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US FDA approves use of Sanofi's meningococcal vaccine in infants
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US FDA approves use of Sanofi's meningococcal vaccine in infants
May 27, 2025 4:51 AM

By Mariam Sunny and Siddhi Mahatole

May 27 (Reuters) - 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.

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