Category: Vaccine

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‘Sustained increases’ reported in flu nationwide, as RSV hits kids hard – NBC News

November 19, 2023

The U.S. is once again facing a deluge of viral illness on the cusp of Thanksgiving and other winter holiday gatherings.

While flu activity is still simmering at low levels overall, "we are now seeing sustained increases across the country," especially in Southeastern states, such as Alabama, Georgia, Louisiana, Mississippi and South Carolina, said Alicia Budd, head of the domestic influenza surveillance team at the Centers for Disease Control and Prevention.

"We expect that we're going to continue to see many more weeks of increasing flu activity," she said.

Budd's team estimates that at least 780,000 people have been sick with flu so far this season, resulting in at least 8,000 hospitalizations and 490 deaths, including one child.

Influenza type A, specifically H1N1, is predominant. That strain is generally not as hard on older adults, Budd said, but added that her team is seeing other strains, as well, that can severely affect anyone.

The strains that are circulating mirror those included in this year's flu shot, Budd said. "That bodes well for how effective the vaccine is going to be at preventing infection" or at least serious illness, she said.

Dr. Mandy Cohen, director of the CDC, said that it's not too late to get vaccinated.

"These are the months when flu likes to circulate, particularly after everyone travels and gathers for Thanksgiving," she told NBC News.

Cohen has been traveling across Texas this week encouraging people to get the vaccine. While flu is a focus, she said that levels of respiratory syncytial virus are high in Texas and across the Southeast.

"RSV is definitely here and affecting, particularly, our youngest children," Cohen said.

Katelyn Jetelina, an epidemiologist at the University of Texas Health Science Center, said that RSV seems to be hitting earlier than usual, a change from pre-Covid years.

"Typically, it would peak around January, February even," said Jetelina. "Now we're starting to see it peak around November, December, which is really quite abnormal."

It is, indeed, a "heavy volume year" when it comes to RSV spread, said Dr. Jeffrey Kahn, chief of pediatric infectious diseases at UT Southwestern Medical Center and Children's Health in Dallas.

"The numbers that we're seeing this year far exceed the numbers we've had in the past," Kahn said. Most kids sick with RSV are stuffed up with congestion, and are coughing and wheezing.

Children who were born prematurely or who have underlying issues with their lung or heart function are at the highest risk.

So far this season, the overall hospitalization rate from RSV is 7.3 per 100,000 people, the CDC reported.

The surge comes amid a shortage of a new drug meant to prevent RSV infection.

Beyfortus, approved by the Food and Drug Administration in July, is intended for babies during their first RSV season. Children up to age 2 who are at high risk for severe illness from the virus can get additional doses during their second RSV seasons.

On Thursday, the CDC and FDA said the agencies had worked to release an additional 77,000 dosesof Beyfortus. It was unclear Friday whether the action would resolve the shortages or simply help.

The supply of Beyfortus at Texas Children's Hospital in Houston remains low, said chief medical officer Dr. Stanley Spinner. "We will not have many left over the next couple of weeks, I'm afraid," he said.

"We know parents are frustrated," Cohen said. "We expect to see additional doses over the next weeks and into the RSV season. We're working with manufacturers on that."

The number of positive Covid cases seems to be plateauing following a summer wave of illness, Cohen said. "Unfortunately, we do expect to see that increase over the next couple of months," she said.

Data from WastewaterSCAN, a group that receives data from wastewater collection sites in 36 states three times a week looking for evidence of viruses shed in sewage, shows that Covid remains widespread, from the Northeast through the Western part of the U.S.

Covid is persisting, said Alexandria Boehm, a professor of civil and environmental engineering at Stanford University and principal investigator and program director for WastewaterSCAN. "It's something to be aware of as we head into the holiday season," said Boehm.

Given the increases in viral activity, some experts are once again turning to masking.

"I'm a mom, and I'm working, and I don't have time to get sick," said Jetelina, who is also the publisher of a newsletter called "Your Local Epidemiologist."

"It's one very small, easy tool that I can use to reduce my risk," she said.

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Erika Edwards is a health and medical news writer and reporter for NBC News and "TODAY."

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'Sustained increases' reported in flu nationwide, as RSV hits kids hard - NBC News

Message by the Director of the Department of Immunization, Vaccines and Biologicals at WHO – October 2023 – World Health Organization

November 19, 2023

Kate O'Brien, Director of the Department of Immunization, Vaccines and Biologicals at WHO

In global healthcare, we are witnessing remarkable progress in the prevention of cervical cancer, a brighter future for malaria control, and a rallying call for more rapid progress on routine vaccinations.

Cervical cancer prevention soars to new heights

The fight against cervical cancer is scaling rapidly, thanks in large part to the growing momentum of HPV vaccination programs. In October, Nigeria, Bangladesh, and Cambodia joined the ranks of countries that include human papillomavirus (HPV) vaccine in the national schedule, following Indonesia's successful national rollout. These nations, home to substantial populations, shoulder a significant portion of the global cervical cancer burden.

Adding to the excitement is the upcoming introduction of HPV vaccination in India, and Pakistan's announcement of their intent to join the ranks of countries protecting women from cervical cancer. In a further boost to this cause, the Democratic Republic of the Congo's National Immunization Technical Advisory Group (NITAG), has recommended adding HPV vaccine to the national vaccination schedule. Collectively, these seven countries account for a third of the global cervical cancer burden, which will be significantly reduced in the future through HPV vaccination in the here and now.

Malaria control: a ray of hope

The battle against malaria is also witnessing a remarkable advance, thanks to the addition of malaria vaccine to the existing toolbox of malaria control interventions. With the completion of the pilot implementation of the RTS, S/AS01 malaria vaccine in Ghana, Kenya, and Malawi we are learning about the dimensions of vaccine impact. Recently presented data show a 13% reduction in all-cause mortality (excluding trauma) among children eligible for vaccination. Notably this impact was achieved at approximately 64-74% coverage, previewing the likelihood of even greater impact as the coverage scales up. Adding malaria vaccine to the portfolio of malaria interventions is about optimizing the mix of interventions, each of which are imperfect. Not only does this ease the health burden and suffering of children and their families, but also translates into substantial cost savings for healthcare systems.

The good news doesn't stop there. Nine additional countries, including Benin, Burkina Faso, Burundi, Cameroon, the Democratic Republic of the Congo, Liberia, Niger, Sierra Leone, and Uganda, are set to introduce the vaccine into their routine immunization programs beginning in early 2024. With a WHO policy recommendation for the second malaria vaccine, R21/Matrix-M, now in place, additional countries are also planning for introduction, given the expectation for sufficient supply, once the R21/Matrix-M vaccine achieves WHO prequalification. Having vaccines against malaria is a testament to the power of innovation and global collaboration in the fight against malaria.

Measles outbreaks and the importance of fully vaccinated children

The immunization community is anticipating the joint report by WHO and the Centers for Disease Control (CDC) on the 2022 measles case and mortality estimates, scheduled for release later today 16th November. Measles, one of the most highly infectious diseases, is making an unwanted comeback, with cases and deaths increasing globally. While Africa and South Asia have faced challenges with measles in the wake of the pandemic, other regions are also contending with outbreaks: from richer countries such as Austria and the UK, to middle-income ones like Russia, South Africa and Trkiye.

Measles is not the sole concern resulting from declining vaccination rates. As vaccine coverage decreases, measles tends to resurface first due to its high contagiousness. However, declining vaccination rates set the stage for other serious vaccine-preventable diseases to reemerge. Measles outbreaks serve as a warning sign for potential outbreaks of severe illnesses such as whooping cough, diphtheria, or polio.

In conclusion, under the banner of "The Big Catch-Up", it is crucial to support countries in reestablishing routine vaccination programs, improving their coverage and reaching the most left out, wherever they are found, in order to prevent large-scale global outbreaks of vaccine-preventable diseases.

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Message by the Director of the Department of Immunization, Vaccines and Biologicals at WHO - October 2023 - World Health Organization

CDC and FDA Expedite the Availability of Additional Doses of New RSV Immunization for Infants | CDC Online … – CDC

November 19, 2023

Today, CDC announced the release of more than 77,000 additional doses of Beyfortus (nirsevimab-alip (100 mg), a long-acting monoclonal antibody designed to protect infants against severe respiratory syncytial virus (RSV) disease.These additional doses will be distributed immediately to physicians and hospitals through the Vaccines for Children Program and commercial channels improving the availability of nirsevimab-alipfor parents seeking to protect their eligible children, particularly those at highest risk of severe illness.

CDC and FDAwill continue to be in close contact with manufacturers to ensure the availability of additional doses through end of this year and for early 2024 to meet the demand.

CDC and FDA are committed to expanding access to this important immunization so that more parents have peace of mind during the winter virus season, said Dr. Nirav D. Shah, CDCs principal deputy director.

Helping to ensure the availability of this preventative option to reduce the impact of RSV disease on eligible babies and young children, families and the health care system remains a priority, said Patrizia Cavazzoni, M.D, director of the FDAs Center for Drug Evaluation and Research. We will continue to use all ourregulatory tools to help bring safe, effective and high-quality medicines to the public.

CDC has taken steps to make the immunization more accessible for doctors to order through the Vaccines for Children program, which provides vaccines to half of Americas children.

Additionally, CDC and FDA have been engaged with groups such as the American College of Obstetricians and Gynecologists, to encourage more doctors to use the RSV maternal vaccine, which can help ensure babies are protected against RSV before they are born.Moreover, CDC has been in regular contact with clinicians across the country, encouraging them to prioritize nirsevimab-alip for infants at highest risk during this period of constrained supply.That list includes young infants up to six months old and American Indian and Alaska Native infants, among other groups.

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CDC and FDA Expedite the Availability of Additional Doses of New RSV Immunization for Infants | CDC Online ... - CDC

About 36M American adults have received the updated COVID vaccine: CDC – ABC News

November 19, 2023

This is equivalent to 13.9% of the U.S. adult population.

November 14, 2023, 2:04 PM ET

5 min read

An estimated 36 million adults in the United States have received the updated COVID-19 vaccine as of Monday, according to new data from the federal government.

Additionally, about 3.5 million children have also gotten the updated shot, according to the survey, which is a sample size of the U.S. population, from the Centers for Disease Control and Prevention.

This is roughly equal to the number of Americans who had received the bivalent booster -- which was targeted against different COVID variants -- by this time last year.

While this means that uptake has not lagged compared to previous seasons, it also means just 13.9% of the adult population has gotten vaccinated.

This is lower than the nearly half of adults who said they planned to get the vaccine in a poll conducted by the KFF COVID-19 Vaccine Monitor in September.

Poll results showed that 23% of U.S. adults said they would "definitely" get the updated booster and 23% said they will "probably" get it.

The updated vaccine is targeted against variants that are currently circulating, which are related to XBB, an offshoot of the omicron variant.

There are formulations made by Pfizer-BioNTech and Moderna for those aged 6 months and older, and a formulation made by Novavax for those aged 12 and older.

The same CDC survey showed that 91 million U.S. adults, or 34.8% of the adult population, have received the flu vaccine and nearly 11 million over the age of 60, 13.5% of this age group, have received the RSV vaccine.

Meanwhile, 23 million children, or 4.9% of the pediatric population, have received the flu shot, data survey showed.

Public health experts usually advise that people receive respiratory virus vaccines by the end of October, but stress that it's never too late to receive shots from pharmacies or doctors' offices.

It comes as respiratory illness activity causing people to seek care remains low in most areas of the U.S., according to data updated this week by the CDC.

For the week ending Nov. 4, 2.9% of outpatient visits have been for respiratory illnesses. This is about half of where it was at the same time last year, but higher than the four preceding seasons, CDC data shows.

Last year's respiratory virus season was unusually early, and activity increased sharply. Experts have said it's possible that this year's trending activity is a sign that we are getting back to the usual timing of 'cold and flu' season following disruptions after the emergence of COVID.

"Last year's early spike was an anomaly, likely influenced by the pandemic's impact on social behaviors and immunity," said Dr. John Brownstein, an epidemiologist and chief innovation officer at Boston Children's Hospital and an ABC News contributor.

"This year's numbers, aligning more closely with pre-COVID patterns, indicate a reestablishment of typical 'cold and flu' season dynamics," he continued. "However, we still have to see how the rest of the respiratory virus season plays out to know for sure."

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About 36M American adults have received the updated COVID vaccine: CDC - ABC News

Humoral immunogenicity assessment after receiving three types of … – Nature.com

November 19, 2023

Humoral immunity is a major factor which plays a critical role in vaccines effectiveness. Despite the fact that the exact neutralizing response is investigated thorough cVNT, which requires biosafety level 3 equipment, Anti-SARS-CoV-2 anti RBD titer can be measured to evaluate humoral responses after infection or vaccination. The sVNT is practical in numerous studies on features of COVID-19, including vaccine efficacy during preclinical and clinical trials of different vaccine candidates and monitoring neutralizing antibody titers in vaccine recipients after mass vaccination7,22,23.

This was a prospective longitudinal study performed on 462 adult participants each receiving 2 doses of either AstraZeneca, COVIran Barekat or Sinopharm vaccines. One month after the injection offirst dose, a significant statistical difference was shown when comparing inactivated vaccine recipients (COVIran Barekat or Sinopharm) with participants who received AstraZeneca vaccine, both in the antibody presence (AstraZeneca 89.4%, COVIran Barekat 62.6%, and Sinopharm 59.0%, P-Value<0.001) and the median antibody titer (AstraZeneca 224.0 (IQR 68.8396.8) BAU/ml, COVIran Barekat 105.6 (IQR 16.0284.8) BAU/ml, and Sinopharm 91.2 (IQR 16.0276.8) BAU/ml, P-Value<0.001). Also, the same results were obtained after the injection of the second dose, antibody presence were as follows: AstraZeneca 98.9%, COVIran Barekat 89.5%, and Sinopharm 92.1% (P-Value<0.001). Also, the median antibody titer was significantly higher in AstraZeneca recipients (AstraZeneca 377.6 (IQR 275.2416.0) BAU/ml, COVIran Barekat 192.0 (IQR 72.0297.6) BAU/ml, and Sinopharm 195.2 (IQR73.6302.4) BAU/ml, P-Value<0.001). Inevitably, the protection offered by neutralizing antibodies through vaccination can be varied due to the differences in vaccine platforms and the interval of doses. Our findings demonstrated that Astra Zeneca has led to higher immunogenicity compared to other available vaccines in Iran.

An Iranian cohort monitoring study has revealed that when comparing AstraZeneca recipients with inactivated vaccines recipients, although the former has a significantly higher immunity during the interval of the first and second dose, after the second dosage no significant difference was found among different vaccine platforms. They concluded that SARS-CoV-2 vaccines, while unable to prevent the infection, can significantly reduce mortality rate24. These results are in line with our findings about the higher anti-SARS-CoV-2 anti RBD IgG detection rate and titer in AstraZeneca recipients.

It is obvious that antibody titers, post-infection or vaccination, cause a range of protective effects specifically by reducing the mortality rate. A study estimated that the required neutralizing antibody titer to completely prevent symptomatic viral infection is approximately sixfold higher compared to what is required to prevent severe outcomes of SARS-CoV-2 infection25.

In this study, we assessed antibodies in participants infected or not infected early in the pandemic during alfa and delta variants circulation time. The assessment of serum antibody activity after the first dose of SARS-CoV-2 vaccination (in September 2020) showed that participants who had previously confirmed infection in each vaccine group, or overall had a significantly higher amount of antibody titer as demonstrated in the RBD-based ELISA assay, except for COVIran Barekat group, which might be due to the low number of infected persons in this group: 11 out of 155 (7.09%). Moreover 2 of 11 COVIran Barekat recipients who had prior infection history, did not produce antibodies after the first vaccine administration. Considering that both of them were young (a 30years old female and 38years old male), they might be non-responders. The impact of these two samples was magnified in such a small fraction. Therefore, when we used Whitney U test for each vaccine group in order to investigate the impact of infection history, it led to a non-significant p-value for COVIran barekat group. These findings confirmed that additional antigenic exposure further improves antibody efficacy against SARS-CoV-2 variants. Protective antibodies from prior infection, with or without vaccination, induced antibodies against the spike protein to interfere with its function26. The antibody response is a crucial aspect of adaptive immunity against viral infections. Based on the predominant isotypes and profiles of somatic hypermutations of the antibodies, the humoral immune response can be divided into two phases. In the extrafollicular (EF) phase, B cells are activated and quickly differentiate into plasma cells in foci outside of the follicle within a few days after the infection. They produce antibodies that contain few somatic hypermutations but can still have reasonably high affinities and neutralize the virus27. Another study revealed the chances of reinfection are significantly lower in individuals who tested positive for antibodies. Furthermore, getting vaccinated after a SARS-CoV-2 infection enhances the impact of this response. Research has found that neutralizing antibodies are present in 99% of people infected with SARS-CoV-2 before. It is believed that the antibodies could provide strong protection against infection and reinfection in individuals without COVID-19 infection history, but were vaccinated previously28.

Many scientists are of the same concern about the waning of neutralizing antibody titers induced through prior infection or vaccination. Besides, the continuous emerge of new Variants Of Concern (VOC) of SARS-CoV-2 due to its broad spread and frequent mutation, has caused several neutralizing antibodies to lose their antiviral activities. However, neutralizing antibodies can recognize different epitopes in spike protein and some of them can neutralize new VOCs. As a result of that, pervious immunity induced by infection or vaccine might alleviate infection. It was suggested that, in order to decrease the VOCs chance of escape from vaccine induced neutralizing antibodies, future vaccines must consider different groups of epitopes of RBD29.

The next step is to develop vaccines which are able to prevent infection completely. Mucosal immunity inducing vaccines might be effective in preventing infection and restricting viral transmission, however, there are still a number of obstacles to overcome to reach their full potential30. Mucosal vaccines have been successful in protecting against diseases, but there are still limitations and risks associated with their clinical development. One concern is that mucosal surfaces are frequently exposed to harmless foreign substances and commensals, which can lead to tolerogenic immune programs that may result in weak induction of pro-inflammatory responses. Effective adjuvants can help break tolerance, however, there are limited mucosal adjuvants that are safe for human use and many require further testing to demonstrate their safety and efficacy. Additionally, antigen dilution can hinder vaccine delivery at mucosal surfaces, where ciliated cells quickly clear away debris and pathogens in a protective mucous layer31.

In this study, previous infection history was significantly related to higher anti SARS-CoV-2 anti RBD IgG titers (P-Value<0.001 after the first dose, P-Value: 0.002 after the second dose). Many studies subscribe to this theory, which states infection history can boost vaccine effectiveness and lead to an increase in antibody titer and furthermore can shorten the interval of vaccine injection and rises in antibody titer21,32,33.

After categorizing participants based on their sex or age, no significant difference was observed in the median antibody titer. AstraZeneca clinical trial phase 2/3 data has not shown any significant difference in neutralizing antibody titer among different age groups, after the second dose injection. The data also demonstrated that neutralizing antibody has been detected among 99% of participants 14days after the second dose injection34. However, another meta-analysis including approximately 7 million participants from 18 studies, has found that vaccine effectiveness in prevention of severe SARS-CoV-2 infection was significantly lower among participants older than 65years old35. It might be due to the fact that different vaccine types were investigated in that study; since it investigated mRNA-based vaccines and Johnson and Johnson vaccine. Moreover, our studys aim was to evaluate antibody titer among university staff and students, leading to 84% of our participants being 50years old or younger, which may result in limitations.

The limitations of this study are: it did not consider children and elderly citizens (>70), cell-mediated immune responses were not assessed, and last but not least, 34% of the participants in the first sampling did not return to partake in the second round of it.

Although, the emergence of new VOCs and waning neutralizing activity of vaccines has faced researchers with a dilemma, how often should we administer SARS-CoV-2 vaccines and more importantly how safe are these repeated injections? Further studies need to address the problems of safety and efficacy of the developed and the under-development vaccines against SARS-CoV-2, which are achievable through real-world surveys.

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Humoral immunogenicity assessment after receiving three types of ... - Nature.com

Vaccine Safety and Effectiveness – SCDHEC

November 19, 2023

Vaccines are included among the Ten Great Public Health Achievements in the period between 1900 and 1999 because they have a long history of successfully protecting people and communities against infectious diseases by reducing the spread of disease and preventing hospitalizations and deaths. Because of vaccines, serious diseases like smallpox have been eliminated and diseases such as polio and diphtheria are now rare in the United States. Most physicians in the U.S. rarely if ever treat a case of measles.

While no vaccine offers 100% protection, they are extremely effective and are our best defense against infectious diseases. Even if the vaccine does not prevent infection in every person, they often reduce the risk of serious disease and death from the disease. The number of people who experience devastating effects from vaccine-preventable infectious diseases is at an all-time low. To continue that success, we must make sure vaccines are safe and readily available.

Vaccines are constantly under study to ensure they are safe and effective. They undergo rigorous studies designed to measure safety as well as how well they work and potential side effects. In addition, once a vaccine is released, the safety of the vaccine continues to be monitored. Vaccines like all medications and procedures have potential risks that must be weighed against the benefits. The risks for serious complications are quite low and are typically comparable to those associated with common prescription medications. At DHEC, we always recommend that you ask your health care provider about what vaccines are best for you and your family.

While there can be side effects from vaccines, severe adverse events are far rarer than complications from vaccine-preventable diseases. Most people do not have serious side effects from vaccines; common side effects include muscle aches or mild fever. Such side effects are often signs the body is building a healthy immune response to protect us from disease.

Certain vaccines are updated periodically to keep up with changes in the germs they protect against. The flu vaccine is updated from season to season to protect against the virus strains that research suggests will be common during the upcoming flu season. The COVID-19 vaccine has been updated to best combat new virus variants, or strains, and would be updated as needed in the future.

The U.S. Food and Drug Administrations (FDA) Center for Biologics Evaluation and Research regulates vaccine use in the United States and works to ensure safety of vaccines at every stage. Before vaccines are approved, the FDA requires that expert researchers show they are effective and safe. The CDC Advisory Committee on Immunization Practices recommends vaccines for certain groups of people once they establish that benefits of a vaccine in preventing disease outweighs potential risks.

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Vaccine Safety and Effectiveness - SCDHEC

Influenza vaccination and major cardiovascular risk: a systematic … – Nature.com

November 19, 2023

Search strategy

A search of the medical English literature was conducted using PubMed/MEDLINE, EMBASE, and the Cochrane CENTRAL up to 1 August 2023. A thorough review was conducted on randomized controlled trials (RCTs) exploring the potential link between influenza vaccination and the subsequent risk of developing CVDs.

The search terms were: myocardial disease and influenza vaccines (Table S1). This study adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement (PRISMA) for its design and reporting (Table S2) (Prospero ID: CRD42023450694)11.

The records obtained from the database searches were amalgamated, and redundancy was addressed through employment of EndNote X7 (Thomson Reuters, Toronto, ON, Canada). Subsequently, two evaluators (MZ and MJN) carried out individual assessments of the records, considering both their title/abstract and full text, in order to exclude any entries that did not align with the study's objectives.

The studies included in the analysis met the following criteria based on the PICOs:

Participants: The patients with a diagnosis of CVDs.

Intervention: Patients with CVDs who received influenza vaccine.

Comparison: Patients with CVDs who received a placebo.

Outcome: Lower risk of cardiovascular events.

Conference abstracts, case reports, and studies comparing high and low doses of influenza vaccination were excluded.

Data extraction was conducted by two investigators (MZ and MJN) and recorded in a Microsoft Excel spreadsheet (XP professional edition; Microsoft Corp, Redmond, WA). The extracted information encompassed various key elements, including the first author's name, publication date, study type, definitions of cases and controls, the number of cases and controls, and the outcomes of the studies.

The quality assessment of the included studies was conducted by two reviewers (MJN and MZ) using the Cochrane tool12. In case of any discrepancies, a third reviewer (FO) was involved. This instrument encompasses a range of domains, which encompass random sequence generation, allocation concealment, blinding of both participants and personnel, blinding of assessors for outcomes, completeness of outcome data, and additional considerations such as selective reporting and potential sources of bias. Each study was categorized as having a low risk of bias when no concerns regarding bias were identified, a high risk of bias when there were concerns about bias or an unclear risk of bias when there was insufficient information available.

The combined outcomes were presented as risk ratios along with corresponding 95% confidence intervals (CIs). To evaluate the level of variability among the studies, both the I2 value and p-value were employed. In cases where minimal statistical heterogeneity was observed (I250% or p0.1), the fixed-effect model was applied. Conversely, if substantial inter-study heterogeneity was identified (I2>50% or p<0.1), the random-effects model was utilized. Assessment of between-study heterogeneity involved the application of Cochran's Q test and the I2 statistic. To assess potential publication bias, Begg's test was employed, where a significance level of p<0.05 indicated noteworthy publication bias. All analytical procedures were conducted using Comprehensive Meta-Analysis Software, Version 3.0 (Biostat, Englewood, NJ).

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Influenza vaccination and major cardiovascular risk: a systematic ... - Nature.com

A strategic approach to addressing patient vaccine hesitancy with … – Wolters Kluwer

November 19, 2023

In the wake of the COVID-19 pandemic, clinicians are now faced with a rise in patients who are hesitant towards vaccination, both for themselves and their children. As early as 2018, the WHO was reporting declining vaccination rates in America, though immunization numbers worldwide are improving overall. It is important to identify the various potential causes of vaccine hesitancy and to be able to approach these patients with compassion while also effectively presenting scientific and medical information that encourages them to understand the truthful benefits and risks of inoculation and the serious potential dangers of avoiding it. What is vaccine hesitancy and what factors contribute to vaccine hesitancy?

It may be difficult for clinicians to understand why patients would avoid vaccinating themselves or their children. However, in order to respect a patients right to make their own decisions about their health and speak to them about their concerns without making them feel disenfranchised, it is important to extend an empathetic understanding of what factors might be contributing to their hesitancy and to do so, it is crucial to define what exactly vaccine hesitancy is.

In The Vaccine-Hesitant Moment, a paper by Dr. Heidi J. Larson et al. published in the New England Journal of Medicine, the authors define vaccine hesitancy as a state of indecision and uncertainty that precedes a decision to become (or not become) vaccinated. They note an overall lack of consensus on the definition of vaccine hesitancy:

In 2015, Peretti-Watel and colleagues pointed to the ambiguous notion of vaccine hesitancy and noted that definitions of vaccine hesitancy tend to be very broad and to embrace heterogeneous people/situations and many different explanatory factors, and they proposed that vaccine hesitancy be considered a kind of decision-making process.

Whereas vaccination is an action, the authors explain, it is important that clinicians understand that vaccine hesitancy is not defined by a single moment but is instead seen as an attitude or sentiment that can shift. This can benefit a clinician trying to promote vaccination, as the period of hesitancy and indecision is a time of vulnerability, as well as opportunity.

Not all patients have the same reason for being nervous about or avoidant of vaccination, and even for a single patient these reasons can shift, the authors continue:

The mutable nature of vaccine hesitancy calls for new modes of analysis to characterize not only the temporal features of hesitancy but also the spatial (e.g., regional) features and the many behavioral manifestations and their effects on vaccine uptake. [...] Real-time data [allows] investigation into contextual events that can help us understand the drivers of hesitancy.

What is the most significant driver of the recent spike in vaccine hesitancy? The answer, as explained by Dr. Larson et al., may not surprise you: the Internet, especially social media sites including YouTube. In an era where patients seek out medical information on their own, they are vulnerable to platforms where anyone can write whatever they please. This creates a landscape of confusing misinformation and disinformation alongside accurate, scientifically based information without providing patients with the basic knowledge or ability to discern one from the other. Disinformation easily spreads across borders, with the hyperconnected digital landscape [offering] a new opportunity for people with shared beliefs to self-organize across geographic regions, influencing and sometimes disrupting public confidence and cooperation.

In addition to the Internet, the Dr. Larson et al. also cite concerns about side effects (such as debunked claims of the MMR vaccine causing autism), distribution methods (i.e., a fear of needles), and ingredients (including preservatives or adjuvants that boost vaccine effectiveness). Additional contextual factors include,

A wider decline in trust of expertise and authority, and different modes of belief-based extremism. Political polarization, as well as libertarian views and alternative health care advocacy, triggers public questioning about the importance, safety, and effectiveness of vaccines.

It is important to get an awareness of the reasons behind patient vaccine hesitancy, Dr. Larson et al. suggest:

Health care providers need to offer support and encouragement and listen to what matters from the patients perspective. Equipping physicians with information on the nature and scope of circulating concerns in their communities may help them address such concerns in the clinic, while also informing appropriate interventions at the community level.

In addition to being region-dependent, vaccine hesitancy also shifts depending on the illness being treated as well as public perception of the vaccine and the danger posed by the illness it prevents. This was demonstrated when the first COVID-19 vaccine and subsequent booster vaccines emerged, explained Dr. Larson et al.:

Sentiments concerning whether to undergo vaccination can change, and change again, as evidenced in multiple surveys showing that Covid-19 vaccine sentiments are influenced by factors such as a new report of vaccine risks or perceptions of increasing or decreasing disease threats.

A timely understanding of the aforementioned drivers of hesitancy can be crucial, the doctors continue, since vaccine acceptance can be increased, but responsiveness to emerging concerns is key:

Timing is everything regarding both the personal moment and the historical moment when it comes to making a decision about vaccination. The uncertainty and constantly evolving nature of the Covid-19 pandemic and response measures, the rapid introduction of new vaccines, emerging variants, and the volatility of the surrounding politics and polarization have all contributed to public questioning and the trends in vaccine hesitancy.

Patient age, race/ethnicity, and income also make an impact on vaccine hesitancy, as shown in Willingness to Get a COVID-19 Vaccine and Reasons for Hesitancy Among Medicare Beneficiaries: Results From a National Survey. In this study, which was performed at the tail end of the first year of the pandemic, Dr. Huabin Luo et al. noted,

Close to 40% of Medicare beneficiaries [surveyed] were hesitant about getting a COVID-19 vaccine, and the hesitancy was greater in racial/ethnic minorities [and those with lower income levels]. Medicare beneficiaries were concerned about the safety of the vaccine, and some appeared to be misinformed. [...] Among those who were hesitant, more than 40% reported that mistrust of the government and side effects [were] the main reasons.

Clinicians at every level can learn to counter vaccine misinformation. The growing prevalence of vaccine hesitancy has changed how medicine is taught, with programs for medical students now incorporating evidence-based training techniques for addressing the vaccine-hesitant such as role-playing. It is crucial, explained Miriam Frisch et al. in Addressing COVID-19 Vaccine Hesitancy: The Role of Medical Students, that this approach is grounded in knowledge of the science behind vaccines as well as an understanding of historical racial and structural biases that contribute to hesitancy.

Early training is important because of how impactful the opinions of clinicians can be on patients decision-making despite rising levels of vaccine hesitancy, said Dr. Larson et al.:

Physicians and other health care providers are still among the most trusted persons when it comes to health care advice. The Wellcome Global Monitor surveyed people in 140 countries and found that 73% of the respondents said that they would trust a doctor or a nurse more than others; the percentage was 90% in the higher-income countries.

Digital analytical tools can act as a means of understanding the localized spread of vaccine hesitancy over time in a clinicians geographical care area such as in this study of COVID-19 vaccine hesitancy in Missouri. Dr. Larson et al. explained that,

New methodologies are needed to monitor emerging vaccine concerns over time and place in order to better inform appropriate responses. Mapping vaccine hesitancy at a local level is one important step toward addressing it, along with other needed interventions at the individual and community levels.

What actionable steps can clinicians take to address vaccine hesitancy without disenfranchising patients? Drs. Jamie Loehr and Margot Savoy have several suggestions in Strategies for Addressing and Overcoming Vaccine Hesitancy in American Family Physician, starting with curiosity towards and non-judgmental awareness of the patients hesitancy:

Most patients [...] are not truly resistant to immunization, and parents largely want clarification and reassurance. Some persons will have specific safety concerns, and providing education that addresses these areas can lead them to follow your recommendations. Discuss vaccine safety in a nonjudgmental way by expressing curiosity, seeking first to understand before pressing to be understood.

Certain clinicians, such as Drs. Shixin Shen and Vinita Dubey in their article Addressing vaccine hesitancy, suggest that personal, storytelling-based communication may be effective as it has commonly been used by the [anti-vaccine] movement, [and may] supplement evidence-based information. Though some studies conflict with this supposition, they suggest,

According to a survey [in the U.S.,] the most common communication practices deemed very effective for convincing [skeptical] parents were personal statements by physicians about what they would do for their own children and about their personal experiences with vaccine safety among their patients, [which] improved attitudes toward vaccination [...] especially for individuals who had lower confidence in vaccines.

Some approaches to managing vaccine hesitancy, such as the three Cs, the CASE approach, and the three As, focus on physician-targeted communication training. However, Drs. Loehr and Savoy cite studies suggesting that these models are overall of low quality and generally lacking in impact, namely that physician-targeted communication training had no detectable effect on vaccine hesitancy. This doesnt downplay the importance of boosting communication skills overall, however, as patients may be less likely to trust physicians who communicate poorly, [so] honing your motivational interviewing skills and practicing active listening does not take away from your ability to talk to patients about vaccine-related decisions. Specifically, they suggest changing the way you bring up vaccinations:

Opening the immunization conversation with a presumptive approach rather than a participatory approach (e.g., saying We have to do some shots, rather than asking, What do you want to do about shots?) can dramatically decrease resistance to vaccine recommendations. In one study, 83% of parents resisted recommendations with a participatory approach vs. only 26% with a presumptive approach, both in vaccine-hesitant parents and in the overall study population. Persistence matters. Nearly one-half of parents who initially resisted following immunization recommendations ultimately accepted them when physicians continued to pursue their recommendations. Conversely, a 2014 systematic review showed that a lack of a health care professional's recommendation was one of the top three reasons children did not get the human papillomavirus vaccine.

What if, despite following guidelines, listening with compassion, and providing information, patients are still hesitant? Be patient, said Drs. Loehr and Savoy, and remember that vaccine hesitancy is not a single moment in time but rather a decision-making process that may shift:

A small percentage of patients will refuse one or more vaccines. We encourage preserving your relationship with the patient and tabling the conversation for another day. In the United States, the parent or patient has the right to make medical decisions, and [...] the Centers for Disease Control and Prevention and the American Academy of Pediatrics recommend against asking patients or their families to leave your practice if they refuse to immunize. [...] Children need health care beyond immunizations, as well as a medical home. In addition, continuing care allows for an ongoing relationship, which might lead to parents being more willing to vaccinate in the future.

Its crucial to stay informed about immunization guidelines for your patients so that you can openly address their concerns. Get up to date with our latest vaccine CME collection to inform yourself on how to approach vaccine hesitancy with patience and compassion.

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COVID vaccine mandates waning in Madison workplaces … – The Capital Times

November 19, 2023

Wisconsin legislators are considering significant limits on an employers ability to require workers to be vaccinated, even as some companies and local governmental agencies in Dane County have dropped COVID-19 shot mandates for employees.

The legislation, heard in a state Assembly Committee on Thursday, is the latest in a line of efforts to weaken vaccine mandates in Wisconsin after a spike in anti-vaccine fervor during the COVID-19 pandemic.

That pushback followed efforts from companies, government agencies and other employers to require the COVID-19 vaccine as a condition of employment. The approved COVID-19 vaccines havebeen deemed safe and effective and millions of Americans have received the shots, with adverse side effects considered rare.

The latest bill would require employers to offer an exemption process for workers who because of religious, medical or philosophical reasons do not wish to get a vaccine.

A business could not require documentation from an employee to back up the exemption request, creating what critics fear is a major loophole.

It doesnt make any sense to me, Rep. Christine Sinicki, D-Milwaukee, said.

While the bill was inspired by the COVID-19 pandemic, its authors say, the language would apply to any vaccine requirements.

Wisconsinites in every facet of life have a right to decide what to put into their bodies, Rep. Shae Sortwell, R-Two Rivers, the bills co-author, told the Assembly Committee on Labor and Integrated Employment. We saw these freedoms of Wisconsin workers compromised during the COVID-19 pandemic. We want to ensure that this does not happen again.

Vaccine requirements begin to fade

While many prominent employers in Dane County announced plans in 2021 and 2022 to require COVID-19 vaccines, some have since dropped the policies.

UW Health "strongly encourages" but no longer requires the COVID-19 vaccine for employees, spokesperson Sara Benzel said in an email. Staff members are required to be vaccinated against influenza, but religious and philosophical exemptions are an option.

Molly Groose high-fives her daughter Clara Groose, 7, after Clara received the COVID-19 vaccine in November 2021. The public health department recommends that people get their vaccine shots and, if eligible, a booster, especially as people gather for the holidays.

In June, the Madison School Board rescinded the district's staff COVID-19 vaccine mandate 21 months after it was first put in place. The Madison Metropolitan School District's medical experts said the wording of the original mandate left it out of date given boosters, and employees had expressed concerns about the cost and staff time to enforce the mandate given the end of the national emergency declaration.

Dane County also dropped a COVID-19 vaccination requirement for its workers, Greg Brockmeyer, director of the countys Department of Administration, said in an email.

Epic, American Family Insurance and Exact Sciences are among the prominent Madison-area businesses who previously said they would require a COVID-19 vaccine. Spokespeople for those businesses did not immediately respond to questions about their current policies.

Rep. Francesca Hong, D-Madison, who is also a Madison restaurateur, said her business asks employees to be vaccinated but does not require it as a condition of employment. But she said she believed the government should not infringe on the rights of private businesses who wish to make immunizations mandatory.

I don't believe the state should be removing anything that undermines public health, she told the Cap Times.

Meningitis, chickenpox shots also targeted

The Legislature has increasingly voted to do away with vaccine requirements for both the COVID-19 shots and other immunizations.

In June, the Legislature blockeda requirement that seventh graders be vaccinated against meningitis, as well as opposing an effort to make it harder to seek out a waiver for the chickenpox vaccine requirement for younger students.

And in 2021, legislators considered a measure that would have prevented private employers from requiring the COVID-19 vaccine at all. While it passed the state Assembly, it was ultimately not considered in the state Senate.

The latest effort involving employer policies is an attempt to mirror the exemption process for K-12 students. Currently, students can get an exemption due to a medical condition or because of their religious or personal beliefs. They could still be excluded from school in the event of an outbreak.

Minnesota and Wisconsin are among 20 states that allow parents to opt out of vaccinating their children. Health Officials say a 95 percent immunization rate is required to prevent outbreaks of diseases like measles.

Sen. Steve Nass, R-Whitewater, one of the bills authors, told the Assembly committee that requiring vaccines can breed mistrust of both the employer and the shots.

He also repeated a common anti-COVID-19-vaccine claim that the shots were potentially dangerous, as they had not been fully approved by the Food and Drug Administration when they began being administered in the United States. Because of this, Nass said people could sue employers who made them get the vaccine.

Both Pfizer and Moderna shots have since received full FDA approval, though more recent variations of the vaccine are under emergency use. But data was still required to demonstrate the vaccines safety in tens of thousands of participants before an emergency use authorization could be issued.

Still, Nass said it was improper for employers to pry into the private lives of workers.

Employer vaccine mandates I believe violate personal privacy, he said. Employees are sensitive to their personal information in the most significant parts of their life. They would prefer not to divulge their medical information to their employers.

Rep. Karen Hurd, R-Fall Creek, criticized the efficacy of vaccines more broadly, saying the eradication of measles was due to people achieving natural immunity by acquiring the disease, not from mass vaccination campaigns.

Both the Centers for Disease Control and Prevention and Pan American Health Organization consider the development of a vaccine against measles, mumps and rubellato becrucialto their 2000 elimination in the United States, as well as essential to continuing to suppress the disease.

Measles cases have again become a problemboth in the U.S. and globally, with the CDCattributing the increaseto 61 million doses of the MMR vaccine being delayed or missed during the COVID-19 pandemic.

Hong, the Madison lawmaker and small business owner, said it was disheartening that people are still airing misinformation about vaccine effectiveness.

It's absolutely absurd that after a vaccine that saved hundreds of millions of lives, after over a million people died from COVID-19, that we are still having conversations of recognizing that it is not just about our personal health, that public health means caring for your neighbor, she said.

Cap Times reporter Scott Girard contributed to this report.

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COVID vaccine mandates waning in Madison workplaces ... - The Capital Times

4th COVID vaccine dose tied to reduced infection, poor outcomes in … – University of Minnesota Twin Cities

November 19, 2023

In a joint report today, the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC) said amid ongoing declines in measles vaccination, cases in 2022 rose by 18%, and deaths were up 43% globally compared to 2021.

The groups detailed their findings in Morbidity and Mortality Weekly Report. Last year, 37 countries reported large or disruptive outbreaks, up from 22 in 2021. The African region was hit hardest, with 28 outbreaks, followed by the Eastern Mediterranean (6), South East Asia (2), and European regions (1).

The researchers also saw coverage gaps of the vaccine, which is given as a two-dose series. Though global vaccine coverage was up modestly between 2021 and 2022, 33 million kids missed a measles vaccine dose, including 22 million who didn't get their first dose and 11 million who never received their second shot. Global coverage rates are still below the 95% two-dose goal needed to protect communities from outbreaks.

Measles deaths were highest in low-income countries, where coverage rates were lower, with no sign of recovery after the pandemic. Of 22 million who missed their second measles vaccine dose last year, more than half were from just 10 countries: Angola, Brazil, the Democratic Republic of the Congo, Ethiopia, India, Indonesia, Madagascar, Nigeria, Pakistan, and the Philippines.

In a CDC press release, Kate O'Brien, MD, the WHO's director for immunization, vaccines, and biologicals, said the report's findings are an alarm bell for action. "Measles is called the inequity virus for good reason. It is the disease that will find and attack those who arent protected," she said.

In a statement, Gavi, the Vaccine Alliance, said the findings reiterate the ongoing need to speed and support recovery following the pandemic. Aurelia Nguyen, Gavi's chief program officer, said filling coverage gaps was a challenge even before the pandemic. "And with cases, outbreaks and preventable deaths rising so sharply due to increased immunity gaps related to the pandemic, it shows how even more important it is that our Alliance provides an unprecedented level of support to countries in 2024," she said.

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4th COVID vaccine dose tied to reduced infection, poor outcomes in ... - University of Minnesota Twin Cities

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