SciCheck Digest
The COVID-19 mRNA vaccines authorized for use were found to be safe and effective in clinical trials and real-world conditions. A professor in Ireland baselessly claims in a video circulating on social media that they are not, and that those who get the vaccines will die as a result within several years.
How were safe and effective COVID-19 vaccines developed so rapidly?
The unprecedented speed of the COVID-19 vaccines was due to multiple factors.
Candidates for an mRNA vaccine — the technology used for the Pfizer/BioNTech and Moderna vaccines — can be quickly designed once scientists know the genetic sequence of the virus and which protein to target. Researchers already knew from past experience with SARS and MERS, which are other diseases caused by coronaviruses, that the spike protein the virus uses to enter cells was likely the right one.
Similarly, Johnson & Johnson has been researching adenovirus-based vaccines — the technology its COVID-19 vaccine uses — for many years in working on vaccines for HIV and Zika, and its Europe-approved Ebola vaccine.
The testing of the vaccines was also sped up by consolidating some of the early testing stages. Companies typically don’t want to proceed with expensive trials until there’s a sign the vaccine will work, but the government took on that financial risk in many cases.
The phase 3 randomized controlled clinical trials were also fast because high levels of disease transmission meant COVID-19 cases quickly accumulated among trial participants. And production capacity was sped along by starting manufacturing even before knowing whether the vaccines would be successful.
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How do we know vaccines are safe?
No vaccine or medical product is 100% safe, but the safety of vaccines is ensured via rigorous testing in clinical trials prior to authorization or approval, followed by continued safety monitoring once the vaccine is rolled out to the public to detect potential rare side effects. In addition, the Food and Drug Administration inspects vaccine production facilities and reviews manufacturing protocols to make sure vaccine doses are of high-quality and free of contaminants.
One key vaccine safety surveillance program is the Vaccine Adverse Event Reporting System, or VAERS, which is an early warning system run by the Centers for Disease Control and Prevention and FDA. As its website explains, VAERS “is not designed to detect if a vaccine caused an adverse event, but it can identify unusual or unexpected patterns of reporting that might indicate possible safety problems requiring a closer look.”
Anyone can submit a report to VAERS for any health problem that occurs after an immunization. There is no screening or vetting of the report and no attempt to determine if the vaccine was responsible for the problem. The information is still valuable because it’s a way of being quickly alerted to a potential safety issue with a vaccine, which can then be followed-up by government scientists.
Another monitoring system is the CDC’s Vaccine Safety Datalink, which uses electronic health data from nine health care organizations in the U.S. to identify adverse events related to vaccination in near real time.
In the case of the COVID-19 vaccines, randomized controlled trials involving tens of thousands of people, which were reviewed by multiple groups of experts, revealed no serious safety issues and showed that the benefits outweigh the risks.
The CDC and FDA vaccine safety monitoring systems, which were expanded for the COVID-19 vaccines and also include a new smartphone-based reporting tool called v-safe, have subsequently identified only a few, very rare adverse events.
For more, see “How safe are the vaccines?”
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Full Story
Update, Aug. 23, 2021: The Pfizer/BioNTech COVID-19 vaccine, which was previously authorized by the Food and Drug Administration for emergency use, received full approvalfrom the agency on Aug. 23 for people 16 years of age and older.
Update, Feb. 10, 2022: The Moderna COVID-19 vaccine receivedfull approvalfrom the FDA on Jan. 31 for individuals 18 years of age and older.
The mRNA vaccines against COVID-19 represent a new vaccine platform, but their development rests on years’ worth of research, including clinical trials. And while the vaccines were developed quickly in response to the pandemic, they have been proven to be safe and effective not only in standard clinical trials but in real-world conditions.
The vaccines in question use modified messenger RNA to provide 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. The cells quickly break down the mRNA.
But as the vaccines are deployed around the country, some have weaponized their novelty to spread misinformation and unfounded claims about their safety.
In one case, a video clip circulating online shows Dolores Cahill — a professor in Ireland who until recently was the chair of the right-wing Irish Freedom Party — baselessly claiming that COVID-19 mRNA vaccines will cause widespread deaths in the coming years.
Cahill specifically alleges that “anyone who’s over 70 who gets one of these mRNA vaccines will probably be — sadly die within about two to three years.”
“And I would say anyone who gets the mRNA injection, no matter what age you are, your life expectancy will be reduced to you know die, if you’re in your 30s, within five to 10 years,” continues Cahill, a professor at the medical school at the University College Dublin who has previously come under criticism for spreading misinformation about COVID-19.
There is no medical evidence for such claims.
In phase 3 trials, the two mRNA vaccines authorized in the U.S. — from Pfizer/BioNTechandModerna — had an efficacy of 94% or higher, whichmeans your approximate risk of getting sick is cut by 94% or more if you are fully vaccinated. A Centers for Disease Control and Prevention study released in March found that, in real-world conditions, the two vaccines were 90% effective in preventing infections. (For more, see our SciCheck stories “A Guide to Pfizer/BioNTech’s COVID-19 Vaccine” and “A Guide to Moderna’s COVID-19 Vaccine.”)
The video clip of Cahill has been repeatedly posted and viewed by tens of thousands on platforms such as Instagram, Twitter and Telegram and is branded as coming from a group called the “World Freedom Alliance,” which Cahill helped found in November. In a videoannouncing the group’s formation, one member referred to COVID-19 as a “hoax”; Cahill said the group would “expose the truth of what’s going on” in order to protect freedoms.
The clip now spreading online is taken from a speaking event in Belfast in March. The full video shows Cahill making a host of other erroneous claims, including that the vaccines “contain nanoparticles and you can be tracked.” The nanoparticles (a unit of size) referencedare actually lipid nanoparticles, material that helps to protect and transport the mRNA to the cell; they are not part of a technology that can track people.
We’ll address some of Cahill’s unsubstantiated claims in the viral clip here.
Unfounded Claim of Future Deaths
It’s unclear what exactly is behind Cahill’s wild and baseless claim that the vaccines will cause all recipients to die within a matter of years. Our inquiries to Cahill went unanswered.
Meanwhile, Grant McFadden, director of the BiodesignCenter for Immunotherapy, Vaccines, and Virotherapy at Arizona State University, told us in an email that “the safety record for the mRNA vaccines is excellent.”
McFadden said that while “we do not yet have long-term data in humans,” there “are no scientific reasons to predict complications in these new vaccines in the coming years.” He added that “common health practices mandate that this will be monitored carefully for years to come.”
In a different videouploaded earlier this year, Cahill also predicts widespread deaths specifically from the mRNA vaccines by misrepresenting old studies unrelated to the mRNA technology.
In one case, shecites a2012 studydealing with vaccine candidates for SARS-CoV (the coronavirus behind theSARS outbreakof 2003).
“What happened in this study is that the animal models after [they] have been challenged got very sick and that some of them died,” Cahill says.
As we noted in a previous story, those vaccine candidates for SARS-CoV were not mRNA vaccines, as Cahill implies. And while the study found that the vaccine candidates being tested 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 haveexplained.
Moreover, that phenomenon, in which a vaccine can lead to worse disease when confronted with a live virus, was not observed in the animal or human trials for the COVID-19 vaccines that received emergency use authorizations.
Cahill in the earlier video similarly references another vaccine trial against respiratory syncytial virus, or RSV. That trial, from the 1960s, also did not involve an mRNA vaccine, as she suggests.
“Most of the children who were given this RSV vaccine, which had the same issue, most of the children experienced severe disease with infection that led to a high frequency of hospitalizations — and two children out of 35 died,” she says. “And the conclusion from this was that the disease was enhanced by the prior vaccination.”
“What people need to know is that with these RNA vaccines is that after you’re vaccinated, for the rest of your life, you will have much higher death as the children did with this study because you were vaccinated,” she adds.
That case actually involved a formalin-inactivated vaccine candidate. Researchers did find that the design of the vaccine candidate resulted in poorly developed antibodies and that the immunized children who still caught RSV suffered worse symptoms than usual. Two children who were part of the trial died as a result of the enhanced disease; the trial stopped and no RSV vaccine has been approved.
But again, this type of phenomenon has not been seen with the COVID-19 vaccines granted emergency use authorization in the U.S.
“Neither COVID-19 disease nor the new COVID-19 vaccines have shown evidence of causing [antibody-dependent enhancement],” the Vaccine Education Center at the Children’s Hospital of Philadelphia reports. “People infected with SARS-CoV-2, the virus that causes COVID-19, have not been likely to develop ADE upon repeat exposure.”
Some scientists who noted the possibility of this issue occurring, as COVID-19 vaccine development was underway, have since said subsequent data helped to quell those concerns.
Dr. Peter Hotez, the dean of Baylor College of Medicine’s National School of Tropical Medicine, said in an email to us that he was among the scientists who flagged the need for researchers “to be on the lookout for immune enhancement” — including in testimony before the House in March 2020 — “based on our work on SARS 1 in rodent models last decade.”
“But as we and others started doing non human primate vaccine trials for SARS 2 it never materialized,” Hotez,also co-director of the Texas Children’s Hospital Center for Vaccine Development, said. “That’s why we do the science.”
Other Baseless Risk Claims
Many vaccine recipients experience pain at the site of injection, fatigue, muscle pain or headache, as we’ve explained. Data from the Pfizer/BioNTech and Moderna trials also show the side effects included joint pain, chills or fever.
A small numberof people in the U.S. have had serious allergic reactions following receipt of the shots. That’s why the CDC advisesthat anyone who has previously experienced anaphylaxis or had any kind of immediate allergic reaction to any vaccine or injection be monitored for a half hour after getting the shot. (The FDA also recommends against vaccination for those who have had a serious allergic reaction to a previous dose of either the Pfizer or Moderna vaccineor one ofthe ingredients of any of the authorized vaccines.)
In the video clip circulating online, though, Cahill suggests without evidence that recipients will go on to “probably have allergy, neuro-cognitive issues, and inflammation, and of course infertility is the major one.”
We’ve previously addressed the lack of evidence for the claim that the COVID-19 vaccines cause infertility. While clinical trials did not probe the issue, loss of fertility has not been reported among thousands of trial participants and it has not been confirmed as an adverse event among the millions who have been vaccinated.
And as for the other supposed long-term effects, Hotez said “there is zero evidence to support such claims.”
“Also there is not even a plausible mechanism, it’s just antivax gobbledygook,” he said.
While Cahill’s claims about supposed long-term effects of the COVID-19 mRNA vaccines aren’t rooted in evidence, there is support for the fact that COVID-19 itself can result in long-term health effects.
Hotez pointed out that some who contract COVID-19 suffer from what’s known as long-haul COVID and continue to report health issues well after being infected. Among such issues, researchers have found that some such patients continue to experience neurological or psychiatric conditions in the months following infection.
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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