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.