Latest news with #Menveo
The Hindu
27-05-2025
- Health
- The Hindu
US FDA approves use of Sanofi's meningococcal vaccine in infants
French drugmaker Sanofi said the U.S. Food and Drug Administration has approved its meningococcal vaccine for use in infants as young as six weeks, making it the first shot intended for the age group. The vaccine, branded as MenQuadfi, is already approved for individuals aged two years and older to protect against the four most common strains of meningococcal bacteria - A, C, W and Y, the company said on 23 May 2025. Meningococcal infections, caused by the Neisseria meningitidis bacteria, can cause serious, sometimes deadly, bloodstream infections, as well as severe swelling in the brain and spinal cord. British drugmaker GSK's shot Menveo is approved in children as young as two months and adults up to 55 years of age. "I think for convenience factor and accessibility... it is nice to have options," said Patty Sabey, a paediatrician with Stanford Medicine Children's Health, ahead of the decision. The approval was based on data from three late-stage studies involving more than 6,000 participants aged six weeks to 19 months, which showed that MenQuadfi was as effective as Menveo when co-administered with other routine paediatric vaccines. Sabey said meningococcal vaccine is not a routine vaccine for infants in the U.S. even though young infants, especially under one year, are at higher risk of infection. The U.S. Centers for Disease Control and Prevention currently recommends all adolescents aged 11 to 12 years should receive a meningococcal vaccine, followed by a booster dose at age 16 years. The agency also recommends that individuals aged two months and older who are at increased risk of the disease should receive the vaccine. According to preliminary data from the CDC, 503 confirmed and probable cases of meningococcal disease were reported last year, the highest since 2013.
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.
