Category: Vaccine

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Merck to Start Trials of New HPV Vaccine and Single-Dose Gardasil Shot – BioSpace

March 15, 2024

Pictured: Merck & Co. headquarters in Silicon Valley iStock/Sundry Photography

Merck has unveiled plans to ramp up its human papillomavirus portfolio with a new vaccine, starting a trial launch in the fourth quarter of this year, the company announced Wednesday at the EUROGIN 2024 HPV Congress.

The new multi-valent HPV vaccine aims to give broader protection against multiple types of the viral infection.

According to Merck, the company has been working to identify new candidates to protect against a more comprehensive array of HPV, with its latest addition to the pipeline using its virus-like particle technology to incorporate more particles and expand coverage. This includes several types that impact Asian and African populations and those of African and Asian descent.

Merck is also planning to conduct trials in male and female patients to evaluate the safety and efficacy of a single-dose regimen of Gardasil 9 versus the approved three-dose regimen.

Evidence continues to emerge showing the importance of Gardasil and Gardasil 9 to public health, Merck CMO Eliav Barr said in a statement. These significant investments build upon our leadership and importantly provide the opportunity to further impactthe global burden of certain HPV-related cancers and disease.

Merck is planning for two separate clinical trials in males and females between 16 and 26 years of age to examine a single doses short- and long-term efficacy and immunogenicity. The trials are expected to enroll patients in the fourth quarter of 2024.

The vaccine is currently cleared for females aged nine through 45 years to prevent several types of cancers caused by HPV types, including cervical, vulvar, oropharyngeal, and head and neck cancers.

Gardasil and Gardasil 9 are key earners for Merck, as the vaccine pulled in over $8.8 billion in revenue in 2023, a 29% increase from 2022.

However, Merck is not stopping with just HPV vaccines. The company is looking to challenge Pfizer in the pneumococcal vaccine arena as the FDA granted priority review for a Biologics License Application for V116, Mercks investigational 21-valent pneumococcal conjugate vaccine, with a PDUFA date set for June 17, 2024.

Merck is also working with Moderna to create a combination of its cancer drug Keytruda and an mRNA vaccine, which has shown improvement in melanoma at the three-year mark.

Tyler Patchen is a staff writer at BioSpace. You can reach him attyler.patchen@biospace.com. Follow him onLinkedIn.

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Merck to Start Trials of New HPV Vaccine and Single-Dose Gardasil Shot - BioSpace

Manufacturing facility expansion to advance next-gen vaccine – European Pharmaceutical Review

March 15, 2024

The first South Korean vaccine manufacturing facility to achieve EU-GMP certification from the European Medicines Agency (EMA) is being expanded to support global supply of a pneumococcal conjugate vaccine.

Overall, the goal of expanded facility is to strengthen [SK biosciences] manufacturing capabilities for global supply [of the pneumococcal conjugate vaccine candidate GBP410]

SK bioscience has announced its manufacturing plant L HOUSE, in Andong, Gyeongsangbuk-do, South Korea, is set to have a facility expansion. The new space will be provide a production base for the next-generation pneumococcal conjugate vaccine candidate GBP410 (SP0202), jointly developed by SK bioscience and Sanofi.

Overall, the goal of expanded facility is to strengthen its manufacturing capabilities for global supply, SK bioscience stated. Two floors will be added to the facilitys existing vaccine manufacturing department. This will generate approximately 4,200m2 of new space, SK bioscience explained. The firm shared that following the facility expansion, it plans to obtain current good manufacturing practice (cGMP) certification for the new facility.

SK bioscience and Sanofi announced positive results from the Phase II clinical trials of the GBP410 vaccine in infants, in June 2023. The data from the studies suggested that the vaccine has blockbuster potential, according to SK bioscience. A global Phase III clinical trial is being planned, with an expected regulatory submission in 2027.

Prior to this new facility expansion, SK bioscience highlighted that in 2021, L HOUSE was the first domestic vaccine manufacturing facility to achieve EU-GMP certification from the European Medicines Agency (EMA).

The pneumococcal vaccine market is predicted to value $10.3 billion by 2028, based on data from Evaluate Pharma.

[The] expanded manufacturing facility [is planned to support] introduction of the pneumococcal conjugate vaccine into the worldwide market

SK bioscience shared that together with Sanofi, the company plans to take advantage of the expanded manufacturing facility to advance the successful introduction of the pneumococcal conjugate vaccine into the worldwide market, including US, Europe, and South Korea.

Following the facility expansion, L HOUSE will firmly establish itself as a global vaccine hub We will make every effort to achieve successful development and supply of a vaccine with blockbuster potential, Jaeyong Ahn, CEO of SK bioscience shared.

According to the World Health Organization (WHO) around one million children are infected with Streptococcus pneumoniae (the pneumococcus) every year, SK bioscience noted.

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Manufacturing facility expansion to advance next-gen vaccine - European Pharmaceutical Review

CDC analysis of RSV vaccines data showed vaccines are safe, not associated with excess deaths, contrary to claim by … – Health Feedback

March 15, 2024

CLAIM

RSV vaccines are linked to deaths and neurological disorders; the CDC glossed over reports of deaths among vaccinated individuals

DETAILS

Inadequate support: The Childrens Health Defense article used the VAERS database to support its claim that RSV vaccines are dangerous, even though this database on its own is inadequate for providing this information. Lacks context: The Childrens Health Defense article claimed that RSV vaccines are unnecessary because the infections are mild and cause cold-like symptoms. However, this is contradicted by the fact that RSV infections can cause pneumonia and bronchiolitis and are the leading cause of childrens hospitalization.

KEY TAKE AWAY

Respiratory Syncytial Virus (RSV) infections are very common during winter. Most of them are mild but complications can lead to pneumonia and bronchiolitis, especially in babies and older adults. RSV vaccines are effective and recommended for people above 60. Current evidence indicates their benefits outweigh their risks. Further research is needed to determine if these vaccines are associated with a higher risk of Guillain-Barr syndrome.

In May of that year, the agency approved two RSV vaccines for use in adults above 60: one from GSK (Arexvy) and one from Pfizer (Abrysvo).

The FDA also approved a monoclonal antibody, nirsevimab (commercialized as Beyfortus) for use in children up to 24 months, and extended Abrysvos approval to pregnant women within 32 to 36 weeks of pregnancy. Vaccination of pregnant women aimed to provide the babies with immunity to RSV during their first months of life.

Several months later, Childrens Health Defense (CHD), an association known for disseminating anti-vaccine disinformation, published an article implying that these treatments were dangerous and should be pulled from the market. However, their interpretation of publicly available safety data on RSV vaccines is misleading, as we explain below.

CHDs article cast doubt on the need to prevent RSV infections, arguing that RSV is only responsible for mild cold-like symptoms. To support this claim, the article included quotes from Meryl Nass and Peter McCullough, both of whom previously shared medical falsehoods. Why would anyone take an RSV vaccine that has a reasonable chance of causing a neurologic illness to prevent colds? said Nass. McCullough claimed that RSV is like a mild cold and easily treated at home.

However, this is an incomplete and misleading picture of the disease. RSV is a common respiratory virus mostly circulating during winter, along with other respiratory viruses like the flu. Most people with RSV infection show classic cold-like symptoms like a runny nose, sneezing, and fever, and recover within one or two weeks.

However, complications can occur, where the infection progresses into lower respiratory tract infections, causing bronchiolitis and pneumonia. RSV infection leads to 2.1 million outpatients visiting the hospital each year. It causes 60,000 to 120,000 hospitalizations and 6,000 to 10,000 deaths each year among adults above 65. For children under five, the virus is responsible for 58,000 to 80,000 hospitalizations and 100 to 300 deaths annually.

According to the U.S. Centers for Disease Control and Prevention (CDC), RSV infection is the most common cause of hospitalization of young children.

Additionally, a surveillance study monitoring 600 young children in need of intensive care because of RSV found that the majority of them were delivered full-term and previously healthy[1]. Since most children get infected by RSV in their early years, this means that even parents of healthy children should consider the risk that their child may suffer from RSV complications.

Apart from the risk of the disease posed to individuals, RSV can also pose a threat to the community at large through its impact on the functioning of the healthcare system.

Indeed, news articles reported that people seeking medical attention in the post-COVID era because of RSV complications in winter strained hospitals capacity and may divert resources from other important needs. In other words, failing to implement protective measures, including vaccination, on a preventable disease may not only expose people to risk of complications from the disease, but may also hinder the proper function of the healthcare system.

Thus, the CHDs implication that vaccinating against RSV is unnecessary because the virus only causes the common cold provides the reader with a misleading picture of the public health threat posed by RSV.

The CHD article claimed that the Vaccine Adverse Events Reporting System (VAERS) already show reports of 34 deaths, 302 serious adverse events and according to news reports this week, a safety signal for Guillain-Barr syndrome (GBS) [a neurological condition even though it had been less than a year since the vaccines approval.

From these figures, the CHD article concluded that the RSV vaccines had been linked to deaths and serious injuries and that experts said that its time to pull [the vaccines] from the market.

Misusing VAERS data is a common method of producing vaccine misinformation, as previous reviews from Science Feedback have documented. CHD repeated this same mistake in their article.

VAERS is a database co-managed by the CDC and FDA where anyone can submit reports of adverse events occurring after vaccination. By casting a wide net for vaccine adverse events, VAERS is designed to assist in detecting rare vaccine side effects that go unnoticed during clinical trials and to monitor unexpected increases in specific adverse events that might indicate a problem with safety.

For example, several cases of intussusception in children who just had received a rotavirus vaccine were reported to VAERS in 1998 and 1999. The unexpected number of VAERS reports prompted the CDC to carry out a more in-depth investigation to validate the reports and to assess the risk. The investigation eventually led to the vaccination recommendation being suspended and the vaccine being recalled.

VAERS can also help detect possible human errors. For example, it is accurate that some young children received RSV vaccines even though this product isnt FDA-approved for them. This prompted the CDC to issue a communication and recommendations to healthcare providers which incorrectly administered the vaccines.

However, VAERS reports need to be combined with additional investigations, such as statistical analyses and clinical follow-ups of affected people, to be useful in detecting side effects and problems with vaccine safety. On their own, VAERS data is insufficient for forming reliable conclusions on vaccine safety and the relationship between a vaccine and an adverse event.

First, the fact that one event occurs after another doesnt mean that one caused the other. Assuming the opposite without any further information is known as the post hoc ergo propter hoc fallacy.

For instance, its possible for an individual who experienced an adverse event following vaccination to have also received another medical intervention that caused the adverse event. Concluding that the vaccine caused the adverse event solely on the grounds the individual got vaccinated previously, without considering their entire medical history, is flawed reasoning.

Second, the fact that anyone can submit a report, including the general public that largely has little to no medical training, means that there is no way to guarantee that submitted information is complete or even accurate.

The disclaimer on the VAERS webpage warns of the same limitation:

VAERS reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable. Reports to VAERS can also be biased. As a result, there are limitations on how the data can be used scientifically.

And:

Anyone, including healthcare providers, vaccine manufacturers, and the public can submit reports to the system. While very important in monitoring vaccine safety, VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness.

In addition, the disclaimer warned against using raw numbers of reports of a given adverse event such as death to establish causal associations, which is what CHD did in its article:

The number of reports alone cannot be interpreted as evidence of a causal association between a vaccine and an adverse event, or as evidence about the existence, severity, frequency, or rates of problems associated with vaccines.

These important caveats dont mean that VAERS isnt useful. But VAERS reports represent only the first step in determining whether an adverse event and a vaccine are linked. Researchers must perform further investigations starting with these reports to arrive at scientifically sound conclusions.

However, the number of deaths and serious adverse events reported to VAERS among people who received the RSV vaccines isnt sufficient evidence of a causal association between the vaccine and the adverse event. Therefore, these numbers alone dont support CHDs claim that the RSV vaccines are dangerous or that they should be pulled from the market.

CHD also claimed that the CDCs Advisory Committee on Immunization Practices (ACIP) primarily focused on [Guillain-Barr Syndrome] safety signals, glossing over deaths and the administration of the vaccines to unauthorized age groups.

Thus, the article implied that the ACIP, which is responsible for assessing the safety of vaccines and issuing vaccine recommendations, overlooked important safety signals related to the RSV vaccines that should have led to pulling them off the market.

However, this is inaccurate. First, the CDC acknowledged and acted upon the incorrect administration of vaccines to some people, as we explained in the previous section.

Second, the ACIP did look at the number of deaths among vaccinated individuals. The CDC presented data on the number of adverse events of special interest after RSV vaccination during the ACIP meeting on 28 February 2024, as shown in slide 22 of this presentation.

CHD was well aware of this presentation as it is explicitly referenced in their article. What CHD may have missed is that the CDC carried out a statistical analysis of the frequency of adverse event reporting, as mentioned in slide 15.

As we explained in the previous section, VAERS data need to be further analyzed in order to provide valid information on vaccine safety. The statistical analysis performed by the CDC aimed at detecting adverse events that showed up at an abnormally high rate.

According to slide 22, the CDC didnt detect safety signals regarding deaths. Thus, the CDC didnt gloss over the death reports, contrary to CHDs claim. In fact, the CDCs statistical analysis didnt show that people were dying at a higher rate than expected in a normal population.

In contrast to deaths, the occurrence of Guillain-Barr Syndrome did raise a safety signal in the CDCs statistical analysis. According to slide 22, the CDC only detected a signal for Guillain-Barr Syndrome among people who received the Abrysvo vaccine but not the Arexvy vaccine. According to slide 28 of the presentation, the observed rate of Guillain-Barr Syndrome in the 21 days after vaccination was 4.6 events per million Abrysvo doses administered, whereas the expected rate was two events per million doses.

However, the health and medicine news outlet STAT reported that it was too early to draw definitive conclusions owing to the small number of detected Guillain-Barr Syndrome cases. STAT also pointed out that several individuals had also received other vaccines, which makes it more difficult to draw a direct relationship between the RSV vaccine and the adverse events.

Citing CDC sources, STAT reported that, between 2,400 and 2,700 RSV hospitalizations, 450 to 520 intensive care unit admissions, and 120 to 140 deaths are averted for one million doses of RSV vaccine administered. As a result, the CDC concluded that the benefits still outweigh the potential risks and maintained its recommendation that adults over 60 get vaccinated against RSV.

The CDCs statistical analysis didnt show a higher-than-expected number of deaths among the population who received the RSV vaccines. By contrast, the CDC found a higher-than-expected number of cases of Guillain-Barr syndrome. However, the number of cases were small, hence theres still not enough data yet to clearly establish a causal relationship between RSV vaccines and Guillain-Barr syndrome.

CHDs claim that RSV vaccines are unsafe relied on the incorrect use of VAERS data, specifically by disregarding the fact that raw figures of adverse event reports cannot be used alone to establish a vaccines safety profile. The CHD article also misleadingly downplayed the public health threat of RSV infection, which causes over 100,000 hospitalizations each year, thus impacting the availability of hospital beds in winter.

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CDC analysis of RSV vaccines data showed vaccines are safe, not associated with excess deaths, contrary to claim by ... - Health Feedback

There will be negative effects. Senate signs off on weakening school vaccine laws – The Fayette Tribune

March 15, 2024

A bill that completed legislation Saturday night loosens West Virginias laws for school-mandated vaccines.

The Senate signed off onHouse Bill 5105with a 20 to 12 vote.

If approved by Gov. Jim Justice, the bill would allow private and parochial schools to develop their own policies for immunizations and provide them legal protections for those choices.

West Virginia law requires students be vaccinated for a series of contagious diseases. The state is currently among five in the country that allow only medical exemptions not religious or philosophical exemptions to those vaccine requirements.

House Bill 5105 would also allow vaccine exemptions for students attending virtual public schools.

Students who participate in West Virginia Secondary School Activities Commission-sponsored activities outside of their school would still be required to be vaccinated. The amended bill also clarifies that if a student is attending some virtual school and some in-person school, the student should follow the requirements of the in-person school.

As the bill passed in the House of Delegates, the bill would have allowed students religious exemptions to vaccines if their parents presented letters.

The bill was amended by theSenate Health Committeeto remove the religious exemptions.

During a speech from the Senate floor, Health Committee Chairman Sen. Mike Maroney, R-Marshall, a physician, called the bill bad and a step backwards for West Virginia.

Theres no question, no question there will be negative effects to families, to children and immunocompromised adults, Maroney said. Not to mention the cost.

I took an oath to do no harm, Maroney said. There is zero chance I could vote for this bill.

Maroney told a reporter after the vote that if it had been up to him, he would not have put the bill on the Health Committees agenda. Legislation that would weaken the states vaccine mandates comes up every year, he said, but this year the bill was a bargaining chip, he said.

We beat it every year because I usually have full rein on my committee but this year I had to run it because the caucus demanded we run it, Maroney said. So we ran it and its just a bad bill. Its bad for West Virginia. There will be a lot of things happen. It might not happen next year or the year after, but they will happen. Its a matter of time.

Theres still 700,000 deaths worldwide due to the same vaccine-preventable diseases, Maroney said. 700,000 every year, like today. We had a polio case in New York three years ago. It was gone for decades. Stuff is coming back. Its going to come back.

Maroney pointed to rubella, also called the German measles, a vaccine-preventable disease that can cause miscarriage and birth defects. The disease is common in other countries but has been eliminated in the United States.

Heres how I can sum it up, he said. The same thing I said when I first started talking [on the Senate floor]: Vaccines were a victim of their own success. Theyre a victim of their own success. Because now people dont realize how [diseases] ravaged the country before because theyve been gone for so long.

Health officials have long touted West Virginias strong vaccination laws as one of the things the state gets right. While several states have had outbreaks of measles, a highly contagious, potentially deadly disease, in recent years, West Virginias last reported measles case was in 2009.

According to the Centers for Disease Control and Prevention, as of March 7, there were 45 measles cases across 17 jurisdictions, including Ohio, Pennsylvania, Virginia and Maryland.

Dale Lee, president of the West Virginia Education Association, called the vaccine bill very troubling. Fortunately, he said, the bill kept the strict rules for public schools and for homeschool or private school students that play SSAC activities.

But they play in the communities, they see each other, Lee said. That herd immunity, as Sen. Maroney so eloquently spoke, is at risk and thats just I believe, and everyone is right, I believe in religious freedom, but I dont know any religion that has said were against vaccines.

The bill awaits approval from Gov. Jim Justice.

Lori Kersey is a reporter with a decade of experience reporting in West Virginia. She covers state government for West Virginia Watch. For more, visit westvirginiawatch.com

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There will be negative effects. Senate signs off on weakening school vaccine laws - The Fayette Tribune

Miller: Government has a role in combating vaccine misinformation – Detroit News

March 15, 2024

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Miller: Government has a role in combating vaccine misinformation - Detroit News

Measles in the US: Vaccines, treatment, and what to do to protect your family – Vox.com

March 15, 2024

So far this year, the Centers for Disease Control and Prevention (CDC) has reported 45 measles cases from 17 jurisdictions. Thats a lot compared with 2023, when 58 cases were reported over the entire calendar year.

Its been nearly 25 years since measles was officially eliminated in the US. The declaration meant the infection hadnt been transmitted continuously anywhere in the country for more than a year. However, it doesnt mean measles couldnt come back: Under certain conditions lots of cases imported from abroad, not enough people vaccinated against the infection, and not enough tools to fight back measles could re-entrench itself stateside.

Thats why public health authorities monitor measles cases and vaccination rates against the infection. And why, when cases rise while vaccination rates drop, they fret.

Measles is a viral infection that causes fever, rash, and cough, which can be complicated by severe, life-threatening infections of the ears, lungs, and brain. Its particularly likely to cause severe disease in children under 5 years old and in immunocompromised people. To make matters worse, its one of the most contagious diseases out there: Infectious particles can hang out in the air or on surfaces for hours, and, on average, each infected person infects another 12 to 18 people.

When measles turns up in the US, its because it was brought to the country from the outside more often than not, by US residents returning from travel abroad. Theres a lot of measles in the world: In 2022, the infection caused more than 9 million cases and killed more than 136,000 people globally, most of them children. Although countries in Eastern Europe, the Middle East, and South Asia currently top the list of measles cases globally, there have also been multiple outbreaks in Western Europe over the past year.

Theres a highly effective vaccine to prevent measles but to protect the youngest babies and immunocompromised people in any population, everyone around them needs to have been vaccinated. Part of whats keeping US public health experts up at night is that, increasingly, thats not the case. Still, its a situation people can do something about if they know how and understand the stakes.

Heres what you need to know.

Unvaccinated children and immunocompromised people especially those receiving certain cancer treatments face the highest risk when measles is in circulation.

Even an uncomplicated case of measles is really awful, said Sarah Lim, an infectious disease doctor and medical specialist at the Minnesota Department of Health, during a press conference on March 12. Measles infections are so often severe that about one in five unvaccinated people who get infected are hospitalized, and between one and three of every 1,000 measles infections end in death.

In its early stages, measles infection can cause a range of symptoms, including high fevers, cough, runny nose, red eyes, and full-body rash. About one-third of infected kids get complications, which can include severe diarrhea, ear infections, and pneumonia. Brain infection that can lead to brain damage and epilepsy, called encephalitis, occurs in about one of every 1,000 kids who get infected with measles.

Measles can also do something else that few other infections are known to do: It can wipe out kids immune memory, leaving them unprotected from other bacterial and viral pathogens. That effect, and the increased susceptibility to other infections that comes with it, can last for years after infection.

Travel to parts of the world where measles circulates widely increases the risk of infection. That makes it important to ensure you and your family are protected from measles in addition to all the other things prior to travel.

The biggest number of measles cases the US has seen over the past 25 years was in 2019, when nearly 1,300 infections were reported over the course of the year. That year, nine out of every 10 cases occurred in unvaccinated people living in close-knit communities. A single outbreak in an Orthodox Jewish community in New York involved 649 cases; another outbreak involving 71 cases occurred in a Washington State community of recent immigrants from the former Soviet Union.

Whats different so far about this years US measles cases is that theyre occurring in lots of little sparks across the nation, as Katelyn Jetelina put it in her recent newsletter. The more embers, the more likely it is that they find unvaccinated pockets and spread like wildfire, she wrote.

We dont yet know whether spread among close-knit communities is contributing to transmission in the US. Although the CDC is reporting where cases are taking place, it hasnt reported the ages or any other demographic information about the people whove been infected. An agency representative declined to share this information with Vox when we reached out on March 12.

Another concerning feature about this years cases is that theyre happening at a time when a relatively large proportion of kids are going unvaccinated against measles. In a November publication, CDC scientists reported 7 percent of kindergarteners hadnt been vaccinated against measles during the 2022-2023 school year. At the same time, vaccine exemptions reached an all-time high, with more than 5 percent of kids exempted in 10 states.

To make matters worse, according to recent reporting in the LA Times, a lot of parents are choosing to delay measles vaccination in their infants, which increases vulnerability to the most severe effects of measles in a group thats already at the highest risk of complications.

The World Health Organization (WHO) cautions that the risk of a measles outbreak increases dramatically if more than 5 percent of people in a community arent vaccinated, which makes these numbers pretty concerning. Whats even more alarming is that these numbers are averages: In some states, as many as 22 percent of people are unvaccinated, and that number is likely much higher in some smaller geographic pockets.

Thats where youre really talking about throwing a match [into a pile of kindling] and having a large fire, says Jane Zucker, an infectious disease doctor and epidemiologist who retired in 2023 after 30 years with the New York City health departments Bureau of Immunization. Thats what youre really most anxious about.

Theres no medicine to treat measles infection once its taken hold, which makes prevention the main strategy for avoiding the virus worst effects.

The best news about measles and the reason most of us have no idea what it looks like is that the vaccine that prevents it is extremely effective and safe.

That vaccine, called MMR because it protects children from measles, mumps, and rubella is what experts call a live-attenuated vaccine. That means its made using a weakened version of the measles virus that cant actually cause the disease. Because they so closely replicate the actual virus, these kinds of vaccines induce the strongest and longest-lasting response of any type of vaccine including Covid-19 vaccines. MMR vaccines are 97 percent effective at preventing symptomatic measles infections.

These vaccines can even protect people after theyre exposed to measles if theyre given within 72 hours of exposure, and theyre extraordinarily safe.

Who should get vaccinated against measles? Babies (lifelong immunity comes after two shots, the first at 12 months old and the second at 4 to 6 years of age) and almost everyone else who doesnt have proof that theyve been vaccinated before should get vaccinated, according to the CDC.

Thats especially true if those people without vaccination proof work in health care or are about to travel to places where theres lots of measles in circulation which these days includes Europe, says Zucker. Babies 6 to 12 months should also get an MMR shot if theyre going to be traveling; because their immune systems arent mature enough at that age for the vaccine to take, theyll still need another two-shot series after their first birthday.

Many adults whove already been vaccinated wont ever need another measles vaccine. Thats because all the versions of measles vaccines in use since 1968 have been strong enough to give lifelong protection against infection. So long as youre certain youve had two vaccines in the years since then that is, its documented somewhere in your medical record that you got them you dont need a repeat. The exception is for adults who only got vaccinated between 1963 and 1967: Because the version used during those years was too weak to give lifelong immunity, theyre not considered protected unless theyve gotten at least one dose of a newer version of the vaccine.

Another group that doesnt need to worry about vaccination is most adults over 65. Measles was so common before the vaccine was available that experts assume people born in those years were exposed and are immune. So if you were born before 1957, you dont need a vaccine unless youre in a high-risk situation for example, you work in health care or youre about to travel to a place where theres a lot of measles in circulation.

There are some people who should wait to get an MMR vaccine if theyre unvaccinated or if their vaccine history isnt clear. Live vaccines like this one are typically not recommended for people with weakened immune systems, which include pregnant folks and some immunocompromised people. Some other conditions also make it sensible to hold off on vaccination have a look at the CDCs answers to Who Should Not Get MMR Vaccine? here and talk to a health care provider if youre not sure what to do.

A blood test called a measles serology can measure the level of measles antibodies in a persons blood. If the level is high, its safe to assume that person is immune to measles, either as a result of vaccination or past infection. But low scores on these tests may not be very meaningful, says Zucker: Many people with low levels of measles antibodies actually have measles protection due to prior vaccination, making it a bad test for determining whether immunizations documented a long time ago are still providing protection. For that reason, the CDC says a history of vaccination supersedes a serology result when it comes to determining whether a person is protected from measles.

Health experts sometimes administer these tests in outbreak settings and during pregnancy, but the results are typically used in ways specific to those scenarios. So you dont need a serology to prove youre vaccinated if the shots are documented in your medical record and in any case, its harmless to get a repeat vaccination even if youve been vaccinated before. If you dont know if youre immune, says Zucker, its easier to just get yourself vaccinated.

Where US measles cases go is really up to us.

Theres hope for controlling measles damage in the US if more parents opt to vaccinate their babies as soon as theyre eligible, if they keep unvaccinated kids home from school, and if they vaccinate their unvaccinated children as soon as they hear about a potential exposure.

Itll also help if public health authorities have adequate support and staffing to educate the public about measles, provide and document vaccination as with immune registries and intervene when outbreaks happen.

However, last years national debt ceiling deal resulted in cuts to states child vaccination programs. Furthermore, the wild nonsense on vaccines that pervades social media and, occasionally, official messaging, as in the case of Floridas surgeon general makes it challenging for many parents to disentangle the common-sense guidance from the crap.

Joshua Barocas, an infectious disease doctor at the University of Colorado, said during March 12s press conference that pushing back against measles is a team effort and that removing shame from the equation is key. Parents are flooded with tons of information, some of that [being] misinformation and so if you are a parent whos been on the fence, now is the time to catch up on your kids delayed vaccines, he said.

I would also encourage health care workers to welcome people with open, non-judgmental arms, Barocas said.

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Measles in the US: Vaccines, treatment, and what to do to protect your family - Vox.com

Dengue: Brazilian single-dose vaccine could help turn tide in the fight against fever – The Conversation

March 15, 2024

Dengue, caused by the virus transmitted by the bite of the female Aedes aegypti mosquito and, to a lesser extent, the Aedes albopictus mosquito, is an acute illness characterized mainly by high fever, body aches and redness of the skin.

A small fraction of those displaying symptoms can experience a worsening disease at the end of the first week. These cases, classified as dengue with warning signs and severe dengue by the World Health Organisation (WHO), are the most worrying, leading to significant morbidity and mortality in tropical and subtropical regions worldwide.

In dengue with warning signs, in addition to the classic symptoms, there may be small amounts of blood on the mucous membranes, haematomas, abdominal pain, vomiting, dehydration, restlessness, dizziness, excessive tiredness and drowsiness.

Severe dengue is a result of a greater systemic inflammatory reaction, which alters blood clotting and leads to fluid loss. The consequences can include intense bleeding and a sudden drop in blood pressure, which are responsible for the shock associated with dengue fever, the main cause of death.

The number of people with severe disease is small compared to the total incidence of the disease. Of the three million confirmed cases of dengue in Brazil in 2023, only 0.1% had the worst symptoms of the disease, according to the WHO.

However, as the number of cases continues to rise in 2024, this small percentage exerts a big impact, with even more pressure on health services. Brazil recorded more than a million suspected cases and dozens of deaths from dengue fever in 2024 up to the beginning of March 2024, according to the Ministry of Health, a quite significant increase compared to the same period in 2023.

This situation is part of a major global increase in the disease, which has already registered five million cases in 129 countries.

Young children and older people can find it more difficult to cope with severe infections due to immunity issues. Another important factor related to severe dengue is that it is more frequent in the second and third infections. As there are four viruses causing dengue worldwide, DENV-1, DENV-2, DENV-3 and DENV-4, a given person can be infected four times.

The chance of developing the most serious symptoms in the first infection is low but increases in the second and third, especially among those in people with other illnesses. This appears to be because antibodies produced by the body against one dengue virus type facilitate the entry of a second dengue virus, which is not completely neutralized. It would seem these enter the cells more easily and multiply more quickly. This mechanism is known as antibody-dependent enhancement. With the number of cases rising, the phenomenon needs special attention.

To avoid this situation, it is preferable to have protection against all four types of dengue viruses. In times of cyclical outbreaks, we can no longer remain uncovered. It will then be up to vaccination to help us achieve this goal.

A dengue vaccine must be able to elicit high efficacy against the four viruses, be safe and be able to, ultimately, help contain the virus spread. In other words, it must induce protection against at least three and preferably to all four dengue viruses at the same time, as if it were four vaccines in one.

Offering this possibility in less time, i.e. in a single dose, could be the game changer for guaranteeing complete protection more quickly, potentially putting a stop onto outbreaks, and protecting those who need it most.

The Butantan Institute has been working on the development of a dengue vaccine since the late 1990s. We recently published the primary phase 3 results of the vaccine candidate in The New England Journal of Medicine.

With just one injection, it provides good protection in a very elastic age range, from two to 60 incomplete years, according to the published results. It also has the differential of being able to be applied to those who have or have not already been infected by the dengue virus.

Protection was observed in all age groups, with 90% in adults aged 18 to 59, 77.8% in those aged seven to 17 and 80.1% in children aged two to six. The analysis of the effectiveness of the immunogen was carried out over two years with just under 17,000 volunteers in 16 research centers. The study is in its final phase and will complete in June 2024.

The next step will be to finalise the dossier with all the study information to apply for registration at Brazils National Health Surveillance Agency (Anvisa) by the second half of 2024.

At a time when dengue is advancing worldwide due to climate change, the arrival of a new single-dose vaccine to prevent epidemics and deaths could be a key weapon in the fight against dengue.

Continued here:

Dengue: Brazilian single-dose vaccine could help turn tide in the fight against fever - The Conversation

How the Anti-Vaccine Movement Pits Parental Rights Against Public Health – Kaiser Health News

March 13, 2024

By Amy Maxmen March 12, 2024

Gayle Borne has fostered more than 300 children in Springfield, Tennessee. Shes cared for kids who have rarely seen a doctor kids so neglected that they cannot speak. Such children are now even more vulnerable because of a law Tennessee passed last year that requires the direct consent of birth parents or legal guardians for every routine childhood vaccination. Foster parents, social workers, and other caregivers cannot provide permission.

In January, Borne took a foster baby, born extremely premature at just over 2 pounds, to her first doctors appointment. The health providers said that without the consent of the childs mother, they couldnt vaccinate her against diseases like pneumonia, hepatitis B, and polio. The mother hasnt been located, so a social worker is now seeking a court order to permit immunizations. We are just waiting, Borne said. Our hands are tied.

Tennessees law has also stymied grandmothers and other caregivers who accompany children to routine appointments when parents are at work, in drug and alcohol rehabilitation clinics, or otherwise unavailable. The law claims to give parents back the right to make medical decisions for their children.

Framed in the rhetoric of choice and consent, it is one of more than a dozen recent and pending pieces of legislation nationwide that pit parental freedom against community and childrens health. In actuality, they create obstacles to vaccination, the foundation of pediatric care.

Such policies have another effect. They seed doubt about vaccine safety in a climate rife with medical misinformation. The trend has exploded as politicians and social media influencers make false claims about risks, despite studies showing otherwise.

Doctors traditionally give caregivers vaccine information and get their permission before delivering more than a dozen childhood immunizations that defend against measles, polio, and other debilitating diseases.

But now, Tennessees law demands that birth parents attend routine appointments and sign consent forms for every vaccine given over two or more years. The forms could have a chilling effect, said Jason Yaun, a Memphis pediatrician and past president of the Tennessee chapter of the American Academy of Pediatrics.

People who promote parental rights on vaccines tend to downplay the rights of children, said Dorit Reiss, a vaccine policy researcher at the University of California Law-San Francisco.

Drop in Routine Vaccination Rates

Misinformation coupled with a parental rights movement that shifts decision-making away from public health expertise has contributed to the lowest childhood vaccine rates in a decade.

This year, legislators in Arizona, Iowa, and West Virginia have introduced related consent bills. A Parents Bill of Rights amendment in Oklahoma seeks to ensure that parents know they can exempt their children from school vaccine mandates along with lessons on sex education and AIDS. In Florida, the medical skeptic leading the states health department recently defied guidance from the Centers for Disease Control and Prevention by telling parents they could send unvaccinated children to a school during a measles outbreak.

Last year, Mississippi began allowing exemptions from school vaccine requirements for religious reasons because of a lawsuit funded by the Informed Consent Action Network, which is listed as a leading source of anti-vaccine disinformation by the Center for Countering Digital Hate. A post on ICANs website said it could not be more proud in Mississippi to restore the right of every parent in this country to have his or her convictions respected and not trampled by the government.

Even if some bills fail, Reiss fears, the revived parental rights movement may eventually abolish policies that require routine immunizations to attend school. At a recent campaign rally, Republican presidential candidate Donald Trump said, I will not give one penny to any school that has a vaccine mandate.

The movement dates to the wake of the 1918 influenza pandemic, when some parents pushed back against progressive reforms that required school attendance and prohibited child labor. Since then, tensions between state measures and parental freedom have occasionally flared over a variety of issues. Vaccines became a prominent one in 2021, as the movement found common ground with people skeptical of covid-19 vaccines.

The parental rights movement didnt start with vaccines, Reiss said, but the anti-vaccine movement has allied themselves with it and has expanded their reach by riding on its coattails.

When Lawmakers Silence Health Experts

In Tennessee, anti-vaccine activists and libertarian-leaning organizations railed against the states health department in 2021 when it recommended covid vaccines to minors, following CDC guidance. Gary Humble, executive director of the conservative group Tennessee Stands, asked legislators to blast the health department for advising masks and vaccination, suggesting the department could be dissolved and reconstituted at your pleasure.

Backlash also followed a notice sent to doctors from Michelle Fiscus, then the states immunization director. She reminded them that they didnt need parental permission to vaccinate consenting adolescents 14 or older, according to a decades-old state rule called the Mature Minor Doctrine.

In the weeks that followed, state legislators threatened to defund the health department and pressured it into scaling back covid vaccine promotion, as revealed by The Tennessean. Fiscus was abruptly fired. Today I became the 25th of 64 state and territorial immunization program directors to leave their position during this pandemic, she wrote in a statement. Thats nearly 40% of us. Tennessees covid death rate climbed to one of the nations highest by mid-2022.

By the time two state legislators introduced a bill to reverse the Mature Minor Doctrine, the health department was silent on the proposal. Despite obstacles for foster children who would require a court order for routine immunizations, Tennessees Department of Childrens Services was silent, too.

Notably, the legislator who introduced the bill, Republican Rep. John Ragan, was among those simultaneously overseeing a review of the agency that would determine its leadership and budget for the coming years. Children belong to their families, not the state, said Ragan as he presented the bill at a state hearing in April 2023.

Democratic Rep. Justin Pearson spoke out against the bill. It doesnt take into account people and children who are neglected, he told Ragan. We are legislating from a point of privilege and not recognizing the people who are not privileged in this way.

Rather than address such concerns, Ragan referenced a Supreme Court ruling in favor of parental rights in 2000. Specifically, judges determined that a mother had legal authority to decide who could visit her daughters. Yet the Supreme Court has also done the opposite. For instance, it sided against a legal guardian who removed her child from school to proselytize for the Jehovahs Witnesses.

Still, Ragan swiftly won the majority vote. Tennessee Gov. Bill Lee, a Republican, signed the bill in May, making it effective immediately. Deborah Lowen, then the deputy commissioner of child health at the Department of Childrens Services, was flooded with calls from doctors who now face jailtime and fines for vaccinating minors without adequate consent. I was and remain very disheartened, she said.

A Right to Health

Yaun, the Memphis pediatrician, said he was shaken as he declined to administer a first series of vaccines to an infant accompanied by a social worker. That child is going into a situation where they are around other children and adults, he said, where they could be exposed to something we failed to protect them from.

We have had numerous angry grandparents in our waiting room who take kids to appointments because the parents are at work or down on their luck, said Hunter Butler, a pediatrician in Springfield, Tennessee. I once called a rehabilitation facility to find a mom and get her on the phone to get verbal consent to vaccinate her baby, he said. And its unclear if that was OK.

Childhood immunization rates have dropped for three consecutive years in Tennessee. Nationwide, downward trends in measles vaccination led the CDC to estimate that a quarter million kindergartners are at risk of the highly contagious disease.

Communities with low vaccination rates are vulnerable as measles surges internationally. Confirmed measles cases in 2023 were almost double those in 2022 a year in which the World Health Organization estimates that more than 136,000 people died from the disease globally. When travelers infected abroad land in communities with low childhood vaccination rates, the highly contagious virus can spread swiftly among unvaccinated people, as well as babies too young to be vaccinated and people with weakened immune systems.

Theres a freedom piece on the other side of this argument, said Caitlin Gilmet, communications director at the vaccine advocacy group SAFE Communities Coalition and Action Fund. You should have the right to protect your family from preventable diseases.

In late January, Gilmet and other child health advocates gathered in a room at the Tennessee Statehouse in Nashville, offering a free breakfast of fried chicken biscuits. They handed out flyers as legislators and their aides drifted in to eat. One pamphlet described the toll of a 2018-19 measles outbreak in Washington state that sickened 72 people, most of whom were unvaccinated, costing $76,000 in medical care, $2.3 million for the public health response, and an estimated $1 million in economic losses due to illness, quarantine, and caregiving.

Barb Dentz, an advocate with the grassroots group Tennessee Families for Vaccines, repeated that most of the states constituents support strong policies in favor of immunizations. Indeed, seven in 10 U.S. adults maintained that public schools should require vaccination against measles, mumps, and rubella, in a Pew Research Center poll last year. But numbers have been dropping.

Protecting kids should be such a no-brainer, Dentz told Republican Rep. Sam Whitson, later that morning in his office. Whitson agreed and reflected on an explosion of anti-vaccine misinformation. Dr. Google and Facebook have been such a challenge, he said. Fighting ignorance has become a full-time job.

Whitson was among a minority of Republicans who voted against Tennessees vaccine amendment last year. The parental rights thing has really taken hold, he said, and it can be used for and against us.

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How the Anti-Vaccine Movement Pits Parental Rights Against Public Health - Kaiser Health News

Vaccine-skeptical mothers say bad health care experiences made them distrust the medical system – The Conversation

March 13, 2024

Why would a mother reject safe, potentially lifesaving vaccines for her child?

Popular writing on vaccine skepticism often denigrates white and middle-class mothers who reject some or all recommended vaccines as hysterical, misinformed, zealous or ignorant. Mainstream media and medical providers increasingly dismiss vaccine refusal as a hallmark of American fringe ideology, far-right radicalization or anti-intellectualism.

But vaccine skepticism, and the broader medical mistrust and far-reaching anxieties it reflects, is not just a fringe position.

Pediatric vaccination rates had already fallen sharply before the COVID-19 pandemic, ushering in the return of measles, mumps and chickenpox to the U.S. in 2019. Four years after the pandemics onset, a growing number of Americans doubt the safety, efficacy and necessity of routine vaccines. Childhood vaccination rates have declined substantially across the U.S., which public health officials attribute to a spillover effect from pandemic-related vaccine skepticism and blame for the recent measles outbreak. Almost half of American mothers rated the risk of side effects from the MMR vaccine as medium or high in a 2023 survey by Pew Research.

Recommended vaccines go through rigorous testing and evaluation, and the most infamous charges of vaccine-induced injury have been thoroughly debunked. How do so many mothers primary caregivers and health care decision-makers for their families become wary of U.S. health care and one of its most proven preventive technologies?

Im a cultural anthropologist who studies the ways feelings and beliefs circulate in American society. To investigate whats behind mothers vaccine skepticism, I interviewed vaccine-skeptical mothers about their perceptions of existing and novel vaccines. What they told me complicates sweeping and overly simplified portrayals of their misgivings by pointing to the U.S. health care system itself. The medical systems failures and harms against women gave rise to their pervasive vaccine skepticism and generalized medical mistrust.

I conducted this ethnographic research in Oregon from 2020 to 2021 with predominantly white mothers between the ages of 25 and 60. My findings reveal new insights about the origins of vaccine skepticism among this demographic. These women traced their distrust of vaccines, and of U.S. health care more generally, to ongoing and repeated instances of medical harm they experienced from childhood through childbirth.

As young girls in medical offices, they were touched without consent, yelled at, disbelieved or threatened. One mother, Susan, recalled her pediatrician abruptly lying her down and performing a rectal exam without her consent at the age of 12. Another mother, Luna, shared how a pediatrician once threatened to have her institutionalized when she voiced anxiety at a routine physical.

As women giving birth, they often felt managed, pressured or discounted. One mother, Meryl, told me, I felt like I was coerced under distress into Pitocin and induction during labor. Another mother, Hallie, shared, I really battled with my provider throughout the childbirth experience.

Together with the convoluted bureaucracy of for-profit health care, experiences of medical harm contributed to one million little touch points of information, in one mothers phrase, that underscored the untrustworthiness and harmful effects of U.S. health care writ large.

Many mothers I interviewed rejected the premise that public health entities such as the Centers for Disease Control and Prevention and the Food and Drug Administration had their childrens best interests at heart. Instead, they tied childhood vaccination and the more recent development of COVID-19 vaccines to a bloated pharmaceutical industry and for-profit health care model. As one mother explained, The FDA is not looking out for our health. Theyre looking out for their wealth.

After ongoing negative medical encounters, the women I interviewed lost trust not only in providers but the medical system. Frustrating experiences prompted them to do their own research in the name of bodily autonomy. Such research often included books, articles and podcasts deeply critical of vaccines, public health care and drug companies.

These materials, which have proliferated since 2020, cast light on past vaccine trials gone awry, broader histories of medical harm and abuse, the rapid growth of the recommended vaccine schedule in the late 20th century and the massive profits reaped from drug development and for-profit health care. They confirmed and hardened womens suspicions about U.S. health care.

The stories these women told me add nuance to existing academic research into vaccine skepticism. Most studies have considered vaccine skepticism among primarily white and middle-class parents to be an outgrowth of todays neoliberal parenting and intensive mothering. Researchers have theorized vaccine skepticism among white and well-off mothers to be an outcome of consumer health care and its emphasis on individual choice and risk reduction. Other researchers highlight vaccine skepticism as a collective identity that can provide mothers with a sense of belonging.

The perceptions mothers shared are far from isolated or fringe, and they are not unreasonable. Rather, they represent a growing population of Americans who hold the pervasive belief that U.S. health care harms more than it helps.

Data suggests that the number of Americans harmed in the course of treatment remains high, with incidents of medical error in the U.S. outnumbering those in peer countries, despite more money being spent per capita on health care. One 2023 study found that diagnostic error, one kind of medical error, accounted for 371,000 deaths and 424,000 permanent disabilities among Americans every year.

Studies reveal particularly high rates of medical error in the treatment of vulnerable communities, including women, people of color, disabled, poor, LGBTQ+ and gender-nonconforming individuals and the elderly. The number of U.S. women who have died because of pregnancy-related causes has increased substantially in recent years, with maternal death rates doubling between 1999 and 2019.

The prevalence of medical harm points to the relevance of philosopher Ivan Illichs manifesto against the disease of medical progress. In his 1982 book Medical Nemesis, he insisted that rather than being incidental, harm flows inevitably from the structure of institutionalized and for-profit health care itself. Illich wrote, The medical establishment has become a major threat to health, and has created its own epidemic of iatrogenic illness that is, illness caused by a physician or the health care system itself.

Four decades later, medical mistrust among Americans remains alarmingly high. Only 23% of Americans express high confidence in the medical system. The United States ranks 24th out of 29 peer high-income countries for the level of public trust in medical providers.

For people like the mothers I interviewed, who have experienced real or perceived harm at the hands of medical providers; have felt belittled, dismissed or disbelieved in a doctors office; or spent countless hours fighting to pay for, understand or use health benefits, skepticism and distrust are rational responses to lived experience. These attitudes do not emerge solely from ignorance, conspiracy thinking, far-right extremism or hysteria, but rather the historical and ongoing harms endemic to the U.S. health care system itself.

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Vaccine-skeptical mothers say bad health care experiences made them distrust the medical system - The Conversation

Chicago and Arizona report more measles cases – University of Minnesota Twin Cities

March 13, 2024

Two more measles cases are confirmed in an outbreak at a Chicago migrant shelter, and health officials in Arizona's Coconino County reported two new cases, one confirmed and one probable.

Illinois and Arizona are among 17 US jurisdictions that have already reported cases this year, part of a global rise in cases occurring amid vaccination gaps.

At an Infectious Diseases Society of America (IDSA) media briefing on measles today, Sarah Lim, MD, a medical specialist with the Minnesota Department of Health, said that, in the first months of 2024, the country has had almost as many measles cases as it did for all of 2023.

She said a drop in vaccination rates in the wake of the COVID pandemic gives the highly contagious measles virus the potential to trigger large outbreaks.

Joshua Barocas, MD, with the University of Colorado School of Medicine, said many cases are mild, but measles can be a devastating disease, with deaths that are fully preventable. He said the measles, mumps, and rubella (MMR) vaccine is a safe and highly effective vaccine that can help people and their communities.

"There's no shame in getting caught up now. Now is the time," he said. "We need to welcome people with open, nonjudgmental arms."

The two new cases at the migrant shelter in the Pilsen neighborhood of Chicago are both adults and bring the number of cases confirmed at the location to four, the Chicago Department of Public Health (CDPH) announced yesterday. The two latest patients are in stable condition.

The two earlier cases at the shelter both involved children, one of whom has recovered and another who is hospitalized and reported to be in good condition.

The CDPH said it and its health partners have assessed nearly all residents of the shelter and administered the MMR vaccine to more than 900 shelter residents. Another 700 residents were found to be immune from previous vaccination or earlier infection and are allowed to leave and enter the shelter again.

Newly vaccinated residents have been instructed to stay at the shelter for 21 days from the date of vaccination, a period when the vaccine confers full immunity.

Chicago officials had earlier reported another unrelated measles case. The five infections reported this year are the city's first in 5 years.

In Arizona, health officials in Coconino Countyhome to Flagstaffyesterday reported one confirmed and one probable measles case.

They identified five locations where people may have been exposed: three medical locations, a fitness center, and a fabric store.

Kim Musselman, MSW, the county's health and human services director, said, "Unvaccinated individuals are at highest risk of developing the disease if exposed. The best protection against measles is to receive the measles vaccine."

In February, three earlier cases were reported by Arizona officials, all in Maricopa County.

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Chicago and Arizona report more measles cases - University of Minnesota Twin Cities

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