SciCheck Digest

The approved and authorized COVID-19 vaccines in the U.S. are effective at preventing severe disease, and experts say the benefits of vaccination for children outweigh any known or potential risk. But social media users have shared video of Dr. Robert Malone misleadingly asserting that the COVID-19 vaccines are “not working” and claiming without evidence that many children “will be hospitalized” and may experience brain damage and infertility due to the vaccines.

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The COVID-19 vaccines provide strong protection against severe disease leading to hospitalization and death — the primary purpose for which they were developed — even against the highly contagious delta and omicron variants.

Dr. Robert Malone, a scientist who has claimed he invented mRNA vaccine technology, used part of his roughly 14-minute speech at a Jan. 23 rally against COVID-19 vaccine mandates to cast doubt on the effectiveness and safety of the COVID-19 vaccines. 

“Regarding the genetic COVID vaccines, the science is settled,” said Malone, who has been barred from Twitter for spreading misinformation. “They’re not working. They are not completely safe.”

He went on to claim that the vaccines were damaging for children, specifically.

“On average, between 1 in 2,000 and 1 in 3,000 children that receive these vaccines will be hospitalized in the short term with vaccine-caused damage,” he later said. “These genetic vaccines can damage your children. They may damage their brains, their heart, their immune system and their ability to have children in the future. Many of these damages cannot be repaired.”

Social media users on a variety of platforms have shared portions of Malone’s speech online, while others have posted the full video of his remarks.

We reached out to Malone to ask for evidence to support his claims, but an automated email reply said, due to a high number of inquiries, he was unavailable to answer our questions.

Contrary to what he said, recently published studies have found that the available vaccines are still effective and overwhelmingly safe, including for children.

Vaccine Effectiveness

Research has shown that, over time, the vaccines available in the U.S. are less effective at preventing a SARS-CoV-2 infection that leads to COVID-19 — especially since the emergence of the delta and omicron variants, both of which have spread more easily than prior coronavirus variants.

However, that alone does not mean that the vaccines are “not working,” if that was the basis for Malone’s claim.

Vaccinated individuals are still less likely to become infected with the virus than those who are not vaccinated, and the vaccines, particularly after a booster dose, are still effective at preventing hospitalizations and deaths due to severe disease, according to recent studies from the Centers for Disease Control and Prevention.

A paper published on Jan. 21 in the CDC’s Morbidity and Mortality Weekly Report looked at COVID-19 incidence rates among unvaccinated and fully vaccinated adults with and without booster doses. Using data from 25 state and local health departments, the authors concluded that the vaccines reduced the risk for infection during periods when delta was predominant and when omicron was emerging.

Throughout October and November, when delta was dominant, unvaccinated individuals had 13.9 times the risk for infection compared with fully vaccinated people who received a booster and four times the risk compared with fully vaccinated people without booster doses, the paper said. Then, during the rise of omicron in December, the unvaccinated still had 4.9 times the risk for infection compared with those who received a booster shot and 2.8 times the risk compared with individuals who only received the primary vaccination series.

The authors said the figures suggested that vaccine effectiveness against infection in December, when compared with the period from October to November, had declined from 93% to 80% for fully vaccinated people with a booster dose and from 75% to 64% for fully vaccinated people without a booster.

Meanwhile, another CDC study, which was published in JAMA on Jan. 21, looked at the effectiveness of the Pfizer/BioNTech and Moderna vaccines – the two mRNA vaccines – against symptomatic infection. The authors reviewed over 70,000 tests from symptomatic adults and found that individuals who had received three mRNA vaccine doses were less likely to test positive for delta and omicron than both unvaccinated individuals and people who received only two vaccine doses. 

However, the authors said the higher odds ratios for symptomatic infection with omicron suggest that boosted individuals had less protection against that variant than for delta.

But even when vaccinated individuals contract the virus, studies also show they are largely protected from severe illness requiring hospitalization — a key goal of the vaccines.

A third CDC study released Jan. 21, and based on thousands of cases in 10 states, found that mRNA vaccine effectiveness against COVID-19-associated hospitalizations during omicron predominance increased to 90% at least 14 days after a third shot — up from 57% at 180 days or more after a second dose. When delta was the dominant variant, vaccine effectiveness against hospitalization was 81% six months or more after a second dose and 94% at or past 14 days after a third dose.

The authors said the results “underscore the importance of receiving a third dose of mRNA COVID-19 vaccine to prevent both moderately severe and severe COVID-19, especially while the Omicron variant is the predominant circulating variant and when the effectiveness of 2 doses of mRNA vaccines is significantly reduced against this variant.”

The CDC recommends a booster for everyone at least 12 years old at least five months after completing their primary vaccination series of the mRNA vaccines and two months after getting a Johnson & Johnson vaccine.

Vaccine Safety

Overall, the CDC says that COVID-19 vaccination is safe for children and recommends the shots for anyone 5 years or older. The American Academy of Pediatrics’ Committee on Infectious Diseases also has advised parents to vaccinate their eligible children against the disease.

At this time, the Pfizer/BioNTech vaccine is the only one authorized in the U.S. for children; no COVID-19 vaccine is currently authorized for kids 4 years old or younger.

We don’t know the exact source of Malone’s concerns about COVID-19 vaccine safety, as he did not respond to our query.

His claim that “between 1 in 2,000 and 1 in 3,000 children that receive these vaccines will be hospitalized in the short term with vaccine caused damage” may have been based on data on vaccine safety in children ages 5 to 11 that was published in the CDC’s MMWR on Dec. 31. 

The paper’s authors reviewed data on 42,504 children who were enrolled in v-safe, a smartphone-based safety surveillance system, and were vaccinated in 2021, between Nov. 3 and Dec. 19. The authors found that 14, or 0.02%, of the children reportedly required care at a hospital following a COVID-19 vaccination.

But, as the paper said, “Whether hospitalization was the result of vaccination could not be determined.”

The “information regarding reason for hospitalization” was only available for five of the children “and included appendicitis (two), vomiting and dehydration (one), respiratory infection (one),” and one case of an infection known as retropharyngeal cellulitis, the paper said. The authors also later discovered that one of the hospitalizations was reported in error, after the parents or guardians of all hospitalized children were contacted.

Furthermore, in its limitations section, the paper also noted that enrollment in v-safe is voluntary and so the reported “data might not be representative of the vaccinated population.”

As we mentioned, Malone also speculated that the COVID-19 vaccines could cause a host of other health problems for children.

“These genetic vaccines can damage your children,” he said. “They may damage their brains, their heart, their immune system and their ability to have children in the future. Many of these damages cannot be repaired.”

To be clear, none of the COVID-19 vaccines are capable of changing someone’s DNA, as Malone’s use of the phrase “genetic vaccines” could lead some to believe. The CDC has explained on its website that neither the mRNA vaccines, nor viral vector vaccines, such as the one made by Johnson & Johnson, “change or interact with your DNA in any way.”

Experts also have said that infertility has not been shown to be a side effect of vaccination.

“There is no evidence that the vaccine can lead to loss of fertility,” the American Academy of Pediatrics says on its FAQ page about COVID-19 vaccination. “While fertility was not specifically studied in the clinical trials of the vaccine, no loss of fertility has been reported among trial participants or among the millions who have received the vaccines since their authorization, and no signs of infertility appeared in animal studies. Similarly, there is no evidence that the COVID-19 vaccine affects puberty.”

As for possible brain damage, vaccination against COVID-19 actually may offer some protection from brain inflammation caused by an infection with SARS-CoV-2.

A CDC study first published in the MMWR on Jan. 7 estimated that, for those 12 to 18 years old, two doses of the Pfizer/BioNTech vaccine was 91% effective against multisystem inflammatory syndrome in children, or MIS-C, a condition the CDC says can cause inflammation in the brain, heart, lungs, kidneys, skin, eyes or gastrointestinal organs. While the CDC says the exact cause of MIS-C is unknown, the condition has been observed in children who had COVID-19.

In the study, which looked at cases from July to December 2021, when delta was predominant, 95% of patients hospitalized with MIS-C were unvaccinated. The authors said the findings, in addition to an earlier analysis estimating 93% vaccine effectiveness against COVID-19–related hospitalizations, “contribute to the growing body of evidence that vaccination is likely effective in preventing severe COVID-19–related complications in children, including MIS-C.”

It’s true that some children may experience a condition known as myocarditis, or an inflammation of the heart muscle, after vaccination. However, research suggests that cases are rare and that patients recover quickly after treatment – although the CDC is investigating the long-term effects.

A study published in the journal Circulation in early December reported on 140 episodes of confirmed or suspected myocarditis in 139 adolescents and young adults ages 12 to 20. The authors found that more than 90% of patients were male, the median patient age was 15.8 years and the most common symptom, chest pain, was experienced by over 99% of patients. Also, nearly 19% of patients were admitted to the ICU; the median hospital stay was two days. There were no reported deaths.

The authors said that “most cases of suspected COVID-19 vaccine myocarditis” in that age group “have a mild clinical course with rapid resolution of symptoms.”

“We feel that it is very important to have children vaccinated for COVID-19,” one of the study’s lead authors, Dr. Jane Newburger, a pediatric cardiology specialist at Boston Children’s Hospital, said in a video about the research. “That’s because myocarditis from the vaccination, and other vaccine-related complications, are really rare, and much more rare than the more serious kinds of complications that can happen after infection with COVID-19 itself.”

For those younger than 12, the CDC’s Dec. 31 study on vaccine safety said “myocarditis among children aged 5–11 years appears rare,” as there were only 11 verified reports to the Vaccine Adverse Event Reporting System, or VAERS, after administration of approximately 8 million vaccine doses. In addition, “in an active vaccine safety surveillance system, no chart-confirmed reports of myocarditis were observed during the 1–21 days or 1–42 days after 333,000 vaccine doses were administered to children of the same age,” the paper said.

No vaccine, including the ones for COVID-19, are “completely safe,” or come without at least some risk, as Malone said. But the CDC and other organizations have determined that, for adults and children, the benefits of vaccination against COVID-19 outweigh any known or potential risk.

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.

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