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US FDA approves use of Sanofi's meningococcal vaccine in infants
US FDA approves use of Sanofi's meningococcal vaccine in infants

The Hindu

time27-05-2025

  • 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.

FDA approves GSK vaccine to combat meningococcal infections
FDA approves GSK vaccine to combat meningococcal infections

South China Morning Post

time15-02-2025

  • 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.

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