Category: Vaccine

IOWA CITY When the phrase something is going around becomes common in schools, offices, and inevitably health care clinics every fall, a frequent fear especially among older patients and the parents of infants is that the something is RSV.

Although the common and highly contagious RSV short for respiratory syncytial virus runs a mild, cold-like course for most people, it can hit infants and patients over 60 hard, even requiring hospitalization.

But, for the first time, a vaccine now is available for those high-risk groups thanks, in part, to University of Iowa Health Care trial work.

There are actually two vaccines on the market, UIHC nurse practitioner Christina Kopp told The Gazette about the shots marketed for adults over the age of 60 and for pregnant women, 32 to 36 weeks pregnant.

Between 58,000 and 80,000 children under age 5 are hospitalized for RSV annually in the U.S., according to the U.S. Centers for Disease Control and Prevention. Between 100 and 300 kids die from RSV nationally every year.

The goal is that the mom can pass the antibodies on to the newborn and have a good antibody supply in that newborn until it starts to drop about six months of age, Kopp said.

Every year in the United States, 60,000 to 160,000 older adults are hospitalized for RSV and 6,000 to 10,000 die, according to the CDC.

The new vaccines became available in May after long-sought Food & Drug Administration approval and after decades of RSV-vaccine related efforts and, more recently, groundbreaking trials.

One vaccine, Arexvy by GSK, is approved for people 60 and older; a second, Abrysvo by Pfizer, also is approved for pregnant women near the end of their term.

Both contain part of the RSV virus and work by inciting an immune response that can protect from future illness.

The UI participated in a clinical trial for the Pfizer RSV vaccine, led by Dr. Patricia Winokur, executive dean of the UI Carver College of Medicine. The UI site enrolled about 150 Iowans.

Winokur said the vaccines were very effective.

They were tested in really big clinical trials, with about 40,000 people in each of the trials for the two vaccines, and about 85 percent of people were protected from having serious RSV disease, Winokur said for a UI Health Care report on the vaccines in October. That is a pretty good track record.

The immunity, according to the trials, seemed to last two years, which is really encouraging, Winokur said.

UIHC, among its current vaccine and treatment trials, is participating in a phase investigating the Pfizer RSV vaccines effectiveness for adults at high risk for severe complications from the virus.

If you are a solid organ transplant recipient, are currently undergoing dialysis, or are currently being treated for cancer, and would be interested in participating in this trial, please complete the survey, according to a UIHC appeal for trial participants.

Other vaccines UIHC is investigating include an mRNA vaccine for shingles, a new pediatric flu vaccine and an updated COVID vaccine.

Steve Varga, UI RSV expert and professor of microbiology and immunology, said RSV can be more threatening to infants because their airways are small and still growing.

But developing an RSV vaccine has been a struggle since scientists started in earnest in the 1960s, according to Varga. Initial trials failed, in that vaccines they tested caused children to experience worse disease than when they were naturally infected with RSV.

The terrible failure of that vaccine trial was such a shock to the scientific community that it effectively halted RSV vaccine development for decades, according to Varga. It also led to many of the new safeguards for conducting and monitoring clinical trials that are used today to ensure the safe development of vaccines and therapies.

A breakthrough in RSV vaccine work came several years ago when scientists determined how to target a protein on the surface of the virus.

Immunology has also advanced significantly, Varga said. And scientists now know why the original vaccine failed.

Still, no RSV cure or treatment exists with supportive care the best bet, including things like Tylenol or ibuprofen as needed, along with rest and fluids.

RSV preventive antibody products have been OKd for infants and young children with conditions that put them at higher risk for severe illness but theyre in short supply, making the vaccines for pregnant women the best way to protect newborns.

The highest risk group is those really young infants, and so getting those pregnant moms able to get vaccinated and transfer those antibodies is a really good protection, said Kopp, the UI nurse practitioner.

Today, pregnant women are advised to get vaccines, including flu, Tdap, COVID and now RSV.

Kopp said she wishes that full list had been available to her a year ago.

Last year, I actually was pregnant myself and had a baby in October of 2022, Kopp said. And I remember hearing about the RSV vaccine coming soon and I was like, I wish that it was available so that I could get it. One of the biggest fears, as a health care provider, is having a newborn at home and worrying about RSV.

People can schedule a flu or COVID shot with the University of Iowa Hospitals and Clinics either online or through My Chart at https://uihc.org/get-vaccinated

People eligible for the RSV vaccines 60 and older, or pregnant women (32 to 36 weeks) can talk with their doctor about getting the vaccine.

Source: UI Health Care

Vanessa Miller covers higher education for The Gazette.

Comments: (319) 339-3158; vanessa.miller@thegazette.com

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New RSV vaccines OK'd for high-risk groups, thanks to UI trial work - The Gazette

The findings from the Swedish Covid-19 investigation for Future Insights is based on data for more than half a million Swedish adults, according to the British Medical Journal.

It shows unvaccinated individuals were almost four times as likely to be diagnosed with long-Covid than those who were vaccinated before first infection.

The researchers point out causality cannot be directly inferred from this observational evidence, but say their results highlight the importance of primary vaccination against Covid-19 to reduce the burden of the condition in the population.

The effectiveness of Covid-19 vaccines against the infection and severe complications of acute Covid-19 are already known, but their impact against long-Covid is less clear because most previous studies have relied on self-reported symptoms.

To address this, researchers investigated the effectiveness of primary Covid-19 vaccination the first two doses and the first booster dose within the recommended schedule against post-Covid-19 condition using data from the SCIFI-PEARL project, a register-based study of the pandemic in Sweden.

Individuals were followed from a first Covid-19 infection until a diagnosis of post-Covid-19 condition, vaccination, reinfection, death, emigration or end of follow-up.The average follow-up was 129 days in the total study population.

Individuals who had received at least one Covid-19 vaccine dose before infection were considered vaccinated.

A range of factors including age, sex, existing conditions, number of healthcare contacts, education level, employment status, and dominant virus variant at time of infection were also accounted for in the analysis.

Of 299,692 vaccinated people with Covid-19, 1,201 (0.4pc) were diagnosed with a post-Covid-19 condition during follow-up, compared to 4,118 (1.4pc) of 290,030 unvaccinated people.

Those who received one or more Covid-19 vaccines before the first infection were 58pc less likely to receive a diagnosis of post-Covid-19 condition than unvaccinated individuals.

And vaccine effectiveness increased with each successive dose before infection. For example, the first dose reduced the risk of post-Covid-19 condition by 21pc, two doses by 59pc, and three or more doses by 73pc.

These findings, combined with evidence from other studies, highlight the association between the immune system and the development of post-viral conditions, and underline the importance of timely vaccination during pandemics, say researchers in a linked editorial.

They call for continued investigation into the evolution of long-term residual symptoms of Covid-19 and other viral illnesses as well as steps to improve the accuracy of recording both recovery and continued illness after infection, and in quantifying key family, social, financial and economic outcomes.

Such estimates are fundamental to unlocking the funding required for future research and increased investment in specialist clinical services.

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One dose of Covid-19 vaccine before first infection is associated with reduced risk of long-Covid, finds study - Irish Independent

In rural areas, especially in developing countries, the long distance to a medical facility may hinder a population from getting vaccinations, and especially booster doses.

Vaccinesfor everything from influenza to COVID-19 to pneumococcal diseasesare stored at a low temperature forstability andare typically administrated through ahypodermicneedle and syringe from a health care professional.

What if we were able to mail people vaccines that dont need refrigeration and they could apply them totheir own skinlike a bandage? asked Thanh Nguyen, associate professor of mechanical engineering and biomedical engineeringat the University of Connecticut.And what if we could easily vaccinate peopleoncewhere theywouldntneed a booster? We couldpotentiallyeradicate polio, measles, rubella, and COVID-19.

The answer, Nguyen believes, is administrating vaccines through aprogrammablemicroneedle array patch with anovelprocess he isdeveloping athis lab at UConn.

By adhering anearly painless, 1-centimeter-squarebiodegradablepatch to the skin, a person can receive apreprogrammed deliveryof highly-concentrated vaccines in powder formover monthsandeliminatethe need for boosters.The primary argument is that getting vaccines and boosters is a pain, Nguyen said. Youhave togo back two or three times to get these shots. With the microneedle platform, you put it on once, anditsdone. You have yourvaccineand you have your boosters. Youdonthave to go back to the doctor or hospital.

This month, UConns Institute of Materials Science received athree-yeargrant from the Bill & Melinda Gates Foundation to support Nguyens research on Single-Administration Self-boosting Microneedle Platform for Vaccines and Therapeutics. The projectsgoalis to develop a low-cost manufacturing process.

TheNguyen Research Grouphas already been working to thermally-stabilize vaccines and other therapeutics so they can stay inside the skin fora long period. In 2020,Nature Biomedical Engineeringpublished a studyby Nguyen and his colleaguesreporting that, in rats, microneedles loaded with a clinically available vaccine (Prevnar-13) against a bacteriumprovidedsimilar immune protectionasmultiple bolus injections.

Weve been able to show this technology is safe and effective in the small animal model, but now the question is, how do we translate it into the commercialized stage and make it useful to the end user, which is the human, he said.

With support from the Gates Foundation, Nguyenwill be able to test his microneedle platform on a larger animala pig, which has skinsimilar tohumans. And if the results are similar, Nguyenpredictsthis technology could be manufactured, at an affordable cost, enabling both domestic and global health impact.

Nguyensmicroneedle platform also caught the attention of the United States Department of Agriculture. In September, the USDA: Research, Education, and Economics division awarded Nguyen with a two-year grant for a study titled Delivery of FMDV Protein Antigens Using a Programmable Transdermal Microneedle System.

The Foot-and-Mouth Disease Virus(FMDV) is a highly contagious disease that affects the health of livestock such as cows, pigs, sheep, and goats.When an outbreak occurs, the disease leaves affected animals weakened and unable to produce meat and milk. FMDV causes production losses and hardships for farmers and ranchers, and has serious impacts on livestock trade.

And while vaccines exist, like with humans, boosters are required tokeep the vaccine effective.

USDA is interested in the technology because the patch will be able to deliver the initial dose and subsequent doses, or boosters, to animals without the need for rounding up and handling multiple animals at once, Nguyen explained. This decreases stress on the animals and increases safety for the animals and their handlers.

The microneedle platform is among the latest applications the Nguyen Research Group is exploring in the arena of vaccine/drug delivery, tissue regenerative engineering, smart piezoelectric materials, electronic implants, and bioelectronics. Since joining the College of Engineering in 2016, Nguyen has discovered a method of sending electric pulses through a biodegradable polymer to assist with cartilage regeneration; hes designed a powerful biodegradable ultrasound device that could make brain cancers more treatable; and he used microneedle patches to deliver antibody therapies, which have been proven successful in treating HIV, autoimmune disorders such as multiple sclerosis, and certain types of cancer.

Christina Tamburro, post-award grants and contracts specialist for UConns Institute of Materials Science said IMS is grateful to both the Gates Foundation and USDA for supporting Professor Nguyens drug delivery research.

This is a wonderful application of material science and this is what were all about. Ultimately, this is going to save lives and it cant get better than that, she said.

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Nguyen Lab Explores Benefits of Using Microneedle Arrays for ... - University of Connecticut

Among a cohort of patients who received a flu vaccine, there was a 26% decreased risk of heart attacks and a 33% reduction in cardiovascular deaths, according to one study.1 These findings suggest a connection between influenza vaccination and reduced risk of cardiovascular diseases (CVDs).

While differing viewpoints exist regarding the impact of influenza vaccination on CVDs, some observational investigations have found a favorable connection between influenza vaccination and the reduction of cardiovascular incidents, such as acute myocardial infarction (MI).

This systemic review published in Scientific Reports, aimed to assess the possible association between influenza vaccination and a decreased likelihood of experiencing cardiovascular events.1

Revealing a compelling insight into the potential benefits of influenza vaccination, our comprehensive meta-analysis, based on the latest randomized controlled trial (RCT) data, demonstrates a significant interaction between influenza vaccination and the reduction of major cardiovascular events, wrote the researchers of the study. Notably, patients who received the influenza vaccine experienced a remarkable risk reduction of over 20% in cardiovascular death.

The researchers conducted a search of 275 English-literature studies using PubMed/MEDLINE, EMBASE, and the Cochrane CENTRAL databases through August 1, 2023, using the search terms myocardial disease and influenza vaccines. The review was conducted on RCTs exploring the potential link between influenza vaccination and the subsequent risk of developing CVDs.

Participants in the analysis had a diagnosis of CVD and the outcome was lower risk of cardiovascular events. Conference abstracts, case reports, and studies comparing high and low doses of influenza vaccination were excluded from the analysis.

The final analysis of 5 studies included 4529 patients who received the flu vaccine and 4530 patients who received a placebo. The average age of participants was 61 years. The study follow-up lasted an average of 9 months.

Of these participants, a total of 517 individuals experienced significant cardiovascular events compared with 621 cases among individuals who were administered a placebo (risk ratio [RR], 0.70; 95% CI, 0.55-0.91). Additionally, there was a decreased risk of heart attacks in vaccinated patients (RR, 0.74; 95% CI, 0.56-0.97) and a significant reduction in cardiovascular death events (RR, 0.67; 95% CI, 0.45-0.98).

These findings revealed a significant link between influenza vaccination and the reduction of major cardiovascular events among patients with recent cardiovascular diseases, in which there may be potential benefits of targeting this high-risk group for vaccination.

Regarding the potential mechanisms behind why vaccination protects heart health, the researchers note the possibilities of lowering inflammation caused by influenza, preventing secondary infections, and ensuring the stability of atherosclerotic plaque, which can become destabilized during the flu.

However, the researchers believe that further research is needed to better understand the precise mechanisms driving this association and to understand the potential long-term impact of influenza vaccination on cardiovascular outcomes.

In the meantime, health care providers and policymakers should take heed of these findings and consider prioritizing influenza vaccination for patients with recent CVDs as a feasible and potentially life-saving preventive measure, wrote the researchers.

This article originally appeared in AJMC.

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Flu Vaccine May Protect Against Heart Attack, Cardiovascular Events - Drug Topics

Do I really need to get the updated COVID-19 vaccine?

Most in the medical field strongly encourage the updated COVID-19 vaccine, but your decision may rely on a few other factors, such as a recent infection, your social circle and your health.

Here is a list of questions you need to ask yourself:

How high is your personal risk?

Do you have a weaker immune system due to age, pregnancy or a health condition such as diabetes or heart disease?

Are you taking medications that make you immunocompromised? This includes anti-rejection drugs for organ transplants, or medications for autoimmune conditions such as lupus, multiple sclerosis or rheumatoid arthritis?

If the answer is yes, get the vaccine.

Whos at risk in your social circle?

Do you care for aging parents or an ill relative? Even the youngest among us are vulnerable.

Particularly infants are unprotected. So children under six months need us to protect around them so that they dont get sick, said Dr. Marianne Sumego, an internal medicine specialist at Cleveland Clinic.

Are you planning for future events in the next few months, such as a wedding or vacation?

The vaccine gives about three months of protection, but it takes a couple of weeks to build immunity, so plan accordingly.

Did you recently have a COVID infection?

If so, you likely also have about a three-month window of protection, but if it hit you pretty hard, you may consider getting the vaccine since cold and flu season hangs around through April.

There are now three updated COVID vaccines available. The MRNA versions from Pfizer and Moderna, and the protein-based Novavax shot is available for those 12 and older regardless if theyve had previous vaccinations.

If youre young, healthy and not a risk to the vulnerable, you may consider skipping it, but remember this advice from Sumego: COVID still causes more hospitalizations and deaths than the other respiratory illnesses that circulate. And so we know that we can reduce that and impact that chance of happening with the COVID vaccine, so why wouldnt you want to give yourself a chance of staying out of the hospital?

Monica Robins is the Senior Health Correspondent at 3News. The information provided in this column is for educational and informational purposes only. Always seek the advice of your physician or other qualified health care provider with any questions you may have regarding a medical condition or treatment and before undertaking a new health care regimen. Never disregard professional medical advice or delay in seeking it because of something you have read in this column or on our website.

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Should I get the updated COVID-19 vaccine? - Cleveland Jewish News

Testing vaccine hesitancy hypotheses using multiple datasets presents challenges. Datasets associated with household-level and contextual factors have different geographic support, defined as the area, shape, size, and orientation of spatial measurement. Data on vaccine acceptance tend to come from household-level surveys; data on political violence are typically point-level event coordinates; data on elections tend to be measured by electoral constituencies (e.g. legislative districts); key development indicators, like road infrastructure, may be available as polyline features. These data come in different formats and structures (delimited text, vectors of location attributes, raster images); areal units are not nested and have misaligned borders; some of the data (e.g. surveys) may not be georeferenced at all. Different data integration choices may yield different results, raising concerns over generalizability [5]. Differences in sampling, question wording and sequence, primary sources, operational definitions, digital image processing algorithms, and other factors ensure that no two datasets are perfect substitutes for one another, making it difficult to distinguish case-specific idiosyncracies from general patterns, and to ask, "what does country A tell us about country B?" Finally, survey data pose a separate challenge of distinguishing "snapshots" of public attitudes from stable long-term trends. We illustrate how to mitigate some of these common challenges. The SUNGEO system accounts for these issues.

SUNGEO allows users to combine data across otherwise incompatible geographic units into a common format, and facilitates the analysis and visualization of processed geospatial data (Fig.1). It includes a user-friendly web interface and API, where researchers can select among many existing variables, choose levels and methods of spatiotemporal (dis)aggregation, interpolation and integration, and decide on the boundaries of their subnational datasets. Its large collection of pre-processed data enables users to replicate their research designs across different scales, data sources, countries, and integration procedures. SUNGEO also includes an open-source software package in the R statistical programming language to process user-supplied data, merge it with pre-loaded geo-referenced data, and produce a more customizable output based on user needs and specifications. It includes an archiving tool, which allows users to contribute original data to the repository.

Overview of the SUNGEO system

This demonstration uses vaccination hesitancy data from the World Bank Groups High Frequency Phone Surveys (HFPS). The HFPS was a longitudinal cohort (panel) study on the socio-economic impacts of COVID-19 conducted in 53 countries and contexts between 2020 and 2022, with a subset of surveys including questions on vaccination hesitancy. We analyzed surveys from Indonesia, Kenya, and Malawi, as they: 1) were larger surveys with rigorous sampling methods representative of the general population; 2) included granular geographic information; and 3) were from three distinct regions (East Africa, Southern Africa, and South-East Asia). The survey datasets include sampling weights, based on the inclusion probabilities of the cell phones and landlines through which respondents were reached, along with first-time and attrition non-response weighting adjustments, and calibration with auxiliary information on regional population size, respondent sex, age group, and educational attainment. More information on each dataset can be found from the World Bank Group [6].

Contextual variables were provided from SUNGEO's preprocessed spatial data archive. Sub-national data on political violence are available for 195 countries through SUNGEO's partnership with the xSub data repository, which hosts leading event databases, including the Armed Conflict Location and Event Data Project (ACLED), the National Violence Monitoring System (NVMS), the Social Conflict Analysis Database (SCAD), and the Uppsala Conflict Data Program's Georeferenced Event Dataset (UCDP-GED). We chose among these by re-estimating our empirical models with each dataset on violence, and selecting the data source that yielded the strongest model fit (NVMS for Indonesia, UCDP-GED for Kenya, SCAD for Malawi; see Additional file 2: Appendix B3). Data on legislative elections in 168 countries are available through the Constituency-Level Elections Archive (CLEA). As a proxy measure for economic development, we used local road density, which can be calculated using the Global Roads Open Access Data Set (gRoads). More information on these datasets can be found from their respective sources [7,8,9,10,11]. We also used SUNGEO to extract data on other geographic variables that may affect attitudes toward, or the availability of, vaccines. These include ethno-linguistic fractionalization, average night light intensity, and terrain (see Additional file 2: Appendix B2 for details and estimation results) [12,13,14].

a. Vaccine surveys

HFPS data are available through the Inter-university Consortium for Political and Social Research (ICPSR). ICPSR secured the World Banks permission to access HFPS data, then carried out a disclosure risk review to prevent direct or inferential re-identification of individuals or organizations. The curation process included generating question text employing the social science variables database to compare across studies,reviewing data to ensure all translations were correct and to create the variable and values list, conducting quality control, and hosting of the data on the ICPSR website in a fully searchable format. Further detail can be found in Additional file 1: Appendix A. In Additional file 2: Appendix B1, we examine sample attrition patterns across rounds, and find that respondents who dropped out of these samples were statistically similar on observables to those who remain.

b) Contextual data

Disaggregated data on violence, elections and economic development are available through SUNGEO. In aggregate form, the violence data are event counts, representing the number of incidents of political violence observed in each spatial unit over the two decades prior to the first survey. The election data are weighted averages of local "Top-1" competitiveness from the most recent legislative election, measured as one minus the winning vote margin, where values of 1 indicate that the most recent parliamentary election was very close, and 0 indicates that it was not competitive because the winner received almost all of the votes. We also considered alternative measures of electoral competitiveness, but the "Top-1" measure yielded a generally stronger model fit (Additional file 2: Appendix B3). The road density data are local sums of primary and secondary road lengths in each administrative unit, divided by that unit's area in square kilometers.

For each country, we used SUNGEO to extract data on political violence, legislative election data, and road infrastructure data, along with other contextual datasets (Additional file 2: Appendix B1). For Indonesia and Malawi, our spatial units were level-2 administrative divisions. For Kenya, we used level-1 administrative divisions.

To link data to household-level vaccine surveys, we used SUNGEO's R package to geocode survey sampling units, assigning a pair of geographic coordinates to each unique location. This allowed us to match each surveyed household to its corresponding level-2 (or level-1, in Kenya) spatial unit, and merge the datasets geographically (see Additional file 2: Appendix B1).

We examined why some households express stable, pro-vaccine preferences, while others remain vaccine hesitant, or change their minds. Vaccine hesitancy varies spatially (across households) and temporally, with households changing their position. In the Indonesian survey, 73% of households gave the same answer to the vaccine intent question in two consecutive rounds (e.g. "yes" in rounds 4 and 5, or "no" in rounds 4 and 5). In Kenya, 68% gave the same answer across two rounds. In Malawi, 63% gave the same answer. Because the same households may give different responses on different occasions, we needed an empirical strategy that explicitly accounts for this shifting dynamic.

We modeled the survey responses as a stochastic process (Markov Chain) with two states. When asked the question, if the vaccination was available for you at no cost, would you take the vaccination, a household may either:

Express an intent to receive the Covid-19 vaccine ("yes"), or

Not express such an intent ("no").

From one round to another, a household will have some probability of staying with their previous response, and some probability of transitioning to another response. We model these transition probabilities as conditional on a series of household-level and contextual covariates:

$$text{Pr}(mathrm{y}_{mathrm{i},mathrm{t}};=;1);=;text{logit}^{-1};left[mathrm{x}_{mathrm{i}}{{theta}}_{0};+;{mathrm{y}}_{mathrm{i},mathrm{t}-1};cdot;{mathrm{x}}_{mathrm{i}}upgamma;+;{alpha}_{{mathrm{k}}_{(mathrm{i})}}+;{tau}_{mathrm{t}};+;{varepsilon}_{mathrm{i},mathrm{t}}right]$$

(1)

where y i,t is 1 if household i says "yes" in round t, and 0 if the household says "no", y i,t-1 is a first-order temporal lag, k(i) is a fixed effect for the administrative unit k in which i is located, t is a fixed effect for each survey round, and i,t are robust standard errors, clustered by administrative unit and survey round. The vector of covariates x i includes household-level measures like respondent's age and gender, and an indicator for whether the household is located in an urban area, as well as contextual information on violence, electoral competitiveness, road density, night light intensity, ELF, and terrain.

0 are regression coefficients for households that said "no" to the vaccine at t-1, and 1=0+ are coefficients for households that said "yes" at t-1. We will use these coefficient estimates to generate predicted probabilities of vaccine intent, and to construct transition probability matrices.

We estimated the model in Eq.(1) separately on integrated survey datasets from Indonesia, Kenya and Malawi.

Link:

Promoting data harmonization to evaluate vaccine hesitancy in ... - BMC Medical Research Methodology

With litigation spanning many countries, the COVID-19 vaccine giants remain engagedin a heated patent war. Inthe latest twist, Pfizers Comirnaty partner BioNTech chalked up a win as the European Patent Office (EPO) snatched back one of Modernas patents, ruling it invalid.

The patent in question protects respiratory virus vaccines, according to its listing in the European Patent Register. Opposers to the patent include BioNTech and Pfizer, as well as Sanofi, the listing notes.

BioNTech understands and welcomes the EPOs decision, a spokesperson said in an emailed statement. According toBioNTech,none of the more than 100 auxiliary requests that Moderna filed with amended claims were deemed sufficient to keep thepatent in an amended form.

The decision "is an important one as we believe that this and others of Modernas patents do not meet the requirements for grant and should never have been granted, the company added.

Meanwhile, Moderna disagrees with the EPOs decision, a spokesperson told Fierce Pharma over email. We continue to believe in the strength and validity of the 565 Patent and will appeal this decision.

Last year, Moderna initiated litigation against BioNTech and Pfizer in the U.S. and Germany, following up with cases in the Netherlands and the U.K. Most recently, the company filed suits in Dublin, Ireland and the Brussels Commercial Court Belgium.

Moderna has made it clear that its litigation doesnt aim to remove Pfizer and BioNTechs Comirnaty from the market, but instead reap compensation and damages from alleged infringement.

While Moderna claims Pfizer and BioNTech copied key features of its patented technologies, the rival partnershave said the mRNA specialist seeks to rewrite the COVID story to put itself in the single, starring role while stretching its already overbroad patents to claim credit for others work.

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Moderna loses a COVID vaccine patent in Europe amid heated clash with BioNTech, Pfizer - FiercePharma

People vaccinated before their first case of COVID-19 are diagnosed with Long COVID almost four times less than unvaccinated people, suggests a large new study published Nov. 22 in the BMJ.

Thats not an entirely new finding. For years, studies have shown that, while vaccinated people can and do develop Long COVID, they are at lower risk than people who havent had their shots. But researchers have come to drastically different estimates about exactly how much protection vaccines offer against Long COVID, with their findings ranging from about 15% efficacy to around 50%.

The new study offers encouraging evidence that people who get vaccinated before their first COVID-19 case are at significantly lower risk of developing long-term symptoms like brain fog and fatigue, with each additional dose received prior to infection offering extra protection. A single pre-infection dose of one of the original COVID-19 vaccines reduced the risk of Long COVID by 21%, two doses by 59%, and three or more doses by 73%, the researchers estimated.

To reach those conclusions, they studied data from more than half a million adults in Sweden who caught COVID-19 for the first time from December 2020 to February 2022. National vaccine records showed that about half of those people had gotten at least one COVID-19 vaccine dose before they got sick, while the others were unvaccinated. Using the participants health records, the researchers then assessed who went on to be diagnosed with Long COVID during the studys follow-up period, which ended in November 2022.

The study looked only at original COVID-19 vaccines, not newer boosters like the one released this fall. It also did not assess Long COVID after reinfections, which in some cases do lead to long-lasting health problems. As such, the findings may not translate perfectly to the present day, when many people have received updated shots and had COVID-19 multiple times.

Long COVID diagnoses were rare across the board during the studys follow-up period, but even less common among people whod been vaccinated before getting sick. About 1.4% of unvaccinated people received a Long COVID diagnosis during the study period, compared to 0.4% of previously vaccinated people.

Of course, theres a difference between having Long COVID and being diagnosed with Long COVID. Many people with symptoms of the condition struggle to get formally diagnosed, and the studys authors acknowledge that some clinicians may not have known how to assess the emerging condition during the period the paper considers. Indeed, prevalence estimates tend to be higher than those reported in the study. In the U.S., for example, an estimated 14% of adults have ever had Long COVID, and an estimated 5% currently do.

Further, observational studies like this one cannot definitively prove cause and effect, only uncover patterns. Even still, the trends reported in the study are promising, given that more than 5.5 billion people around the world have now received at least one dose of a COVID-19 vaccine.

In the study, vaccines were linked with particularly high efficacy against Long COVID in men, tracking with prior findings that women are disproportionately likely to develop the condition. Vaccines also seemed to work especially well for adults ages 55 to 64, contrary to some previous studies that concluded Long COVID risk increases with age.

Recent immunization also seemed to be especially protective against Long COVID, compared to vaccination more than four months prior to acute illnesswhich may be an extra argument for continuing to get boosters as they come out.

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Vaccinated People Are 4 Times Less Likely to Get Long COVID | TIME - TIME

Global vaccination trends are telling us both good news and bad news stories, nearly four years after the start of a global pandemic. On the plus side, some childhood immunizations have begun recovering to pre-COVID rates. Against that, almost half of the 73 countries that reported pandemic-related declines in vaccine rates have either flatlined or continue to drop. Also on the downside, UNICEF reported earlier this year that public trust in vaccinations had eroded worldwide. And that includes the U.S., where one new pandemic documentary aims to probe (and show ways to ease) this distrust.

The film, called A Shot in the Arm, couldnt be more timely. Confidence in vaccine safety has dropped for two years in the U.S., according to a recent survey, while belief in misinformation has grown. A new report from the Centers for Disease Control (CDC) meanwhile recorded the highest-ever vaccine exemption rate for children entering kindergarten, in the 202223 school year.

Public health and policy experts are alarmed, but not all point to the same culprits. Some, such as health law expert Timothy Caulfield of the University of Alberta, blame misinformation and conspiracy theories spewed by antivaccine crusaders for the decline. So does the prominent vaccine scientist Peter Hotez, who, in a recent interview with Scientific American, argued that a well-oiled, well financed antiscience ecosystem is undermining public trust in vaccines.

However, other experts, such as Julie Leask, an Australian social scientist who studies all the different reasons that cause people not to vaccinate, point to a more complicated mix of psychological, socioeconomic and ideological factors that, yes, does include the influence of crusading antivaccine activists. In our postpandemic world, trust in public health and government has been severely tested, and bad actors are having their day, Leask said, in an e-mail. At the same time, she also urges science communicators to wrestle with the appeal of high-profile vaccine opponents like Robert F. Kennedy, Jr. I do think people need to engage with the anxieties beneath what he says, rather than attack it on a manifest level or just attack him, she added.

The new documentary premiering this month evocatively captures those deep-seated anxieties. A Shot in the Arm unfolds at the onset of the pandemic, when fear and confusion paralyzed society. The film then chronicles the rhetorical battlefield that pitted earnest public health professionals, who preached cautionary social measures and the science of immunization, against the blustery, self-appointed watchdogs of medical freedom who inveighed against masks, lockdowns and the COVID vaccine.

Who should we listen to, who should we trust? the documentary asks, in its exploration of denialism. It seems like a no-brainer. During an interview in the film, Kennedy is challenged to name any vaccines in history he thought were a benefit to mankind. I was sure that, if nothing else, Jonas Salk and polio would roll off his tongue. Instead, Kennedy demurred: Um, I dont know the answer to that.

As The New Yorker put it in July, this scion of a famous political family is roiling with conspiracy theoriesabout everything from the CIA and Wi-Fi, to the COVID vaccines and the cause of AIDS. Despite such a mindset, or perhaps because of it, Kennedy is surging as a third-party presidential candidate. Comedians have mocked him, and family members have deplored and condemned his views. It hasnt mattered. (Like Donald Trump, Kennedys superpower is shamelessness.) So perhaps it is time, as Leask suggests, to engage with whatever is roiling the people who seem drawn to his message.

In a 2022 Nature Medicine paper, scientists with the London School of Hygiene and Tropical Medicine write that some of the factors fueling vaccine hesitancy, such as anxieties around the pace of technological change or feelings of political disempowerment, are not within the control of the medical community. The authors acknowledge that rampant misinformation plays a significant role in undermining confidence in public health authorities, but focusing only on the information ecosystem can obscure the wider sociocultural, historical, institutional and political context.

That context is essential to an understanding of vaccine hesitancy in some communities, such as Black Americans, who have long faced inequities in health care and also carry a historical memory of immoral medical experiments. (A Shot in the Arm, addresses this issue with its attention to the notoriously unethical Tuskegee syphilis study.)

On that broader note, the 2022 paper argued that acute public anxieties during the pandemic became intertwined with a legacy of distrust in medical and government institutions. Opportunistic misinformation peddlers exploited this legacy. The authors concluded: Like the virus that gave rise to them, it seems probable that myths and conspiracies around COVID-19 and vaccines will be things that we all need to learn to live with and manage for some time to come.

This seems prescient, given Kennedys recent ascendance in a political sphere already filled with demagogues, some in Congress who are politicizing dangerous nonsense about vaccines. Thats a recipe for disaster, which we already got a bitter taste of from the infamous January 6 Capitol riot. A Shot in the Arm shows the jarring scene of the MAGA Health Freedom rally, when leading anti-vaxxers joined with Stop the Steal organizers, a confederation of conspiracy mongers, to rile up the angry mob in Washington, D.C. I wish I could tell you that this pandemic is really dangerous, antivaccine leader Del Bigtree shouted from a lectern. I wish I could believe that voting machines worked and that people cared. Youve been sold a lie!

Since then, the MAGA and antivaccine movements have continued to merge into a potent Frankenstein ideology, stitched together out of mistrust for experts, that threatens to further erode trust in government institutions as well as scientistsat least among Republican voters.

Against this worry, the bigger picture offers encouragement on the vaccine front. A new and comprehensive Texas A & M University survey found that Americans are overwhelmingly supportive of all vaccination mandates. This tracks with findings from a survey published earlier this year by the Pew Research Center.

This also suggests that conspiracy theories and alternative facts are not poisoning the minds of most Americans about childhood immunizations. Thats a relief. As the science writer Michael Specter wrote in his 2009 book, Denialism: Choosing to vaccinate an infant requires faithin pharmaceutical companies, in public health officials, in doctors, and, above all, in science.

Its true that a good number of vaccine-hesitant people have lost such faith. But they are not a monolith, cautions Leask, and shouldnt be broadly labeled as antiscience if we have any hope of restoring their trust in the scientific establishment. Field studies and the literature on science communication suggest approaching vaccine reluctant individuals respectfully and from a position of empathy.

Theres a scene towards the end of A Shot in the Arm that reflects empathys effectiveness. It comes when the noted vaccine expert Paul Offit of the University of Pennsylvania appears on a podcast hosted by a vaccine-refusing parent. Youve been saying a lot of things that make a whole lot of sense, she acknowledges to him at one point, before imploring her audience to engage in a respectful dialogue on vaccines. People need to stop treating each other so mean and so badly, the parent activist urges her listeners, so we can get somewhere.

That sounds like a worthy prescription for our polarized times, in general; its also an Rx that would surely help build long-standing trust in the vaccines that protect us and our loved ones from infectious diseases.

This is an opinion and analysis article, and the views expressed by the author or authors are not necessarily those ofScientific American.

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'A Shot in the Arm' Documentary Treats Vaccine Denialism with a Dose of Empathy - Scientific American

The U.S. Army sent a letter to former service members dismissed for refusing the COVID-19 vaccine, informing them they can request corrections of their discharge records, as the military branch reportedly struggles with recruitment three years after the onset of the pandemic.

The letter, which gained traction on social media, was addressed to former service members and notified of "new Army guidance regarding the correction of military records for former members of the Army following the rescission of the COVID-19 vaccination requirement."

It states, "as a result of the rescission of all current COVID-19 vaccination requirements, former Soldiers who were involuntarily separated for refusal to receive the COVID-19 vaccination may request a correction of their military records from either or both the Army Discharge Review Board (ADRB) or the Army Board for Correction of Military Records (ABCMR)."

The letter, signed by Brigadier General Hope C. Rampy, of the U.S. Army Director of the Military Personnel Management Office of the Deputy Chief of Staff, goes on to link to three forms where "individuals can request a correction to military personnel records, including regarding the characterization of discharge."

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A soldier receives a COVID-19 vaccine from Army Preventative Medical Services on Sept. 9, 2021 in Fort Knox, Kentucky. (Jon Cherry/Getty Images)

"Individuals who desire to apply to return to service should contact their local Army, US Army Reserve (USAR) or Army National Guard (ARNG) recruiter for more information," it concludes.

An Army spokesperson on Sunday confirmed the authenticity of the letter to Fox News Digital.

The spokesperson said the letter, dated November 1, does not explicitly ask former Army members dismissed for refusing the COVID-19 vaccine to return to service.

The Army provided additional information on Monday.

"As part of the overall COVID mandate recession process mandated by Congress, the Army mailed the letters following Veterans Day weekend to approximately 1,900 individuals who had previously been separated for refusal to obey the mandatory COVID vaccination order," Army spokesperson Lt. Col. Ruth Castro told Fox News Digital in an emailed statement Monday.

"The letter provides information to former servicemembers on how to request a correction of their military records," Castro added.

The Instagram accounts @analyzeeducate and @northernprovisions, jointly shared a copy of the letter to their combined hundreds of thousands of followers on Saturday.

Preventative Medicine Services NCOIC Sgt. First Class Demetrius Roberson administers a COVID-19 vaccine on Sept. 9, 2021 in Fort Knox, Kentucky. (Jon Cherry/Getty Images)

"The US Army has sent letters to soldiers that were discharged for refusing to take the COVID-19 vaccine, offering to correct their records. Most, if not all, of the soldiers that were kicked out for not getting the vaccine were given a discharge that was other than honorable," the post says. "The letter indicates that the Army is hoping these soldiers will apply to return to service."

"The military in general has been going through a major recruiting crisis for the past two years. For both FY2022 and 2023, only the Marine Corps and the Space Force met or exceeded their recruitment goals. The Army, Navy, and Air Force all missed their targets by a long shot," the accounts go on to say.

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"The size of the active duty Army has shrunk from 485k in 2021 to 452k right now," the post added. "This is the smallest active duty Army since 1940. In 2022, they missed their recruitment goal by 15,000 soldiers. This crisis has necessitated changes made to policy, including the removal of a policy that mandated recruits have a high school diploma or GED equivalent. Although, after a lot of backlash that policy was quickly reinstated. Around 8,000 soldiers were kicked out for not getting the vaccine, which is a lot even if you dont take the context of the recruiting crisis into account. The letters that were sent out have been verified by the Army as well."

In 2021, the Pentagon, with the support of military leaders and President Biden, mandated COVID-19 vaccination for all military service members. (Jon Cherry/Getty Images)

On Oct. 3, the U.S. Army announced a transformation of its recruiting enterprise, stressing how "the armed forces facing the most challenging recruiting environment in a generation."

At a press conference from the Pentagon, Secretary of the Army Christine Wormuth and Chief of Staff of the Army Randy George detailed sweeping changes in how the Army will identify and recruit talent by expanding focus past high schoolers to a larger share of the youth labor market and create "an increasingly permanent and specialized talent acquisition workforce."

They said the Army expects to have ended fiscal year 2023 with nearly 55,000 recruiting contracts, including roughly 4,600 for the Armys Delayed Entry Program recruits who will ship in the 2024 fiscal year. As a result, the Army said it will meet its end-strength goal of 452,000 for active-duty soldiers.

"The competition for talented Americans is fierce, and it is fundamentally different than it was 50 or even 20 years ago," Wormuth said.

Task and Purpose noted the Army separated about 1,900 active duty service members for refusing the COVID-19 vaccine during the nearly year-and-a-half it was mandatory.

Regarding recruitment woes, the outlet also cited a July 2022 memo from the Department of the Army stating that "Americas military faces the most challenging recruiting environment since the All-Volunteer Force was established in 1973, driven in part by the post-COVID labor market, intense competition with the private sector, and a declining number of young Americans interested in uniformed service." The memo said, "currently, only 23 percent of 17- to 24-year-old Americans are fully qualified to serve."

Citing data provided by the military branches, CNN reported in October that only 43 of the more than 8,000 U.S. service members discharged from the military for refusing to be vaccinated against COVID-19 have sought to rejoin eight months after the vaccine mandate was officially repealed.

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Defense Secretary Lloyd Austin officially rescinded the COVID-19 vaccination order for service members on Jan. 10, 2023.

Austin had issued a memo on Aug. 24, 2021, requiring service members to be vaccinated against COVID-19. According to Task and Purpose, thousands of troops unsuccessfully sought religious exemptions from the inoculation, including 8,945 soldiers, 10,800 airmen and guardians, 4,172 sailors, and 3,717 Marines.

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Army sends letter to troops dismissed for refusing COVID vaccine amid military's recruitment woes - Fox News