Meningococcal group B vaccine(GlaxoSmithKline Biologicals SA)

GSK’s fully liquid presentation of its meningococcal vaccine Menveo has been approved by the European Commission (EC) to protect individuals aged two years and older against invasive meningococcal disease (IMD). The single-vial presentation is designed to simplify the vaccination process by offering healthcare providers an option that does not require reconstitution before use. IMD is an uncommon but serious illness caused by the bacterium Neisseria meningitidis. It is a major cause of meningitis and septicaemia, and can result in long-term consequences such as neurological damage, amputations, hearing loss and nervous system problems. Although anyone can contract IMD, babies, young children and those who are in their late teens and early adulthood are among those at the highest risk. Menveo is designed to help protect IMD caused by bacterial groups A, C, W, and Y and has already been approved in the EU as a powder and solution that are mixed together to make a solution for injection. The EU regulator’s decision on the new presentation follows a recent recommendation from the European Medicines Agency’s human medicines committee and was supported by positive results from two phase 2b trials, which showed that the fully liquid form of the vaccine had comparable immunogenicity, tolerability and a comparable safety profile to the existing formulation. The original presentation of Menveo, which is also approved for use in individuals aged from two years, is unaffected by the approval. Philip Dormitzer, head of global vaccines research and development at GSK said the company is “dedicated to finding innovative solutions that simplify immunisation and support vaccine uptake”. “We remain committed to safeguarding individuals from bacterial meningitis, and we will persist in our efforts to prevent this devastating disease among at-risk populations in the EU,” he said. GSK also has an investigational five-in-one meningococcal vaccine in its pipeline which combines the antigenic components of Menveo and its approved meningococcal group B vaccine Bexsero. The candidate, MenABCWY, was accepted for regulatory review by the US Food and Drug Administration in April, following positive results from a phase 3 trial involving individuals aged ten to 25 years.

Vaccines are available as part of the UK routine immunisation schedule to prevent some types of meningitis. Credit: Billion Photos via Shutterstock. New data from the UK Health Security Agency (UKHSA) indicates significant progress in combating meningitis caused by meningococcal group C (MenC), with cases falling by 99% since the introduction of a routine vaccination programme in 1999. Between July 2023 and June 2024, only three MenC cases were recorded. Other meningococcal strains, including groups A, W, and Y, also remain at low levels due to widespread immunisation. However, meningococcal group B (MenB)—responsible for the majority of meningitis and septicaemia cases in the UK—continues to be a public health concern. Meningitis is the inflammation of the tissues surrounding the brain and spinal cord. It can be fatal and requires immediate medical care. Of the 341 confirmed cases of meningococcal disease reported in England over the last year, 88% (301 cases) were caused by MenB. Despite the availability of a vaccine, uptake has been declining. In 2022-2023, 91% of children received the first two doses of the MenB vaccine, down by 0.5% from the previous year while booster coverage fell to 87.6%. Adolescent vaccination rates also show room for improvement. The MenACWY vaccine, which targets groups A, C, W, and Y, saw uptake rates of 68.6% in year nine and 73.4% in year ten. Dr Shamez Ladhani, a consultant epidemiologist at UKHSA, cautioned that while progress against MenC is promising, continued vigilance is needed. “Thanks to the power of vaccines, we are now on the brink of defeating meningococcal C disease in the UK, but the fight against these deadly diseases that cause meningitis and septicaemia continues with meningococcal B still causing most of the 341 cases last year,” Ladhani said. The UK’s meningitis vaccination schedule includes the Hib/MenC vaccine, administered to children at one year of age, and the MenB vaccine, given at eight weeks, 16 weeks, and one year. Teenagers receive the MenACWY vaccine in school years nine and ten. The MenB vaccine, marketed as Bexsero, is produced by GSK while the MenC vaccine component is part of a combination vaccine developed by Pfizer . Both vaccines have contributed significantly to reducing meningococcal disease cases in the UK. The success in reducing MenC cases demonstrates the effectiveness of vaccination programmes, but the challenges with MenB mirror issues seen globally. Epidemics of meningitis are seen across the world, particularly in sub-Saharan Africa, and vaccine hesitancy and logistical barriers remain significant obstacles to achieving higher coverage rates.