Meningococcal group B vaccine(Pfizer Inc.)

The Food and Drug Administration on Friday 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 GSKs 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 Pfizers other vaccine Trumenba in children aged 16 and older.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 GSKs 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 Childrens Health Defense. At the pandemics height, Kennedy pressed for the FDA to revoke authorization of COVID-19 vaccines.While hes said he wont take away anyones 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.Correction: A prior version of this story included a line that incorrectly described the dosing regimen required to complete Meningococcal B vaccination. '

GSK’s five-in-one meningococcal vaccine Penmenvy has been approved by the US Food and Drug Administration (FDA) for use in individuals aged from ten to 25 years. Invasive meningococcal disease (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 and hearing loss. 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. GSK’s Penmenvy combines the antigenic components of its approved Bexsero and Menveo meningococcal vaccines to target five common IMD-causing serotypes (A, B, C, W and Y). It is hoped that the combination vaccine will simplify meningococcal delivery and lead to higher vaccine uptake. The FDA’s decision was supported by positive results from two late-stage trials, which evaluated Penmenvy’s safety, tolerability and immune response in over 4,800 people aged ten to 25 years. GSK’s chief scientific officer, Tony Wood, said the company is “excited about the opportunities ahead to help improve meningococcal vaccination coverage in the US, especially for IMD caused by serogroup B”. Also commenting on the approval, Judy Klein, president and founder of Unity Consortium, a non-profit organisation focused on adolescent health and immunisation in the US, said: “The consequences of IMD can be devastating for those who contract it, for their families and friends”. She continued: “Pentavalent menABCWY vaccines could help address the disease by providing protection against the five vaccine-preventable serogroups in one vaccine and making it easier for adolescents to get the coverage they need.” The authorisation follows the FDA’s approval of Pfizer’s pentavalent meningococcal vaccine in October 2023. Like Penmenvy, Penbraya combines the components from Pfizer’s Trumenba and Nimenrix meningococcal vaccines to protect against serotypes A,B, C, W and Y. The US Centers for Disease Control and Prevention, which has noted that combining vaccines may mean that more adolescents and young adults get their recommended vaccines on time, will now meet to discuss recommendations for the appropriate use of Penmenvy.