October 10, 2022 — The FDA has approved a vaccine that women can take during their third trimester of pregnancy to prevent whooping cough, better known as whooping cough, in infants under two months old.
This is the first time the FDA has approved a vaccine to prevent disease in infants that is given to their mothers during pregnancy, Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. Press release.
“Babies are most at risk of pertussis and serious complications. Although vaccination is the best method of protection, infants under two months of age are too young to be protected by the childhood pertussis vaccine series,” Marks said.
The vaccine is called Boostrix and is produced by GlaxoSmithKline. It is given in a single injection and stimulates antibodies in the mother that are transferred to the fetus, the FDA said. The vaccine produced no adverse effects on the mother, fetus or newborn in clinical trials, the FDA said.
Citing the CDC, the FDA said 4.2% of pertussis cases reported in the United States in 2021 were in infants younger than 6 months, with about 31% requiring hospitalization.
Since 2010, up to 20 babies die each year from whooping cough, the CDC said. Between 10,000 and 50,000 cases of whooping cough have been reported each year since 2010, according to the CDC.
The FDA previously approved Boostrix to protect pregnant women from whooping cough. The FDA approved Boostrix in 2005 for people ages 10 to 18 and later approved the vaccine for people 18 and older.
Whooping cough usually begins with cold symptoms, but then leads to severe coughing spells, which can last for several weeks or even months.