Key Takeaways
Toxic shock syndrome (TSS) is a rare but potentially life-threatening condition thats caused by toxin-producing bacteria. When most people think of toxic shock, the first risk factor that leaps to mind is usually high absorbency tampons. But TSS isnt just linked to tampons or even menstruationanyone can develop it. If it goes untreated, TSS can lead to organ failure and even death.
New research from Austria has offered a glimpse into a future where it could be much easier to prevent TSS: with a vaccine.
The candidate vaccine, rTSST-1v, has completed a successful phase 2 clinical trial in which it showed it could offer protection for at least two years. Of the 126 participants in the study, more than 80% developed protection against TSS after the first dose.
The vaccine candidate is a detoxified version of TSST-1, the toxin responsible for 75% of all TSS cases, Andreas Roetzer, PhD, head of vaccine research and development at Biomedical Research & Bio-Products, told Verywell.
Staphylococcus aureus (staph) is often the cause of TSS, but Streptococcus pyogenes (strep) can also cause it.
Heres how the vaccine works and what the approval process could look like.
The TSS vaccine is designed to get the body to make neutralizing antibodies, which can prevent the onset of TSS. According to Roetzer, the neutralization aspect is key because it could stop symptoms and reduce the need for antibiotic treatment.
Depending on the expected efficacy of the vaccine, it could prevent all hospitalizations from TSS, Sharon Nachman, MD, a board-certified pediatric infectious disease specialist at Stony Brook Medicine, told Verywell.
The vaccines trial data has been promising so far, showing that most participants had a four-fold increase in antibodies after getting the first round of the vaccine (seroconversion). And 18 months later, over 85% of participants had protection after getting the third shot.
If approved, the TSS vaccine would be given intramuscularly, like a tetanus shot. Roetzers team plans to do follow-up trials 60 months after the initial vaccination and expects that a two-dose vaccine would be enough to provide life-long protection.
While Roetzer said that toxic shock syndrome is relevant for premenopausal women as soon as menarche (menstruation) starts, the vaccine is intended for everyone.
Since using menstrual products like tampons is a known risk factor for TSS (and menstrual toxic shock syndrome is used to differentiate it from other risk factors), young teens would likely be one of the priority groups for the vaccine.
Testing the efficacy and safety of a TSS vaccine could take several years, according to Nachman. A lot of the timing will depend on who the key populations are determined to be. For example, a study focused on preventing TSS in teens who are just starting to have periods would require observing how well the vaccine works over a fairly long time.
Nachman said that the vaccine would also need to undergo a phase 3 clinical trial to prove that its safe and effective at preventing TSS on a larger scale. That part of the trial would typically involve several hundred to several thousand patients.
While we dont have a vaccine yet, there are treatments for TSS, including:
Its also important to remember that TSS doesnt just affect women who have menstrual cyclesit can strike patients with weak immune systems, chronic wound infections, chronic illness, and people having surgery. An approved TSS vaccine would likely reduce the need for antibiotics and prevent hospitalizationsand could even save lives.
Toxic shock syndrome (TSS) isnt just linked to tampons; it can happen to anyone, including people with chronic wounds and illnesses, as well as those having surgery. A vaccine for TSS is in the works and could someday help prevent the potentially life-threatening infection.
National Library of Medicine: MedlinePlus. Toxic shock syndrome.
Schoergenhofer C, Gelbenegger G, Hasanacevic D, et al. A randomized, double-blind study on the safety and immunogenicity of rTSST-1 variant vaccine: phase 2 results. EClinicalMedicine. 2024;67:102404. doi:10.1016/j.eclinm.2023.102404
TeensHealth. Toxic shock syndrome.
Billon A, Gustin MP, Tristan A, et al. Association of characteristics of tampon use with menstrual toxic shock syndrome in France. EClinicalMedicine. 2020;21:100308. doi:10.1016/j.eclinm.2020.100308
Centers for Disease Control and Prevention. Streptococcal toxic shock syndrome.
By Kayla Hui, MPH Kayla Hui, MPH is the health and wellness ecommerce writer at Verywell Health.She earned her master's degree in public health from the Boston University School of Public Health and BA from the University of Wisconsin-Madison.
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Published: Jan. 24, 2024 at 10:33 a.m. ET
By Chris Wack
Capricor Therapeutics shares were up 7% at $4.42 after the company said its proprietary StealthX exosome-based multivalent vaccine for the prevention of SARS-CoV-2 has been selected to be part of Project NextGen.
The stock hit its 52-week low of $2.68 on Nov. 10, and is down 3% in the past 12 months.
Project...
By Chris Wack
Capricor Therapeutics shares were up 7% at $4.42 after the company said its proprietary StealthX exosome-based multivalent vaccine for the prevention of SARS-CoV-2 has been selected to be part of Project NextGen.
The stock hit its 52-week low of $2.68 on Nov. 10, and is down 3% in the past 12 months.
Project NextGen is an initiative by the U.S. Health and Human Services Department to advance a pipeline of new, innovative vaccines providing broader and more durable protection for Covid-19.
As part of Project NextGen, the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, will conduct a Phase 1 clinical study with Capricor's StealthX vaccine, subject to regulatory approval. NIAID's Division of Microbiology and Infectious Diseases would oversee the study.
The StealthX vaccine is a proprietary vaccine developed internally by Capricor using exosomes that were engineered to express either spike or nucleocapsid proteins on the surface. Preclinical results from murine and rabbit models showed the StealthX vaccine resulted in robust antibody production, potent neutralizing antibodies, a strong T-cell response and a favorable safety profile.
Write to Chris Wack at chris.wack@wsj.com
Fair Access
Another 19 African countries have plans to join the programme bringing more than just hope to a continent that suffers the vast majority of malaria deaths
Mon 22 Jan 2024 10.13 EST
The rollout of the worlds first malaria vaccine began in Cameroon on Monday, which is said to be a transformative chapter in Africas public health history.
The RTS,S vaccine 662,000 doses of it will be administered to children in the west African country, the first to be vaccinated after successful trials of the drug in Ghana, Kenya and Malawi between 2019 and 2021.
It marks a scaling up of the fight against malaria in Africa, where 95% of deaths from the disease occur, most among children under five.
We are not just witnessing but actively participating in a transformative chapter in Africas public health history, said Dr Mohammed Abdulaziz, the division head at the Africa Centres for Disease Control and Prevention, headquartered in Ethiopia, at a joint online briefing with the World Health Organization. For a long time we have been waiting for a day like this it brings more than just hope, it brings a reduction in the mortality and morbidity associated with malaria.
Public health experts say communication with the public will be crucial to the vaccines success to ensure that it is trusted, that people bring their children back for all four doses, and that people understand it will be most effective when combined with other measures, such as sleeping under insecticide-treated bed nets.
We need messaging, we need communication, and we need to use trusted voices, said Abdulaziz. We need to use health workers who are very close to the community. We need to listen to the community, to what they are saying and also monitor how we are being received.
Kate OBrien, the director of the WHOs immunisations and vaccines department, said that based on the trial data, RTS,S also known as Mosquirix would saves tens of thousands of lives.
Another 19 African countries plan to introduce the vaccine this year, with hopes that 6.6 million children could be reached. Deliveries are due for Burkina Faso, Liberia, Niger and Sierra Leone.
Mbianke Livancliff, from the Cameroon nonprofit Value Health Africa, said there has been excitement in the country since the vaccines were delivered in November. The organisation has held community meetings and open discussions to introduce people to the vaccine and its approval process, to deal with peoples concerns and stave off any potential hesitancy.
It has been an exciting moment. Families are excited, they are happy to have this major development and they are saying this is effective and this is what we have been waiting for, Livancliff said.
In the Cameroon city of Douala, at the private Angels Clinic, six-month-old Nobah Adel screamed as she was scratched by the needle administering her first dose of the vaccine on Monday morning.
Even if she cries, Im very happy today, said her mother, Dani Widal, who heard about the vaccine campaign a week ago. I have three children and all are always sick with malaria. I hope that the vaccine will finally help her not to be sick like her brother and her sister.
Widal had queued with her daughter for three hours to get the vaccine. I live in a neighbourhood where there are a lot of mosquitoes. I spend more than 30,000 francs [39] every three months because of malaria.
Kamela Isabelle Madjouwou, a nurse at the centre, said a malaria vaccine was essential. Cameroon recorded more than 6m cases in 2022 and malaria accounted for 12% of deaths among children under five in 2021. The vaccine will reduce mortality and the consequences of this terrible disease, she said.
Thomas Breuer, the chief global health officer at GlaxoSmithKline, which produced the vaccine said it was a significant development: After more than 35 years of dedicated work with our partners to develop the worlds first malaria vaccine, Mosquirix, its rewarding to see it in routine use for the first time. Were excited that more malaria-endemic countries are preparing to introduce the vaccine over the coming months.
A second malaria vaccine, R21/Matrix-M, produced by the University of Oxford, is due to be rolled out later this year.
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Infants born to unvaccinated mothers who had COVID-19 during pregnancy were at high risk for developing neonatal respiratory distress, the longitudinal, cohort COMP study found.
The odds of developing respiratory distress were threefold higher (OR 3.06, 95% CI 1.08-10.21) in infants born to unvaccinated mothers diagnosed with COVID-19 while pregnant compared with COVID-exposed infants born to COVID-vaccinated mothers, Mary Catherine Cambou, MD, of the University of California Los Angeles (UCLA), and colleagues reported in Nature Communications.
"This was not something we were expecting to see, as none of the babies were diagnosed with COVID-19 themselves," co-author Karin Nielsen-Saines, MD, also from UCLA, told MedPage Today in an email. "We also noted that respiratory distress was not transient and lasted several days."
However, when pregnant participants had received at least one mRNA vaccine dose prior to SARS-CoV-2 infection, the odds of their infants developing neonatal respiratory distress dropped to 0.33 (95% CI 0.10-0.96) -- a 67% decline, the authors pointed out.
Maternal COVID-19 disease severity also appeared to be associated with the incidence of neonatal respiratory distress. Thirteen percent of pregnancies met criteria for severe or critical COVID-19. Among infants with respiratory distress, 21% were born to mothers with severe or critical COVID-19, while only 6% of babies without respiratory distress were born to women with severe disease (P=0.009).
Approximately 56% of infants with respiratory distress were either late preterm or term deliveries and 44% were preterm. "We were surprised to find out that [the results] could not be explained by prematurity alone," Nielsen-Saines said.
Notably, a proteomic subanalysis revealed that preterm infants with respiratory distress had significantly heightened inflammatory responses (OR 10.87, P=0.0036), cellular responses (OR 31.88, P=0.0002), and chemotactic responses (OR 109.7, P=0.0108), when compared with a control group of infants from healthy, unexposed pregnancies.
"The molecular analysis showed that a possible mechanism to explain this phenomenon is dysregulation of the airway cilia," Nielsen-Saines said. "Another marker that was elevated was [immunoglobulin E], which is associated with inflammation and allergic responses, as in the case of reactive airway disease."
The study followed mother-infant pairs that included 221 mothers with laboratory-confirmed SARS-CoV-2 infection during pregnancy and 227 exposed fetuses. Between April 2020 and August 2022, 199 infants were born. Seventeen percent of neonates were diagnosed with respiratory distress. In infants unexposed to COVID-19, respiratory distress typically has a much lower incidence of just 5.2% to 6.4%, and is usually more common in preterm infants with less mature lung anatomy, the authors noted.
Among pregnant individuals enrolled in the study, 68% were unvaccinated prior to infection. Severe or critical COVID-19 occurred in 16% in this group, compared with only 4% of those who were vaccinated. "The greatest number of COVID-19 cases among mothers in this cohort was in winter 2020, when the ancestral variants were circulating," the authors wrote. However, most pregnant persons had received a COVID-19 vaccine before the Alpha variant emerged, they said.
Researchers found no association between neonatal respiratory distress and the pregnancy trimester when mothers had COVID-19. They also found no association between respiratory distress and maternal race or ethnicity. Half of the pregnant persons in the study identified as Black, Hispanic, or Latina, 25% as white, and 24% as Asian, mixed race, or other.
The study sample size was small and therefore results should be interpreted with caution, the authors noted. Also, participants in the study received treatment from a large tertiary and quaternary medical center, and they may have been sicker than the general population, the authors said.
Katherine Kahn is a staff writer at MedPage Today, covering the infectious diseases beat. She has been a medical writer for over 15 years.
Disclosures
The study was funded by the Simons Foundation Autism Research Initiative, the UCLA W.M. Keck Foundation COVID-19 Research Award Program, and the National Institutes of Health.
The authors reported no competing interests.
Primary Source
Nature Communications
Source Reference: Man OM, et al "Respiratory distress in SARS-CoV-2 exposed uninfected neonates followed in the COVID Outcomes in Mother-Infant Pairs (COMP) study" Nat Commun 2024; DOI: 10.1038/s41467-023-44549-5.
Count Trace Adkins as one who has no regrets over taking the COVID vaccine.
Were over 3 years since the first vaccine for COVID-19 was rolled out, and the debate surrounding the vaccine is still raging as fierce as ever.
But one person whos not second-guessing his decision to get vaccinated is Trace Adkins.
The country star sat down with Bill Maher for an episode of hisClub Randon with Bill Maherpodcast and discussed his thoughts on the vaccine.
After admitting that hes gotten COVID twice despite being vaccinated, Maher jokingly asked Adkins whether he thought the vaccine had a chip in it to track him:
I dont buy into all that crap. Im like, Give me a vaccine for everything that youve got one for.
Ill take em. Im not scared of that sh*t.
Maher pointed out that Adkins likely wasnt scared because of all that hes been through, like getting shot in the heart:
I just dont think theyre trying to put something in the vaccines to control us. Give me a vaccine for everything.
Or that it makes us feminine or whatever? I didnt notice that either.
I mean, I know its 2024 but I dont think Adkins deep voice would ever be confused as feminine
During the interview, Adkins also came to the defense of Jason Aldean and Morgan Wallen, denying that either of the stars are racist and arguing that the attempts to cancel them have only made them bigger stars.
Maher admits that he had never heard much about Aldean before the controversy surrounding his hit song Try That In A Small Town, but that the entire controversy was a smear job.
The people who just want to get you are the ones who piss me off. And I felt like there was no smoking gun
Theres just different kinds of Americans. You cant bully the people who grew up in Tennessee or Louisiana into being you. It sounds like Jason Aldean, hes a country guy. This is the kind of sh*t hes into, and the kind of stuff he thinksYou cant bully people into not being who they are. And they are no worse than you.
And Adkins called the controversy silly, arguing that its actually helping Jason Aldean:
Its all so silly anyway. The grievance junkies turn on somebody and they try to cancel them, and all its gonna do, hes gonna sell more records than he ever has and its gonna make him bigger than hes ever been.
He had no idea, man. You know how many music videos Ive done that Ive called up the director and went, Hey man, now what about this location where were shooting this thing? And if I did do that it would only be because I didnt know where I was going.
Maher adds:
Its not the way to fight racism, by just making sh*t up to point your finger at somebody.
And he also brought up Morgan Wallen for his own controversy:
Maybe Im naive but I just dont think these people are racist.
It was a sentiment that Trace agreed with based on his own experience:
Ive been around both of those guys. Theyre good guys. Theyre not racist.
And he also joked that after seeing whats happened to Wallens career, hed be happy to be canceled:
He sold out two nights in a row, 55,000+ tickets each night. God, cancel ME.
You can check out the full conversation on Bill Mahers podcast here, with the conversation about Aldean and Wallen starting around the 42 minute mark.
23 January 2024
Image source, Getty Images
There was an "alarming" nearly 45-fold increase in measles cases in Europe last year, the World Health Organization (WHO) says.
Health chiefs are warning that cases are still rising and "urgent measures" are needed to prevent further spread.
Some 42,200 people were infected in 2023, compared to 941 during the whole of 2022.
The WHO believes this is a result of fewer children being vaccinated against the disease during the Covid pandemic.
In the UK, health officials said last week that an outbreak of highly contagious measles in the West Midlands could spread rapidly to other towns and cities with low vaccination rates.
More than 3.4 million children under the age of 16 are unprotected and at risk of becoming ill from the disease, according to NHS England.
Millions of parents and carers are being contacted and urged to make an appointment to ensure their children are fully vaccinated against measles. The measles, mumps and rubella (MMR) vaccine is given in two doses - the first around the age of one and the second when a child is about three years and four months old.
The vaccine is very effective at protecting against measles, but only 85% of children starting primary school in the UK have had both jabs.
Speaking about the situation in Europe, Dr Hans Kluge, regional director at the WHO, said: "We have seen, in the region, not only a 30-fold increase in measles cases, but also nearly 21,000 hospitalisations and five measles-related deaths. This is concerning.
"Vaccination is the only way to protect children from this potentially dangerous disease."
Measles can be a serious illness at any age. It often starts with a high fever and a rash, which normally clears up within 10 days - but complications can include pneumonia, meningitis, blindness and seizures.
Babies who are too young to have been given their first dose of vaccine, pregnant women and those who have weakened immune systems are most at risk. During pregnancy, measles can lead to stillbirth, miscarriage and a baby being born with a low birth weight.
All countries in the European region are being asked to detect and respond to measles outbreaks quickly, alongside giving vaccines to more people.
The WHO said measles had affected all age groups last year - young and old alike.
Overall, two in five cases were in children aged 1-4, and one in five cases were in adults aged 20 and above.
Between January and October 2023, 20,918 people across Europe were admitted to hospital with measles. In two countries, five measles-related deaths were also reported.
Vaccination rates for the first dose of the MMR vaccine, which protects against measles, slipped from 96% in 2019 to 93% in 2022 across Europe. Uptake of the second dose fell from 92% to 91% over the same period.
That seemingly small drop in vaccination take-up means more than 1.8 million children in Europe missed a measles vaccination during those two years.
"The Covid-19 pandemic significantly impacted immunisation system performance in this period, resulting in an accumulation of un-[vaccinated] and under-vaccinated children," the WHO reported.
With international travel booming once again, and social-distancing measures removed, the risk of measles spreading across borders and within communities is much greater - especially within under-vaccinated populations, it said.
Even countries that have achieved measles elimination status are at risk of large outbreaks, the WHO warned.
It says that 95% of children need to be vaccinated with two doses against measles in all communities to prevent the spread of the highly-contagious disease.
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Opinion
Only one case was confirmed in Scotland last year. In England and Wales, more than 200 children were diagnosed in the last four weeks of 2023 alone
Wed 24 Jan 2024 03.00 EST
The UK was once so good at dealing with measles that in 2017 and 2021 the World Health Organization declared that we had successfully attained elimination status for the disease, meaning that not one endemic case had been detected in the prior year. But those days are over, with more than 200 children diagnosed with measles in England and Wales in the last four weeks of 2023. The UK Health Security Agency has declared a national incident not only because of the cases appearing, but also owing to overall low MMR vaccination rates, which leave a very large population of children at risk of infection.
Incredibly, about 25% of children in parts of London enter school unvaccinated. NHS England data suggests that more than 3.4 million children under 16 across the country are unvaccinated. This puts them at considerable risk, and measles is incredibly infectious. One person can infect about 12 to 18 others, and it spreads through respiratory means, such as coughing, sneezing and breathing. If about 95% of the population is vaccinated the virus stops circulating as it cant find susceptible hosts, but it appears vaccination rates in many areas are below that number.
Just two doses of vaccine should confer lifelong sterilising immunity, meaning those fully vaccinated are not only protected from infection but are also very unlikely to transmit the virus to anyone else. So whats the best way to get kids vaccinated? Scotland offers a lesson here. In Scotland, 95.9% of children had one dose by the time they were five years old, while 89.7% had two doses. The result? There was only one laboratory-confirmed case of measles in Scotland during all of 2023. Edinburgh University researchers suggest that Scotlands increase in vaccination rates during the Covid-19 pandemic may have been linked to flexible working for parents (which meant they could attend vaccination appointments) and mobile vaccination centres.
This is a basic premise in global health: if you want parents to vaccinate their children, make it accessible, free and easy, so it can fit within their daily commitments and constraints. And thats true whether its Uganda, Pakistan, Scotland or England. As Kirsten Watters, Camdens council director of health and wellbeing, said: When talking to parents, we know that most do intend to vaccinate their children, and theyve got high levels of confidence and trust. Its just that theyre finding it difficult to organise those appointments. The majority of parents do end up vaccinating their children, but it only takes a few barriers inability to make an easy appointment, faraway vaccine centres, confusing or inaccessible messaging to drop the vaccination rate a few percentage points below the critical 95% threshold, and the virus can begin to take hold.
And yes, there are other issues, such as general hesitancy about vaccines after Covid-19 and the growing online conspiracy movement, as well as genuine concerns about whether vaccines are necessary, given potential side effects. The pandemic definitely introduced many people to the world of anti-vax theory and doubt, to say nothing of previous issues such as Andrew Wakefields study in 1998 falsely linking MMR vaccination to autism, the influence of which has proved stubbornly hard to dislodge despite its having been discredited. But we shouldnt overstate antivax sentiment. The fact that vaccination rates are vastly different in some pockets of the UK coverage is about 90% in the south-west, for instance tells us the main difference is probably logistical. We need outreach to communities and better rollout of vaccines to areas of low coverage, all mediated through trusted health professionals.
Fortunately, the government has announced a vaccination campaign in England, recruiting teachers, GPs, and community leaders to promote vaccination, and rolling out pop-up vaccination centres in convenient locations such as schools. If the approach works, it needs to be built into the yearly campaign, so that vaccination rates never dip this low again.
I remember giving talks at global health meetings in 2003 and 2004, making the case for reducing the price of the measles vaccine for poor countries so that health ministries could acquire doses and save childrens lives. At that time, measles was considered a problem in low- and middle-income countries. We thought the problem had been solved in Britain and the United States.
Measles was once a common and deadly disease for children here. In 1962, Roald Dahls daughter Olivia died at the age of seven from measles complications. When a safe combined MMR vaccine was approved, the beloved childrens author advocated for parents to take it up. In a letter reflecting on the low uptake of measles vaccination in 1986, he wrote: It is not yet generally accepted that measles can be a dangerous illness. Believe me, it is. In my opinion, parents who now refuse to have their children immunised are putting the lives of those children at risk.
Eliminating most viruses is a tall order, but its a realistic target for measles given the MMR vaccine. Measles, mumps and rubella are all nasty diseases that should be stuck in the past. Dahls daughter didnt have the choice of a vaccine, but children in Britain today dont have to suffer the same fate. They live in 2024, not 1962.
Do you have an opinion on the issues raised in this article? If you would like to submit a response of up to 300 words by email to be considered for publication in our letters section, please click here.
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The potentially fatal disease diphtheria is caused by bacteria the club-shaped, Gram-positive, Corynebacterium diphtheriae bacilli shown in this microscope photo. CDC via AP hide caption
The potentially fatal disease diphtheria is caused by bacteria the club-shaped, Gram-positive, Corynebacterium diphtheriae bacilli shown in this microscope photo.
It had been over 30 years since the last case of diphtheria was seen in Guinea. So when patients began showing up six months ago with what looked like flu symptoms fever, cough and sore throat doctors weren't alarmed. Until the children started dying.
That's when they realized that this longtime scourge, long quashed by vaccination, was back.
As of December 2023, there have been around 25,000 cases of diphtheria in West Africa and 800 deaths. In Guinea, the cases were clustered in Siguiri, a rural prefecture in the country's northeast, and early data showed that 90% occurred in children under the age of 5.
Diphtheria is a highly contagious bacterial infection spread through direct contact with infected sores or ulcers but primarily through breathing in respiratory droplets. The bacteria then releases toxins, causing inflammation that blocks the airways; a thick mucus-like substance (called a "pseudomembrane") can form at the back of the throat.
"This can kill by suffocating the patient," says Adlard Shyaka, medical coordinator for Doctors Without Borders in Guinea. "But also the toxin moves through the body and can damage the heart, the kidneys, the nervous system." Such damage via suffocation, myocarditis, kidney failure and nerve malfunctioning means diphtheria is fatal in up to 50% of cases without treatment.
The disease, which was a global scourge for much of the 20th century, is also almost entirely preventable through vaccination. After the diphtheria inoculation was included on the World Health Organization's essential vaccine list in the 1970s, cases decreased dramatically worldwide. "Now, it's an almost forgotten disease," says Shyaka.
But that doesn't mean this outbreak is surprising, according to Ankur Mutreja, a global health specialist with the Cambridge Institute of Therapeutic Immunology and Infectious Disease. "Diphtheria is and has always been a disease of poverty," he emphasizes, with social unrest and poor vaccination coverage explaining most outbreaks nowadays. "It's not just the West Africa outbreak but numerous other [recent] outbreaks after the earthquake in Haiti, after war in Syria, in Bangladesh when the Rohingyas were displaced in 2017," Mutreja says.
Guinea was particularly vulnerable because of its low diphtheria vaccination rate only 47% in 2022, with the hardest-hit Siguiri prefecture having even lower coverage at 36%. COVID-19 disrupted routine vaccination campaigns in West Africa and was associated with an uptick in vaccine mistrust, Mutreja says. But for diphtheria and other preventable childhood illnesses, the immunization problem predated the pandemic due to supply chain difficulties, insufficient funding, and complacency, among other reasons, leaving the region vulnerable to a cluster of cases swelling into an outbreak.
In Guinea, Doctors Without Borders says its staff has supported local health workers in addressing diphtheria. Together, they've reduced mortality at Siguiri's Center for the Treatment of Epidemics from 38% to 5% over the past few months. Patients with mild symptoms are sent home with antibiotics, while more severe cases are admitted to the hospital and treated with an antitoxin, as appropriate.
However, shortages of both vaccines and antitoxins continue to hamper a full-scale response to the diphtheria outbreak, according to Louise Ivers, an infectious disease physician and the director of the Harvard Global Health Institute. Presently, only two or three companies make the antitoxin, and each batch of 1,500 doses takes about four weeks to prepare, harvested from horse blood. "Nobody wants to make it," says Ivers, because of how rarely this antitoxin is usually needed there were fewer than 9,000 cases globally in 2021 and how impoverished communities facing diphtheria tend to be. "That puts it into the category of low likelihood of commercial profit."
The only sure way this outbreak ends is through vaccination, suggests Ivers, who has firsthand experience responding to diphtheria in Haiti between 2003 and 2012. However, similar market dynamics may help explain the global shortage of diphtheria vaccines. "If we can catch back up with DPT [vaccines] and diphtheria boosters and get our communities highly vaccinated," she says, "then we can prevent outbreaks."
But the scarcity of vaccines means they've only been available for patients and their close contacts in Siguiri. As diphtheria continues to spread in Guinea, Mutreja worries about growing antibiotic resistance and the spread of new variants, which could render existing antitoxins and vaccines ineffective. In fact, resistance has already been increasing, decade over decade, for the past 122 years, as Mutreja described in a 2021 study in Nature Communications. "We mustn't take our eye off the ball with diphtheria. Otherwise, we risk it becoming a major global threat again, potentially in a modified, better-adapted form," he says.
While this present surge of diphtheria cases is indeed unprecedented for West Africa, it is really a symptom of larger issues in global health, including insufficient infectious disease surveillance, poor vaccination rates and scarcity of public health resources, suggests Shyaka. He's not only worried about Guinea's current diphtheria outbreak but also what other diseases are on the horizon, including meningitis, measles and whooping cough.
"The resurgence of diphtheria is an important indicator that we are far in the red zone of outbreaks of vaccine-preventable outbreaks."
Simar Bajaj is an American journalist who has previously written for The Atlantic, TIME, The Guardian, Washington Post and more. He is the recipient of the Foreign Press Association award for Science Story of the Year and the National Academies award for Excellence in Science Communications.
In September 2017, Britain was basking in the glory of a public health success story. No indigenous cases of measles had been recorded for three years. Decades after a sham study threatened to permanently undermine trust in the MMR jab, which protects against measles, mumps and rubella, the World Health Organization declared the disease had been eliminated for the first time in the UK.
Dr Mary Ramsay, then head of immunisation at Public Health England (PHE), expressed delight. This is a huge achievement and a testament to all the hard work by our health professionals in the NHS to ensure that all children and adults are fully protected with two doses of the MMR vaccine.
The WHO accolade came with a warning shot, however. We cannot become complacent, said Zsuzsanna Jakab, then WHO regional director for Europe. Outbreaks continue to cause unnecessary suffering and loss of life. Routine immunisation coverage is decreasing.
Less than two years later, the UK had been stripped of its measles-free status.
Today, the country is in the midst of a measles emergency. Public health officials are scrambling to stem an alarming tide of infection. And the UK Health Security Agency (UKHSA), which replaced PHE during the Covid pandemic, has been forced to declare a national incident, signalling a major public health risk from one of the worlds most contagious viruses.
Hundreds of children have been sickened by measles in recent weeks. Officials fear a growing outbreak in the West Midlands could spread to other towns and cities unless urgent action is taken to boost vaccination uptake.
A staggering 3.4 million under-16s are at risk of getting the virus, officials believe, and letters are being sent to parents of unvaccinated children. GPs are setting up extra clinics and vaccine buses are targeting communities with low vaccination rates.
The unfolding crisis has alarmed the UKs top health officials.
Were at a point where theres a very large susceptible population of children, Prof Sir Andrew Pollard, chair of the Joint Committee on Vaccination and Immunisation, told the Guardian in an interview this week. To keep measles at bay, we need to have over 95% of children vaccinated. The NHS figures suggest that were at about 85%.
Data released by the UKHSA showed there have been 216 confirmed measles cases and 103 probable cases in the West Midlands since 1 October last year. Four-fifths (80%) were found in Birmingham, while 10% were identified in Coventry. Most were in children aged under 10.
Now that its got started, with a virus that is so infectious its much more infectious than Covid was then if there are people who are unvaccinated, it can spread like wildfire, said Pollard. The reason why thats so worrying is that it then finds individuals who rather than just getting a horrible illness, will actually get serious complications or die from it.
In some people, measles can affect the lungs and brain and cause pneumonia, meningitis, blindness and seizures. Pollard said: There are some risk groups: people whose immune system doesnt work well, children on cancer treatments for example. Younger children are more at risk than older children from severe complications. But there will also be some completely healthy children who can get very severe illness or even die from this virus.
Its extremely worrying to be in this situation where the spark of this fire has started, we dont quite know where it will end, but we could stop it if we got vaccines out there to protect children.
So how did Britain go from eliminating measles to the brink of a measles catastrophe? Why have MMR vaccination rates fallen? And how can the country get out of this mess?
Experts say a combination of factors is likely explain the fall in vaccination rates and the measles crisis now engulfing Britain.
The rise in cases is partly a legacy of the pandemic, says Prof Stuart Neil, head of the department of infectious diseases at Kings College London. Vaccinations against many diseases, including measles, were neglected as people focused on Covid. Vaccine uptake has fallen across the board over the pandemic partly because of hesitancy to go to doctors during it, he said.
Another challenge is that the children who missed their first jabs between 2020 and 2022 are now older than the age group typically seen routinely at GP surgeries for vaccination programmes. In the UK, children are offered two MMR doses first at age one, then at three years and four months. But if your child was born during the pandemic, they may have been missed and need to catch up.
It is never too late to get vaccinated, said Dr Doug Brown, chief executive of the British Society for Immunology. We encourage parents to ensure their children are up to date with their MMR vaccines and catch up on any missed ones as soon as possible.
Pollard said there had been a gradual decline in MMR coverage for years before the pandemic, which had cumulatively increased the threat of a full-blown measles crisis.
In one year thats manageable but successively over years you build up this increasing pool that allows the virus to transmit, he said. If you think about the accumulation of cohorts of children over several years, each year that you have low coverage, theres more and more children added to this pool of susceptible people, which means that when the virus does arrive, you can have these explosive outbreaks.
Falling vaccination rates and the demise of Britains measles-free status also stems from people not knowing or forgetting about the risks of measles. Due to the success of the UK immunisation programme, many parents will have no first-hand experience of measles, said Dr David Elliman, a paediatrician at Londons Great Ormond Street hospital. It would be a great tragedy if we have to learn from the sad deaths of children, before the disease is taken seriously.
Bogus claims made in 1998 by Andrew Wakefield about the MMR vaccine still have an impact, says Prof Helen Bedford, professor of childrens health at the UCL Great Ormond Street Institute of Child Health. Not because the false claims still hold weight with the public, but because children not vaccinated due to the scare are now adults and may be helping the virus to spread.
Over 25 years ago, MMR vaccine uptake fell because of highly publicised but subsequently discredited research suggesting a link with autism, said Bedford. Unsurprisingly, given the intense media coverage at the time, many parents preferred not to have their children vaccinated. Those children are now young adults.
Over the years, the number of unvaccinated people has accumulated in the population, enabling measles to take hold and spread quickly within communities.
Most experts agree that misinformation about the MMR jab is very unlikely to play a significant role in declining vaccination rates. It is too easy to blame anti-vaccine sentiment for the measles outbreaks, said Bedford. Although some mistrust of vaccines may play a small part, research shows that parental vaccine confidence remains high, she added.
Asking questions about vaccination is to be encouraged, but we need trained staff to do this, and the NHS and general practice are under significant pressures, with cuts to funding and staffing.
Pollard believes families struggling to access vaccination programmes is a much bigger factor than misinformation. We know the greatest pockets of low coverage are in the parts of the country where families find it hardest to access vaccination services, he said.
Nationally, strategies promised by the NHS and government to boost vaccination rates urgently need to be enacted, says Dr Ronny Cheung of the Royal College of Paediatrics and Child Health.
NHS England recently published its vaccination strategy, which focused on addressing challenges around access and included proposals to provide flexible and convenient vaccination services. This is an extremely welcome development but we are concerned that implementation plans for this strategy are not nearly as ambitious as we need them to be, said Cheung. The current aim is full implementation by 2025-26.
Two years seems an unacceptably long wait. Were already arriving late to this work and are feeling the effects of low uptake, particularly in the MMR vaccine. This is urgent we must get to work straight away.
Pollard points out that the UK is not unique when it comes to rising cases of measles. Seven years after the WHO warned the then measles-free UK against complacency, this week it warned of a 30-fold rise in cases across Europe.
More than 30,000 cases were reported by 40 of the regions 53 member states between January and October last year, compared with 941 cases in the whole of 2022. Two in five cases were in children aged one to four, while one in five were among people aged 20 and over.
There are measles outbreaks happening all over the world, said Pollard. This is a worrying moment globally.
The only way out? Increase vaccination rates by encouraging parents to get their children jabbed against measles, experts say. The virus is spreading today so we need to be vaccinating children today, says Pollard. There isnt any time to wait. This is urgent and tomorrow may be too late.
GAITHERSBURG, Md., January 24, 2024 Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M adjuvant, today announced that the United Kingdoms (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorizationi for Nuvaxovid XBB.1.5 dispersion for injection, COVID-19 Vaccine (recombinant, adjuvanted) (NVX-CoV2601) for active immunization to prevent COVID-19 in individuals aged 12 and older.
Todays MHRA authorization is recognition of the role our vaccine can have in protecting the British public against COVID-19 this year, said John C. Jacobs, President and Chief Executive Officer, Novavax. We are in ongoing conversations with additional U.K. partners to identify potential opportunities to offer our protein-based non-mRNA COVID-19 vaccine to all eligible individuals who want one. We believe this is critical to supporting long-term, broad uptake of a seasonal COVID-19 vaccine in the U.K.
Authorization was based on non-clinical data showing that Novavaxs updated COVID-19 vaccine induced functional immune responses for XBB.1.5, XBB.1.16 and XBB.2.3 variants. Additional non-clinical data demonstrated that Novavaxs vaccine induced neutralizing antibody responses to subvariants JN.1, BA.2.86, EG.5.1, FL.1.5.1 and XBB.1.16.6 as well as CD4+ polyfunctional cellular (T-cell) responses against EG.5.1 and XBB.1.16.6. These data indicate Novavaxs vaccine can stimulate both arms of the immune system and induce a broad response against circulating variants.1,2
In clinical trials, the most common adverse reactions associated with Novavax's prototype COVID-19 vaccine (NVX-CoV2373) included headache, nausea or vomiting, muscle pain, joint pain, injection site tenderness, injection site pain, fatigue and malaise.
i. Additional efficacy and safety data are being collected.
This medicine is subject to additional monitoring. This will allow quick identification of new safety information. If you are concerned about an adverse event, it should be reported on a Yellow Card. Reporting forms and information can be found at https://coronavirus-yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store. When reporting please include the vaccine brand and batch/Lot number if available.
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The trade name Nuvaxovid has not been approved by the U.S. Food and Drug Administration.
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For more information on Nuvaxovid, including the Summary of Product Characteristics with Package Leaflet, adverse event reporting instructions, or to request additional information, please visit the following websites:
About Nuvaxovid XBB.1.5 dispersion for injection, COVID-19 Vaccine (recombinant, adjuvanted) (NVX-CoV2601)
NVX-CoV2601 is an updated version of Novavaxs prototype COVID-19 vaccine (NVX-CoV2373) formulated to target the Omicron XBB.1.5 subvariant. It is a protein-based vaccine made by creating copies of the surface spike protein of SARS-CoV-2 that causes COVID-19. With Novavax's unique recombinant nanoparticle technology, the non-infectious spike protein serves as the antigen that primes the immune system to recognize the virus, while Novavaxs Matrix-M adjuvant enhances and broadens the immune response. The vaccine is packaged as a ready-to-use liquid formulation and is stored at 2 to 8C, enabling the use of existing vaccine supply and cold chain channels.
About Matrix-M Adjuvant
When added to vaccines, Novavax's patented saponin-based Matrix-M adjuvant enhances the immune system response, making it broader and more durable. The Matrix-M adjuvant stimulates the entry of antigen-presenting cells at the injection site and enhances antigen presentation in local lymph nodes.
About Novavax
Novavax, Inc. (Nasdaq: NVAX) promotes improved health by discovering, developing and commercializing innovative vaccines to help protect against serious infectious diseases. Novavax, a global company based in Gaithersburg, Md., U.S., offers a differentiated vaccine platform that combines a recombinant protein approach, innovative nanoparticle technology and Novavax's patented Matrix-M adjuvant to enhance the immune response. Focused on the worlds most urgent health challenges, Novavax is currently evaluating vaccines for COVID-19, influenza and COVID-19 and influenza combined. Please visit novavax.com and LinkedIn for more information.
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Statements herein relating to the future of Novavax, its operating plans and prospects, the scope, timing and outcome of future regulatory filings and actions, including the availability of its updated XBB version of its Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (NVX-CoV2601) and the timing of delivery and distribution of its vaccine are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, challenges satisfying, alone or together with partners, various safety, efficacy, and product characterisation requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; challenges or delays in obtaining regulatory authorisation for its product candidates, including its updated XBB version of its COVID-19 vaccine in time for the fall 2023 vaccination season or for future COVID-19 variant strain changes; challenges or delays in clinical trials; manufacturing, distribution or export delays or challenges; Novavaxs exclusive dependence on Serum Institute of India Pvt. Ltd. for co-formulation and filling and the impact of any delays or disruptions in their operations on the delivery of customer orders; challenges in obtaining commercial adoption of our updated protein-based non-mRNA XBB COVID-19 vaccine, NVX-CoV2373 or any COVID-19 variant strain-containing formulation; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax's Annual Report on Form 10-K for the year ended December 31, 2022 and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov and www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
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