Category: Corona Virus Vaccine

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Despite vaccine shortages, many younger people in New York City accessed vaccines ahead of schedule, particularly in high-income areas, according to new research at Columbia University Mailman School of Public Health.

Low-income areas with high proportions of older people demonstrated lower coverage rates than wealthier areas in the first three months of vaccine rollout, and higher mortality over the year. The findings are published in the Journal of Urban Health.

"A vaccine program that prioritized those at greatest risk of COVID-19-associated morbidity and mortality would have prevented more deaths than the strategy that was implemented," said Nina Schwalbe, adjunct professor of population and family health at Columbia Mailman School.

"When rolling out a new vaccine, policymakers must account for local conditions of high-risk population groups. If New York had focused limited vaccine supply on low-income areas with high proportions of residents 65 or older, overall mortality might have been lower."

The researchers describe the rollout plan and the timetable for the various groups and when they received their vaccinations. Beginning on December 14, 2020 New York administered its first vaccines to high-risk hospital workers, leading to all adults 70 years and older (on January 4, 2021), 60 and older (10 March 2021); 50 and older (23 March) and all adults 30 years and older (on March 30 2021).

During this period, the New York State Department of Health in collaboration with the New York City Department of Health and Mental Hygiene delivered vaccines primarily through fixed-point mass vaccination sites.

The researchers analyzed linked Census Bureau data and New York City Health administrative data aggregated at the level of modified zip code tabulation areas (MODZCTA). Race, income, and age data by MODZCTA were obtained from the US Census Bureau. Calculations were based on COVID-19 mortality rates per 100,000 population in each MODZCTA from December 1, 2020 to December 31, 2021.

"In New York, as elsewhere, the probability of dying from COVID-19 was not equally distributed across the population. The single greatest risk factor for COVID-19-related mortality was older age; low-income households were also particularly vulnerable," noted Schwalbe.

By the last week of March, the mean vaccination rate for 65+ ranged from 53 percent in the poorest quintile to 75 percent in the wealthiest. The maximum coverage was 99 percent among those 65+ in the wealthiest area versus 68 percent in the poorest. One year later when vaccines were widely available, 65+ residents had median vaccination coverage exceeding 87 percent, including in the lowest wealth area.

"Our analysis explores whether New York widened vaccination eligibility too quickly in the face of vaccine shortages rather than focusing first on those at higher risk, begging the question of whether older New Yorkers living in low-income communities would have been better served in the face of COVID-19 vaccine shortages if distribution had been targeted toward them," noted Schwalbe.

At a time when vaccine supply was still limited, many lower-risk, younger people accessed vaccines ahead of schedule, particularly in high-income suggesting "misallocation" of doses that could have been provided to older people, who had higher case fatality rates, according to Schwalbe and colleagues, which could have been corrected by authorities through more stringent enforcement of state mandated guidelines on distribution criteria.

"While it is plausible that access for younger people was granted to those in scheduled professions or having underlying health risks, this is unlikely to account for the magnitude of difference between low and high-income zip codes," noted Schwalbe.

"Our analysis provides clear evidence of why U.S. policymakers must target their distribution approach to providing access to lifesaving technologies in short supply, focusing first on those most at risk of severe morbidity and mortality."

Co-authors are Marta C Nunes, Medical Research Council, University of the Witwatersrand, Johannesburg, and Center of Excellence in Respiratory Pathogens, Hospices Civils de Lyon, and Centre International de Recherche en Infectiologie, Universit Claude Bernard Lyon 1, Inserm; Clare Cutland, University of the Witwatersrand; and Brian Wahl, Johns Hopkins Bloomberg School of Public Health; and Daniel Reidpath, Queen Margaret University, Edinburgh and Monash University.

More information: Journal of Urban Health (2024). DOI: 10.1007/s11524-024-00853-z

Journal information: Journal of Urban Health

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Study finds many younger people from high income neighborhoods jumped the eligibility queue for COVID-19 vaccines in NYC - Medical Xpress

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As unprecedented as the outbreak of COVID-19 felt, it was far from the first time a deadly disease has swept the globe. Historians have identified epidemics and pandemics dating as far back as 430 B.C. Records tell us how these diseases spread and how many people died, but not people's personal experiences of the crises.

COVID-19 presented a rare opportunity to document in real-time how people processed the tumult of a pandemic, and how necessary public health measures affected their lives. Starting in the earliest days of the 2020 outbreak, a team of researchers at the University of Washington conducted real-time surveys of King County residents, asking what measures people had taken to protect themselves, how their daily lives had been affected and what worried them most.

The results, published in the journal PLOS One, provide a glimpse into the subtle effects that public health measures like social distancing and stay-at-home orders had on the community.

UW News spoke with Kathleen Moloney, research scientist at the UW Collaborative on Extreme Event Resilience, and Nicole Errett, a UW assistant professor of environmental and occupational health sciences and director of the new Center for Disaster Resilient Communities, to discuss the study, how people experienced those early months and what public health practitioners can learn for future pandemics.

Kathleen Moloney: Unfortunately, COVID-19 is unlikely to be the last pandemic we face. To fully understand this pandemic's impacts and better prepare for the next, we need research studies like ourswhere data was collected in real time, from March to May of 2020that document the lived experiences of communities during the pandemic. For example, by documenting how people in King County experienced the social distancing measures in real-time, our study provides valuable insights into which negative impacts were most acute during the early stages of the pandemic.

Our results, combined with evidence from other research studies, can provide direction for researchers and policymakers to explore effective interventions for future pandemics.

Nicole Errett: It is really important to start collecting data in the immediate aftermath of a disaster to understand effects on health and well-being, but researchers face a variety of administrative, logistical and ethical challenges when designing rapid-response research studies. By sharing our approach in this paper, we can provide ideas and guidance for other investigators while designing studies for future disasters, whether those are caused by an infectious disease or natural hazard.

KM: During the height of the COVID-19 pandemic, we often heard comparisons to the 1918 influenza pandemic, as closures of schools, businesses and other community gathering spaces were implemented in response to both. However, it isn't really possible to compare the experiences of those who lived through COVID-19 with those who lived through the 1918 Flu and other pandemics throughout history, because there weren't any research studies conducted at the time to document those experiences. That's why rapid-response disaster research, like our study, is so important.

KM: I don't think of protecting public health and individual well-being as opposing priorities that need to be balanced. Public health, as a field, is dedicated to protecting and improving the health and well-being of the individuals that make up communities.

Disruptions to employment and schooling can negatively impact long-term health outcomes, and ideally, these potential consequences should be considered when thinking through the type and duration of social distancing measures. Unfortunately, all the empirical research needed to inform those decisions was limited prior to this pandemic.

KM: I want to give the caveat that our survey only captured participants' self-reported behavior at a single point in time. For example, someone who responded to the survey on March 19th, 2020, that they had not stopped going to the gym might have stopped the next week, when the statewide Stay Home, Stay Safe order was issued. Our survey was also a convenience sample, and therefore shouldn't be considered representative of the compliance of King County residents as a whole with various social distancing recommendations.

With that said, those numbers were still slightly surprising. The narrative we often hear of public acceptance of COVID-19 social distancing measures is that compliance was initially high, and then decreased over time due to factors such as message fatiguethere's research documenting this phenomenon. We need additional research to confirm this, but our results might indicate that there was also an initial lag in compliance with the social distancing recommendations implemented in response to COVID-19.

Overall, these measures still appear to have been effective, despite imperfect or slightly delayed compliance among certain residents.

NE: At the time of our survey, our understanding of disease transmission was still evolving. It's possible that people took measures they thought were protective (like hand washing) while attending these gatherings, based on their understanding of transmission at the time. It would have been interesting to re-survey folks at various time points throughout the pandemic to see how their behavior evolved as the pandemic, and our understanding of the disease, progressed.

KM: Two findings surprised me in particular. First, less than half of our participants described impacts to their social lifeI expected the percentage to be much higher. It would be interesting to know how that result might change if we surveyed the same participants at a later point in the pandemic, when social distancing measures had been in place for longer.

I was also surprised to see the poorest average well-being reported by those over the age 65, and the highest average well-being reported by 18-to-34 year olds. This is in contrast to several other national-scale studies in the US and Europe, which found worse mental health impacts in young adults.

Given that older adults are more likely to reside alone in the U.S. than in most other countries and report high rates of social isolation and loneliness even during non-pandemic times, interventions to mitigate the mental health impacts of future pandemics on older adults probably deserve special attention.

KM: Knowing which negative impacts are most prevalent at various points in the pandemic, and how these impacts differ between groups, can help us develop more specific, more effective interventions to prevent these unintended consequences in the future. We saw that employment and financial impacts were the top concern for every age group except those 65 and olderthis group expressed higher concern about physical health and social impacts. So while an early intervention to mitigate the financial impacts of a future crisis on younger adults could be effective, we would likely want to prioritize different resources for older adults.

What's also interesting is that many of the concerns our participants reported, both in written narratives and the close-ended survey questions, were about impacts to others, rather than themselves.

Concern and empathy for fellow community members' well-being is something that we should want to cultivate for many reasons, but specifically in a pandemic context, there's evidence that decreased concern for others' well-being is correlated with decreased compliance with non-pharmaceutical interventions. Something we should also think about while preparing for future crises is how we can foster the concern for others and the sense of community that were clearly present during the early stages of the pandemic to make sure they endure.

NE: The pandemic influenced the developmentor at least accelerated the uptakeof systems that allowed many folks to work safely from the comfort of their own home without financial or employment impacts. However, folks with jobs in "essential" services and sectors often had to physically report to work, and often interface with the public.

My colleague, Marissa Baker, found that folks that couldn't work from home are lower paid. Accordingly, I'd suspect that employment and financial concerns would be disproportionately borne among lower wage workers, who would have to choose between their health and safety and their income. In advance of the next pandemic, we need to figure out ways to keep these folks safe and at work.

More information: Kathleen Moloney et al, Assessing community-level impacts of and responses to stay at home orders: The King County COVID-19 community study, PLOS ONE (2024). DOI: 10.1371/journal.pone.0296851

Journal information: PLoS ONE

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Researchers discuss the unseen community effects of COVID-19 stay-at-home orders - Medical Xpress

R. Jude Samulski, one of the fathers of gene therapy, argues that rare diseases should be treated free of charge: With what we learn from them, we can treat the rest of the world for more complex diseases, he said in an interview with EL PAS. Rare diseases affect very few people and are often caused due to a single genetic mutation. This makes them an ideal target for gene therapies. This type of treatment takes advantage of the ability of viruses to hijack the cellular machinery of living beings, modifying them and using them as a means of transport to introduce the protein that is missing due to a mutation. During the pandemic, another technique capable of inciting the organism to produce molecules with therapeutic capacity was applied on an unprecedented scale. Messenger RNA technology makes it possible to design an RNA in the laboratory with instructions for making a piece of virus as in Covid vaccines or a protein that is missing because of a genetic disease.

On Wednesday, a paper published in the journal Nature laid out the results of a preliminary trial to treat a rare disease with injections of messenger RNA. The targeted disease is propionic acidaemia, an ailment that affects one in 100,000 babies, and which is caused by mutations in the PCCA and PCBB genes. These defects prevent the body from producing the enzymes needed to break down food properly and facilitate the accumulation of substances with toxic effects. The first symptoms appear, in many cases, from birth, in the form of vomiting, dehydration or eating difficulties. Gradually, damage to the brain and the nervous system, growth retardation, arrhythmias or recurrent pancreatitis appear. For the time being, apart from liver transplantation, there are only palliative treatments and many affected babies die within their first year of life.

The experimental treatment, called mRNA-3927 and produced by the biotechnology company Moderna, one of the manufacturers of the Covid vaccines, is designed to restore the production of the absent enzymes by introducing the instructions for their manufacture into the liver of the patients. This early-stage study tested the efficacy and safety of the therapy in 16 people between the ages of one and 28. In eight of the patients, the metabolic decompensations caused by the disease were reduced by 70%. Although side effects such as vomiting or diarrhea were observed, the safety of the therapy is not considered to be a problem. However, the authors acknowledge that the small number of patients treated makes it difficult to assess whether the results are significant.

Gloria Gonzlez, Director of Innovation and Transfer at the Center for Applied Medical Research at the University of Navarre and a specialist in gene therapy for liver diseases, considers that there is an undeniable medical need for this type of treatment and that the work presented in Nature offers a very promising alternative. However, the researcher believes that there is a lack of information. I am interested in knowing what effects this treatment has on parameters that go beyond metabolic decompensation, to see if they gain weight or if they have a better quality of life, she says. There are other factors that make it difficult to assess if the treatment can be useful in combating the disease. Some patients are past adolescence, which means they have milder versions of the disease and the therapeutic effect may be pronounced in them than in patients with more severe symptoms. Additionally, the authors of the research are looking for a therapeutic dose, which they believe would be the highest. If the [clinical endpoint] is decompensation events and in the last cohort [in which the highest dose is tested] you dont have any events, its difficult for you to conclude what the therapeutic dose is, explains Gonzalez.

From a practical point of view, Gonzlez points out that the application of these injections which would have to be performed every two weeks throughout a patients life in a hospital suggests that it would be an expensive and complex treatment, a disadvantage compared to gene therapies, the effects of which can last for years. A treatment for propionic acidaemia is of most interest in young children, when the life-long effects of the disease can still be avoided. I would like to see if the patients clinical condition can be reversed if they have a better quality of life much more than other parameters. The fact that they dont mention anything in the article leads me to think that the effects they have seen have not been so dramatic, Gonzalez concludes.

Ignacio Prez de Castro, director of the Gene Therapy Unit at the Institute for Rare Diseases Research in Madrid, values the safety of the therapy presented by the Moderna team, although it carries the disadvantage that it would be a lifelong treatment. Although gene therapies with viruses are more durable, they present more risks and are not usually administered at very young ages unless there is no alternative. This would make it possible that messenger RNA therapies could be used in combination with other more durable therapies, to avoid the appearance of damage before a gene therapy can be applied. Prez de Castro also points out that a therapy such as mRNA-3927 is useful for liver diseases, but it is much more difficult for the lipid particles [that carry the RNA] to reach muscle or nerve tissue, something that will make it difficult to extend its use to other rare diseases.

Dwight Koeberl, a pediatrician at Duke University Hospital and co-author of the study, acknowledges that mRNA therapy would have a potential downside if there were a gene therapy available that treated propionic acidaemia. For now, the only stable treatment available is liver transplantation, which is not readily available. Giving RNA infusions seems reasonable in the current situation, if the therapy successfully treats propionic acidaemia, he adds. Studies will still be necessary to verify that this condition is met.

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Trial tests Covid vaccine technology against a rare disease that affects babies - EL PAS USA

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Scientists have developed a machine-learning approach to track the evolution of SARSCoV2, the virus that causes COVID-19, and potentially other viruses, according to a study published in the Proceedings of the National Academy of Sciences.

Since the onset of the COVID-19 pandemic, 1,185,413 people in the United States have died from the virus, according to data collected by the Centers for Disease Control and Prevention.

RNA viruses, such as SARSCoV2, mutate rapidly once inside a host. Most RNA viruses including HIV-1 or influenza acquire a high number of mutations to the point where, in many cases, no two copies of the virus inside one person have the exact same genome.

These mutated strains can then jump to the general population, pushing forward the evolution of these viruses at a global level. While SARSCoV2 has been reported to mutate at lower rates compared to similar viruses, it has shown a high capacity to evolve with new variants appearing suddenly instead of progressively.

This observation challenges the previous idea of low mutation capacity of SARS-CoV-2, said Ramon Lorenzo-Redondo, Ph.D., assistant professor of Medicine in the Division of Infectious Diseases and bioinformatics director of the Center for Pathogen Genomics and Microbial Evolution (CPGME), who was a co-author of the study.

The origins of these highly mutated variants such as omicron, which acquired a very high number of mutations rapidly, is still poorly understood, he said.

In the study, Lorenzo-Redondo and his collaborators applied a novel next-generation sequencing method to sequence the genome of SARS-CoV-2 from thirty individual nasal swab samples obtained within a 19-day window.

With this new method, developed by senior study author Esteban Domingo, Ph.D., and study co-author Celia Perales, Ph.D., investigators at the Spanish National Research Council, the team was able to capture a wide representation of every mutant of the virus present inside each patient. This way, they could study if minority mutations generated inside an infected patient could be the origin of mutations that later get transferred to the general population.

Then, utilizing a machine-learning model first developed by Lorenzo-Redondo and Soledad Delgado, Ph.D., associate professor at the Polytechnical University of Madrid, the investigators visualized genetic data from the samples into maps which showed the many variations of the virus inside a single host and charted their predicted survival and proliferation in relation to the other variants.

The technique may allow scientists to track how viruses like SARS-CoV-2 evolve over time inside a single person and predict dangerous mutations, Lorenzo-Redondo said.

"With this technique, we can go deeper. We can analyze evolution and analyze how the virus is adapting to a person and how it evolves to counter the immune system," Lorenzo Redondo said. "Some of these adapted viruses then might become important at a population level."

By sequencing SARS-CoV-2 inside an individual, investigators observed how the virus "tested" a mutation in its spike protein in some individuals, which has been reported to alter viral entry. This specific spike protein mutant variant was a small subset inside of some of these hosts, but subsequently, it quickly overtook other variants due to its superior infectivity and became the dominant strain globally during the first months of the pandemic.

The findings may explain how new variants materialize and jump from person to person and become dominant, strengthening the entire viral population, Lorenzo Redondo said.

"This is very interesting because it seems to suggest that all these big jumps that we see, for example in the omicron wave of COVID-19, might be happening at the intra-host level in multiple patients at the same time and then get transferred to the general population," he said.

Moving forward, Lorenzo Redondo and his collaborators will aim to use this combination of novel molecular biology techniques and machine learning approaches to map intra-host evolution in SARS-CoV-2 and other viruses, he said. His group also hopes to use the approach to predict how a virus may evolve in the future and potentially stop dangerous strains from taking hold.

"The next step is: can we use machine learning methods to predict possible future mutations by knowing what the virus has already explored and what type of advantage it gave it inside the host?" Lorenzo Redondo said.

More information: Soledad Delgado et al, Incipient functional SARS-CoV-2 diversification identified through neural network haplotype maps, Proceedings of the National Academy of Sciences (2024). DOI: 10.1073/pnas.2317851121

Journal information: Proceedings of the National Academy of Sciences

Excerpt from:

Using machine learning to track the evolution of COVID-19 - Medical Xpress

2024 Big Ten Champion in the 100 freestyle Bence Szabados has announced on Instagram that he will return to Michigan to use his COVID-19 fifth year during the 2024-2025 season.

Szabados competed for the Wolverines as an undergrad and finished up his season at NCAAs swimming in prelims of the 50 free (19th, 19.09) and 100 free (41st, 42.43). He swam on four of Michigans relays helping them score in three of them. The Michigan men finished 14th at NCAAs last week, higher than their 20th place finish from 2023.

In February, Szabados won his first Big Ten title winning the 100 free in a 42.09. He also was 2nd in the 50 freestyle swimming a 19.00, finishing 2nd in back-to-back seasons. Both swims were personal best times. He won the B final of the 100 free in a 46.05, another personal best.

Szabados scored 80 individual points at Big Tens, the 2nd most of the Michigan men. Only Gal Groumi scored more points with 92 total. Szabados was the teams highest senior scorer by a large margin as the next highest-scoring senior was Ansel Froass who scored 35 points. The team went on to finish 3rd out of eight teams, finishing only behind Indiana and Ohio State.

Notably, his best finish at Big Tens during his freshman season was 12th in the 200 butterfly as he swam a 1:46.32 for 12th then. He hasnt swam the 200 fly at a championship meet since then, instead, swimming the 50 free on day one instead of competing in the 100 free and 200 fly on the final day of a championship meet.

Szabados will be pursuing a Master of Management from the Ross School of Business. He told SwimSwam, Once I was accepted it was an opportunity that was really hard to say no to as its one of the best business schools in the country. On top of that, Matt and the new coaches have made a lot of really great changes within the program, both from a performance and culture standpoint. The vibes at practice were so great this past year and I wanted to continue to experience that as well as be a part of rebuilding the program and getting Michigan back to where it should be.

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Big Ten Champion Bence Szabados Returning To Michigan For COVID-19 Fifth Year - SwimSwam

New NIAID report on maternal COVID-19 vaccination offers direct evidence of protection for newborns | Image Credit: 395077344 - stock.adobe.com.

Vaccination against the SARS-CoV-2 virus during pregnancy has been demonstrated in multiple studies to offer a protective effect for both mothers and babies, but a new study led by the National Institute of Allergy and Infectious Diseases (NIAID) provides further evidence of just how far this protection goes.1

The CDC already recommends vaccination during pregnancy for the protection of expectant mothers, citing data on the safety and efficacy of COVID-19 vaccines during pregnancy. CDC guidance also suggests that vaccination during pregnancy can pass valuable protection on to newborns in the first months of lifebefore they are eligible to receive a COVID-19 vaccine themselves.2

Numerous studies have shown that COVID-19 vaccination during pregnancy can elicit an immune response in infants for months after birth, but these reports have relied on retrospective data. The new NIAID report is the first to provide direct evidence that maternal vaccination during pregnancy can create measurable antibody levels for months after birth, says Cristina Cardemil, MD, MPH. Cardemil is a medical officer in the NIAID Division of Microbiology and Infectious Diseases and was lead author of the new report, published in Pediatrics in February 2024.

Previous retrospective studies on maternal COVID-19 vaccination lacked direct measurements of antibodies in mother/infant pairs over time to see who was getting sick, she explains. Previous research was also unclear when it came to determining how long protection from maternal vaccines would last.

What we did know 6 months or a year ago is there were studies showing antibodies at delivery in vaccinated mothers, and the suggestion was that the protection could last for some time. But it was more of an open-ended question as to how long it would last, Cardemil explains.

The new study shows that there were high levels of antibodies at birth in infants whose mothers had been vaccinated or received a booster during pregnancy. Specifically, mothers who received 2 or 3 doses of messenger RNA COVID-19 vaccines during pregnancy had measurable levels of full-length spike immunoglobulin G, pseudovirus 614D, live virus D614G, and Omicron BA.1 and BA.5 neutralizing antibodies at birth. Those infants were followed throughout 2021 and 2022, and infants born to those boosted mothers were 56% less likely to develop a COVID-19 infection in the first 6 months of life compared with infants of nonboosted mothers.1

The protection can last at least 6 months, according to the report, offering protection until infants can receive their own dose of a COVID-19 vaccine.

At this point in the pandemic, millions of pregnant individuals have received COVID-19 vaccines. We have a lot of data to indicate its a very safe and effective vaccine during pregnancy, says Cardemil. We know that moms who are infected during pregnancy are at a real risk for complications both for themselves and their unborn children.

Other new data from the study show how vaccine protection could fluctuate by variant. In this study, researchers tested for 5 different antibodies at birth, some that bind to the virus and others that neutralize the virus. All the antibodies were produced as a result of vaccination with the original COVID-19 vaccines formulas, she says, adding there were no bivalent or updated vaccines available at the time the study cohort was immunized.

This is an especially important finding, Cardemil adds, considering that even those original vaccines were able to offer protection against Omicron and other newer variants that emerged long after the initial maternal vaccination. Cardemil says this finding also indicates that even older versions of COVID-19 vaccines could offer mothers and their babies protection against new and emerging variants that are not technically covered by the vaccine that was administered.

Thats a very strong finding that shows these vaccines that were created against the original variant that has evolved several times still provide protection that we are looking for, she says. It doesnt have to be the perfect match to what is circulating that minute. The vaccines are broad enough to protect against future circulating viruses.

For clinicians, Cardemil says the study helps to demonstrate the importance and benefit of maternal vaccination. Natural immunity from a previous COVID-19 infection can wane over time, and as the years pass since the pandemic it can be easy to lose sight of the toll the virus can take on infants, Cardemil says.

I think from my perspective, now that were several years into the pandemic and we have both prevention and treatment methods, people have lost sight of how COVID-19 can still land you in the hospital, she says.

Infections in older adults and other vulnerable populations often get the most attention when it comes to COVD infections, but Cardemil says that infants under age 1 year have the same rates for hospitalization and death as older adults. That fact that older adults can receive the COVID-19 vaccine while infants younger than 6 months cannot makes the threat of a COVID-19 infection more severe in the newborn group, she says.

The group thats most vulnerable for COVID-19 are potentially unprotected, Cardemil says. For newborns up to 6 months of age, thats a gap in immunity. But now we know we can fill that gap through maternal vaccination.

Click here for more from the April issue of Contemporary Pediatrics.

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New NIAID report on maternal COVID-19 vaccination offers direct evidence of protection for newborns - Contemporary Pediatrics

Glen Pyle, Member, IMPART,Dalhousie University

COVID-19 is a respiratory disease. Yet, from the earliest days of the pandemic, the cardiovascular risks associated with SARS-CoV-2 infection were clear: individuals with severe cases of COVID-19 often died from cardiovascular complications, and those with pre-existing cardiovascular disease were more likely to have severe illness or die.

In short, the cardiovascular system has played a central role in COVID-19 since the beginning.

It is not surprising that as debate over COVID-19 and vaccines flared that cardiovascular disease was a central issue. Those opposed to vaccination often make claims of cardiovascular risks that exceed any benefits. But when data on COVID-19, vaccines and cardiovascular health are reviewed, the conclusions are clear: vaccines are safe and effective at reducing the cardiovascular complications that are a hallmark of COVID-19.

A new study of 20.5 million people in the United Kingdom, Spain and Estonia used electronic health records to determine how COVID-19 vaccines affect cardiovascular complications following SARS-CoV-2 infection. Roughly the same number of vaccinated and unvaccinated subjects were included, and the vaccinated group consisted of people who received at least one of the AstraZeneca, Pfizer, Moderna or Janssen vaccines.

The study found that common cardiovascular complications of COVID-19 including blood clots, stroke, arrhythmias and heart attacks were substantially reduced in the vaccinated group, with protective effects lasting up to a year after vaccination.

While this most recent study represents one of the most comprehensive investigations into the cardiovascular benefits of COVID-19 vaccination, its findings are consistent with earlier, smaller studies.

A 2022 study of 231,037 people found two doses of COVID-19 vaccines reduced the risk of stroke and heart attack up to four months after a breakthrough infection.

A subsequent study of 1.9 million people found that while two doses of the mRNA vaccines or one dose of the Johnson & Johnson vaccine protected against major cardiovascular events following COVID-19, even a single dose of the mRNA vaccines offered some benefit in reducing the risk of cardiovascular complications.

Health-care decisions require a weighing of the risk and benefits of treatments, and for COVID-19 vaccines the low cardiovascular risks favour vaccination. A study of over four million vaccinated Australians found no increase in sudden cardiac death. Even patients with pre-existing heart failure do not have an increased risk of worsening heart failure, myocarditis, or blood clots following vaccination.

Although the safety of COVID-19 vaccines is well-established, it does not mean there are no risks. A review of 99 million individuals in the Global Vaccine Data Network confirmed earlier studies that found an increased risk of myocarditis and pericarditis, which is seen primarily in young males historically the group most at risk for myocarditis before COVID-19 emerged.

While individuals at higher risk for these complications should consult with their health-care providers in making decisions about vaccination, it should be noted that the risk for myocarditis and pericarditis is generally higher with COVID-19, even in this cohort.

Studies have also found that extending the time between first and second doses of the COVID-19 mRNA vaccines beyond the initially recommended three-week interval decreases the risk of myocarditis. Furthermore, post-vaccine myocarditis tends to be transient with very good recovery and is less severe than that associated with COVID-19.

The risk of myocarditis in young people has led some to claim that the benefits of COVID-19 vaccines are negated when stacked up against the chance of heart inflammation. A statement from the American Heart Association confirms that the risks of cardiovascular complications in young people with more mild cases of COVID-19 (symptoms lasting less than four days) are low, but notes that there are concerning signs for those who experience more severe illness with infection.

Furthermore, other cardiovascular risks associated with infection must be considered in weighing risks and benefits. These include multisystem inflammatory syndrome or MIS-C and cardiac arrhythmias a far more common risk of COVID-19 than myocarditis.

Finally, the claim that COVID-19 is harmless in children is not true: in Canada COVID-19 is the sixth leading cause of death for children aged one to 14 years, and tenth for people 15 to 19 years old. Overall, studies find that even in young people the benefits of vaccination exceed the risks, particularly when it comes to cardiovascular disease.

There are individuals whose health conditions preclude COVID-19 vaccination, and others for whom health risks may outweigh the benefits. But, for the vast majority of people including young and otherwise healthy people COVID-19 vaccination is not only safe, but the cardiovascular protection it offers could be life-saving.

This article is republished from The Conversation under a Creative Commons license. Read the original article.

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Cardiovascular risks and COVID19: New research confirms the benefits of vaccination - Dal News

Pictured: Facade of Moderna's building in Massachusetts/iStock, hapabapa

A Delaware District Court on Wednesday sided with RoivantsubsidiaryArbutus Biopharma and Genevant Sciences in their ongoing patent infringement case against Moderna regarding the lipid nanoparticle delivery system used in the latters COVID-19 vaccine.

The patents were licensed to Genevant, a joint venture between Arbutus and Roivant. Judge Mitchell Goldberg in a 37-page opinion agreed with Arbutus and Genevants interpretation of two out of the three disputed claims in the case.

One claim concerned the total percentage of lipids present in the delivery particle. Moderna argued that the particle should refer to the finished lipid particle, which does not require further processing. The pharma also insisted that the lipid percentages must be understood as the exact ranges recited in the claim, unless the language of the patent explicitly implies some uncertainty.

Arbutus and Genevant made the case for the plain and ordinary meaning of the word particle and that the lipid percentages encompass their standard variation based on the number of significant figures recited in the claim.

Goldberg agreed with Arbutus and Genevant on both points, writing that the language of the patent claim does not require the lipid particle to be a finished particle that is completely free from further processing.

On the question of the precision of lipid percentages, Goldberg noted that Moderna has not established that Plaintiffs removal of the word about constituted a clear and unmistakable disclaimer of the rules of rounding, adding that a person with an ordinary skill in the art would understand that the rules of rounding and significant figures apply to the claimed ranges.

Goldberg also ruled in favor of Arbutus and Genevant regarding the second claim, agreeing that the claim of a cationic lipid having a protonatable tertiary amine should be interpreted using its plain and ordinary meaning, instead of Modernas proposal to include other qualifiers.

Arbutus and Genevant first filed their patent infringement lawsuit against Moderna in February 2022, alleging that the vaccine developer had used their lipid nanoparticle technology without license or proper compensation.

The plaintiffs seek fair compensation for Modernas use of our patented technology without which Modernas COVID-19 vaccine would not have been successful, Arbutus CEO William Collier said at the time.

The trial for the case is set to begin in April next year, according to Reuters.

Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

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Judge Rules Against Moderna in COVID-19 Patent Fight with Roivant Subsidiary - BioSpace

The Province of Ontario has launched a campaign to encourage COVID-19 vaccination for people at higher risk of severe illness from COVID-19. In alignment with the National Advisory Committee on Immunization (NACI) recommendations, the Ministry of Health is recommending that the following individuals who are at increased risk of severe illness from COVID-19 receive a dose of an XBB COVID-19 vaccine in Spring 2024:

For these groups, its especially important to get the XBB COVID-19 vaccine this spring if they havent already received one in Fall 2023. This vaccine targets the XBB strain of the Omicron variant, offering added protection against severe COVID-19 and possibly against current variants.

Individuals may be eligible to receive an XBB COVID-19 vaccine if it has been 6 months from their previous COVID-19 vaccine or COVID-19 infection (whichever is later). All other individuals are not currently recommended to get an additional COVID-19 vaccine dose this spring and should wait until further guidance from the Ontario Ministry of Health, unless otherwise directed by their healthcare provider.

Getting your COVID-19 Vaccine:

For parents and caregivers

OPH is strongly encouraging all parents and caregivers to ensure their children and youth are up to date on routine vaccinations, especially their measles vaccination.

Families of children and youth facing barriers to immunization can book an appointment through Kids Come First.

OPH is also offering routine childhood immunizations through its Neighbourhood Health and Wellness Hubs on a drop-in basis for people who may be facing additional barriers to immunization and reporting.

More info is available at: ParentingInOttawa.ca/Immunization.

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Spring COVID-19 vaccines now available in the community to individuals at increased risk - Bay Ward Bulletin

TOPLINE:

Receipt of the bivalent COVID-19 vaccine was not associated with an increased stroke risk in the first 6 weeks after vaccination with either the Pfizer or Moderna vaccines, a new study of Medicare beneficiaries showed.

"The clinical significance of the risk of stroke after vaccination must be carefully considered together with the significant benefits of receiving an influenza vaccination," the authors wrote. "Because the framework of the current self-controlled case series study does not compare the populations who were vaccinated vs those who were unvaccinated, it does not account for the reduced rate of severe influenza after vaccination. More studies are needed to better understand the association between high-dose or adjuvanted influenza vaccination and stroke."

Yun Lu, PhD, of the Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, was the lead and corresponding author of the study. It was published online on March 19 in JAMA.

Some stroke cases may have been missed or misclassified. Additionally, the study included only vaccinated individuals a population considered to have health-seeking behaviors which may limit the generalizability of the findings. The study was conducted using COVID-19 bivalent vaccines, which are no longer available.

This work was funded by the US Food and Drug Administration through an interagency agreement with the Centers for Medicare & Medicaid Services. Lu reported no relevant financial relationships. The other authors' disclosures are listed in the original paper.

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No Increased Stroke Risk After COVID-19 Bivalent Vaccine - Medscape