Vaccine Ingredient SM-102 Is Safe

SciCheck Digest

The COVID-19 vaccine from Moderna uses an ingredient called SM-102 to deliver the mRNA that carries instructions for how to develop antibodies against the novel coronavirus. A widely shared video is now spreading the falsehood that SM-102 is harmful, but the warning label it shows is for chloroform, not SM-102.

How do we know vaccines are safe?

No vaccine or medical product is 100% safe, but large randomized controlled trials, involving tens of thousands of people and reviewed by multiple groups of experts, revealed no serious safety concerns and showed that the benefits outweigh the risks. 

As with any vaccine, safety is also being monitored as the shots are rolled out to members of the public to ensure there are no side effects of concern. A very small number of severe allergic reactions, for example — which are expected with any vaccine — have occurred with some of the authorized COVID-19 vaccines. The CDC said the reaction – anaphylaxis – occurred in 2 to 5 people per million vaccinated. This reaction “almost always occurs” within a half hour of receiving a shot, and vaccination providers have medicine to immediately treat it, the CDC said.

Also, after investigating 15 cases of a rare clotting condition out of nearly 8 million Johnson & Johnson vaccinations, the CDC and Food and Drug Administration are warning of a suggested increased risk of the conditions, which occurred in women and resulted in three deaths as of April 21. The CDC said “women younger than 50 years old especially should be aware of the rare risk of blood clots with low platelets after vaccination, and that other COVID-19 vaccines are available where this risk has not been seen.” For more, see “Q&A on the Rare Clotting Events That Caused the J&J Pause.” (As of May 24, the agencies had identified 32 total cases among more than 10.2 million J&J vaccines administered. There still have been three deaths, as of May 7, according to the CDC.)

For the COVID-19 vaccines, the CDC and FDA vaccine monitoring systems include a new smartphone-based tool called v-safe that allows enrollees to report any reactions to the vaccine.

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How do we know what ingredients are in a vaccine?

The full ingredient list for any authorized COVID-19 vaccine can be found in a variety of documents on the Food and Drug Administration’s website, including in a fact sheet for vaccine recipients that’s available in numerous languages. 

Both the Pfizer/BioNTech and Moderna vaccines contain messenger RNA, or mRNA; a variety of fatty molecules, or lipids, to protect the mRNA; and a few other ingredients, including salts and sugar, to keep the vaccine stable and at a similar acidity to the human body. The Johnson & Johnson, or Janssen, vaccine contains a harmless adenovirus — a type of virus that typically causes the common cold — modified with the genetic material for SARS-CoV-2, as well as salts as stabilizing and buffering agents.

There are no preservatives, egg or latex in the vaccines.

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Full Story

The COVID-19 vaccine from Moderna — which has been administered more than 121 million times since the Food and Drug Administration granted it an emergency use authorization in December — includes 10 ingredients.

A widely circulating claim has seized on one of those ingredients to mislead people into believing that the vaccine is unsafe.

Moderna’s vaccine underwent clinical trials — with about 30,000 volunteers in its third phase — that were overseen by an independent data and safety monitoring board. The results were reviewed not only by the FDA, but also by an outside panel of experts advising the agency, as we’ve explained. Another independent group, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, also reviewed the data and recommended use of the vaccine.

Despite that, a video posted to TikTok on May 14 is spreading the false claim that SM-102, an ingredient in Moderna’s vaccine, is harmful. That video has amassed more than a million views and migrated to Instagram, where it has racked up even more views.

Misinformation peddlers with large followings — including Alex Jones and Mike Adams — have also picked up the claim and boosted its visibility.

They’ve added a veneer of government secrecy, too. Both Jones and Adams falsely claimed that the state of Connecticut revealed previously withheld information that the vaccine contains a “deadly” ingredient. But what they point to is a state Department of Health fact sheet on vaccine ingredients – which has been publicly available since the Moderna vaccine was granted an EUA in December. There has been no recent revelation about a secret ingredient.

The viral TikTok video doesn’t use the Connecticut example; it just shows the website for a health care network in New Jersey that posted an article about the vaccine ingredients in January.

All of the videos and posts focus on the same ingredient, though — SM-102, which is a lipid, a fatty molecule that doesn’t dissolve in water. We’ll explain more about it below.

The only evidence offered to support the false claim that SM-102 is dangerous is a misrepresentation of the website for a company called Cayman Chemical, which sells scientific research materials.

Cayman Chemical offers a version of SM-102 for research purposes that is packaged in chloroform, a potentially toxic chemical. So the safety data sheet from Cayman Chemical for that product includes warnings related to chloroform — not SM-102.

But both Jones and the viral TikTok video present that sheet as though the warnings are related to SM-102.

Jones, for example, said in his video, “Let’s go ahead and read over what this thing does.” He then flashed the safety data sheet across the screen and read: “Suspected of causing cancer; suspected of damaging fertility and the unborn child; causes damage to the central nervous system, the kidneys, the liver, and the respiratory system through prolonged or repeated exposure.”

He concludes, “They want you to take two shots of this and then recurring booster shots.”

But, as we said, those warnings are for chloroform — the same list of hazards is included on the National Center for Biotechnology Information’s entry for that chemical.

The center lists no hazards for SM-102.

Chloroform is not an ingredient in Moderna’s vaccine.

Cayman Chemical explained in a press release that the product featured in these videos and posts is from its division that makes compounds for research use only. The company has a separate division that makes active pharmaceutical ingredients for human and veterinary use, which have to comply with strict guidelines from the FDA.

The safety data sheet shown in the videos “accurately represents that the mixture of chemicals in the product are 90% chloroform (a common solvent) and 10% SM-102. While it is a common solvent, chloroform has several known serious hazards, which have been included on Cayman’s [safety data sheet],” the press release said.

“Neither the National Institute for Occupational Safety and Health (NIOSH), Registry of Toxic Effects of Chemical Substances (RTECS), or the European Chemicals Agency (ECHA) Classification and Labelling Inventory list any hazards associated with SM-102,” the release also said.

SM-102 is a type of lipid, Dr. Lee Riley, chair of the Division of Infectious Disease and Vaccinology at the University of California, Berkeley School of Public Health, explained in a phone interview with FactCheck.org. Moderna’s vaccine uses it as a fatty bubble, a delivery vehicle, for messenger RNA, which gives instructions to cells on how to make antibodies for the virus that causes COVID-19.

“RNA on its own (naked RNA) is highly prone to being chewed up and falling apart,” Joshua Andersen, associate professor of biochemistry at Brigham Young University, said in an email to FactCheck.org. “The only way these RNA vaccines ever stood a chance is if the RNA could somehow be stabilized. So these lipids serve as a carrier and stabilizer of the RNA in the vaccine.”

“Imagine a small bubble (made of lipids) containing the RNA that helps deliver it to our cells,” he said.

The TikTok video misleadingly highlighted part of Cayman Chemical’s safety sheet that said its version of SM-102 for research was not meant for “human or veterinary use.” But that version is not a vaccine ingredient. Andersen explained that “the ‘not for human consumption’ issue has to do with the fact that this version of SM-102 is not formulated for human consumption. This particular formulation is designated ‘research use only’ (ROU) because it’s in chloroform and it’s not purified to the standard needed for human consumption. We have super stringent standards for making something consumable, which really should be confidence inspiring to vaccine skeptics.”

So, the product used in the social media posts is not the same one that is used in the vaccine — and the warning labels they show are for a different chemical that’s not included in the vaccine.

In addition to the claim about SM-102, Jones also repeated some other claims in his video that we’ve recently debunked. We’ll list them here:

• Jones claimed that nearly half of the workers at the National Institutes of Health and the CDC haven’t taken the vaccine “because they know it’s experimental, it’s not really a vaccine.” But, as we wrote, federal health officials estimated at a Senate hearing that so far about 60% of their employees have been vaccinated. They didn’t say anyone had refused to get vaccinated.
• Jones showed a clip of a nurse fainting after she received the vaccine and said, “folks are getting sick, collapsing.” But as we explained before, that clip was selectively edited from a news report to show the nurse fainting. It didn’t show her quick recovery afterward, when she explained that she is prone to fainting when triggered by even a slight pain.
• Jones also suggested that the vaccine is part of Bill Gates’ plan to “depopulate the earth.” In a 2010 TED Talk focused on developing new technologies to drastically reduce carbon dioxide emissions, Gates briefly mentioned reducing the rate of population growth. As we explained, a conspiratorial video misleadingly edited Gates’ talk to suggest his “wish” was to depopulate the planet through vaccines.

For more information on the Moderna vaccine, see SciCheck’s article: “A Guide to Moderna’s COVID-19 Vaccine.”

Editor’s note: SciCheck’s COVID-19/Vaccination Project is made possible by a grant from the Robert Wood Johnson Foundation. The foundation has no control over our editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation. The goal of the project is to increase exposure to accurate information about COVID-19 and vaccines, while decreasing the impact of misinformation.

Sources

U.S. Food and Drug Administration. Press release. “FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine.” 18 Dec 2020.

U.S. Food and Drug Administration. Moderna COVID-19 Vaccine EUA Fact Sheet for Recipients and Caregivers. Revised 6 Mar 2021.

Centers for Disease Control and Prevention. The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Moderna COVID-19 Vaccine — United States, December 2020. 20 Dec 2020.

Connecticut Department of Public Health. “What Ingredients are in the COVID-19 Vaccine?” 4 Feb 2021.

Hackensack Meridian Health. “A Simple Breakdown of the Ingredients in the COVID Vaccines.” 11 Jan 2021.

Cayman Chemical. Safety data sheet. Article number: 33474. 11 Apr 2021.

National Center for Biotechnology Information, National Library of Medicine. Compound summary: Chloroform. Updated 22 May 2021.

National Center for Biotechnology Information, National Library of Medicine. Compound summary: SM-102. Updated 22 May 2021.

Cayman Chemical. Press release. “SM-102 for Research Use Only (RUO).” 19 May 2021.

Riley, Lee. Chair of the Division of Infectious Disease and Vaccinology, University of California, Berkeley School of Public Health. Telephone interview. 20 May 2021.

Andersen, Joshua. Associate Professor of Biochemistry, Brigham Young University. Email response. 20 May 2021.

Jones, Brea. “Posts Distort Testimony of Federal Health Officials on Employee Vaccinations.” FactCheck.org. 21 May 2021.

Hale Spencer, Saranac. “Anti-Vaccine Posts Use Deceptively Edited Video Clip.” FactCheck.org. Updated 4 Jan 2021.

Fichera, Angelo. “Video Targets Gates With Old Clip, Misleading Edit.” FactCheck.org. 5 Mar 2021.

The post Vaccine Ingredient SM-102 Is Safe appeared first on FactCheck.org.

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