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MRNA Vaccines Protect Against COVID-19 Mortality, Contrary To Misleading Posts

SciCheck Digest

Numerous studies have shown the mRNA COVID-19 vaccines are safe and effective in preventing severe disease and death from COVID-19. But some social media posts are citing a criticized study that focuses on overall mortality to falsely imply the vaccines are harmful and don't work.

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Both mRNA COVID-19 vaccines, from Moderna and Pfizer/BioNTech, showed excellent results in the clinical trials. There were no serious safety concerns reported for either of them, and both were more than 90% effective in preventing symptomatic and severe COVID-19.

With the arrival of new viral variants and the passage of time, the vaccines no longer provide strong protection against mild disease, but many studies have shown that these vaccines work very well in preventing severe COVID-19 and death. One estimate suggests that COVID-19 vaccines prevented more than 3 million deaths in the U.S.

Johnson & Johnson's COVID-19 vaccine, which is designed differently and uses a harmless adenovirus to trigger an immune response, showed a slightly lower efficacy. Although no serious safety issues were detected in the clinical trials, rare cases of a dangerous blood clotting condition combined with low blood platelets known as thrombosis with thrombocytopenia syndrome were reported in the U.S. Shortly after the vaccine was authorized for use. In 2022, the FDA limited its authorization. Now that the last doses expired in May, the vaccine is no longer available in the country.

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But some social media posts are citing a recent study that reanalyzed data from the original trials to compare the impact of both types of vaccines — the mRNA and adenovirus vector COVID-19 vaccines — on deaths from all causes, to incorrectly imply that the mRNA vaccines are dangerous or have no effect on mortality from COVID-19.

"Researchers inadvertently reveal mRNA covid vaccines are NOT ASSOCIATED WITH LOWER MORTALITY in reassessment of Random Control Trials (RCTs)," reads a post on Instagram, which also misleadingly implies that the original trial data were interpreted incorrectly. "27 of the 31 deaths in the RCTs that took either Moderna or Pfizer were blood, heart, or artery related, to the shock of no one who's been paying attention," the post adds.

"COVID Shots Had ZERO Impact on Reducing Deaths, Study Finds," reads the headline of an item on a conservative website.

The posts do not specify overall mortality, leading many viewers to incorrectly assume the vaccines don't protect against death from COVID-19.

Cases of inflammation of the heart muscle or its surrounding tissue, known as myocarditis and pericarditis, have occurred after mRNA COVID-19 vaccination, mostly in young men and after a second dose. But cases are rare and patients usually respond well to medicine and recover quickly.

The Moderna and Pfizer/BioNTech mRNA COVID-19 vaccines have not been linked to any other heart problems. Nor have they been shown to increase the risk of death. Study after study has confirmed the benefits outweigh the small risks.

The cited study was published in April in the journal iScience by researchers from Denmark, the Netherlands, and Germany. The authors reanalyzed mortality data reported in the various clinical trials and found that the adenoviral vaccines appeared to reduce death from any cause, while the mRNA vaccines did not. They concluded that the adenoviral vaccines might have some beneficial effects.

Scientists have questioned the study since it was posted a year ago as a preprint. At that time, the study was also misinterpreted and used to misleadingly claim mRNA vaccines offer "no mortality benefit" at all, as our colleagues from PolitiFact wrote.

The authors have acknowledged the limitations of the study and responded to some critics, but have not explicitly corrected claims stating the vaccines are dangerous or don't reduce COVID-19 mortality.

"It is not possible to say, based on our findings, that 'mRNA COVID-19 vaccines are not effective or harmful,'" Dr. Christine Stabell Benn, the lead author, told us in an email.

But Benn, who is a member of a controversial committee gathered by Florida Gov. Ron DeSantis to advise the state on public health issues, also told us the results from the clinical trials "do not exclude" the possibility that the vaccines "are associated with considerable harm." As we've reported, DeSantis' committee of contrarian experts held a roundtable in December claiming the COVID-19 vaccines were too risky.

The iScience Study

The iScience study's goal was to determine if the COVID-19 vaccines had broad effects on the immune system, beyond the vaccine's ability to prepare the immune system to better fight off the coronavirus. In particular, the authors wanted to use the available trial data to see if the vaccines had an effect on overall mortality.

Two of the authors of the study, Benn and Peter Aaby, both professors at the University of Southern Denmark, have been studying what are called non-specific effects of vaccines, or secondary vaccine effects, for decades.

Typically, vaccines targeting a particular disease are not expected to have any effects on other diseases, since the immune system is responding to specific pathogen. But some epidemiology studies suggest that some vaccines may have broader effects. The concept is still understudied and many questions remain, according to a report of a workshop on the topic held by the National Institute of Allergy and Infectious Diseases in July 2021.

To study the COVID-19 vaccines' effects on overall mortality, the researchers counted the deaths reported in the two main mRNA trials and in five trials of three different adenovirus vector vaccines. They then combined the data for each vaccine type and compared it.

For the mRNA vaccines, there were a total of 74,193 participants in both the Pfizer/BioNTech and the Moderna trials. Among them, there were 61 deaths: 31 in the vaccine groups and 30 in the placebo groups. Half of the non-COVID-19 deaths (27 of 54) were related to cardiovascular issues, the study found, and the vaccines had no beneficial effect on those deaths, according to the researchers.

"There were no obvious benefits for these vaccines beyond preventing COVID mortality, which is not surprising," said Dr. Peter J. Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine, after reviewing the study for us. "And we know, for instance, that after vaccines became widely available in the United States, the benefits of mRNA vaccines in terms of preventing mortality from COVID-19 were overwhelming."

In the adenovirus vector vaccines trials included in the study, there were a total of 122,164 participants, with 46 deaths among them: 16 in the vaccine groups, 30 in the placebo groups. Therefore, the researchers concluded, the data suggested these vaccines were associated with a reduction in overall mortality, which they attributed to a lower COVID-19 mortality and a lower cardiovascular mortality (there were no cardiovascular deaths in the vaccine groups and eight in the placebo ones).

"The results suggest that adenovirus-vector vaccines compared with placebo have beneficial non-specific effects, reducing the risk of non-COVID-19 diseases. The most important cause of non-COVID-19 death was cardiovascular disease, against which the data for the current RCTs suggest that the adenovirus-vector vaccines provide at least some protection," researchers said.

The authors speculate that the adenovirus vector vaccines "prime the immune system in a way similar to a 'live' vaccine," which is the kind of vaccine that uses weakened virus and has most often been found in their previous studies to have non-specific effects.

But to other scientists, these results are being overinterpreted. The data does not allow for a meaningful analysis, they say, since the vaccine trials were not designed to assess mortality and the available data is minimal.

"It's hard to say anything very conclusive," Hotez, who participated in the NIAID workshop on secondary vaccine effects, told us about the paper. If anything, he said, it can generate a hypothesis that would need much broader testing and research.

"The claims about mRNA vaccines, including the purported cardiovascular effects, are based on far too few events to make any realistic conclusions," Gideon Meyerowitz-Katz, an epidemiologist from the University of Wollongong in Australia, told us in an email.

"Moreover, we have an enormous wealth of more recent evidence demonstrating that mRNA vaccines save lives. This particular analysis takes a handful of deaths from very different populations – the mRNA vaccine trials were conducted in a very different patient population to the adenovirus vector vaccine trials – and inappropriately compares them."

He also said it was concerning that the study used trial data for the Sputnik vaccine, a Russian adenovirus COVID-19 vaccine. Meyerowitz-Katz and others have found data inconsistencies with that trial, raising questions about how trustworthy it is.

Dr. David R. Boulware, a professor of medicine at the University of Minnesota Medical School, told us the fact that the trials were held in different locations is very significant.

"[T]he adenovirus vaccine trials … were run mostly in low and middle income countries where the overall case fatality rate was 2%. The mortality in the mRNA vaccine trials, mostly run in high-income countries, was 0.3%. Deaths were too few to show any reduction," he told us in an email.

Benn and her team responded to these concerns in May 2022 after the preprint was published, and again in May 2023. They say the study results should not be dismissed because of the limited data.

"Our key message is that yes, data is regrettably limited, but it does show differences in mortality effect between the two major vaccine types that if true would have major global health implications," Benn wrote on Twitter.

Regardless of whether the adenoviral vaccines have beneficial non-specific effects, it's incorrect to suggest that the mRNA vaccines don't protect against COVID-19 mortality, or to imply that they're dangerous.

Editor's note: SciCheck's articles providing accurate health information and correcting health misinformation are made possible by a grant from the Robert Wood Johnson Foundation. The foundation has no control over FactCheck.Org's editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation.

Sources

McDonald, Jessica. "A Guide to Moderna's COVID-19 Vaccine." FactCheck.Org. Updated 21 Apr 2023.

McDonald, Jessica. "A Guide to Pfizer/BioNTech's COVID-19 Vaccine." FactCheck.Org. Updated 21 Apr 2023.

McConeghy, Kevin W., et al. "Effectiveness of a Second COVID-19 Vaccine Booster Dose Against Infection, Hospitalization, or Death Among Nursing Home Residents — 19 States, March 29–July 25, 2022." MMWR. 30 Sep 2022

COVID-19 Vaccine Effectiveness Update. CDC website. Updated 23 Mar 2023.

Tenforde, Mark W., et al. "Effectiveness of mRNA Vaccination in Preventing COVID-19–Associated Invasive Mechanical Ventilation and Death — United States, March 2021–January 2022.' MMWR. 25 Mar 2022.

Haas, Eric J., et al. "Impact and effectiveness of mRNA BNT162b2 vaccine against SARS-CoV-2 infections and COVID-19 cases, hospitalisations, and deaths following a nationwide vaccination campaign in Israel: an observational study using national surveillance data." The Lancet. 5 May 2021.

Fitzpatrick, Meagan C., et al. "Two Years of U.S. COVID-19 Vaccines Have Prevented Millions of Hospitalizations and Deaths." The Commonwealth Fund. 13 Dec 2022.

Robertson, Lori. "A Guide to Johnson & Johnson's COVID-19 Vaccine." FactCheck.Org. Updated 17 May 2023.

Robertson, Lori, and Eugene Kiely. "Q&A on the Rare Clotting Events That Caused the J&J Pause." FactCheck.Org. Updated 6 May 2023.

Coronavirus (COVID-19) Update: FDA Limits Use of Janssen COVID-19 Vaccine to Certain Individuals. FDA. Press Release. 5 May 2022.

Janssen (Johnson & Johnson) COVID-19 Vaccine. CDC. Updated 10 May 2023.

Benn, Christine S., et al. "Randomized clinical trials of COVID-19 vaccines: Do adenovirus-vector vaccines have beneficial non-specific effects?" iScience. 19 May 2023.

Selected Adverse Events Reported after COVID-19 Vaccination. CDC. Updated 7 Mar 2023.

Benn, Christine Stabell (@StabellBenn). "Many people have commented on our recently published analysis of the overall mortality effect of the mRNA and adenovirus-vector vaccines. We addressed the comments in this article when the preprint was published: https://linkedin.Com/pulse/response-comments-our-recent-preprint-paper-christine-stabell-benn/ 1/5." Twitter. 16 May 2023.

Benn, Christine Stabell. Response to the comments to our recent preprint paper. LinkedIn. 4 May 2022.

"Governor Ron DeSantis Petitions Florida Supreme Court for Statewide Grand Jury on COVID-19 Vaccines and Announces Creation of the Public Health Integrity Committee." Ron DeSantis website. Press release. 13 Dec 2022.

McDonald, Jessica, and Catalina Jaramillo. "DeSantis' Dubious COVID-19 Vaccine Claims." FactCheck.Org. Updated 2 May 2023.

Non-specific effects of vaccines. Bandim Health Project website. Accessed 25 May 2023.

NIAID workshop on secondary vaccine effects. Nature Immunology. 22 Oct 2021.

Hotez, Peter J. Dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston, Texas. Phone interview with FactCheck.Org. 19 May 2023.

Meyerowitz-Katz, Gideon. Epidemiologist from the University of Wollongong in Australia. Email to FactCheck.Org. 18 May 2023.

Bucci, Enrico M., et al. "Data discrepancies and substandard reporting of interim data of Sputnik V phase 3 trial." The Lancet. 22 May 2021.

Sheldrick, Kyle A., et al. "Plausibility of Claimed Covid-19 Vaccine Efficacies by Age: A Simulation Study." American Journal of Therapeutics. Sep 2022.

Boulware, David R. Professor of medicine at the University of Minnesota Medical School. Email to FactCheck.Org. 17 May 2023. Benn, Christine Stabell (@StabellBenn). "Our key message is that yes, data is regrettably limited, but it does show differences in mortality effect between the two major vaccine types that if true would have major global health implications. 4/5." Twitter. 16 May 2023.

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A Universal Flu Vaccine: The Dream Inches Just A Bit Closer To Reality

Seasonal influenza kills hundreds of thousands of people every year due to a constantly changing virus and highly inefficient vaccine production. A universal flu vaccine could deal with the first problem, and mRNA technology with the second.

One of the first clinical trials of an experimental flu vaccine that works against most, if not all, strains of flu recently yielded positive results, and a new study of a similar vaccine — this one using mRNA technology — just began enrolling volunteers.

Creating a universal influenza vaccine has long been vaccinologists' dream.

Seasonal flu kills an estimated 400,000 people annually worldwide, most of them old or very young. Annual U.S. Deaths over the past decade ranged from roughly 12,000 to 52,000, depending on the severity of disease caused by that season's main strain, except during the COVID-19 pandemic when social distancing and other factors resulted in lower flu mortality.

Uptake of flu vaccines is low, largely because a new shot or nasal spray is needed every year due to the influenza virus's ability to change slightly but far more frequently than most other viruses.

The production process is cumbersome and slow. Scientists make educated guesses about which of the influenza strains circulating during South Asia's summer monsoon season are likely to out-compete the others in the West the following winter. Those three or four strains are then grown in fertilized eggs for use in the seasonal flu vaccines.

The scientists' predictions are not always accurate. Sometimes there's a poor match between some of the strains in the vaccine and the strains that circulate in the United States during that flu season.

A universal vaccine against most strains of flu would take much of the guesswork out of flu vaccination and could confer longer-lasting protection, so the annual flu shot would be a thing of the past.

Scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC) designed an experimental non-RNA vaccine, known as H1ssF, to elicit immunity against a broad range of viruses. A phase I clinical trial of 52 volunteers found that it was safe, well-tolerated and induced broad antibody responses, according to two research articles published last monthin Science Translational Medicine by first authors Sarah F. Andrews, Ph.D., staff scientist, and Alicia T. Widge, M.D., staff clinician and associate chief for clinical research and development, and their VRC colleagues.

Messenger RNA was discovered only in the 1960s, and the first vaccine to use it was against Ebola in Africa, a target population so small that there was no commercial development in the U.S. The first mRNA vaccines to win approval from the FDA were the Pfizer and Moderna vaccines against COVID-19. They were highly effective and produced in record time, no eggs required.

Using this technology for a universal flu vaccine could provide many benefits.

The early-stage clinical trial that just began enrolling 50 healthy adults at Duke University School of Medicine in Durham, N.C. Will test a new vaccine, also developed at NIAID, that is similar to the universal influenza vaccine described in the recently published papers. But this investigational vaccine, manufactured at the Duke Human Vaccine Institute, uses an mRNA platform.

ClinicalTrials.Gov describes the H1ssF-3928 mRNA-LNP trial as consisting of three sequential groups of 10 participants each who will receive single low, medium or high doses, with pauses in between groups to evaluate safety. A fourth group will get an "optimal dose" based on data from the first three.

A fifth group will receive the current quadrivalent seasonal influenza vaccine so that researchers can compare immunogenicity and safety and, secondarily, efficacy. Participants will be followed for up to a year after vaccination to measure how long the immune response lasts and whether it remains effective over time as the virus continues to undergo small changes, known as drifts.

Emmanuel "Chip" Walter, M.D.

"This is an exciting moment," principal investigator Emmanuel "Chip" Walter, M.D., chief medical officer of the Duke Human Vaccine Institute and director the Duke Vaccine and Trials Unit. "As we continue to test additional vaccine candidates, we move closer to the ultimate goal of modernizing the flu vaccine in a way that provides better, longer-lasting protection against a virus that kills hundreds of thousands of people worldwide each year."

As big a killer as seasonal influenza is — to say nothing of the misery endured by multitudes who are laid up in bed by the disease — the possibility of a bird flu pandemic caused by a virus against which no humans have any immunity is much scarier.

"The hope for a universal vaccine," Walter said in an emailed response to questions from Managed Healthcare Executive, "is to include coverage against avian influenza strains."

A Universal Flu Vaccine Is Getting Closer To Reality

Image: Maksim Shmeljov (Shutterstock)

We might be one major step closer toward ending the scourge of the seasonal flu. This week, the U.S. National Institutes of Health announced the start of a phase I clinical trial testing out a potential universal flu vaccine. The safety and immune response of the experimental shot will be compared to a typical annual flu vaccine.

The candidate was developed by researchers at the NIH's National Institute of Allergy and Infectious Diseases' (NIAID) Vaccine Research Center. It's a mRNA-based vaccine, much like the first generation of covid-19 vaccines. The NIH is conducting the trial in conjunction with Duke University in North Carolina; they plan to enroll up to 50 healthy volunteers between the ages of 18 and 49.

The volunteers will be divided into several groups. Three groups will receive one of three dosages of the vaccine, in order to figure out an optimal dose. Once that's figured out, a fourth group will be given this dose. A fifth group will act as a sort of control and will be given the standard seasonal flu vaccine, which provides protection against the four strains predicted to be in circulation during the current season. Following vaccination, the volunteers will be monitored for up to a year.

The seasonal flu remains a serious public health threat in America. Prior to the arrival of covid-19, it was often the single deadliest infectious disease seen annually in the country. Each year from 2010 to 2020, for instance, the flu is estimated to have killed between 12,000 to 52,000 people and hospitalized between 140,000 to 710,000. Millions of Americans are sickened annually, costing billions in lost wages.

The seasonal flu vaccine does prevent many of these flu-related illnesses, hospitalizations, and deaths. But its effectiveness can vary widely from year to year, depending how well scientists have predicted the upcoming season's circulating strains. And since the influenza virus quickly mutates, any protection it provides is temporary and has to be renewed annually. So a truly universal flu vaccine—one that can induce a sustained and broad immune response to current and future flu strains—is a holy grail in medicine.

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"A universal influenza vaccine would be a major public health achievement and could eliminate the need for both annual development of seasonal influenza vaccines, as well as the need for patients to get a flu shot each year," said Acting NIAID Director Hugh Auchincloss in a statement. "Moreover, some strains of influenza virus have significant pandemic potential. A universal flu vaccine could serve as an important line of defense against the spread of a future flu pandemic."

It will likely take years for any universal flu vaccine currently in development to reach the public even if successful. But in the best-case scenario, we may have several to pick from. In April, the Vaccine Research Center reported encouraging phase I results from a trial of a similar candidate vaccine that uses non-mRNA technology, while another NIH-led trial of a different experimental flu vaccine began last year.

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