Category: Vaccine

London: An international clinical trial testing a novel cancer immunotherapy, which may prevent skin cancer from recurring, has recruited its first patient in Britain this week. The mRNA-based technology, the vaccine tech used for some COVID vaccinations, is aimed at people who have already had high-risk melanomas - the most serious form of cancer - removed. For the trial, University College London Hospitals (UCLH) doctors are giving it alongside another drug, pembrolizumab or Keytruda, that also helps the immune system kill cancer cells.

One of the first patients to sign up for the trial is British musician Steve Young, 52, from Hertfordshire, east England, who was diagnosed with stage II melanoma, which was removed.

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The personalised treatment works by instructing the body to make up to 34 proteins, each targeting "neoantigens" identified by gene sequencing and thought to be driving the cancer in that particular patient. The neoantigens are proteins found only on the cancer cells, and the individualised neoantigen therapy is designed to prime the immune system to attack the tumour cells in each patient, while Keytruda blocks an immunological "brake" that protects the cancer.

The new Phase 3 clinical trial, being led by UCLH, is evaluating the combination of mRNA-4157 (V940) and Keytruda (pembrolizumab) versus a current standard of care (pembrolizumab) as a risk-reducing treatment option for patients with resected high-risk, stage IIB to IV melanoma.

It follows a successful Phase 2 study, which found that in patients with stage IIIB to IV resected melanoma, this treatment option almost halved the risk of cancer recurrence or death after three years compared with treatment with Keytruda alone among patients with advanced melanomas following surgical removal of cancer.

Melanoma is characterised by the uncontrolled growth of pigment-producing cells. The rates of melanoma have been rising over the past few decades, with nearly 3,25,000 new cases diagnosed worldwide in 2020. In the UK, melanoma is the fifth most common type of cancer, accounting for about 8,400 new cases every year.

The mRNA technology was developed by Moderna in conjunction with Merck Sharp and Dohme (MSD), which used the learning from COVID research development and is expected to contribute to new treatments for cancer patients.

Researchers are now hoping that the Phase 3 study, which is running in several sites across the UK, will confirm the findings of the earlier trial. The Phase 3 trial, named INTerpath-001, will enrol around 1,089 patients across the world. The primary outcome measure is recurrence-free survival, with overall survival and metastasis-free survival as secondary outcomes.

V940-001 is a Phase 3 global, randomised, double-blind, placebo- and active-comparator-controlled study. This means Steve Young knows he is receiving Keytruda, but will not find out if he is getting the personalised cancer treatment or a placebo.

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UK cancer patient joins trial for world's first skin cancer vaccine - ETHealthWorld

UK pharma major GSK (LSE: GSK) has launched a lawsuit against Pfizer (NYSE: PFE) and BioNTech (Nasdaq: BNTX).

The suit accuses the companies of breaching GSK mRNA vaccine technology patents in their development of the Comirnaty vaccine for COVID-19. The jab swiftly became a top-selling pharma product to help the world to move on from the pandemic, earning Pfizer $43 billion in global revenue in one year alone.

GSK claims that the research in question

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GSK sues Pfizer and BioNTech over mRNA billions - The Pharma Letter

Pictured: Sign above the entrance to a U.S. courthouse/iStock,Mariakray

GSK on Thursday sued Pfizer and BioNTech, alleging that the pharma partners have infringed patents related to the mRNA technology of their COVID-19 vaccine Comirnaty, according to Reuters.

In its complaint, filed with the U.S. District Court of Delaware, GSK claims Pfizer and BioNTech made use of seminal mRNA research from Christian Mandl, who in 2008with a team of researcherssuccessfully addressed long-standing hurdles regarding the use of mRNA molecules as vaccines.

The Mandl team successfully overcame the many challenges and discovered the novel lipid and mRNA formulations and methods for their use to raise an immune response against immunogens, GSKs filing noted, adding that the company obtained exclusive rights to the Mandl research in 2015, when it bought a substantial portion of Novartis vaccines unit.

Despite its ownership, GSK alleges that Pfizer and BioNTech knowingly used the Mandl research to develop Comirnaty. BioNTech has cited the work of Mandls team in its patent applications, while Pfizer has likewise pointed to the Mandl research in at least one of its presentations.

Pfizer and BioNTechs mRNA vaccines exploit the fundamental technologies invented by the Mandl team, GSK wrote in its lawsuit, noting that the defendants did not acquire a license to practice the GSK inventions before or since commercializing their COVID-19 shots.

As compensation for the alleged patent infringement, GSK is seeking damages including an on-going license fee as well as related attorney fees and other expenses.

A Pfizer spokesperson in a statement to Reuters said that the company is confident in our IP position around Comirnaty and that it will vigorously defend its position against GSK. BioNTech declined to provide comment.

Thursdays lawsuit adds to Pfizer and BioNTechs legal troubles surrounding Comirnaty. The partners are also locked in a patent battle with Moderna, which in August 2022 claimed infringement on certain patented mRNA technology. Modernas lawsuit focuses on the specific chemical modifications to the mRNA molecule used in Comirnaty, as well as the process of encoding the full-length spike protein contained in a lipid nanoparticle.

Pfizer and BioNTech fired back in August 2023 and asked the U.S. Patent Trademark Office for an inter partes review, claiming that some of Modernas patents were invalid for being too broad and for seeking to claim ownership of established knowledge.

Last week, the U.S District Court of Massachusetts granted Pfizer and BioNTech motion to pause Modernas lawsuit until after the resolution of the inter partes proceedings.

Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

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GSK Sues Pfizer and BioNTech Over Alleged COVID-19 Patent Infringement - BioSpace

New claim from GlaxoSmithKline is latest in litany of lawsuits against rivals | US lawsuit, potentially worth billions of dollars, is filed as UK trial kicks off between Moderna, Pfizer and BioNTech.

GlaxoSmithKline (GSK) has entered the fray of COVID-19 vaccine lawsuits with a lawsuit that could cost Pfizer and BioNTech billions of dollars.

The mammoth biopharma firm filed a lawsuit yesterday, April 25, claiming that fellow UK firm Pfizer and Germany-based BioNTech infringed five patents related to its revolutionary messenger RNA (mRNA) technology in their blockbuster COVID-19 vaccines.

GSK alleges that it began to develop mRNA vaccines in 2008more than a decade before the SARS-CoV-2 disease emerged in 2019and that the defendants Comirnaty vaccine infringe its patent rights.

Scientists and researchers working under the leadership of vaccinologist Christian Mandl, and Andrew Geall, the named inventor of the patents-in-suit, discovered formulations comprising lipids and mRNA molecules encoding a viral immunogen that provide protection from viral infection, said GSK in the 65-page complaint.

According to the District of Delaware suit, the team filed patent applications in 2010 for the five patents in suit which describe technology for delivering fragile mRNA into human cells (US patent numbers 11,638,693; 11,638,694; 11,666,534; 11,766,401; and 11,786,467.

GSK argues that the foundation of defendants technical and financial success with COVID-19 vaccines is the technology of its patented inventions.

Defendants have repeatedly touted the speed at which they produced their original COVID-19 vaccine and were later able to modify it to address new viral strains, but have consistently failed to acknowledge how they applied [its] revolutionary platform to do so.

The biopharma firm added that the defendants have reaped billions of dollars in revenue from infringing GSKs patents-in-suit and continue to benefit, without ever obtaining a licence.

mRNA lawsuits pile up

The complaint adds to the myriad high-stakes lawsuits in US and EU courts involving Pfizer and BioNTech, first brought by Moderna in August 2022.

Moderna claims that Pfizer and BioNTech infringed its patents related to mRNA innovations with their Comirnaty vaccine.

But in November, the US biotech firm suffered a setback after the European Patent Office (EPO) declared an mRNA patent held by the firm to be invalid.

And earlier this month, the defendants successfully paused the suit in the US until the resolution of two inter partes review (IPR) proceedings initiated by the Patent Trial and Appeal Board (PTAB).

In their appeal, they argued that Moderna had rewritten history to eliminate the contributions of many brilliant and dedicated scientists and place itself in the single, starring role.

The legal battle in the UK saw a trial kicked off at the High Court on Tuesday, April 23, after Pfizer and BioNTech sued Moderna in September 2022, seeking to revoke Moderna's mRNA technology.

Representing GSK is a large team from Desmarais, including John Desmarais, Todd Kraus, Amanda Potter, Karl Mullen and Alexander Walker; and Kelly Farnan and Sara Metzler at Richards, Layton & Finger.

Counsel for Pfizer and BioNTech have not yet been named.

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GSK: Pfizer, BioNTech 'reaped billions of dollars' from stealing COVID-19 patents - Life Sciences Intellectual Property Review

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Reuters

Apr 25, 2024 at 3:50 pm GMT

** Shares of vaccine makers Pfizer PFE.N and BioNTech BNTX.O fall between 2% to 3%

** Drugmaker GlaxoSmithKline GSK.L sues BNTX and PFE accusing them of infringing its patents related to messenger RNA (mRNA) technology in the companies' blockbuster COVID-19 vaccines

** GSK says that PFE and BNTX's Comirnaty vaccines violate its patent rights in mRNA-vaccine innovations developed "more than a decade before" the outbreak of the COVID-19 pandemic

** GSK also asked the Delaware federal court for an unspecified amount of monetary damages from both companies that includes an ongoing patent-licensing fee

** A Pfizer spokesperson said in a statement that the company is "confident in our IP position around Comirnaty" and intends to "vigorously defend" against GSK's claims, while a BioNTech spokesperson declined to comment

** Including session moves, PFE down 11.3% and BNTX down 18.1% YTD

Reporting by Sneha S K in Bengaluru

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Pfizer, BioNTech fall as GSK sues over 19 vaccine technology - XM

Pfizer-BioNTech

The Pfizer-BioNTech vaccine (brand name: Comirnaty) was granted full Food and Drug Administration (FDA) approval in August 2021 for people ages 16 and older. Before that, it was the first COVID vaccine to receive FDA Emergency Use Authorization (EUA) back in December 2020, after the company reported that its vaccine was highly effective at preventing symptomatic disease. This is a messenger RNA (mRNA) vaccine, which uses a relatively new technology. It must be stored in freezer-level temperatures, which can make it more difficult to distribute than some other vaccines.

Status: Pfizers vaccine has been updated over time to target new virus variants. First introduced in December 2020, the original COVID mRNA vaccines from both Pfizer and Moderna protected against the original SARS-CoV-2 virus. They were replaced in September 2022 by bivalent vaccines, which targeted both the original virus and Omicron variants BA.4 and BA.5. New updated vaccines in September 2023 replaced the bivalent shots with ones targeting the XBB lineage of the Omicron variant.

The original and bivalent vaccines are no longer in use, and it has yet to be decided whether updated shots will be administered annually, like the flu shot.

Who can get it: People 6 months and older. The CDC has specific recommendations for the following groups, noting that anyone who recently had COVID may need to consider delaying their vaccination by 3 months:

Possible side effects: Pain, redness, or swelling at the site where the shot was administered, and/or tiredness, headache, muscle pain, chills, fever, or nausea throughout the rest of the body. If these side effects occur, they should go away in a few days. A few side effects are serious, but rare. These include anaphylaxis, a severe reaction that is treatable with epinephrine (the drug in EPIPENs).

FDA warnings: The FDA added a warning label on the mRNA vaccines regarding serious (but rare) cases of inflammation of the heart muscle (myocarditis) and of the outer lining of the heart (pericarditis) in adolescents and young adults, more often occurring after the second dose of an mRNA vaccine. The inflammation, in most cases, gets better on its own without treatment.

How it works: It uses mRNA technology, which is a way of sending instructions to host cells in the body for making copies of a spike protein (like the spikes you see sticking out of the coronavirus in pictures). Our cells recognize that this protein doesnt belong, and the immune system reacts by activating immune cells and producing antibodies. This will prompt the body to recognize and attack the real SARS CoV-2 spike protein if you become exposed to the actual virus.

How well it works: The 2023-2024 updated vaccines were approved based on preclinical studies of their efficacy against the latest circulating strains. Some people may still become infected even though they have been vaccinated, but the goal of the vaccines now is to prevent severe disease, hospitalization and death. Research has suggested that people who are infected after vaccination also are less likely to report Long COVID (defined as signs, symptoms, and conditions that continue or develop after acute COVID infection), compared to those who were not vaccinated.

In its preclinical data, Pfizers updated COVID vaccine produced strong immune responses to XBB.1.5.

In its recommendations for the most recent vaccines, the CDC also cited a study showing the risk of cardiac complications, including myocarditis (an inflammation of the heart muscle), in males 12-17 years old was 1.85.6 times higher after a COVID infection compared to after COVID vaccination.

In December 2020, Pfizer-BioNTechs Phase 3 clinical data for its original vaccine showed 95% efficacy for preventing symptomatic COVID. Later data on real-world effectiveness for adults showed that the protection from the mRNA two-dose primary series waned over time, suggesting that updated vaccines would be needed to bring the immune system back to robust levels.

The FDA granted the Moderna vaccine (brand name: Spikevax) full approval for people 18 and older in January 2022, upgrading the vaccines EUA, which was granted in December 2020 (a week after Pfizer-BioNTech). Moderna uses the same mRNA technology as Pfizer-BioNTech and had a similarly high efficacy at preventing symptomatic disease when the companies applied for authorization; it also needs to be stored in freezer-level temperatures.

Status: Modernas COVID vaccine has been updated over time to target new virus variants. First introduced in December 2020, the original COVID mRNA vaccines aimed to protect against the original SARS-CoV-2 virus. They were replaced in September 2022 by bivalent vaccines designed to prevent both the original virus, and Omicron variants BA.4 and BA.5. New updated vaccines in September 2023 replaced the bivalent shots with ones targeting the XBB lineage of the Omicron variant.

The original and bivalent vaccines are no longer in use, and it has yet to be decided whether updated shots will be administered annually, like the flu shot.

Who can get it: People ages 6 months and older. The CDC has specific recommendations for the following groups, noting that anyone who recently had COVID may need to consider delaying their vaccination by 3 months:

Possible side effects: The side effects are similar to Pfizer-BioNTechs vaccine: Pain, redness, or swelling at the site where the shot was administeredand/or tiredness, headache, muscle pain, chills, fever, or nausea throughout the rest of the body. If any of these side effects occur, they should go away in a few days. A few side effects are serious, but rare. These include anaphylaxis, a severe reaction that is treatable with epinephrine (the drug in EPIPENs).

FDA warnings: The FDA placed a warning label on the Moderna vaccine regarding a likely association with reported cases of heart inflammation in young adults. This inflammation may occur in the heart muscle (myocarditis) or in the outer lining of the heart (pericarditis)it more often occurs after the second dose of an mRNA vaccine. The inflammation, in most cases, gets better on its own without treatment.

How it works: Similar to the Pfizer vaccine, this is an mRNA vaccine that sends host cells in the body instructions for making a spike protein that will train the immune system to recognize it. The immune system will then attack the spike protein the next time it sees one (attached to the actual SARS CoV-2 virus).

How well it works: The 2023-2024 updated vaccines were approved based on preclinical studies of their efficacy against the latest circulating strains. Some people may still become infected even though they have been vaccinated, but the goal of the vaccines now is to prevent severe disease, hospitalization, and death. Research has suggested that people who are infected after vaccination also are less likely to report Long COVID compared to those who were not vaccinated.

To support its 2023-2024 updated shot, Moderna shared clinical trial data that showed a strong immune response against some of the variants that are common now, including XBB.1.5, EG.5, and FL.1.5.1. Antibody responses after vaccination were about 17-times higher against XBB 1.5 and about 10-times higher against BA.2.86.

In its recommendations for the most recent vaccines, the CDC also cited a study showing the risk of cardiac complications, including myocarditis (an inflammation of the heart muscle), in males 12-17 years old was 1.85.6 times higher after a COVID infection compared to after COVID vaccination.

Modernas initial Phase 3 clinical data in December 2020 was similar to Pfizer-BioNTechsboth vaccines showed about 95% efficacy for prevention of COVID. Later data on real-world effectiveness for adults showed that the protection from the mRNA two-dose primary series wanes over time, but booster doses brought the immune system back to robust levels.

The Novavax vaccine (brand names: Nuvaxovid and Covovax) was the fourth COVID vaccine to be administered in the U.S (after Johnson & Johnson, which is no longer available). This vaccine, which is a protein adjuvant, had a 90% efficacy in its clinical trial, performing almost as well as the mRNA vaccines in their early trials. It is simpler to make than some of the other vaccines and can be stored in a refrigerator, making it easier to distribute.

Status: The FDA amended its earlier Novavax authorization to allow for a new adjuvanted 2023-2024 Novavax vaccine for ages 12 and older to target the XBB.1.5 strain in October 2023, a few weeks after the updated mRNA shots were approved. The Novavax vaccine is the only non-mRNA updated COVID vaccine available in the U.S.

The previous Novavax vaccine is no longer authorized in the U.S.

Who can get it: People 12 and older. There are specific recommendations for the following groups:

Possible side effects: Injection site tenderness, fatigue, headache, muscle pain. There were rare cases of myocarditis and pericarditis (six cases in 40,000 participants) in the clinical trial.

How well it works: Novavax has reported that its updated COVID vaccine can generate an immune response against emerging strains of the coronavirus. Earlier studies of its original vaccine showed it to be 90% effective overall against lab-confirmed, symptomatic infection and 100% effective against moderate and severe disease in Phase 3 trial results published in The New England Journal of Medicine in December 2021.

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Comparing the COVID-19 Vaccines: How Are They Different? - Yale Medicine

After cow-to-cow transmission of avian influenza A subtype H5N1 in US dairy herds led to a cow-to-human transmission in Texas, the Association of State and Territorial Health Officials convened a panel of experts for a scientific symposium on Thursday to talk about the public health implications.

"The risk to the general public remains low," said Vivien Dugan, PhD, director of the Influenza Division at the Centers for Disease Control and Prevention (CDC). And should there be an outbreak, vaccine development measures are in place, she added.

From the sequencing data, "we can expect and anticipate that [the candidate vaccine viruses] will provide good protection," she explained.

Establishing candidate vaccine viruses "are the precursor to moving into large-scale vaccine production," Dugan explained. Should that be needed, the candidate viruses can be used by manufacturers to produce new vaccines.

The CDC is also actively partnering with commercial diagnostic developers and testing companies in case there is a need to scale-up testing, Dugan said.

The only current human case in the United States was reported on April 1 and confirmed by the CDC within 24 hours, reported Sonja Olsen, PhD, associate director for preparedness and response of the Influenza Division at the CDC.

The person had direct exposure to cattle and reported eye redness, consistent with conjunctivitis, as the only symptom. The person received treatment and has recovered, and there were no reports of illness among the person's household contacts, Olsen said.

The only other detection of the virus in a human in the United States was in 2022 and it was associated with infected poultry exposure. That person also had mild illness and recovered, Olsen explained.

Since 1997, when the first case of human infection was reported globally, "there have been 909 [human cases] reported from 23 countries," Olsen said. "About half [52%] of the human cases have resulted in death." Only a small number of human cases have been reported since 2015, but since 2022, more than two dozen human cases have been reported to the World Health Organization.

Experience with the virus in the United States has been about a year behind that in Europe, said Rosemary Sifford, DVM, chief veterinary officer at the US Department of Agriculture. In the United States, the first detection in January 2022 was in wild birds; this was followed the next month by the first detection in a commercial poultry flock.

In March of this year, the United States had its first detection in cattle, specifically dairy cattle. But testing has shown that "it remains very much an avian virus. It's not becoming a bovine virus," Sifford reported.

Earlier this week, in an effort to minimize the risk of disease spread, the USDA issued a federal order that requires the reporting of positive influenza tests in livestock and mandatory testing for influenza of dairy cattle before interstate movement.

"As of today, there are affected herds in 33 farms across eight states," reported Olsen.

Tests are ongoing to determine how the virus is traveling, but "what we can say is that there's a high viral load in the milk in the cattle, and it appears that the transmission is happening mostly within the lactating herds," Sifford reported. It is unclear whether that is happening during the milking of the cows or whether contaminated milk from a cow with a high viral load is transmitting the virus to other cattle.

"We are strongly encouraging producers to limit the movement of cattle, particularly lactating cattle, as much as possible," she says.

"We haven't seen anything that would change our assessment that the commercial milk supply is safe," says Donald Prater, DVM, acting director of the Center for Food Safety and Applied Nutrition at the US Food and Drug Administration (FDA).

In the federal and state milk safety system, he explained, nearly 99% of the commercial milk supply comes from farms that participate in the Grade A program and follow the Pasteurized Milk Ordinance, which outlines pasteurization requirements.

Because detection of the virus in dairy cattle is new, there are many questions to be answered in research, he reported. Among them:

A critical question regarding the potential risk to humans is how much milk would have to be consumed for the virus to become an established infection. That information is essential to determine "what type of pasteurization criteria" are needed to provide "acceptable public health outcomes," Prater said.

The CDC is currently using the flu surveillance system to monitor for H5N1 activity in people. The systems show no current indicators of unusual influenza activity in people.

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Avian Flu Threat Still Low and Vaccine Measures Are Ready - Medscape

Immunization with inactivated vaccines while receiving the disease-modifying therapy natalizumab for highly active multiple sclerosis (MS) is safe and immunogenic, with no increased risk for disease progression, new research shows.

The study, the first to examine vaccine safety and immunogenicity in highly active MS, revealed high seroprotection rates following receipt of vaccines for COVID-19 and hepatitis A and B, regardless of the duration of treatment with natalizumab.

On the basis of these findings, investigators created an algorithm that clinicians can use to map an immunization schedule in patients who might otherwise delay initiation of disease-modifying therapy until they are fully vaccinated.

"We observed seroprotection rates exceeding 90% for hepatitis A, hepatitis B, and mRNA COVID-19 vaccines, and all vaccines demonstrated a favorable safety profile, with no exacerbation of disease activity detected," lead author Ren Carvajal, MD, of the Department of Neurology-Neuroimmunology, Multiple Sclerosis Centre of Catalonia (Cemcat), Hospital Universitari Vall d'Hebron, Universitat Autnoma de Barcelona, Barcelona, Spain, told Medscape Medical News. "This points to potential benefits for patients with highly active MS who require both immunization and high-efficacy therapies that may impact vaccine responses."

The study was published online on April 12 in JAMA Network Open.

Today's high-efficacy therapies for MS may increase the risk of acquiring new infections, reactivate latent pathogens, or worsen ongoing infectious conditions, and immunogenicity of vaccination can be compromised by immunosuppressive agents, particularly CD20 therapies, researchers note.

As a result, many clinicians opt to delay initiation of such therapies until vaccination schedules are complete to avoid exposure to vaccine-preventable infections. But delaying treatment can potentially affect disease progression.

Reports of disease worsening following vaccination "have raised controversy around vaccine safety," the authors write. The issue is especially relevant to those with highly active MS due to the scarcity of available data in this population.

The motivation for the study "stemmed from the complex balance clinicians face between initiating highly effective therapies promptly in patients with highly active MS and ensuring adequate protection against preventable infections through vaccination," Carvajal said.

Researchers analyzed data on 60 patients (mean age, 43 years; 44 female; mean disease duration, 17 years) participating in one of two prospectively followed cohorts: The Barcelona Clinically Isolated Syndromes Inception Cohort and the Barcelona Treatment Cohort. Data included demographic, clinical, radiologic, and biological data as well as regular clinical assessments, evaluations of the Expanded Disability Status Scale (EDSS), and MRI scans.

Patients enrolled in the current study had received at least one of these vaccines between September 2016 and February 2022: hepatitis A virus (HAV), hepatitis B virus (HBV; enhanced immunity high load or adjuvanted), or COVID-19 (BNT162b2 [Pfizer-BioNTech], mRAN-1273 [Moderna], or ChAdOx1-S [recombinant; AstraZeneca]).

The researchers conducted a retrospective, self-controlled analysis to compare the annualized relapse rate, EDSS score, and new T2 lesions counts during the 12 months before and after vaccination in patients with short- and long-term treatment duration.

They also compared John Cunningham virus serostatus between the two periods, as well as immunoglobulin G titers for each vaccine.

The global seroprotection rate was 93% (95% CI, 86%-98%). Individual vaccine rates were 92% for HAV, 93% for HBV, and 100% for COVID-19.

There was a significant reduction between the pre- and postvaccination periods in mean relapse rates (P= .004) and median number of new T2 lesions (P = .01).

There were no changes in EDSS scores before and after vaccinations and duration of natalizumab treatment had no impact on safety and immunogenicity.

'Viable Option'

The researchers used their findings to create a proposed algorithm to inform immunization decisions in patients with highly active MS who require prompt initiation of high-efficacy disease-modifying therapy.

The algorithm is "integrated into a risk-minimization strategy tailored for patients with highly active MS, emphasizing in this case the pivotal role of natalizumab in averting treatment delays and providing adequate protection against potentially severe infections," Carvajal said.

Participants who initiated or continued treatment with natalizumab completed their vaccination regimen without any incidents of progressive multifocal leukoencephalopathy (PML) or disease activity rebound following natalizumab discontinuation.

This suggests that using natalizumab for a brief duration might be a "viable option to contemplate," the authors noted.

Commenting on the findings for Medscape Medical News, Grace Gombolay, MD, assistant professor of pediatrics in the Division of Pediatric Neurology and director of the Pediatric Neuroimmunology and Multiple Sclerosis Clinic, Emory University, Atlanta, Georgia, said the study "demonstrates that vaccines are safe and do not trigger attacks in patients with MS on natalizumab, and that immunity as measured by antibodies is preserved in MS patients who receive natalizumab."

This "contrasts with other treatments, as decreased antibody responses in COVID-19 are noted in certain treatments," said Gombolay, who was not part of the study. "If both disease control and immunity against infection are the goals for the patient, then natalizumab is a reasonable option."

"However, this must be balanced with other considerations," she added, including the risk for PML and pregnancy.

This study was supported by grants from the European Committee for Treatment and Research in Multiple Sclerosis, Instituto de Salud Carlos III, and the European Union. Carvajal reported receiving grants from Vall d'Hebron Institut de Recerca and the European Committee for Treatment and Research in Multiple Sclerosis and honoraria from Roche, Novartis, BIIB-Colombia, Merck, and Sanofi outside the submitted work.Gombolay serves as media editor forPediatric Neurology and as associate editor of theAnnals of the Child Neurology Society. She is also a part-time CDC consultant for acute flaccid myelitis and received an honorarium as a speaker at the Georgia Neurological Society meeting, sponsored by Academic CME and TG Therapeutics.

Batya Swift Yasgur MA, LSW, is a freelance writer with a counseling practice in Teaneck, New Jersey. She is a regular contributor to numerous medical publications, including Medscape and WebMD, and is the author of several consumer-oriented health books as well as Behind the Burqa: Our Lives in Afghanistan and How We Escaped to Freedom (the memoir of two brave Afghan sisters who told her their story).

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Vaccine Safety and DMT for Highly Active MS: New Data - Medscape

The latest data from the European Centre for Disease Prevention and Control (ECDC) reveal a concerning uptick in vaccine-preventable diseases such as measles and pertussis across Europe, following decreased levels throughout the COVID-19 pandemic period. The findings were released as part of the 2024 European Immunization Week, taking place April 21-27, and emphasize a critical need for heightened vaccination campaigns to protect public health.

After a period of low activity between 2020 and 2022, the number of measles cases began increasing in 2023, persisting across several EU member states. From March 2023 to February 2024, more than 5770 measles cases were reported, with at least five deaths.

Infants younger than 1 year face the highest risk owing to their inability to receive vaccinations, relying on immunity in the community for protection. Measles, known for its high transmissibility, necessitates that at least 95% of a population receive two doses of measles-containing vaccine to halt transmission.

A surge in pertussis cases also emerged in mid-2023 across various EU/EEA countries, with preliminary data indicating a more than 10-fold increase compared with 2022 and 2021. Newborns and infants, who are vulnerable owing to incomplete vaccination, face heightened risks for severe illness and mortality. Timely administration of all recommended pertussis-containing vaccines is imperative to safeguard this group, with vaccination during pregnancy offering additional protection for young infants.

"The measles and pertussis outbreaks are just two examples [showing] that, despite the dramatic decrease in cases and mortality over the past decades, different vaccine-preventable diseases continue to circulate and still inflict suffering in those unprotected or vulnerable," cautioned Andrea Ammon, director of the ECDC, during a press conference.

Mumps: Although considered minor, the uptick in mumps cases warrants attention. In 2022, 27 EU/EEA countries collectively reported 2593 cases of mumps, marking an increase in the overall notification rate from 0.4 to 0.7 case per 100,000 population compared with 2021.

Diphtheria: This disease remains rare in EU/EEA countries, yet 2022 saw a concerning rise with 359 reported cases, which were predominantly cutaneous diphtheria. Notably, more than 60% of diphtheria cases occurred in a country different from the one in which they were notified, indicating potential challenges in surveillance and response.

Invasive meningococcal disease: In 2022, a surge in invasive meningococcal disease was recorded across all EU/EEA countries, totaling 1149 confirmed cases and resulting in 110 deaths. This marks a stark increase from 2021, in which 612 cases and 48 deaths were reported.

As outbreaks of vaccine-preventable diseases persist across EU/EEA countries, concerted efforts are imperative to pinpoint immunity gaps within the population, particularly among individuals who may have missed or postponed their vaccinations. Action is required to ensure equitable access to vaccinations, particularly among vulnerable and marginalized groups such as refugees, migrants, and asylum seekers.

The ECDC reaffirmed its commitment to bolster national vaccination programs and to uphold vaccine quality, safety, and efficacy, while striving for universal and equitable access for all.

Ammon emphasized that EIW, which takes place across Europe every year in the final week of April, serves as an opportunity to reflect on the monumental impact vaccines have had and continue to have on people worldwide and their role in overall health and well-being across all age groups. The European Region of the World Health Organization has designated "Protecting Generations" as the theme of EIW 2024, commemorating 50 years of the Essential Programme on Immunization.

"Achieving and maintaining high vaccination uptake, disease surveillance, and prompt response actions to control outbreaks remain the key actions against these diseases. Vaccines have protected many generations, and we should ensure that this continues to be the case," Ammon said.

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Vaccine-Preventable Diseases Surge: Europe Sounds the Alarm - Medscape

The Imvanex vaccine is one of two available vaccines that are used to protect against the mpox virus. Vaccines were widely used during the 2022 mpox outbreak. But currently no vaccines are available in the Democratic Republic of Congo, which has reported thousands of cases so far this year. Alain Jocard /POOL/AFP via Getty Images hide caption

The Imvanex vaccine is one of two available vaccines that are used to protect against the mpox virus. Vaccines were widely used during the 2022 mpox outbreak. But currently no vaccines are available in the Democratic Republic of Congo, which has reported thousands of cases so far this year.

In the Democratic Republic of Congo, the fight against mpox previously known as monkeypox is entering a new phase.

While many are anxious to contain the outbreak the largest mpox outbreak ever recorded in the DRC with more than 4,500 cases so far this year experts say that's not yet possible: There are no vaccines or treatments in the country right now, and even the testing capacity is severely limited. Instead, this new phase of the mpox fight involves simply getting a better understanding of what exactly is going on.

"We've been doing a lot of groundwork and building support and trying to strengthen things. And now, I hope, we're at a pivot point," says Dr. Jennifer McQuiston of the U.S. Centers for Disease Control and Prevention. "Over the next three weeks, we expect to learn a lot about what's happening on the ground."

The CDC has worked with the DRC for 15 years but has increased their efforts in response to the current mpox outbreak, as has the World Health Organization. They've helped the DRC expand its testing capacity by opening labs in some of the most affected, remote areas. The CDC has also helped fund local epidemiological teams that can provide a more granular understanding of mpox cases.

The DRC's mpox outbreak is noteworthy not only for its size but for the changing nature of the virus.

According to Africa CDC, 11 African countries have reported mpox cases but the DRC is the clear epicenter, with a caseload three times what it was this time last year. The virus, which usually jumps from a small animal to a human and then spreads between people, causes painful lesions and sometimes fever, malaise and even death.

The concern is heightened because the type of mpox circulating, called Clade I, is 10 times deadlier than the type of mpox that caused a worldwide outbreak in 2022. About 10% of Clade I cases are fatal; DRC has confirmed 311 mpox deaths this year. In addition, early evidence suggests there is a new strain of the mpox virus in the eastern part of the DRC that's circulating among sex workers and seems to be sexually transmitted. Clade I has never been known to transmit sexually.

Other countries and international organizations have been working to balance their desire for quick action against the DRC's right to address its own health plans and priorities. The nation is juggling a number of pressing health challenges, including measles, cholera and plague.

"We have work to do," says Dr. Mandy Cohen, the director of the CDC. "[We] have to work with a sovereign country. And they have a lot of health threats... And so helping them work through not just mpox but their overall response is really what we're trying to do."

Earlier this month, the Africa Centres for Disease Control and Prevention the public health agency of the African Union helped convene a high-level emergency meeting on mpox in Kinshasa, DRC. The meeting brought together hundreds of experts.

By the end of the meeting, the DRC had announced its intent to use vaccines against mpox although it still needs to approve the vaccines and draw up a strategy for delivery. In addition, the DRC said it would work quickly to approve a treatment option.

Vaccines have been used to combat mpox outbreaks in other places, including the U.S., Europe and Japan. So far, they have not been approved for use in most African nations.

One challenge is that there is very limited data on how the vaccines work in children who represent the majority of mpox cases in the DRC and also minimal data on its use in populations that deal with other health issues, like malnutrition. In March, the WHO's vaccine advisory committee recommended the off-label use of the mpox vaccine in children but urged further study.

There are also major logistical challenges to rolling out an mpox vaccination effort, given that most of the cases are in remote areas and parts of the country face violent unrest. Now that the DRC has declared its intent to use two types of mpox vaccines, its National Regulatory Authority is meeting for a vaccine assessment. While mpox vaccines are likely months away, these steps are being heralded as progress as is the country's acknowledgement of the scale of the concern.

"This situation constitutes a public health emergency," said Samuel-Roger Kamba, the Minister of Health in the DRC, speaking in French at the Africa CDC meeting's closing ceremony. "The Democratic Republic of Congo remains very concerned by the scale and severity of the mpox epidemic which is raging in 23 of the country's 26 provinces."

Nicaise Ndembi, a virologist and senior adviser to the director-general of the Africa CDC, says that, so far, that speech has not been followed by an official declaration of a health emergency. "Meetings are meetings, right? Except if we really take action," he tells NPR.

Ndembi says there are a lot of considerations that come into play before an official declaration can be issued. Many countries vividly and bitterly remember how travelers from numerous African countries were banned after Botswana and South Africa shared news about the discovery of Omicron, which was then a new strain of COVID. These bans cost the countries economically and drew criticism since simultaneous cases in Europe did not receive the same response. "So, it's very sensitive," he says.

Nonetheless, Ndembi says his instinct is that the scientific evidence merits a health emergency, particularly because the DRC borders nine countries and the virus could spread through travelers as it did in 2022.

"I would say: Declare! Because, by declaring, you have access to the drugs, you have access to the vaccines. We don't need to go through all the approval processes. And that will open the door for international support to mobilize resources," he says.

But in the interim, there are steps that can be taken, including disease surveillance, emergency response communication, infection prevention control and improved clinical care, even without mpox treatments in the country, says Dr. Rosamund Lewis, the WHO's technical lead and emergency manager for mpox.

"Small children [with mpox] can become dehydrated very quickly. When you have enlarged lymph nodes in the neck and sores in the mouth, children can't eat or drink. So without access to rehydration methods, nasogastric tubes, intravenous [fluids] if needed without basic medical care that you would take for granted anywhere else the children have a very high risk of severe disease and death, which we're seeing in the data," explains Lewis.

"Our responsibility, as a global community, is to support and accompany the DRC in their actions," she says.

"I will remind everyone that in two and a half, three years of mpox response, there hasn't been a single penny of donor money invested at a global level for controlling mpox," adds Dr. Michael Ryan, executive director of the WHO's Health Emergencies Programme. "So while the concerns of the world are very well known, I don't see the concerns of the world reflected in the investment of resources needed to actually contain this virus."

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Mpox outbreak in DRC raises global concerns. Where are the vaccines? : Goats and Soda - NPR