This article has been reviewed according to ScienceX's editorial process and policies. Editors have highlighted the following attributes while ensuring the content's credibility:
fact-checked
peer-reviewed publication
trusted source
proofread
close
The unique circumstances arising from the COVID-19 pandemic altered a long-held convention that doctors provide care regardless of personal risk.
In a study assessing doctors' tolerance for refusing care to COVID-19 patients, Duke Health researchers identified a growing acceptance to withhold care because of safety concerns.
"All the papers throughout history have shown that physicians broadly believed they should treat infectious disease patients," said the study's lead author, Braylee Grisel, a fourth-year student at Duke University School of Medicine.
"We figured our study would show the same thing, so we were really surprised when we found that COVID-19 was so different than all these other outbreaks," Grisel said.
In a study published on April 24 in the journal Clinical Infectious Diseases, the researchers analyzed 187 published studies culled from thousands of sources, including academic papers, opinion pieces, policy statements, legal briefings and news stories. Those selected for review met criteria for addressing the ethical dilemma posed by treating a novel infectious disease outbreak over the past 40 years.
Most articlesabout 75%advocated for the obligation to treat. But COVID-19 had the highest number of papers suggesting it was ethically acceptable to refuse care, at 60%, while HIV had the least number endorsing refusal of care at 13.3%.
The trendline stayed relatively stable across outbreaks occurring from the 1980s until the COVID-19 pandemic hitwith just 9% to 16% of articles arguing that refusing care was acceptable.
What changed with COVID? The authors found that labor rights and workers' protections were the chief reasons cited in 40% of articles during COVID, compared with only about 17%19% for other diseases. Labor rights were cited the least often for HIV care, at 6.2%.
Another significant issue cited during the COVID pandemic was the risk of infection posed to doctors and their families, with nearly 27% of papers discussing this risk, compared to 8.3% with influenza and 6.3% for SARS.
"Some of these results may be because we had the unique opportunity to evaluate changing ethics while the pandemic was actively ongoing, as COVID-19 was the first modern outbreak to put a significant number of frontline providers at personal risk in the United States due to its respiratory transmission," said senior author Krista Haines, D.O., assistant professor in the departments of Surgery and Population Health Sciences at Duke University School of Medicine.
The authors noted that the COVID pandemic had several unique characteristics that collectively altered the social contract between doctors and patients, potentially driving changes in treatment expectations. Such factors included:
The authors note the ongoing debate over whether vaccination status should be considered in the decision to treat a patient.
"There was a great deal of discussion among frontline providers and ethicists on how best to allocate scarce resources," the authors wrote. "Patients who refused vaccination were at a higher risk of complications while also putting other patients and providers at risk. Arguments were made based on reciprocity, medical triage, and personal responsibility to exclude patients who refused vaccines from consideration when ventilators and other resources were limited."
Grisel said the study's finding provides insight regarding how care should be provided in future pandemics. What had been a fairly solid expectation that physicians were obligated to provide care despite the risks to themselves now appears to have softened. It is unclear how these results may change in the future when the pandemic is less of an active threat.
"This study really shows how outside pressures in the sociopolitical sphere influence and affect doctors and care providers," Grisel said. "In future pandemics, we may need to become more aware of how the risks and outside pressures of an active pandemic influence willingness to provide care. Health care systems can learn how to mitigate these influences to ensure that hospitals are adequately staffed to meet patient needs."
More information: Krista Haines et al, The Ethical Obligation to Treat Infectious Patients - A Systematic Review of Reasons, (2024). DOI: 10.1093/cid/ciae162
Journal information: Clinical Infectious Diseases
CLAIM
COVID-19 vaccinations affect your risk of sudden cardiac death
DETAILS
Inadequate support: Current evidence doesnt indicate a causal relationship between risk of sudden cardiac death and COVID-19 vaccination.
KEY TAKE AWAY
Sudden cardiac death (SCD) occurs when the heart loses functionality due to changes in the hearts electrical signaling. There is no current evidence supporting a link between sudden cardiac death and COVID-19 vaccination. Myocarditis is inflammation of the heart muscle and is typically caused by infections like viruses. Studies have found a rare risk of myocarditis in young and adolescent males after the second dose of a COVID-19 mRNA vaccine. Not all cases of myocarditis lead to SCD.
This isnt the first time this policy appeared in social media posts. Some of these posts date back to July 2022, when the policy was shared in a local Facebook group. Outlets including PolitiFact and New Jersey radio station 101.5 also previously fact-checked these posts.
Sudden cardiac death (SCD) is an unexpected death that occurs in response to loss of heart function, typically within one hour of the onset of symptoms. Cardiac arrest causes the heart to stop pumping blood and can lead to SCD if not treated immediately with emergency interventions like cardiopulmonary resuscitation (CPR) and defibrillation.
Because the symptoms of cardiac arrest can begin suddenly and without warning in some people, its sometimes referred to as sudden cardiac arrest. According to the European Society of Cardiology (ESC):
Most sudden cardiac arrests occur in the community and in individuals not previously known to have increased risk. A cardiac arrhythmia, called ventricular fibrillation, causes the heart to cease pumping and blood flow stops. If blood flow is not restored in time, the individual passes out and dies within 10 to 20 minutes.
The Myocarditis Foundation and the ESC both say that sudden cardiac arrest generally cant be reliably predicted. However, some health screenings, such as stress tests or electrocardiograms, may help to identify increased risk of cardiovascular disease.
Vaccines must adhere to strict safety standards. Different phases of clinical trials are required before vaccines are licensed and distributed for public use. Vaccines are also continuously monitored for risk of side effects and adverse events after theyve been approved by the FDA.
Current evidence indicates that SCD isnt a risk of COVID-19 vaccination.
In April 2024, the CDC published a study evaluating immediate or contributing causes of death via death certificates of young adults aged 16 to 30 in Oregon[1]. The aim of the study was to determine risk of SCD among adolescents and young adults after COVID-19 vaccination.
To do this, they examined deaths that werent caused by COVID-19 and could potentially be cardiac-related. They further narrowed down the deaths of interest by looking at only deaths that had occurred within 100 days of COVID-19 mRNA vaccination. The researchers chose this time period given evidence that adverse events associated with vaccination tend to occur within 42 days of vaccination.
From these remaining death certificates, just three deaths occurred within 100 days of an mRNA COVID-19 vaccination.
The researchers determined that death in all three cases was due to natural causes. More specifically:
The first [male] death was recorded as having occurred in a natural manner 21 days after COVID-19 vaccination. The immediate cause of death noted on the death certificate was congestive heart failure attributed to hypertension [] The second decedent had received a COVID-19 vaccine dose 45 days before the date of death; the cause of death was recorded as undetermined natural cause. [] Only one of these [female] deaths occurred within 100 days of having received an mRNA COVID-19 vaccine dose; the decedent died 4 days after COVID-19 vaccination. The manner of death was recorded as natural, and the immediate cause was listed as undetermined but as a consequence of chronic respiratory failure with hypoxia attributed to mitral stenosis.[1]
A December 2023 study of Italian autopsy records also found no evidence to indicate an association between increased risk of SCD after COVID-19 vaccination[2]:
Causes of SCD in young people, including those who experienced SCD within 30 days of their COVID-19 vaccination, were consistent with prepandemic causes as established by rigorous autopsy.[2]
In 2021, Morris Sussex Direct Family Practice, a private general practitioner in Lake Hopatcong, New Jersey, instituted a new policy regarding sports physical clearance for student athletes. In the policy, the practice shared it wouldnt clear student athletes to participate in sports without additional testing if they had received a COVID-19 vaccine.
The policy claimed this was a precautionary measure due to worldwide experience and vaccine adverse event monitoring. The practice still lists this policy on its website.
The policy may stem from concerns about the alleged link between myocarditis, COVID-19 vaccination, and sudden death. Science Feedback addressed this alleged link in previous claim reviews. As we explained, COVID-19 is a higher risk factor for myocarditis than COVID-19 vaccination.
Science Feedback reached out to Anthony Lucatorto, the physician who runs the practice, to verify the reasons for putting the new sports physical policy into place. His office confirmed that the policy was put into place in 2021, but did not provide specific reasons for instituting it. We will update this review if new information becomes available.
Claims that COVID-19 vaccines increase the risk of SCD may be due to a conflation of SCD with myocarditis, a known side effect of COVID-19 mRNA vaccination.
Myocarditis is inflammation of the heart muscle. Its a rare condition generally caused by viruses or infections, including COVID-19. While myocarditis often resolves with treatments such as rest and medication, it can sometimes permanently damage the heart muscle. This damage can introduce complications in the hearts ability to pump blood and in some cases may lead to cardiac arrest and SCD.
Concerns regarding the risk of myocarditis after COVID-19 vaccination initially arose in April 2021 after reports of myocarditis surfaced in the Vaccine Adverse Event Reporting System (VAERS). VAERS data is used to identify potential patterns and safety problems with vaccines approved for use in the U.S.
As indicated in Figure 1 below, males aged 12 to 24 most commonly reported an incident of myocarditis to VAERS following COVID-19 vaccination. Reports of myocarditis among individuals within these age- and sex-stratified groups were highest after receiving a second dose of an mRNA COVID-19 vaccine.
Figure 1 VAERS data of reported rates of myocarditis following mRNA COVID-19 vaccination as of 26 May 2022. Source: U.S. Food and Drug Administration (FDA)
The CDCfurther shared:
Though cases of myocarditis and pericarditis are rare, when cases have occurred, they have most frequently been seen in adolescent and young adult males within 7 days after receiving the second dose of an mRNA COVID-19 vaccine.
Several published studies have since shown there is indeed a rare risk of myocarditis after COVID-19 mRNA vaccination in young and adolescent males[3-7]. However, this association doesnt automatically mean that vaccinated people also run a higher risk of SCD. As explained earlier in this claim review, current evidence doesnt indicate a risk of SCD following COVID-19 vaccination.
Social media posts implying that COVID-19 mRNA vaccines cause SCD, based on a clinics policy of screening athletes heart health post-COVID vaccination, are unsubstantiated and misleading. Current evidence doesnt support an association between an increased risk of SCD and COVID-19 vaccination. While myocarditis is a known risk factor of COVID-19 mRNA vaccination among young and adolescent men, conflating myocarditis risk and SCD, or assuming that all cases of myocarditis lead to SCD, is misleading.
Presidential hopeful Robert F. Kennedy Jr. made an appearance onReal Time with Bill Maher on Friday, pushing back on claims that he is anti-vaccine.
Maher began the segment by pressing Kennedy on running mate Nicole Shanahan, who spoke out against the Moderna vaccine.
Shes not gonna . . . I think those vaccines need to . . . We need to have, again, true double blind placebo control trials, Kennedy struggled to explain.
Notably, the results of a phase III double-blind clinical trial of the Moderna vaccine were published in 2021.
Kennedy went on to discuss vaccine skepticism in the American public, possibly fueled by claims he made, saying,Theres 25% of Americans who believe that they know somebody who was killed by a COVID vaccine.
Its true that a 2023 poll concluded that 34% of Americans believe COVID vaccines have contributed to deaths. Although, beyond their initial FDA clearance, multiple studies have shown that COVID vaccines are safe.
Kennedy then spouted a debunked claim that those who took the Pfizer vaccine in a clinical trial saw a 23% increase in death rate.
Maher, who said he himself was an early skeptic, touted the effectiveness of the vaccine in response to Kennedys and, eventually, the twocame to an agreement, with Maher arguing for mak[ing] it a case by case basis.
The pairs shared agita with vaccine mandates is in contrast with scientists, who hold that a large threshold of populations must be vaccinated for them to be maximally effective.
Im not anti-vaccine, Kennedy said. Im called that because its a way of silencing me.
Kennedys long history of vaccine skepticism was reported on in a 2005 article originally published by Salon, in which he argued that a link between compounds in vaccines and autism existed. The article was retracted after evidence suggesting critical errors and potential fraud in the cited studies emerged.
Watch RFK Jr. on "Real Time" here:
Bill Maher took presidential candidate Robert F. Kennedy Jr. to task on Fridays episode of Real Time with Bill Maher, over his and his running mates persistent efforts to spread anti-vaccine misinformation.
Maher has consistently platformed RFK Jr. throughout his presidential campaign, touting his guts and integrity, as hes promulgated misinformation about COVID-19 vaccines. The presidential candidate's unsavory anti-vax rhetoric was once again pushed to the forefront of his campaign, when his running mate Nicole Shanahan called for a recall of the Moderna vaccine, earlier this month. Apparently the comment didnt sit so well with Maher.
But your Vice Presidential pick wants to recall the Moderna vaccine, thats the one I got, said Maher, who looked out onto the laughing audience. Do you agree with that? Recall it?
Appearing to be taken off-guard, RFK Jr. sputtered in response. I think those vaccines need to, we need to have again true double-blind placebo controlled trials on that, he said. There is 25 percent of Americans who believe that they know somebody who was killed by a Covid vaccine.
Killed? Maher asked.
Killed. 25 percent of Americans. 52 percent of Americans believe that the vaccines are causing injuries, including death. 52 percent, RFK Jr. responded. He then dove into describing the results of the Pfizer vaccines clinical trial study, but his argument was less than convincing to the talk show host.
People who got the vaccine had a 23 percent higher death rate, from all causes, at the end of that study, RFK Jr. said.
That could not be the disease itself? Maher asked, incredulously.
If it is, then the vaccine doesnt work, RFK Jr. said. The audience began applauding, but Maher quickly shut it down, forced to fact-check his friend in Real Time.
Well, no no, thats not, thats not true at all, he said. And Im someone who did not want to get the vaccine, and didnt think I should have been made to get it. But it does work. Maher contended that the vaccine had only killed, mostly the obese and the very elderly.
Most people are alive today, I think, because of the vaccine. I think thats the truth. Does it also have complications? Yes, he said. But they couldve had worse issues if they got the disease.
RFK Jr. went on the defensive. I think that [if] people want vaccines, they should be able to get it, Im not anti-vaccine, he said.
Well people think you are, Maher replied.
In response, the presidential candidate, who had just spouted blatant misinformation about vaccines, argued that that term is often used to silence him. RFK Jr. instead clarified that he is simply against vaccine mandates, an essential tool in ensuring that vaccines can work the most effectively.
The world has become a much safer place to be a young child in the last 50 years. Since 1974, infant mortality worldwide has plummeted. That year, one in 10 newborns died before reaching their first birthday. By 2021, that rate had fallen by over two-thirds.
A lot of factors drove this change: lower poverty and better nutrition, cleaner air and water, and readily available antibiotics and other treatments. But one of the biggest contributors, a new study from the World Health Organization (WHO) concludes, was vaccines.
Vaccines alone, the researchers find, accounted for 40 percent of the decline in infant mortality. The paper authored by a team of researchers led by WHO epidemiologist and vaccine expert Naor Bar-Zeev estimates that in the 50 years since 1974, vaccines prevented 154 million deaths.
Of that 154 million, 146 million lives saved were among children under 5, including 101 million infants. Because the averted deaths were so concentrated among young people, who on average would go on to live for 66 years, vaccines gave their beneficiaries an astounding 9 billion additional years of life.
The paper was commissioned on the 50th anniversary of the WHOs Expanded Programme on Immunization, which launched in 1974 to build on the success of the agencys work eradicating smallpox. It covers a critical period of time. The previous decades had seen a spree of important, newly developed vaccines: a joint diphtheria, pertussis, and tetanus vaccine in 1948, a polio vaccine in 1955, a measles vaccine in 1963. While rolled out quickly in wealthy countries, these immunizations were, as of 1974, not broadly available in the Global South, even as the diseases they prevented wreaked massive damage.
Over the ensuing half-century, through vaccination campaigns led by the WHO and later Gavi (a multilateral group formerly called the Global Alliance for Vaccines and Immunization), that changed radically. In sub-Saharan Africa in 2021, 68 percent of 1-year-olds received a first dose of the measles vaccine, 78 percent received the tuberculosis vaccine, and 7071 percent received the vaccines against hepatitis B, polio, and diphtheria/tetanus/pertussis.
This progress yielded massive gains. The measles vaccine, in particular, deserves pride of place in this story. The researchers conclude that it averted 93.7 million deaths from 1974 onward, accounting for the most deaths averted by vaccines in general. In terms of lives saved, the runners-up tetanus (28 million saved), pertussis (13.2 million), and tuberculosis (10.9 million) pale in comparison. Stamping out measles through vaccination enabled it to go from an omnipresent, fast-spreading lethal threat to a relic of the past though anti-vaccine activists threaten to undo some of that progress.
The data is a reminder that vaccines have historically been one of our best tools for saving lives and that redoubling efforts to discover and distribute new ones for diseases like malaria and tuberculosis could have a similarly transformative effect.
Studying the effect of vaccines across all continents, and across a 50-year time frame, is a daunting project. Its not for nothing that this paper has 21 authors. (And lets give them the credit theyre due. They are: Andrew Shattock, Helen Johnson, So Yoon Sim, Austin Carter, Philipp Lambach, Raymond Hutubessy, Kimberly Thompson, Kamran Badizadegan, Brian Lambert, Matthew Ferrari, Mark Jit, Han Fu, Sheetal Silal, Rachel Hounsell, Richard White, Jonathan Mosser, Katy Gaythorpe, Caroline Trotter, Ann Lindstrand, Katherine OBrien, and Naor Bar-Zeev.)
The paper is essentially combining three separate kinds of data and research results:
Put simply: They used what we know about how many people got vaccinated in the last five decades and how well vaccines work to construct a version of history where all that vaccination didnt occur, and adjusted actual death rates and health statistics accordingly.
This necessarily involves filling in some gaps in the data. They note that in many countries, our data on vaccine coverage starts in 1980, not 1974; in these places, they argue that vaccine coverage was so meager that assuming no coverage in 1974 and a steady increase thereafter is appropriate. They also conduct sensitivity analyses showing that other ways of handling this problem produce similar headline results.
The years of health life data allows another vantage point on gains from vaccination. Some diseases, like polio, are less lethal than the likes of measles but can cause lifelong negative health impacts, up to and including muscle paralysis. (For instance, while many doctors no longer think Franklin Delano Roosevelts paralysis was due to polio, it easily could have been.)
Any way you slice the data, vaccines saved a ton of lives and prevented a ton of suffering.
The past few years have been wonderful for vaccination, mostly due to the tremendously positive impact of the rapidly developed Covid-19 vaccines, but also somewhat perilous. In the US, the share of adults saying all children should be vaccinated against measles, mumps, and rubella has fallen, specifically among Republicans, a likely aftershock of how polarized the Covid vaccine issue has gotten. In that context, its important to remember just how much immunization has given us. In a half-century, its given people 9 billion additional years to live their lives. Thats nothing short of miraculous.
Yes, I'll give $5/month
Yes, I'll give $5/month
We accept credit card, Apple Pay, and Google Pay. You can also contribute via
Key points
The WHO Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC) meets regularly to assess the impact of SARS-CoV-2 evolution on the performance of approved COVID-19 vaccines. This includes meeting in person approximately every six months to determine the implications of SARS-CoV-2 evolution on COVID-19 vaccine antigen composition and to advise WHO on whether changes are needed to the antigen composition of future COVID-19 vaccines. The twice-yearly evidence review by the TAG-CO-VAC is based on the need for continued monitoring of the evolution of SARS-CoV-2 and the kinetics and protection of vaccine-derived immunity.
In May 2023, the TAG-CO-VAC recommended the use of a monovalent XBB.1 descendent lineage, such as XBB.1.5, as the vaccine antigen. In December 2023, the TAG-CO-VAC advised retaining the use of a monovalent XBB.1 descendent lineage, such as XBB.1.5, as the vaccine antigen. Several manufacturers (using mRNA, protein-based and viral vector vaccine platforms) have developed COVID-19 vaccines with a monovalent XBB.1.5 formulation which have been approved for use by regulatory authorities and introduced into COVID-19 vaccination programmes in some countries. Previous statements from the TAG-CO-VAC can be found on the WHO website.
The TAG-CO-VAC reconvened on 15-16 April 2024 to review the genetic and antigenic evolution of SARS-CoV-2; immune responses to SARS-CoV-2 infection and/or COVID-19 vaccination; the performance of currently approved vaccines against circulating SARS-CoV-2 variants; and the implications for COVID-19 vaccine antigen composition.
The published and unpublished evidence reviewed by the TAG-CO-VAC included: (1) SARS-CoV-2 genetic evolution with support from the WHO Technical Advisory Group on SARS-CoV-2 Virus Evolution (TAG-VE); (2) Antigenic characterization of previous and emerging SARS-CoV-2 variants using virus neutralization tests with animal antisera or human sera and further analysis of antigenic relationships using antigenic cartography; (3) Immunogenicity data on the breadth of neutralizing antibody responses elicited by currently approved vaccine antigens against circulating SARS-CoV-2 variants using animal and human sera, including modelling data; (4) Vaccine effectiveness estimates (VE) of currently approved vaccines during periods of circulation of XBB.1 and JN.1 lineages; (5) Preliminary immunogenicity data on immune responses following infection with circulating SARS-CoV-2 variants; and (6) Preliminary preclinical and clinical immunogenicity data on the performance of candidate vaccines with updated antigens shared confidentially by vaccine manufacturers with TAG-CO-VAC. Further details on the publicly available data reviewed by the TAG-CO-VAC can be found in the accompanying data annex. Unpublished and/or confidential data reviewed by the TAG-CO-VAC are not shown.
The TAG-CO-VAC acknowledges several limitations of the available data:
As of April 2024, nearly all circulating SARS-CoV-2 variants reported in publicly available databases are JN.1 derived variants. As virus evolution is expected to continue from JN.1, future formulations of COVID-19 vaccines should aim to induce enhanced neutralizing antibody responses to JN.1 and its descendent lineages. One approach recommended by TAG-CO-VAC is the use of a monovalent JN.1 lineage (GenBank: OY817255.1, GISAID: EPI_ISL_18538117, WHO Biohub: 2024-WHO-LS-001) antigen in vaccines.
The continued use of the current monovalent XBB.1.5 formulation will offer protection given the neutralizing antibody responses to early JN.1 descendent lineages, and the evidence from early rVE studies against JN.1. However, it is expected that the ability for XBB.1.5 vaccination to protect against symptomatic disease may be less robust as SARS-CoV-2 evolution continues from JN.1. Other formulations and/or platforms that achieve robust neutralizing antibody responses against currently circulating variants, particularly JN.1 descendent lineages, can also be considered.
In accordance with WHO SAGE policy, vaccination programmes should continue to use any of the WHO emergency-use listed or prequalified COVID-19 vaccines and vaccination should not be delayed in anticipation of access to vaccines with an updated composition. WHO stresses the importance of access to and equity in the use of all available COVID-19 vaccines.
Given the limitations of the evidence upon which the recommendations above are derived and the anticipated continued evolution of the virus, the TAG-CO-VAC strongly encourages generation of data on immune responses and clinical endpoints (i.e. VE) on the performance of all currently approved COVID-19 vaccines against emerging SARS-CoV-2 variants, and candidate vaccines with an updated antigen over time.
As previously stated, the TAG-CO-VAC continues to encourage the further development of vaccines that may improve protection against infection and reduce transmission of SARS-CoV-2.
A new mouth-spray vaccine reportedly stops urinary tract infections (UTIs) from coming back again and again, as can happen in many people prone to the condition.
The pineapple-flavored vaccine, called Uromune, has so far been tested in one study without a placebo group and one completed gold-standard clinical trial. Both studies suggest that, for more than half of the participants, the vaccine helped ward off recurrent UTIs for months. It will need more testing to be fully approved but shows promise.
"Vaccines would be a game changer for a huge number of people who are, at the moment, stuck with long-term UTIs and there's nothing that can help them," Jennifer Rohn, a researcher who specializes in renal medicine at University College London and was not involved in the studies, told Live Science.
UTIs can cause debilitating pain; abdominal cramping; and an urge to urinate when you don't need to. Approximately 50% of women will have a UTI at least once in their life; of those, 22% will experience recurrent infections.
Women are about 30 times more likely to get UTIs than men.
Related: Dangerous 'superbugs' are a growing threat, and antibiotics can't stop their rise. What can?
Many patients who develop UTIs repeatedly are prescribed preventive antibiotics to help reduce their risk of future infections. Yet research shows that heavy reliance on antibiotics has led to the emergence of multidrug-resistant bacteria. Plus, antibiotics can wipe out helpful bacteria in the body along with the disease-causing kind.
Get the worlds most fascinating discoveries delivered straight to your inbox.
UTI vaccines could offer an alternative approach, and Uromune is one such vaccine. The spray contains a mixture of the four bacteria most commonly responsible for recurrent UTIs: Escherichia coli, Klebsiella pneumoniae, Enterococcus faecalis and Proteus vulgaris.
"Together, they make up about 88% of urinary tract infections," Dr. Glenn Werneburg, a physician-scientist at the Cleveland Clinic who was not involved in the studies, told Live Science. For the vaccine, these bacteria are inactivated by heat so that the proteins on their surface are still intact and thus can be identified by the immune system.
The vaccine is sprayed under the tongue because exposing the base of the tongue, the tonsils and the roof of the mouth is thought to trigger a strong immune response in "mucosal" tissues. These include the lining of the urinary tract and bladder, Werneburg said.
Scientists first tested the vaccine in a U.K.-based trial of 75 female participants; there was no comparison group that didn't use the spray. In that study, 59% of the women who used the spray daily for three months had no subsequent UTIs for the following year. These participants had experienced three or more UTIs in the year prior to receiving the vaccine.
In a second phase of the study, the scientists followed up with nearly 40 of the original participants, and they also added 17 men to the trial. In that group they found that, for 48 of them, the vaccine was still very protective nine years after its initial administration. These participants had remained UTI-free over that period and had no adverse effects.
On average across the whole group, all the patients remained UTI-free for about 55 months, or about 4.5 years.
The findings of this study were presented at the European Association of Urology Congress in Paris on April 6. Uromune has also been tested in one gold-standard clinical trial with a placebo group. In that trial, 56% and 58% of women who used the spray for three and six months, respectively, remained free of UTIs for up to nine months, compared to only 25% of the placebo group.
"I'm excited about these findings because it's more evidence that this vaccine may be an excellent alternative for these patients," Werneburg said.
Both the trials had limitations. For instance, the vaccine has only been tested for uncomplicated UTIs, meaning infections that don't involve catheters, fever, the kidneys or other complicating factors, for example.
"Some of the people who are most prone to infection are people with neurogenic lower urinary tract dysfunction and people with chronic indwelling catheters," Werneburg said. "I really look forward to trials that assess the vaccine's safety and efficacy in these populations."
Not everyone responded to the vaccine in these initial trials. But "given how complicated UTI is and how every patient has something different going on different bugs, different immune systems half of the people responding is actually really good," Rohn said.
One possible reason some patients did not respond could be that they were infected by types of bacteria not included in the vaccine. Bacteria can also hide from the immune system and antibiotics by sticking to the bladder wall and coating themselves with a slimy shield. Other UTI vaccines being tested in mice could potentially target these germs.
Uromune has not yet been approved by the Food and Drug Administration for any use in the U.S. However, currently, it's available for compassionate use in 26 countries, meaning it's available to people who aren't enrolled in a formal trial but who haven't responded to other treatments. Time will tell if it will earn full approval for UTI prevention.
This article is for informational purposes only and is not meant to offer medical advice.
Ever wonder why some people build muscle more easily than others or why freckles come out in the sun? Send us your questions about how the human body works to community@livescience.com with the subject line "Health Desk Q," and you may see your question answered on the website!
Media Advisory
Saturday, April 27, 2024
Study highlights need for defined markers of mpox immunity to inform public health use.
A dose-sparing intradermal mpox vaccination regimen was safe and generated an antibody response equivalent to that induced by the standard regimen at six weeks (two weeks after the second dose), according to findings presented today at the European Society of Clinical Microbiology and Infectious Diseases Global Congress in Barcelona. The results suggest that antibody responses contributed to the effectiveness of dose-sparing mpox vaccine regimens used during the 2022 U.S. outbreak.
The mpox virus has been present in west, central and east Africa for decades, with the first human case identified in 1970. In May 2022, a global mpox outbreak caused by the clade IIb strain of the virus provided the first epidemiologic evidence of community mpox transmission outside of historically affected countries. The Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN, sold as JYNNEOS) vaccine was made available to help contain the outbreak in the United States. The National Institutes of Healths (NIH) National Institute of Allergy and Infectious Diseases (NIAID) sponsored a study of dose-sparing strategies to extend the limited vaccine supply.
The mid-stage study enrolled 225 adults aged 18 to 50 years in the United States who had not previously been vaccinated against mpox or smallpox. Participants were randomized to receive either the standard Food and Drug Administration-approved MVA-BN regimen, a regimen containing one-fifth of the standard dose, or one with one-tenth of the standard dose. The standard dose was injected under the skin (subcutaneously), while the dose-sparing regimens were injected between layers of the skin (intradermally). Participants in all study arms received two injections 28 days apart and were monitored for safety and immune response.
Two weeks after the second dose (study day 43), participants who received one-fifth of the standard dose had antibody levels equivalent to those of participants receiving the standard MVA-BN regimen, based on predefined criteria. By day 57, participants who received one-fifth of the standard dose had lower antibody levels than those in the standard regimen arm; the clinical significance of this difference is unknown. Participants who received one-tenth of the standard dose had inferior antibody levels at all measurements. The most reported adverse events were mild, local injection-site reactions. Adverse events were similar across all arms of the trial, and no serious adverse events related to the vaccine were reported.
The authors note that because there are no defined correlates of protection against mpoximmune processes confirmed to prevent diseasethese findings cannot predict the efficacy of dose-sparing regimens with certainty. Real-world data from the Centers for Disease Control and Prevention and others have shown similar vaccine effectiveness for the dose-sparing regimen given intradermally and the standard regimen given subcutaneously. A study of the standard MVA-BN regimen in adolescents is ongoing and will report findings later this year.
NIH is grateful to the research sites and volunteers who participate in studies to improve the mpox response.
For more information about this study, please visit ClinicalTrials.gov and use the identifier NCT05512949.
Frey et al. Safety and Immunogenicity of Fractional Doses of Modified Vaccinia Ankara-Bavarian Nordic. European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Global Congress in Barcelona, Spain. Saturday, April 27, 2024.
Andrea Lerner, M.D., M.S., medical officer in NIAIDs Division of Microbiology and Infectious Diseases, is available to discuss this research.
NIAID conducts and supports researchat NIH, throughout the United States, and worldwideto study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
NIHTurning Discovery Into Health
###
the-daily-record.com wants to ensure the best experience for all of our readers, so we built our site to take advantage of the latest technology, making it faster and easier to use.
Unfortunately, your browser is not supported. Please download one of these browsers for the best experience on the-daily-record.com
Independent presidential candidate Robert F. Kennedy Jr. said an interview excerpt of him saying there is no vaccine that is safe and effective has been misused Friday.
I made that statement on Lex Fridman[s] podcast, Kennedy said on HBOs Real Time with Bill Maher Friday.
Yes, host Maher responded.
And, it was an answer to a question that Lex had asked me about, Are there any vaccines and if you go back and look at this, cause that statement has been misused, I would never say that, Kennedy continued. What I said was, he asked me Are there any vaccines that are safe and effective? And I said, It appears like some of the live virus vaccines, appear to be both safe and effective.
And then I said, Theres no vaccines that are safe and effective, and I was gonna continue that sentence, If you ask for the product to be measured against other medical products with placebo-controlled double-blind studies. Lex interrupted me.
In an episode of Fridmans podcast from July 2023, Kennedy said that some of the live virus vaccines are probably averting more problems than theyre causing, when asked if he can name any vaccines that he thinks are good.
Theres no vaccine that is safe and effective, Kennedy continued, before Fridman started speaking again.
Kennedy has faced criticism in the past for his anti-vaccine activism, including from members of his own family. His niece, Maeve Kennedy McKean, and siblings former Maryland Lt. Gov. Kathleen Kennedy Townsend (D) and former Rep. Joseph P. Kennedy II (D-Mass.) said in a Politico column that his anti-vaccination work is wrong and dangerous in a Politico column from 2019.
The challenge for public health officials right now is that many people are more afraid of the vaccines than the diseases, because theyve been lucky enough to have never seen the diseases and their devastating impact, the three wrote.
But thats not luck; its the result of concerted vaccination efforts over many years. We dont need measles outbreaks to remind us of the value of vaccination.
Kennedy told Maher during the Friday night appearance he is not anti-vaccine, but that the label is a way of silencing him.
Im called that because its a way of silencing me, but I have said for 17 years, Im not anti-vaccine. I just want good science. People should be able to make informed choices, Kennedy said.
I am against vaccine mandates, Kennedy added.
For the latest news, weather, sports, and streaming video, head to The Hill.
