misleads a consumer; the consumer’s interpretation is ‘reasonable’; and the misrepresentation is ‘material,’ i.e., the consumer purchased the product because of the representation.”

“None of those are present here,” he added. “There is no misrepresentation about the nature of these vaccines — indeed, there’s an ocean of information about exactly what they are and how they work.”

Erroneous ‘Gene Therapy’ Assertion

Again referencing the Moderna and Pfizer/BioNTech vaccines, Hotze falsely claims: “These so-called vaccines, which are manufactured using cells derived from human babies that were aborted in the 1970s, should more accurately be called experimental gene therapy. They are untested, unproven experimental gene therapy that poses a much greater danger and risk to your health than the COVID-19.”

We’ll first address his false assertion that the vaccines are an “experimental gene therapy” — an allegation he makes repeatedly throughout his video.

The FDA’s website defines gene therapy as a “technique that modifies a person’s genes to treat or cure disease.”

Sherkow, who has written about gene therapy, said the mRNA vaccines don’t qualify as such.

“The mRNA vaccines do not modify a person’s genes, i.e., their genome,” he said. “They’re transcripts of the virus’s Spike gene that get translated into protein and expressed in cells; the mRNA degrades afterwards. The genome remains unchanged.”

Likewise, the co-directors of the Texas Children’s Hospital Center for Vaccine Development recently explained why the “gene therapy” claims are inaccurate, in a piece addressing vaccine myths for the Washington Post.

“[T]he mRNA delivered through lipid nanoparticles in a vaccine does not enter our genome. It becomes a template for cells to make compounds of amino acids on molecules called ribosomes in the cytoplasm compartment of the cell, outside the nucleus (where the DNA resides),” Dr. Peter Hotez and Maria Elena Bottazzi wrote. “Our immune system then responds to the new peptide, which resembles the spike protein on the coronavirus. Therefore, it’s not correct to say that the mRNA vaccines are equivalent to ‘gene therapy,’ as some critics of the vaccines have claimed.”

And Hotze’s claim that the mRNA vaccines are “manufactured using cells derived from human babies that were aborted in the 1970s” is wrong, too.

As we’ve explained before, fetal cells obtained from two aborted pregnancies in the early 1960s, one in Sweden and one in England, were made into cell lines that are used to grow virus to make some vaccines — such as varicella (chickenpox), rubella and hepatitis A. But those cells aren’t present in the vaccines themselves, since the virus is purified before it goes into a syringe.

The mRNA vaccines from Pfizer/BioNTech and Moderna, however, aren’t made from a virus and are not manufactured using those fetal cell lines, as Hotze claims. That said, one of the cell lines was used to test those two mRNA vaccines to ensure they worked.

A third vaccine approved in the U.S. — a single-dose vaccine from Johnson & Johnson that does not use the mRNA platform — is made by using an adenovirus that is produced using a retinal cell line that was first obtained from a fetus in 1985, according to the Vaccine Education Center at the Children’s Hospital of Philadelphia. Like other vaccines manufactured using the cell lines, fetal cells are not actually present in the J&J COVID-19 vaccine.

Distortion Behind Claim of Danger

Hotze distorts the facts in attempting to claim that the mRNA vaccines are dangerous.

He claims that the vaccines will cause your immune system to “be hyper-charged because it’s having to fight off all these viral proteins that your own body is making all the time, and it will overreact when exposed to any type of coronavirus in the future.” He goes on to say that, in previous studies dealing with coronaviruses, “the animals died from an immune system hyper reaction, when they were later exposed to the coronavirus against which they had been previously vaccinated.”

There is no evidence that the COVID-19 mRNA vaccines result in such an immune response.

Hotze’s website post of the video references a commentary article from October, before any COVID-19 vaccine was authorized by the FDA, in which two researchers warned about the possibility that COVID-19 vaccine candidates could cause antibody-dependent enhancement of disease, or ADE. ADE is a phenomenon that occurs when a previous infection or vaccination generates antibodies that don’t neutralize the virus but instead enhance the virus’ ability to infect cells, which can lead to a worse illness instead of preventing it.

But the animal studies cited in the commentary piece didn’t deal with mRNA vaccines, as Hotze suggests. One 2012 study that’s referenced found that vaccine candidates for SARS-CoV (the coronavirus behind the SARS outbreak of 2003) caused mice to develop eosinophilia — a high count of a type of white blood cells — when exposed to the live virus. The animals didn’t die, as our fact-checking colleagues at Reuters have explained.

Dr. Anna Durbin, a professor of international health at Johns Hopkins University who researches vaccines at the Center for Immunization Research, told us in an email that the issue of ADE in relation to SARS-CoV vaccine candidates dealt with inactivated vaccines — not mRNA vaccines. She said the specific immune response issue observed with those vaccine candidates has not been observed with any of the COVID-19 vaccines being used in the U.S.

“We have not seen any cases of enhanced SARS-CoV-2 disease, either in animal models or in vaccinated humans,” she added.

Other experts also have explained that there is no evidence indicating ADE is an issue with the COVID-19 vaccines.

Derek Lowe, a medicinal chemist, explored the issue in February on his blog on the website of the journal Science Translational Medicine and explained that animal studies are specifically designed to look for signs of ADE. He said the research into SARS-CoV vaccines provided helpful lessons for developing SARS-CoV-2 vaccines. (A vaccine for SARS was never approved, as the outbreak ended and there are no known human cases of the disease.)

“So here’s the short version: no sign of ADE during the preclinical animal studies. No sign during the human clinical trials. No sign during the initial vaccine rollouts into the population,” he concluded. “And (so far) no sign of ADE even with the variant strains in different parts of the world. We have things to worry about in this pandemic, but as far as I can tell today, antibody-dependent enhancement does not seem to be one of them.”

Editor’s note: FactCheck.org does not accept advertising. We rely on grants and individual donations from people like you. Please consider a donation. Credit card donations may be made through our “Donate” page. If you prefer to give by check, send to: FactCheck.org, Annenberg Public Policy Center, 202 S. 36th St., Philadelphia, PA 19104. 

Sources

15 U.S. Code § 45 – Unfair methods of competition unlawful; prevention by Commission. Legal Information Institute, Cornell Law School. Accessed 18 May 2021.

Antibody-dependent Enhancement (ADE) and Vaccines.” Children’s Hospital of Philadelphia. 5 Jan 2021.

Cardozo, Timothy and Ronald Veazey. “Informed consent disclosure to vaccine trial subjects of risk of COVID‐19 vaccines worsening clinical disease.” International Journal of Clinical Practice. 28 Oct 2020.

Do COVID-19 Vaccines Cause Antibody-dependent Enhancement (ADE)?” Children’s Hospital of Philadelphia. YouTube. 10 Feb 2021.

Durbin, Anna. Professor of international health, Johns Hopkins University. Email to FactCheck.org. 23 Mar 2021.

Fact check: A 2012 study did not use mRNA vaccines or result in animals dying from disease.” Reuters. 2 Feb 2021.

Garrett, Robert T. “Texas Supreme Court lets coronavirus orders stand, despite outcry by conservatives.” Dallas Morning News. 31 Jul 2020.

Hotez, Peter and Maria Elena Bottazzi. “Five myths about coronavirus vaccines.” Washington Post. 19 Mar 2021.

Immunization: The Basics.” Centers for Disease Control and Prevention. Updated 16 May 2018.

Lowe, Derek. “Antibody-Dependent Enhancement and the Coronavirus Vaccines.” In The Pipeline. Science Translational Medicine. 12 Feb 2021.

McDonald, Jessica and Catalina Jaramillo. “Viral Video Makes False and Unsupported Claims About Vaccines.” FactCheck.org. 22 Jan 2021.

McDonald, Jessica. “A Guide to Pfizer/BioNTech’s COVID-19 Vaccine. FactCheck.org. Updated 3 Mar 2021.

McDonald, Jessica. “A Guide to Moderna’s COVID-19 Vaccine.” FactCheck.org. Updated 3 Mar 2021.

News & Views: Getting Familiar with COVID-19 Adenovirus-replication-deficient Vaccines.” Children’s Hospital of Philadelphia. 15 Feb 2021.

Sherkow, Jacob. Law professor, University of Illinois. Email to FactCheck.org. 18 Mar 2021.

Understanding mRNA COVID-19 Vaccines.” Centers for Disease Control and Prevention. Updated 4 Mar 2021.

Vaccine Ingredients – Fetal Cells.” Vaccine Education Center, Children’s Hospital of Philadelphia. Accessed 19 Mar 2021.

Warning Letter | Health & Wellness Center International One, L.L.C. dba Hotze Vitamins.” Food and Drug Administration. 2 Dec 2020.

What is Gene Therapy?” Food and Drug Administration. 25 Jul 2018.



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