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Euronews
22-05-2025
- Health
- Euronews
Why the UK is offering vaccines for gonorrhoea – and the EU isn't
In a world first, the United Kingdom is rolling out a vaccine to prevent gonorrhoea – but it is not likely to reach patients in mainland Europe anytime soon. The jab will be offered through the UK's National Health Service to people in England at high risk of contracting gonorrhoea, after a vaccine advisory committee concluded in 2023 that it could help reduce the country's surge of sexually transmitted infections (STIs). In studies, the vaccine was between 32.7 per cent and 42 per cent effective against gonorrhoea, the advisory group found. That means the jab could help reduce, but not completely eliminate, the risk of infection. The vaccine, known as 4CMenB and sold by GSK as Bexsero, was not originally created with gonorrhoea in mind. It's been authorised for more than a decade in both the UK and the European Union to prevent meningococcal disease, which causes meningitis and bloodstream infections. The UK has recommended that babies receive the vaccine since 2015, with Ireland, Italy, Portugal, France, and Germany later following suit. Uptake has been spotty elsewhere in the EU. The bacteria that cause meningococcal disease and gonorrhoea are closely genetically related. Real-world data from New Zealand and elsewhere indicate that the 4CMenB jab could be particularly effective against gonorrhoea, though a randomised trial in France concluded that it was not effective. The vaccine hasn't been approved to prevent gonorrhoea in the UK, meaning the NHS programme will offer it for off-label use. Beginning in August, gay and bisexual men who have a recent STI or history of multiple sexual partners will be eligible for immunisation, in the hopes of slowing the bacteria's spread. England saw 85,000 new gonorrhoea cases in 2023, the highest level since records began in 1918, the NHS said. The vaccine 'has the potential to help us to turn that around,' Matt Phillips, president of the British Association for Sexual Health and HIV, said in a statement. But other Europeans won't have access to the jab. The EU's scientific advisory group is not considering whether it should be authorised to prevent gonorrhoea, and a GSK spokesperson told Euronews Health that the drugmaker is not in talks with regulators to change that. Meanwhile, health authorities in France and Italy told Euronews Health that the jab is not on their agendas, and a German representative pointed to a review that found mixed results on the efficacy of the vaccine to prevent gonorrhoea. The Norwegian public health agency noted that the vaccine offers 'some protection' against gonorrhoea, but it stopped short of endorsing the jab. Gonorrhoea is one of the most common STIs, with nearly 97,000 confirmed cases in 28 European countries in 2023 – up 31 per cent from the year before, according to the European Centre for Disease Prevention and Control (ECDC). Cases have been rising among all age groups and among both women and men, with men who have sex with men accounting for 58 per cent of cases in 2023. Gonorrhoea can cause burning during urination, discharge from the genitals, and pain in the lower abdomen or testicles. It can lead to serious health issues if left untreated, such as pelvic inflammatory disease in women. Symptoms typically appear two weeks after infection, but many people don't have symptoms and can unknowingly spread gonorrhoea to their sexual partners. Gonorrhoea can be treated with antibiotics, though the surge of cases in recent years raises the risk that people will be infected with drug-resistant strains that are harder to treat. That's one problem the UK is hoping to address with the new vaccination programme, according to Dr Sema Mandal, deputy director of the UK Health Security Agency. 'This vaccination programme is a hugely welcome intervention at a time when we're seeing very concerning levels of gonorrhoea, including antibiotic resistant gonorrhoea,' Mandal said in a statement. A startup in France is leveraging artificial intelligence-backed physics principles in the hope of speeding up the process of making new drugs. Currently, developing a new medicine takes a company 10 to 15 years on average, with research conducted in a lab environment – and a lot of trial and error before they enter multiple stages of human clinical trials. It's also an expensive process, with only 10 to 20 per cent of experimental drugs in clinical trials eventually being approved. Those are problems the France-based Aqemia is trying to solve. The company, founded in 2019 by quantum physics researcher Maximilien Levesque and Emmanuelle Martiano, a former consultant for Boston Consulting Group, aims to use artificial intelligence (AI) to more efficiently create new molecules for drugs that treat cancers of the head, neck, and chest, such as lung cancer. It wants to "develop medicine faster in a frugal and accurate way," Dr Véronique Birault, Aqemia's vice president of translational sciences, told Euronews Health at the company's new London hub, which opened in January. To do so, Aqemia is using both AI and fundamental physics, which Levesque worked on during his academic career. Many healthcare companies are turning to AI tools in the drug discovery process, but they usually need to be trained on a large corpus of data – which doesn't always exist for these new molecules, according to Levesque. For example, "there aren't billions and billions and billions of drugs for chest cancer" that the AI models could be trained on, Levesque told Euronews Health. Instead of feeding their AI model with raw data, the team feeds it the rules of physics at the level of atoms and molecules tied to specific diseases. That includes a mathematical equation that Levesque solved, which the team says can be leveraged to identify "better molecules" that are "more effective". "It's as if, rather than swallowing lists of numbers, you had a maths teacher teaching you how to count," Levesque added. Aqemia isn't the only company betting on AI for drug discovery. Worldwide, 10 major pharmaceutical companies have signed more than 130 deals for AI collaborations since 2021. AI models can quickly analyse datasets to uncover patterns, helping scientists predict which molecules are linked to certain diseases and identifying promising drug candidates for new drugs or treatments. To some extent, they can also help forecast how people will respond to new drugs. For example, Google's AlphaFold system – which won the Nobel Prize in Chemistry in 2024 – uses AI to predict a protein's 3D structure and how it will interact with other molecules. Aqemia has signed partnerships with pharmaceutical giants like Sanofi, Servier, and Johnson & Johnson to research potential new drugs, Levesque said. But he cautioned that even as the company works on speeding up the molecular development phase, it can't influence the clinical development stage, which takes an average of nine years. Some research indicates that may also be changing. A handful of AI-discovered molecules are in early stage trials, with cancer-related drugs making up about half of those in phase one and phase two studies. Aqemia could be part of the next wave. "Our internal programmes are progressing and we already have programmes showing efficacy and non-toxicity on mice with cancer," he said. The company hopes to launch clinical trials testing new molecules in late 2026 or early 2027.
Yahoo
18-02-2025
- Health
- Yahoo
GSK's 5-in-1 meningococcal shot wins FDA approval
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. The Food and Drug Administration on Saturday gave a green light to a new meningococcal vaccine from GSK. Dubbed Penmenvy, the '5-in-1' shot is approved for people aged 10 through 25 years old and targets the five most common types of bacteria that cause invasive meningococcal disease, which can lead to life-threatening complications. Penmenvy combines components of GSK's existing shots Bexsero and Menveo. By simplifying immunization, it could help boost vaccination rates, which have remained low due to a complex vaccine schedule. 'Any new opportunity to increase access to what is just so critical to individual and public health, is a good thing,' said Julie Howard, a clinical advisor at the pharmaceutical consulting firm MMIT. Invasive meningococcal disease is a serious illness involving infection of the spinal cord and brain, which can lead to swelling. Even with treatment, bacterial meningitis can be fatal; about 1 in 6 people who contract invasive meningococcal disease die. The disease can affect people of all ages. The bacterium called neisseria meningitidis is the leading cause of meningococcal disease. The five strains circulating in the U.S. are known by their serogroup: A, B, C, W, and Y. The CDC recommends children aged 11 or 12 receive a 'MenACWY' vaccine, followed by a booster dose at age 16. The agency also urges people discuss MenB vaccination with their physician, but recommends vaccination for anyone ages 10 years or older who are at an increased risk of the disease. In 2023, drugmaker Pfizer received an FDA OK for a shot dubbed Penbraya, which, like Penmenvy, covers five serotypes. However, the CDC says full coverage against MenB must include a dose of Pfizer's other vaccine Trumenba in children aged 16 and older. Howard said GSK's single pentavalent shot is logistically simpler than the two-dose scheduled required of Pfizer's. The two companies already compete against each other in other markets. Both gained approval in 2023 for RSV vaccines in older adults. GSK has kept majority market share since then, although Pfizer has recently made some headway. But sales of RSV vaccines broadly have dropped after the CDC narrowed its recommendation guidelines. A key panel advising the CDC on vaccines is set to meet later this month and is scheduled to discuss GSK's shot as well as potential updates to dosing and schedules. Vaccine schedules — and any changes to them — will be under the microscope now that Robert F. Kennedy Jr., a prominent vaccine critic, is confirmed as head of the Department of Health and Human Services. Kennedy has for decades promoted vaccine misinformation, claiming they cause more harm than good, and lead to autism in children. He also founded and previously chaired an anti-vaccine group called Children's Health Defense. At the pandemic's height, Kennedy pressed for the FDA to revoke authorization of COVID-19 vaccines. While he's said he won't take away anyone's vaccines, he will hold substantial influence over their regulation as HHS secretary. For example, he could change the federal Vaccines for Children program, which covers vaccines for children whose families cannot afford them. Vaccines protecting against meningococcal disease, measles and human papillomavirus, among others, are covered by the program. Kennedy has previously criticized meningococcal vaccine requirements.
South China Morning Post
15-02-2025
- Health
- South China Morning Post
FDA approves GSK vaccine to combat meningococcal infections
The US Food and Drug Administration (FDA) approved British drug maker GSK's combination vaccine to protect against meningococcal infection for use in people aged 10 through 25 years, the company said on Saturday. Meningococcal infections, caused by bacteria called Neisseria meningitidis, can lead to severe, sometimes deadly, bloodstream infections as well as severe swelling in the brain and spinal cord. The vaccine, called Penmenvy, combines the immune response-generating components of two of the company's approved vaccines, Bexsero and Menveo, to protect against the five most common strains of meningococcal bacteria, according to a GSK statement. In 2023, there were 438 confirmed and probable cases of meningococcal disease reported in the United States, according to the US Centres for Disease Control and Prevention (CDC). Cases of meningococcal disease have increased sharply since 2021, now exceeding pre-pandemic levels in the US, according to the CDC. 'Having a combined vaccine which will offer these vaccines in one injection can simplify the vaccination, which can help improve vaccination rate,' said Patty Sabey, a paediatrician with Stanford Medicine Children's Health.
