A vaccination to prevent pertussis, more often known as whooping cough, in infants under two months of age has been approved by the FDA for use by pregnant women during their third trimester of pregnancy.
Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, stated in a news release that this is the first time the FDA has approved a vaccination to prevent a disease in infants that is given to their mothers during pregnancy.
“Babies are most likely to contract pertussis and experience major side effects from it. Although immunisation is the most effective means of prevention, infants under two months of age cannot receive the paediatric pertussis vaccine series, according to Marks.
The vaccine is made by GlaxoSmithKline and is known as Boostrix. According to the FDA, it is administered as a single shot and increases maternal antibodies that are passed on to the foetus. During clinical studies, the vaccination had no negative effects on the mother, foetus, or baby, according to the FDA.
The FDA said that, according to the CDC, 4.2% of pertussis cases recorded in the US in 2021 involved infants less than 6 months, with around 31% of those cases necessitating hospitalisation.
According to the CDC, whooping cough has been responsible for up to 20 infant deaths annually since 2010. Since 2010, between 10,000 and 50,000 cases of whooping cough have been documented year, according to the CDC.
Boostrix has previously been given FDA approval to shield expectant mothers from whooping cough. In 2005, the FDA approved Boostrix for use in children aged 10 to 18, and in 2007 it was approved for use in adults.
Cold symptoms typically precede whooping cough, which then causes violent coughing fits that can endure for weeks or even months.