No sign spike proteins from COVID-19 vaccines, including Novavax, are dangerous

Following news that a COVID-19 vaccine from drug maker Novavax has been found in a trial to be 90% effective, a widely shared social media post alleged that the vaccine is dangerous. 

The post came from Jane Ruby in response to a tweet about a June 14 New York Times story about Novavax announcing the results of a 29,960-person clinical trial in the U.S. and Mexico. 

The vaccine contains a "dangerous spike protein," Ruby tweeted. "Novavax injection just dumps millions of spike proteins right into your body."

Ruby adds: "Can’t wait to see all the myocarditis from that."

There’s no evidence to support the claim that spike protein is dangerous. The spike proteins produced as a result of vaccination help stimulate the body’s defenses against COVID-19. The U.S. Centers for Disease Control and Prevention calls them "harmless."

Ruby, whose Twitter account identifies her as "Dr. Jane Ruby," is not a medical doctor. She describes herself as a health economist and "New Right political pundit" with a doctorate in psychology. Her LinkedIn profile shows he has a background in pharmaceutical research and nursing.

We messaged Ruby via Twitter but didn’t get a reply.

We have fact-checked other spike protein claims, finding that there is no evidence they present any serious health risk on their own. 

We rated False a claim by Canadian viral immunologist Byram Bridle that the COVID-19 vaccines’ spike protein means people are being inoculated "with a toxin." Experts said there is no evidence that the vaccines produce a toxin that could cause heart problems and neurological damage, as Bridle alleged.

We also rated False a claim that COVID-19 vaccines’ "spike protein is very dangerous, it's cytotoxic," which means toxic to cells. U.S. public health authorities and vaccine experts said there is no evidence that the vaccines’ spike protein is toxic or "cytotoxic." 

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Ruby’s mention of myocarditis alludes to reports of a higher-than-expected number of cases of heart inflammation developing in mostly young people after they received doses of mRNA-based COVID-19 vaccines from Pfizer-BioNTech and Moderna, which use a different mechanism than the Novavax vaccine to induce an immune response.

The Centers for Disease Control and Prevention announced that it will convene an emergency meeting on June 18 to discuss a possible link between the condition and the vaccines. Other health organizations, like the European Medicines Agency, are also investigating.

So far, there’s no conclusive evidence that these cases are caused by the vaccines or the spike proteins.

Novavax, which is seeking to become the fourth company with a vaccine approved for use in the U.S., said the trial showed its vaccine "demonstrated 100% protection against moderate and severe disease, 90.4% efficacy overall." The company said it plans to seek regulatory authorizations during the third quarter of 2021 and expects to be able to manufacture 100 million doses per month by the end of the quarter.

A spokesperson for Novavax said its vaccine is derived from the genetic sequence of the SARS-CoV-2 virus spike protein. "It is a harmless protein that can neither replicate nor can it cause COVID-19," she said. "It ‘teaches’ your immune system to recognize the virus so that when exposed to the real thing, your body is prepared to mount an effective immune response."

The protein-based Novavax vaccine is similar in its approach to the influenza vaccine Flublok, containing a single viral protein, the SARS-CoV-2 surface protein, said Dr. Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia and a member of the U.S. Food and Drug Administration’s vaccine advisory committee.

"This protein has not been shown to be dangerous," he said. "It's just a single viral protein similar to the hepatitis B and human papillomavirus vaccines, and are remarkably safe." 

"The SARS-CoV-2 virus, on the other hand, reproduces itself thousands of times, and is incredibly dangerous."

The National Institutes of Health said data from the trial "indicate the investigational vaccine was generally well-tolerated." The most common side effects were mild to moderate pain at the injection site, fatigue, headache and temporary muscle pain.

We rate the post False.