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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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
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.
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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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.
March 13, 2024
5 min read
COVID-19 Leaves Its Mark on the Brain. Significant Drops in IQ Scores Are Noted
Research shows that even mild COVID-19 can lead to the equivalent of seven years of brain aging
By Ziyad Al-Aly & The Conversation US
Eva Almqvist/Alamy Stock Vector
The following essay is reprinted with permission from The Conversation, an online publication covering the latest research.
From the very early days of the pandemic, brain fog emerged as a significant health condition that many experience after COVID-19.
Brain fog is a colloquial term that describes a state of mental sluggishness or lack of clarity and haziness that makes it difficult to concentrate, remember things and think clearly.
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Fast-forward four years and there is now abundant evidence that being infected with SARS-CoV-2 the virus that causes COVID-19 can affect brain health in many ways.
In addition to brain fog, COVID-19 can lead to an array of problems, including headaches, seizure disorders, strokes, sleep problems, and tingling and paralysis of the nerves, as well as several mental health disorders.
A large and growing body of evidence amassed throughout the pandemic details the many ways that COVID-19 leaves an indelible mark on the brain. But the specific pathways by which the virus does so are still being elucidated, and curative treatments are nonexistent.
Now, two new studies published in the New England Journal of Medicine shed further light on the profound toll of COVID-19 on cognitive health.
I am a physician scientist, and I have been devoted to studying long COVID since early patient reports about this condition even before the term long COVID was coined. I have testified before the U.S. Senate as an expert witness on long COVID and have published extensively on this topic.
Here are some of the most important studies to date documenting how COVID-19 affects brain health:
Large epidemiological analyses showed that people who had COVID-19 were at an increased risk of cognitive deficits, such as memory problems.
Imaging studies done in people before and after their COVID-19 infections show shrinkage of brain volume and altered brain structure after infection.
A study of people with mild to moderate COVID-19 showed significant prolonged inflammation of the brain and changes that are commensurate with seven years of brain aging.
Severe COVID-19 that requires hospitalization or intensive care may result in cognitive deficits and other brain damage that are equivalent to 20 years of aging.
Laboratory experiments in human and mouse brain organoids designed to emulate changes in the human brain showed that SARS-CoV-2 infection triggers the fusion of brain cells. This effectively short-circuits brain electrical activity and compromises function.
Autopsy studies of people who had severe COVID-19 but died months later from other causes showed that the virus was still present in brain tissue. This provides evidence that contrary to its name, SARS-CoV-2 is not only a respiratory virus, but it can also enter the brain in some individuals. But whether the persistence of the virus in brain tissue is driving some of the brain problems seen in people who have had COVID-19 is not yet clear.
Studies show that even when the virus is mild and exclusively confined to the lungs, it can still provoke inflammation in the brain and impair brain cells ability to regenerate.
COVID-19 can also disrupt the blood brain barrier, the shield that protects the nervous system which is the control and command center of our bodies making it leaky. Studies using imaging to assess the brains of people hospitalized with COVID-19 showed disrupted or leaky blood brain barriers in those who experienced brain fog.
A large preliminary analysis pooling together data from 11 studies encompassing almost one million people with COVID-19 and more than 6 million uninfected individuals showed that COVID-19 increased the risk of development of new-onset dementia in people older than 60 years of age.
Autopsies have revealed devastating damage in the brains of people who died with COVID-19.
Most recently, a new study published in the New England Journal of Medicine assessed cognitive abilities such as memory, planning and spatial reasoning in nearly 113,000 people who had previously had COVID-19. The researchers found that those who had been infected had significant deficits in memory and executive task performance.
This decline was evident among those infected in the early phase of the pandemic and those infected when the delta and omicron variants were dominant. These findings show that the risk of cognitive decline did not abate as the pandemic virus evolved from the ancestral strain to omicron.
In the same study, those who had mild and resolved COVID-19 showed cognitive decline equivalent to a three-point loss of IQ. In comparison, those with unresolved persistent symptoms, such as people with persistent shortness of breath or fatigue, had a six-point loss in IQ. Those who had been admitted to the intensive care unit for COVID-19 had a nine-point loss in IQ. Reinfection with the virus contributed an additional two-point loss in IQ, as compared with no reinfection.
Generally the average IQ is about 100. An IQ above 130 indicates a highly gifted individual, while an IQ below 70 generally indicates a level of intellectual disability that may require significant societal support.
To put the finding of the New England Journal of Medicine study into perspective, I estimate that a three-point downward shift in IQ would increase the number of U.S. adults with an IQ less than 70 from 4.7 million to 7.5 million an increase of 2.8 million adults with a level of cognitive impairment that requires significant societal support.
Another study in the same issue of the New England Journal of Medicine involved more than 100,000 Norwegians between March 2020 and April 2023. It documented worse memory function at several time points up to 36 months following a positive SARS-CoV-2 test.
Taken together, these studies show that COVID-19 poses a serious risk to brain health, even in mild cases, and the effects are now being revealed at the population level.
A recent analysis of the U.S. Current Population Survey showed that after the start of the COVID-19 pandemic, an additional one million working-age Americans reported having serious difficulty remembering, concentrating or making decisions than at any time in the preceding 15 years. Most disconcertingly, this was mostly driven by younger adults between the ages of 18 to 44.
Data from the European Union shows a similar trend in 2022, 15 percent of people in the EU reported memory and concentration issues.
Looking ahead, it will be critical to identify who is most at risk. A better understanding is also needed of how these trends might affect the educational attainment of children and young adults and the economic productivity of working-age adults. And the extent to which these shifts will influence the epidemiology of dementia and Alzheimers disease is also not clear.
The growing body of research now confirms that COVID-19 should be considered a virus with a significant impact on the brain. The implications are far-reaching, from individuals experiencing cognitive struggles to the potential impact on populations and the economy.
Lifting the fog on the true causes behind these cognitive impairments, including brain fog, will require years if not decades of concerted efforts by researchers across the globe. And unfortunately, nearly everyone is a test case in this unprecedented global undertaking.
Should you still wear a mask in public? Is it safe to attend concerts or travel right now? Experts are increasingly recommending that we consult COVID-19 wastewater data to make decisions like these. And, they say, the pandemic revealed the true potential of monitoring what's in our poop.
Wastewater monitoring isn't entirely new. Epidemiologists have been using it to keep track of polio outbreaks for decades, Amy Kirby, Ph.D., microbiologist and program lead for the National Wastewater Surveillance System at the Centers for Disease Control and Prevention, tells TODAY.com.
Before the pandemic, researchers knew they could find evidence of enteric viruses, which infect the gut, in wastewater samples, Yinyin Ye, Ph.D., assistant professor of civil, structural and environmental engineering at the University of Buffalo, tells TODAY.com.
It "makes sense" that we'd find viruses like those in feces and sewage, Ye says. But, before the pandemic, "people never thought wastewater could be used to track respiratory viruses," she says. It wasn't until COVID-19 came along that experts realized how helpful wastewater monitoring could be in tracking other types of viruses as well, she explains, including respiratory viruses.
As other COVID monitoring tools we once relied on have become less useful, wastewater is an increasingly valuable tool to make safer choices. Heres what experts want you to know about COVID-19 wastewater monitoring and what those numbers mean for you.
Early in the pandemic, individual groups of researchers proved they could detect the coronavirus in wastewater, particularly on college campuses.
For instance, experts at the University of Arizona even used it to help contain an outbreak on campus as early as August 2020. In 2021, a group at Emory University used wastewater to spot a rise in COVID-19 on campus when students returned from spring break.
From there, the CDC began monitoring wastewater for COVID-19 in 2020 (the first widespread sewage monitoring program in the U.S., Kirby says), and ramped up the program in 2022.
Today, wastewater monitoring is also helping researchers keep tabs on other illnesses, such as Mpox, norovirus and hepatitis A.
When people are infected with SARS-CoV-2, the virus that causes COVID-19, they shed bits of the virus in their feces whether or not they have noticeable symptoms. That's why the CDC started looking into wastewater monitoring for COVID in the first place, Kirby says.
"We were really focused on, how can we get a better idea of those people that are infected but may not have any symptoms or may have very mild symptoms?" she says. "We know they're still going to shed virus in their feces, and so we can detect those cases (through wastewater monitoring) and look at how they impact the overall trends in a community."
Ye and Kirby both noted that researchers still aren't entirely sure why we shed this virus, a respiratory virus, in our stool. It could be a result of swallowing viral particles in respiratory secretions orof the virusreplicating in the gut the same way foodborne illnesses do, Kirby says.
"We don't know. But, for our purposes, it doesn't really matter," Kirby explains. "We know that it's there and (that it's a) great signal to understand what's going on in the community."
As it turned out, not only does wastewater reflect general trends in the spread of COVID-19 within a community, but it also does so relatively quickly. Throughout the pandemic, Kirby says, experts noted wastewater trends changing four to six days before case numbers or test positivity showed the same change.
"It really is the first sign that cases are starting to pick up in a community," she says. "It's also the first sign that cases are starting to go down," which is a major advantage over other metrics.
Experts use a familiar test polymerase chain reaction technology (PCR) to look for viral RNA in untreated wastewater, explains Ye, whose team is involved with COVID wastewater monitoring for much of western New York. Depending on the type of PCR test the researchers use, they can also look for changes in the viral genetics, giving them a heads-up about possible shifts in coronavirus variants.
Different labs may have different protocols for detecting the viral particles, analyzing the data and making sure their results are accurate, Hoerger says. For example, if heavy rain dilutes rainwater, it can be challenging to account for that in interpretations, he says.
Ye stresses that public health officials are only looking at this data at the community level. They're not monitoring wastewater at the individual or household level. (No one is keeping track of what you, as an individual, are pooping out.)
And, for the record, researchers believe the viral particles in feces to be inactive, Ye says. To date, no one has contracted COVID-19 via exposure to wastewater, the CDC says.
In previous years, we may have relied on case numbers or test positivity to assess how much and how quickly COVID-19 was spreading in our area.
But those metrics "aren't very useful anymore," Hoerger says, for two major reasons: First, a lot of people aren't getting tested at all anymore for COVID-19, he says. And, second, if they do get tested, that's likely happening at home with a rapid test, which isn't reported to any public health agency.
On the other hand, one major benefit of wastewater monitoring is that "it doesn't require any individual to do any testing," he explains. "It's just tracking what's going on in a community."
Wastewater data also has the advantage of being highly local and, therefore, relevant to what's going on in your area, Ye says.
To find COVID-19 wastewater monitoring data in your area, take a look at your local public health department website. The CDC also keeps track of local sewage numbers and national numbers.
"We have about 1,500 sites that are doing testing, and that covers over 40% of the US population," Kirby says. "So we're covering a big chunk of the population."
That said, if you don't have local wastewater monitoring in your community, Hoerger recommends keeping an eye on the national or state-level numbers. "When things are getting bad nationally, there's a good chance that things could be bad locally, or they're about to be bad," he says.
But local information is always going to be the most helpful, Ye says, noting that trends can be different from county to county. And rural areas, which often aren't connected to larger sewage systems, may not be counted in those estimates, she explains. Researchers are working on ways to reach those areas right now, she says.
Also, keep in mind that the numbers you're seeing on the dashboard may be a week or two behind what's actually happening in the community, Hoerger says. For example, Ye says the samples for her lab are typically collected once or twice per week, and those numbers are included in health department updates the following Monday or Friday.
It's not entirely clear how wastewater numbers may translate to actual case numbers in the community. But spikes in wastewater monitoring generally do mirror spikes in actual COVID-19 cases.
"There's not a direct correlation," Kirby explains, "(but) we know that when you see so wastewater concentrations increase twofold, cases in the community have also increased twofold."
Additionally, when traveling, Ye checks wastewater trends for her destination to plan out what precautions she may need to take.
When looking at the data, you don't need to get deep into what the specific numbers might mean, Kirby says. "Focus on the trends and not so much the levels," she says. "That's the best way (for the general public) to interpret that data." The CDC wastewater trends dashboards are designed to be intuitive and used for this exact purpose, she adds.
Both Kirby and Ye recommend thinking of wastewater monitoring data like a weather report for health. In the future, Ye hopes "we can use wastewater data as a kind of forecast to tell us if theres a higher possibility youll get COVID tomorrow."
For now, Kirby hopes people check the data to decide if they should wear a mask on public transit or scale back on indoor events, for instance. Incorporating that kind of decision-making into your day-to-day, Kirby says, will go a long way to keeping communities healthy."
The research, led by Queenslands chief health officer Dr John Gerrard, followed about 2400 people who caught COVID-19 and about 2700 people with other respiratory infections, including influenza.
COVID-19 testing at St Vincents Hospital, Sydney, during the pandemic, 2020. Louise Kennerley
A year after infection, 3 per cent of people who were COVID positive reported moderate to severe impairment (i.e. long COVID). Among the people who had caught the flu or another respiratory illness, it was 4.1 per cent.
After controlling for factors including age, sex and whether participants were Indigenous, the researchers concluded there was no evidence that COVID-19 infection made impairment more likely.
Gerrard said long COVID appeared to be a severe and distinct disease simply because of the huge number of infections during the pandemic.
We believe it is time to stop using terms like long COVID, Gerrard said. They wrongly imply there is something unique and exceptional about longer-term symptoms associated with this virus.
Queensland Chief Health Officer John Gerrard. Getty
This terminology can cause unnecessary fear, and in some cases, hypervigilance to longer symptoms that can impede recovery.
The research will be presented at the European Congress of Clinical Microbiology and Infectious Diseases in April, but it hasnt been published in a peer-reviewed journal.
An earlier iteration of the study, in which the researchers reported the status of participants 12 weeks after infection, was published in last year, however.
In the BMJ study, Gerrard and his research colleagues found similar rates of ongoing symptoms and long-term impairment between those infected with COVID and the flu.
A virologist from the Kirby Institute analyses antibody reaction with the COVID-19 Omicron variant in 2021. Kate Geraghty
They concluded in the BMJ study that long COVID may manifest as a post-viral syndrome of no greater severity than seasonal influenza.
The study was limited by the fact participants with pre-existing illnesses werent identified, and it focused on a highly vaccinated population contending with Omicron, a variant than the ancestral strain.
Long COVID has forced Sydney resident Stephenie Watts to hospital twice and fundamentally rearranged her life. Watts was outraged by the suggestion long COVID should be folded in to other post-viral illnesses.
I felt really frustrated by the fact theyre saying [the phrase] causes unnecessary fear and is probably harmful, because it really undermines the seriousness of the long COVID, Watts said.
Stephenie Watts has suffered cognitive impairment since acquiring COVID-19. Kate Geraghty
Long COVID really does describe what happens to oneself. It was triggered by COVID and you have this long tail of ensuing illness.
Watts has suffered through more than three years of brain inflammation, chronic pain and vascular impacts from long COVID.
I cant walk more than 30 metres without stopping. I can no longer go to the shops because I cant walk the distance in the shops. I cant work because of the migraines and I cant drive, she said.
My whole identity has really been washed away from this.
Watts also cited that found COVID increased the risk of 64 diseases and other negative health impacts 18 months after infection. The seasonal flu was associated only with six.
Jeremy Nicholson, professor of medicine at Murdoch University, said the question at hand was whether long COVID was truly a unique condition worthy of its own name, or just another syndrome caused by a range of viruses.
Unfortunately, this question cannot be simply answered in this work, Nicholson said. The study is observational, based on reported symptoms with no physiological or detailed functional follow-up data.
Without lab analysis of the patients, and without knowing for sure that long COVID isnt physiologically different to other post-viral syndromes, the evidence to dismiss it isnt there, he argued.
This terminology can cause unnecessary fear, and in some cases, hypervigilance to longer symptoms that can impede recovery.
Until this is resolved, we should still use the long COVID term because it pinpoints exactly the underlying viral cause for a given individual, which may be relevant to future treatments, Nicholson said.
Professor Paul Fisher from La Trobe University is working to find signatures in the gut, immune system or blood cells that could help diagnose long COVID and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), and to tell us if there are any biological differences between long COVID and ME/CFS.
Weve done some work on blood cells, and weve looked at thousands of differences between ME/CFS and healthy controls. And weve done the same with a small number of long COVID patients, Fisher said. They are really similar, if not identical.
The government announced $50 million in research funding into long COVID last year after an inquiry into the illness. Fisher said some ME/CFS researchers have applied for that funding in the hope of finding the link between general post-viral syndromes and long COVID.
Researchers will travel to Canberra later this month with Emerge Australia, the lead organisation for people with ME/CFS, to discuss recommendation 8 of the inquiry, which pushed for more ME/CFS research funding.
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In the wake of the COVID-19 pandemic, scientists have been racing to develop effective treatments and preventatives against the virus. A recent scientific breakthrough has emerged from the work of researchers aiming to combat SARS-CoV-2, the virus responsible for COVID-19.
Led by Jin Kim Montclare and her team, the study, published in the Biochemical Engineering Journal, focuses on the design and development of a novel protein capable of binding to the spike proteins found on the surface of the coronavirus. The goal behind this innovative approach is twofold: first, to identify and recognize the virus for diagnostic purposes, and second, to hinder its ability to infect human cells.
The engineered protein, resembling a structure with five arms, exhibits a unique featurea hydrophobic pore within its coiled-coil configuration. This feature enables the protein not only to bind to the virus but also to capture small molecules, such as the antiviral drug Ritonavir.
Ritonavir, already utilized in the treatment of SARS-CoV-2 infections, serves as a logical choice for integration into this protein-based therapeutic. By incorporating Ritonavir into the protein, the researchers aim to enhance the treatment's efficacy while simultaneously targeting the virus directly.
The study marks a significant advancement in the fight against COVID-19, showcasing a multifaceted approach to combating the virus. Through a combination of protein engineering and computational design, the team has devised a promising strategy that may revolutionize current treatment modalities.
Although the research is still in its early stages, with no human or animal trials conducted as yet, the findings offer a proof of principle for the therapeutic potential of the designed protein. The team has demonstrated its ability to enhance the protein's binding affinity to the virus spike protein, laying the groundwork for future investigations.
The potential applications of this protein-based therapeutic extend beyond COVID-19. Its versatility opens doors to combating a range of viral infections, offering a dual mode of actionpreventing viral entry into human cells and neutralizing virus particles.
Furthermore, the success of this study underscores the importance of computational approaches in protein design. By leveraging computational tools such as Rosetta, the researchers have accelerated the process of protein engineering, enabling rapid iterations and optimization.
The development of this novel protein represents a significant step forward in the ongoing battle against COVID-19. As research progresses, the integration of computational design and protein engineering holds promise for the development of innovative therapeutics with broad-spectrum antiviral capabilities. While challenges remain, this study offers hope for a future where effective treatments against emerging viral threats are within reach.
More information: Dustin Britton et al, Dual coiled-coil protein domain mimic and drug delivery vehicle for SARS-CoV-2, Biochemical Engineering Journal (2024). DOI: 10.1016/j.bej.2024.109261
