Meningococcal group A, C, W-135 and Y conjugate vaccine(Novartis Pharma AG)

Bengaluru: 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 Friday. 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 Dr. Patty Sabey, a pediatrician 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 pediatric 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. (Reporting by Siddhi Mahatole and Mariam Sunny in Bengaluru; Editing by Sriraj Kalluvila and Leroy Leo)

GSK’s five-in-one meningococcal vaccine has been recommended by the US Centers for Disease Control and Prevention’s (CDC) immunisation panel as part of the adolescent meningococcal vaccination schedule. Penmenvy combines the antigenic components of GSK’s approved Bexsero and Menveo meningococcal vaccines to target five common invasive meningococcal disease (IMD)-causing serotypes (A, B, C, W and Y). The Advisory Committee on Immunization Practices (ACIP) has recommended that individuals aged over ten years be given a single dose of Penmenvy as an alternative to the separate administration of MenACWY and MenB vaccinations when both vaccines would be given in the same visit, typically at age 16. It is hoped that this will simplify meningococcal vaccine delivery and lead to higher uptake. The CDC will now review ACIP’s recommendation as it makes a final decision on Penmenvy. 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. Babies, young children and those who are in their late teens and early adulthood are among those at the highest risk. GSK’s chief scientific officer, Tony Wood, said: “We welcome this positive recommendation that can help strengthen disease prevention efforts in the US. “Pentavalent vaccines can reduce the number of injections required to help protect against invasive meningococcal disease – especially disease caused by serogroup B. Their use could improve immunisation rates among adolescents and young adults in the US, who are at an age with increased risk.” The recommendation comes just two months after the US Food and Drug Administration (FDA) approved Penmenvy for use in individuals aged from ten to 25 years. The regulator’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 in this age population. Judy Klein, president and founder of Unity Consortium, a non-profit organisation focused on adolescent health and immunisation in the US, welcomed the FDA’s decision: “The consequences of IMD can be devastating for those who contract it, for their families and friends… 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.”