Anivive Lifesciences (Anivive) announced it will present the findings from its groundbreaking research on developing a systemic antifungal vaccination, which would be the first worldwide. Anivive will share the findings during the World Vaccine Congress happening April 1-4.
According to the release, Edward Robb, DVM, chief strategy officer at Anivive is leading a team of researchers at Anivive that are collaborating with the Valley Fever Center for Excellence at the University of Arizona.1 The joint efforts have led to the development of a novel vaccine candidate to target coccidioidomycosis fungal infection, commonly referred to as Valley Fever.
Robb will present the findings on behalf of the team and will focus his lecture on the crucial need for an effective antifungal disease, especially considering the increase of fungal infections across the world as well as the challenges faced when developing this kind of vaccination. A study published earlier this year inThe Lancet Infectious Diseasesfound that the global incidence and mortality from invasive fungal diseases is substantially higher than previously thought.2
The study used data collected from 85 papers on individual countries and global disease burden from 2010 to 2023 and estimated that over 6.55 million people are affected by an invasive fungal infection and 3.8 million reported deaths. Researchers of the study also noted that these estimates do not include influenza or COVID-19 outbreaks. Out of those reported deaths, about 68% were directly connected to a fungal infection.2
"We are at a pivotal moment in the fight against fungal infections," said Robb. "The development of an antifungal vaccine represents a transformative approach to combating these pervasive and often overlooked pathogens. I am honored to share our findings at the World Vaccine Congress and contribute to the global dialogue on vaccine innovation."
The research conducted by Robb and his team was a collaborative effort bringing together private and public enterprises to create a significant breakthrough within vaccinology and could lead researchers to become the first to prevent a systemic fungal infection that is common in dogs and humans. Current and traditional treatment options are often long and costly therapies with the risk of relapse as well as drug resistance. A vaccine of this nature can offer an alternative by using the bodys immune system to prevent the infection altogether.
The presentation will give attendees insights into the vaccines mechanisms of action, preclinical studies for efficacy, and the microbial safety of the vaccine.
References
The incidence of hepatitis A in Uzbekistan has risen steeply in recent months, with a concerning number of children infected with the virus. According to Maftuna Saidova, the head of the Information Service of the Committee for Sanitary and Epidemiological Well-being and Public Health, more than 9,500 children were diagnosed with hepatitis A by early February. The increase in cases has been particularly notable in the Andijan, Bukhara, Namangan, Surkhandaryo, Samarkand and Fergana regions, and in the Republic of Karakalpakstan.
Tashkent resident Nilyufar Sadikova became ill with hepatitis A last year. "I infected the children one by one: the disease manifested itself after 30 days in each child, says Sadikova. No one in the family was vaccinated.
Highly contagious, the hepatitis A virus spreads via direct contact with sick people, or through the ingestion of contaminated food or water. Once in the body, the virus causes an inflammation of the liver, producing symptoms that include fever, malaise, appetite loss, diarrhea and vomiting, abdominal pain and jaundice. Unlike the related hepatitis B and C viruses, hepatitis A does not cause chronic disease but in rare cases it does precipitate acute liver failure, which can be deadly. WHO estimates that more than 7,000 people worldwide died of hepatitis A infections in 2016.
Inactivated hepatitis A vaccines have been available for children older than one year since the early 1990s. After her children got sick, Sadikova says, their school began the process of vaccination against hepatitis A. Sadikova says she regrets that she did not vaccinate her children against this disease earlier.
In Uzbekistan, like in many countries, the hepatitis A vaccine is not included in the national vaccination schedule, meaning that it is not one of the vaccines provided by the state, free of charge. Still, many kindergartens and schools, according to internal rules, require parents to vaccinate their children against this disease privately.
According to the Medek Plus Vaccination Center in Tashkent, the cost of hepatitis A vaccination averages 350,000 Uzbek soms (about US$ 28).
The Ministry of Health of Uzbekistan warned that in neighbouring Kazakhstan, there has also been an increase in cases of hepatitis A infection, and recommended that parents vaccinate especially children aged two years and older, as well as those in contact with them. According to the Ministry of Health of Kazakhstan, that country has registered 850 cases of infection so far this year, which is almost twice as for the equivalent period a year ago.
Uzbek Health officials have emphasised the importance of vaccination in preventing the transmission of the virus, highlighting that vaccination can prevent the spread of the virus in 9498% of cases.
According to paediatrician Diloram Akhrorova, the primary focus of hepatitis A vaccination has been on children aged 18 months to 14 years, with the vaccine providing immunity for up to 15 years following administration. A single dose of the vaccine is considered sufficient, and no additional booster shots are required.
But not all parents welcome the hepatitis A vaccination campaign in schools. Tashkent resident Nodira Akbarova is among the sceptical. After the winter holidays, the school announced that they would vaccinate all primary school children who had not received the vaccine against hepatitis A. But Im not sure I will give my consent to this, says the woman. Akbarova cites her confidence that most cases of this disease end in complete recovery to explain her reluctance to vaccinate.
However, the Ministry of Health of Uzbekistan is warning that for people with weakened immunity and health problems, there is a risk of rapid development of disease with a fatal outcome.
According to the Committee for Sanitary-Epidemiological Welfare and Public Health, in the past year, 365,167 children across the country were vaccinated against hepatitis A. However, despite these vaccination efforts, the increasing incidence of hepatitis A presents a considerable burden on both the population and the health care system.
The experiences of health care facilities and professionals in dealing with the hepatitis A swell underscore the need for heightened awareness, proactive measures and effective management of the disease, said the Committee for Sanitary-Epidemiological Welfare and Public Health.
Controlling the virus will demand a collaborative effort, with participation from state authorities, health workers and the public.
Now that a measles outbreak has hit 18 states, Utah health officials are bracing for what could come.
The potential danger is exacerbated by a sharp decline in vaccination rates among children entering kindergarten, including the measles, mumps and rubella vaccine.
According to the Utah Department of Health and Human Services, kindergarteners exempt from vaccination have hovered at around 5% for a long time. In the last two years, however, that jumped to 7.2%.
Including other factors, like vaccination non-compliance and online schooling, 87.3% of kindergarteners are adequately vaccinated statewide. For herd immunity, health officials look for a 95% vaccination rate.
Rich Lakin, the immunization program director at the Utah Department of Health and Human Services, said misinformation and safety concerns have been large drivers in vaccination rate decreases.
A lot of the exemptions are not because the parents are against vaccinations, Lakin added. It's because they come to school and they're not prepared. And an easy way to get their child enrolled in school right away is to just to claim an exemption.
Exemptions can be claimed for medical, personal or religious reasons. The most common category is personal. Parents only need to click through an online educational module to receive it.
During the 2022-2023 school year, 11.2% of kindergarteners in the Wasatch health district started school without an MMR vaccine. The exemption rate in Wasatch also jumped from 7.1% to 10.9% in just one year.
The numbers that we are seeing are unprecedented, said Aubreigh Parks, the nursing and wellness supervisor for the Wasatch County School District.
She said much of this change came in the aftermath of the pandemic when skepticism about vaccines became commonplace. As a result, Parks sees her role as an educator to combat parents fears surrounding vaccination as crucial.
Parents deserve a health care provider who will sit down with them and have these educated conversations addressing these fears. Parents need help accessing valid, evidence-based guidelines and understanding how that information they've heard or seen is incorrect.
In the meantime, shes worried about the potential for measles cases to pop up in the coming weeks especially with spring break starting next week. Beyond illness, theres the risk of learning loss among students already trying to catch up after the pandemic.
If two connected measles cases are found in the same school, state policy mandates that every student without an MMR vaccine not attend school for at least three weeks.
The exclusion period can go longer than that initial 21 days from exposure because technically they have to stay out depending on how many more cases occur. These students would have to stay out for 21 days after the date of the last known cases measles rash onset, Parks said.
She has never experienced a measles case in the district but at this point all of us in this state, not just Wasatch County School District, are sitting ducks. Were all sitting and watching and waiting for us to be next.
Its heartbreaking because I know that the students education could potentially be impacted by something that's very preventable. And it's heartbreaking because it tells me how much distrust there has been between health care [providers] and patients.
Transparency campaigners and some political opponents have sought to put pressure on the Commission to discuss the case, but von der Leyen has so far avoided addressing it. In a reply to a direct question put to her by POLITICO about missing text messages, von der Leyen said: Everything necessary about that has been said and exchanged. And we will wait for the results.
In 2022, EPPO announced it was looking into the EUs vaccine procurement more generally, but this is the first time that the office has been linked with Pfizergate explicitly.
The case now being looked at by EPPO brings together several different legal, political and financial strands and it intersects with lawsuits that pharmaceutical giant Pfizer brought against Hungary and Poland.
Last year, Baldan, a 36-old Belgian lobbyist who is represented by the same lawyer that represents French vaccine-skeptic group Bon Sens, lodged a criminal complaint in Belgium in connection to von der Leyens role in the vaccine negotiations with Pfizer over what he alleges were acts of "interference in public functions, destruction of SMS, corruption and conflict of interest," according to legal information provided by his lawyer.Bon Sens hasput forward its own legal challenges in connection with Pfizergate.
The addition of European governments to his complaint adds weight to what might otherwise have been seen as a personal crusade. Hungary, led by Viktor Orbn, a steadfast opponent of von der Leyen, also filed a complaint in connection to the Commission presidents role in vaccine negotiations with Pfizer, according to two insiders with knowledge of the case, speaking on condition of anonymity because of its sensitivity.
Poland lodged its own complaint last November, a Polish government spokesperson confirmed. However, following the election of Tusk in December, the new government is working [to] withdraw Poland from these proceedings, the spokesperson said.
An outbreak of bird flu is affecting dairy cows in the U.S. Charlie Neibergall/AP hide caption
An outbreak of bird flu is affecting dairy cows in the U.S.
The recent spread of avian influenza in dairy cattle in the U.S. has startled even some scientists who've tracked a global outbreak of the virus over the last few years.
"There's a heap of unknowns right now," says Richard Webby, a virologist at St Jude Children's Research Hospital.
How widespread is the virus in dairy cattle? What could this mean for humans? None of this is clear yet.
The first cases of this H5N1 bird flu strain emerged in North America among wild migratory birds in late 2021 and soon spread to poultry farms. It's now showing up among dairy cows and at a major egg producer and one person who had close contact with cows has been infected.
"This particular version of the H5N1 virus is teaching us that some of the things we thought we knew about flu were wrong," Webby says.
The current outbreak has affected many new wild bird species and persisted for longer than previous ones. The virus has also popped up more often in mammals, both in the wild and on farms, and at times led to a wave of infections and death.
"We are in fairly unprecedented, uncharted territory, globally in relationship to avian influenza," says Dr. Peter Rabinowitz, director of the UW Center for One Health Research.
But federal officials and scientists stress the risk to the public still remains low.
So far, the virus does not appear to have mutated in a way that would make it significantly more dangerous. While concerning, the one human case, they say, is consistent with how people usually catch these viruses, through direct exposure to a sick animal.
But scientists are watching this outbreak closely. Here's more of what they are learning.
While it's still early days, Webby says the genetic sequencing collected from infected cattle hasn't turned up anything that "immediately screams, this virus has changed, and that's why these cows are getting infected."
"It just seems to be fairly typical of the viruses that have been detected in birds in various regions," he says.
Sequencing of the virus in the Texas patient did show "minor changes," including one mutation associated with viral adaptation to mammals that's appeared in other human cases, according to a report from the Centers for Disease Control and Prevention.
However, there's no indication from those previous infections that this mutation makes the virus more likely to spread among humans.
This change does seem to have happened when the virus jumped from a cow to the person, but there's nothing altogether alarming about it, says Angie Rasmussen.
"It doesn't look like there's any indication that this has adapted itself to spread efficiently between humans, and to routinely cause severe disease," says Rasmussen, a virologist at the Vaccine and Infectious Disease Organization at the University of Saskatchewan.
But she says this human case and the infections in dairy cattle are clear warnings: "The less human or cow transmission we have, the fewer of these mutations the virus can acquire."
It's generally rare for people to catch any type of bird flu and human-to-human spread is even rarer.
During the current outbreak, this version of H5N1 has only been detected in a handful of humans in the last few years globally, and there aren't any documeneted cases of human-to-human transmission.
In the Texas case, the person's only symptom was eye redness after being exposed to cattle. It's the second known H5N1 infection of a human in the U.S. In 2022, a poultry worker in Colorado was exposed to sick chickens and developed a mild illness.
Some recent human infections have led to severe illness in other countries, including Ecuador, Chile and China. "This is a virus that doesn't infect humans very well, but can not all the time cause very significant disease when it does."
Historically, human infections with avian influenza were often traced back to close contact with birds, specifically in markets or on farms.
"If you're exposed to bird feces, if you're exposed to dead birds, if you're around a lot of live birds, you're going to be exposed to more of that," says Rasmussen.
Unlike the seasonal influenza viruses that infects humans, H5N1 doesn't have the ability to easily attack our upper respiratory tract, so it doesn't tend to spread among humans.
However, the virus can bind to receptors in the lower respiratory tract. This may be one reason that people who develop respiratory infections with bird flu "can get very, very sick with severe pneumonia because those receptors are located deep in the lungs," says Rasmussen.
Of course, scientists are looking out for any signs that the virus has adapted to better target our upper respiratory tract.
The recent case in Texas also raises the possibility of "mucosal exposure," meaning the person may have come in contact with the virus and then touched their eyes, although the details and what that might mean for tranmission are unclear, she says.
A central question for scientists right now is whether there's significant transmission of the virus between dairy cattle.
Cases have been detected in herds in Texas, Michigan, Kansas and New Mexico, and are suspected in other states, as well.
Evidence suggests infected wild birds may have been the initial source of the infection, but "it's hard to explain exactly what's going on without some degree of mammal-to-mammal spread," says Webby.
Others tracking the outbreak agree.
"The way people are telling me it gets on their farm and moves, I'd be very surprised if this was not being spread from cow to cow," says Joe Armstrong, a veterinarian at the University of Minnesota.
In early February, Armstrong started tracking reports of a mysterious illness in dairy cattle on the Texas panhandle and other states. He says just how many of these cases can be attributed to avian influenza still remains fuzzy.
"If we have wild birds involved and other wildlife, it's almost impossible to keep livestock and wildlife separate completely," he says.
While cows are falling sick, it's not proving to be deadly, says Armstrong. And so far, federal officials emphasize the commercial milk supply is not at risk because products are pasteurized.
Currently it's not clear exactly how bird flu is spreading among mammals, and to what extent infections are mostly happening after some kind of contact with infected birds.
But scientists worry about sustained mammal to mammal transmission of avian influenza because that gives the virus more opportunities to adapt to that host and acquire mutations that could make it better suited to mammals.
There have been large die offs of marine mammals in South America and a particularly alarming outbreak on a mink farm in Spain.
In both of those examples, the virus had evolved a couple of "mammal adaptive mutations" that haven't yet been seen in cows, says Louise Moncla, a virologist at the University of Pennsylvania.
Cows are typically infected by a different type of influenza, so that makes it hard to speculate about the risk posed to humans.
"It's just simply very unusual and very odd," says Moncla.
Unlike pigs known to be intermediary hosts for human and bird viruses there is no data that show that cows are an important intermediary host for these viruses, she says.
An ongoing outbreak in livestock not only threatens the industry, but also makes it more likely that other animals will be exposed, or the workers themselves.
"In general, we have not paid a lot of attention to these workers, even though they've often been sort of like the canary in the coal mine, the first evidence of a transmission event," says Rabinowitz.
Federal health officials stress that they are taking the situation seriously.
'The United States has been preparing for avian flu outbreaks for more than 20 years," CDC director Dr. Mandy Cohen told NPR's All Things Considered. "It's very different from what we experienced, for example, at the beginning of COVID, when we were seeing a brand new novel virus where we didn't have tests, we didn't have treatment and we didn't have vaccine."
The U.S has a limited stockpile of vaccines that were developed for early strains of H5N1 that could be tapped if there's any human-to-human spread.
Immune-stimulating ingredients, known as adjuvants, can be added to these older vaccines in order to broaden the immune response so that it better covers mismatched strains. In addition, mRNA technology could be leveraged to produce new vaccines, says Dr. Wilbur Chen, at the University of Maryland's School of Medicine.
"All of those can be used in a pandemic response," he says,
Chen says part of the ongoing preparation for the possibility of more human cases could include manufacturing limited quantities of vaccines.
Dr. Ashish Jha, dean of Brown University's school of public health, says he would not be surprised if there are more cases in humans, most likely other farm workers.
But he says it's not yet time to start mobilizing a larger pandemic response say, pumping out millions of vaccines because the chances that will be needed are very very low.
"If you are seeing it widespread in farm workers, you want to think about vaccinating farm workers. If you start seeing it in non farm workers with evidence of human-to-human transmission, that's when you start wanting to think about vaccinating a much broader set of the population," he says.
Brooke Ibraham feels fortunate that her grandparents, Harold Brown, 92, and Darlene Brown, 87, havent been ill with COVID.
She credits their avoidance of infection to receiving regular COVID vaccinations and boosters.
Harold, who has dementia, is cared for by his wife with the support of family members. Initially, finding a way for the couple to receive vaccinations was difficult because Harold has been homebound for years
When Ibraham called the Muskegon County Health Department, she was surprised to find that there wasnt a local program to provide COVID vaccinations to homebound residents. But the health department did refer her to Disability Rights Michigan (DRM), which is collaborating with the Michigan Department of Health & Human Services to support vaccinations for homebound residents.
Finding a solution
Working with DRM, she has been able to schedule appointments by text message. Every time a new booster came out, she texted DRM asking to set up an appointment for her grandparents. The in-home vaccinations have been crucial because Harold can't get in and out of a vehicle.
"It would be quite an ordeal if we had to bring him somewhere," Ibraham says. "My grandfather probably just wouldn't have access because it would have been too difficult to get him anywhere. He just doesn't have the strength to get in and out of a vehicle, and nobody else has the strength to get him in and out of a vehicle."
Harold Brown, 92, and Darlene Brown, 87, have received their COVID vaccines at home.
Between family members and professional caregivers coming and going from the house, the Browns likely have been exposed to the disease that the Center for Disease Control says has killed more than 1.1 million people.
In spite of everyones best effort to keep them as safe as possible, there have been times when family members have visited the Muskegon couple only to test positive for COVID a day or two later.
Thankfully they haven't had an infection, says Ibraham. It's a real big peace of mind because I dont know how my grandfather would fare. And my grandma has congestive heart failure and lots of autoimmune issues.
Mobile vaccine clinics
Ibrahams family situation is similar to hundreds across the state, says Tamela Phillips, a DRM vaccine advocate. DRM was given a state grant to ensure that the residents with disabilities had access to COVID vaccinations.
When our grant started, we really had no idea of what direction to move in, says Phillips. We started getting phone calls from people who were interested in getting some assistance with getting the vaccines because they were homebound. They had great difficulties, typically because of mobility.
She discovered that the state had contracts with mobile vaccine clinics, so she contacted them and found that DRM could tap into these resources to provide vaccines to people with disabilities who are homebound.
For several months, Phillips worked as an intermediary connecting those with disabilities who needed vaccines with mobile vaccine clinics. Then the state ended that service when demand for vaccines ebbed because fewer people were experiencing transportation issues.
We realized that we needed to take the vaccines to the people and make them accessible, Phillips said. And so just as we were getting better at that, the state decided to pause the vaccine clinics.
Going where needed
Mark McWilliams, director of advocacy strategies and vaccination advocacy for Disability Rights Michigan, received permission from the state to use part of the nonprofits grant to contract with a mobile vaccine clinic.
DRM now contracts with DocGo to provide vaccinations at community events and at residential facilities, such as nursing homes or adult foster care facilities. Often, clinics are paired with visits to peoples apartments. For example, during a clinic held at an apartment building geared to seniors or those with disabilities, nurses go up to the apartments of those unable to come to common spaces for vaccines.
DocGo's Amanda McMann packs supplies for an in-home COVID vaccination visit.
Amanda McMann, operations supervisor with DocGo, has been with the Muskegon office of the national mobile medical services company for 2 1/2 years. Shes part of the team supporting the DRM effort, which has resulted in 270 homebound vaccinations in 2023, part of an overall total of 2,793 COVID-19 and 1,431 flu shots. Of the 1,636 patients served, 684 self-identified as having a disability, according to DocGo records.
Disability Rights Michigan has pretty much been the driving force behind our ability to get out into the communities and provide those services for people who are at home, McMann says.
They get a lot of the referrals for us. It's been a great resource for people who are unable to get out of their homes, once they know that that kind of service is available.
Most people are eternally grateful when McManns team shows up to make a house call.
I'm just extremely proud to be able to participate in a program helping people in communities across the state, especially people who might be overlooked right now, McMann says.
Grant expires in September
Ibraham reached out to DRM to make arrangements for her homebound grandparents to get vaccines.
When Brooke heard a new COVID booster was coming out, she would text me. I would get her permission, and I would get a referral for her grandparents, Phillips says.
The community knows that we can get these vaccines out, so we get contacted either by a caretaker or the person themselves, Phillips says. We built this reputation of providing this service to people that just cannot get the vaccine themselves for the last two years.
The grant for this program expires in September. DRM is working on building a resource for people who will need help after its grant expires.
A lot of these people have come to depend on us, Phillips says. We've built relationships with these community partners. We're just really concerned about what's going to happen to all these people with disabilities who cannot get out once we're done.
Shandra Martinez is the lead writer for the Disability Inclusion series. Shes also the managing editor of The Lakeshore and Rapid Growth.
Photos of Amanda McMann by Shandra Martinez. Photo of the Harold and Darlene Brown is courtesy of their family.
Disability Inclusion is a series exploring the state of Michigans growing disability community. It is made possible through a partnership with Disability Rights Michigan.
Englands NHS is calling its recent campaign to boost vaccination rates a success amidst a surge in measles, mumps, and rubella (MMR) cases.
Latest data released by the health service shows that there were 23% more vaccinations in the first quarter of 2024 compared to the same time last year.
A total of 360,964 jabs were delivered between January and March this year, compared to 293,847 in 2023. The biggest jump was seen in those aged five to 25 years old, with vaccinations up four-fold in that group between 2024 and 2023.
In January, the UK Health Security Agency (UKHSA) declared a national incident following a surge in measles outbreaks across Britain. The highly contagious measles virus can cause serious illness and, in some cases, even death, in children and adults. It is also dangerous if caught during pregnancy, potentially resulting in stillbirth, miscarriage, and low birth weight.
In the same month, the NHS started contacting millions of patients and carers in England to book their children in for a catch-up vaccine with a GP. The campaign also targeted those in the 11 to 25 year-age group in areas with low vaccine uptake rates such as London and the West Midlands.
At the time, the NHS said its figures indicated that more than 3.4 million children under 16 years of age were unprotected against the three infectious diseases. There have been 934 confirmed cases of measles in England since the beginning of October last year, according to data from the UKSHA. The West Midlands accounted for around half of the cases seen since January.
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UKSHA head of immunisation Dr Mary Ramsay said: The big increase in people, especially children, getting their MMR vaccine following our recent marketing campaign on missed immunisations is fantastic to see.
The NHS uses MSDs M-M-RVaxPro and GSKs Priorix for MMR vaccines. The shots were approved for use in the UK in 1997 and 2006, respectively. They are recommended for all babies and young children, with adults able to receive one if unvaccinated.
Two doses of the vaccines are required, resulting in lifelong protection with high efficacy against the three viruses which are easily spread between unvaccinated people.
The World Health Organization (WHO) has said 95% vaccine coverage would eliminate measles in a population completely.
The US has also seen a surge in measles cases, with the Centers for Disease Control and Prevention (CDC) reporting 97 cases in 2024 so far. Over half of the patients diagnosed with the virus were hospitalised. The CDC issued a health alert urging travellers, especially children, to get vaccinated. A statement from the American Medical Association echoed the call for vaccinations. The US also uses MSDs M-M-R II and GSKs Priorix.
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Gritstone bios gamble on a novel endpoint has backfired. The cancer vaccine failed to trigger hoped-for changes in circulating tumor DNA (ctDNA), causing the phase 2 trial to miss its primary endpoint and leaving the biotech clinging to immature survival data.
Investigators randomized 104 patients with metastatic microsatellite stable colorectal cancer to take one of two front-line therapies. All patients received induction and maintenance chemotherapy. Around half of the subjects also received Gritstones personalized neoantigen cancer vaccine, Bristol Myers Squibbs Yervoy and Roches Tecentriq during the maintenance phase.
The primary endpoint looked at changes in ctDNA. On that measure, Gritstones drug combination was numerically worse than chemotherapy alone, with the molecular responses in the vaccine and control arms coming in at 30% and 41.7%, respectively. Gritstone attributed the result to its misunderstanding of how ctDNA would change after treatment.
With regard to defining molecular response, we simply got it wrong, Gritstone CEO Andrew Allen, M.D., Ph.D., said in a statement. CtDNA levels in both arms decreased on chemotherapy for longer than we anticipated, generating similar short-term molecular response rates across arms and rendering our protocol measure of ctDNA change uninformative.
While the study missed its primary endpoint, Allen latched on to progression-free survival (PFS) data to contend that the results are highly encouraging. The PFS rate was higher in the vaccine group than in the control arm after six months and nine months. However, the lines crossed around the 12-month mark, creating a short period in which PFS probability was higher in the control arm.
The hazard ratio favored the vaccine regimen, clocking in at 0.82 in the overall population, but the wide confidence intervals make it impossible to draw firm conclusions. Gritstone reported a hazard ratio of 0.52 in a subgroup of high-risk patients. PFS data are more mature in the subgroup, leading Allen to call the result a striking signal, but, again, the confidence intervals are wide enough that the vaccine may be less effective than the control. Allen had discussed what would be a good PFS result at an event in March.
The separation [of the curves], of course, is likely and important, but the lifting of the tail is what we really care about, Allen said at the time. The CEO cited Bayers Stivarga as an example of a drug that shifted PFS by about two months [and is] not widely used because survival is basically no different.
Gritstone picked ctDNA, rather than the widely used and accepted PFS, as its primary endpoint because of concerns about pseudo progression. The term describes people whose tumors appear to grow after treatment but then shrink. That happens when T cells enter tumors and proliferate. Initially, this causes lesions to grow, but they then collapse as the immune cells wipe out the tumor.
Evidence of pseudo progression made Gritstone a little bit leery about PFS, Allen said, and led it to make ctDNA the primary endpoint. The hope was that ctDNA would provide a clear signal that the therapy is working and make the case for pushing ahead to an overall survival (OS) readout that will provide the truest test of efficacy.
Instead, the study missed the ctDNA endpoint, leaving Gritstone looking to immature PFS results that, at best, show trends favoring the vaccine to make the case for its therapy. The biotech expects to have mature PFS data in the third quarter of 2024, with OS data set to follow in the first half of next year.
The timing of the readouts is important, because Gritstones cash is running low. The biotech ended last year with $79.2 million, a sum it told investors would fund operations into the third quarter of 2024. Gritstone proposed a public offering in the immediate aftermath of the phase 2 data Monday and later priced a $32.5 million sale at $1.65 a share.
Gritstones share price has bounced between a low of $1.14 and high of $3.33 over the past year. The stock fell almost 33% in the wake of the updates Monday, falling to $1.58 in after-hours trading.
An unprecedented crisis looms over supplies of injectable poliomyelitis vaccine, or IPV - a crucial tool in India's efforts to eradicate polio - as French drugmaker Sanofi has shut down its manufacturing plants in the country, documents reviewed by ET showed. Sanofi - a leading supplier of the vaccine - ceased production of its IPV brand ShanIPV in December 2023, triggering concerns among health experts regarding an imminent supply disruption that may hobble the country's most ambitious immunisation campaign.
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IPV is manufactured by only two companies - Sanofi Pasteur and Serum Institute of India (SII). Pune-based SII started its supplies of the vaccine only in 2021. Sanofi is believed to cater to over 80% of India's IPV dose requirements.
"Having been a long-standing contributor to India's journey to become polio-free, we stay dedicated to supporting India's public health programme for polio eradication in alignment with the authorities." In September 2023, however, Sanofi had announced in a public notice that due to the discontinuation of the manufacturing and marketing, the product may not be available in the market. IPV is an integral part of India's Universal Immunization Programme (UIP) that provides free immunisation to children against 12 preventable diseases including measles, diphtheria, hepatitis B, and tuberculosis. IPV was introduced into UIP in 2015 as part of a global polio endgame strategy.
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"Time is running out to find alternate supply arrangements," a public health expert told ET on the condition of anonymity. "By now, the government should have floated tenders or placed additional orders to Serum. This shows the callousness as it will affect polio surveillance and polio control measures."
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Pune-based SII may need to ramp up its capacity to bridge the demand shortage, experts said. The IPV shots are administered to children at six weeks, 14 weeks and nine months. While oral polio drops are administered at birth and then at 6,10,14 months and 1.5 years. India was the first country to introduce fractional doses in 2016 to dissipate a shortage of IPV.
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Sanofi has made multiple submissions to the union health ministry, cautioning against the impending supply challenges and had sought relaxation of a condition for continuation of such supplies, the documents showed.
However, Sanofi at that time had maintained that supplies of the polio vaccines will remain unimpacted.
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Sanofi has made multiple submissions to the union health ministry, cautioning against the impending supply challenges and had sought relaxation of a condition for continuation of such supplies, the documents showed.
The company had noted that while its product (IPV vaccine) is fully compliant during the term of the tender with a residual shelf-life of less than 18 months, a second condition requires that the manufacturing date of the product does not exceed six months at the time of the supply.
Since ShanIPVs shelf life is 36 months, thus meeting the primary requirement of the tender, we would humbly request you to kindly consider relaxation of the second criteria, that is the product should not be older than six months at the time of supply, the company said in a letter sent in June last year.
It clearly stated that the company would not be able to adhere to the six-month shelf-life clause from May 2024 onwards. Such a relaxation would not in any way impact the clinical profile of the vaccine, it pointed out.
The deadline mentioned in the letter implies that the last date for production of the vaccine was in December 2023.
People aware of the matter said Sanofis vaccine supplies may not be impacted till the end of this month, but any further delay in making an alternate plan could hinder the shelf-life condition of its existing tender agreement.
Sanofi had also volunteered to make a one-time exception of extending half of the total volume of product that exceed six months from the manufacturing date at no extra cost.
As an alternative to ShanIPV, Sanofi is understood to have accelerated the process to seek regulatory approval for Imovax polio, a 10-dose IPV that it sells across the world.
Meanwhile, it is learned that Sanofi may sell its Medchal and Muppireddypally facilities to Gland Pharma, one of the largest generic injectables manufacturers. Gland was picked among two other shortlisted entities Bharat Biotech and SII. This, however, could not be confirmed from Gland Pharma.
Meanwhile, the health ministry is planning to hand over procurement of IPV to its central procurement agency CMSS, which may further delay the procurement of the polio vaccines.
Questions from ET sent to the health ministry remained unanswered.
A senior government official, though, said things are under control. If need be, we will use option clause, which gives the government the right to increase the quantity to be ordered up to 20-30% from the current supplier. In this case it will be Serum Institute of India, he said.
UIP is one of the largest public health drives of the government targeting over 27 million new-borns and 29 million pregnant women annually.
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Photo Credit: Peter Hansen
Study found a decreased risk of any and severe respiratory syncytial virus (RSV) lower respiratory disease in the group that received the vaccine compared to the group that received the placebo, and the vaccinated group had a higher risk of preterm birth than the placebo group.
Evidence Rating Level: 1 (Excellent)
Study Rundown: RSV is a major cause of respiratory tract infections in young children, particularly infants under six months. The virus particularly affects those living in low- and middle-income countries, where interventions are needed. Vaccinations for other viruses have shown to be effective in mothers, thus an RSV vaccine was proposed for maternal use, based on the RSV fusion (F) protein. A phase three trial (RSV MAT-009) was conducted as a double-blind, randomized control trial across 24 countries. The participants were assigned randomly using a 2:1 ratio to receive either one intramuscular injection of 120 g of RSVPreF3-Mat or the placebo. The primary outcomes included any medically assessed RSV-associated lower respiratory tract disease, and any RSV-associated tract disease in infants between birth to six months of age. The sites in low- and middle-income countries were mainly located in the southern hemisphere, whereas the sites in high-income countries were mainly in the northern hemisphere, making it impossible to understand geographic or socioeconomic factors that could have affected the results. Overall, the risk of any severe RSV-associated lower respiratory tract infection was lower in those receiving the RSVPreF3-Mat than in those receiving the placebo; however, the risk of preterm birth was higher in the RSVPreF3-Mat group comparatively.
Click to read the study in NEJM
In-Depth [randomized controlled trial]: Vaccination protecting against RSV during pregnancy may be beneficial for infants, but there has not been enough data on the vaccines safety. Thus, the studys main focus was the safety of infants between birth and 12 months of age and any or severe medically assessed RSV-associated lower respiratory tract infection in infants between birth and six months. Eligible participants included healthy women between the ages of 18 and 49 years of age with a singleton fetus between the gestational age of 24 weeks and 34 weeks with no known fetal abnormalities. In total, 5,328 pregnant women who met the criteria were vaccinated before enrollment and included in the study, along with 5,233 infants. Of these infants, 3426 were placed in the vaccine group and 1,711 in the placebo group. In the vaccinated group, there were 16 cases of RSV-associated lower respiratory tract infections, whereas in the placebo group, there were 24 cases of the disease (vaccine efficacy, 65.5%; 95% credible interval, 37.5 to 82.0). Also, the vaccinated group reported eight severe, medically assessed RSV-associated lower respiratory infections, while the placebo group reported 14 cases (vaccine efficacy, 69.0%; 95% credible interval, 33.0 to 87.6). Preterm birth occurred in 6.8% of infants in the vaccine group but only in 4.9% of infants in the placebo group (relative risk, 1.37; 95% confidence interval [CI], 1.08 to 1.74; P=0.01). In the vaccine group, 0.4% of infants (13 of 3494) died neonatally, whereas, in the placebo group, 0.2% of infants (3 of 1739) died neonatally (relative risk, 2.16; 95% CI, 0.62 to 7.56; p=0.23). Overall, the group who received RVPreF3-Mat had lower risks of any RSV-associated lower respiratory tract disease and severe RSV-associated lower respiratory tract disease when compared to the placebo group.
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