Oct. 10, 2022 — The FDA has approved a vaccine that women can take in their third trimester of pregnancy to prevent pertussis, better known as whooping cough, in infants younger than two months.
This is the first time the FDA has approved a vaccine to prevent a 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 news release.
“Babies are at highest risk for getting pertussis and having serious complications from it. While vaccination is the best method for providing protection, infants younger than 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’s given in a single shot and boosts antibodies in the mother which are transferred to the fetus, the FDA said. The vaccine produced no side effects on the mother, fetus, or newborn during 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 have died yearly from whooping cough, the CDC said. Between 10,000 and 50,000 to whooping cough cases have been reported yearly since 2010, the CDC said.
The FDA has previously approved Boostrix to protect pregnant women from whooping cough. The FDA approved Boostrix in 2005 for people 10-18 years old and later approved the vaccine for people 18 and older.
Whooping cough usually starts with cold symptoms but then leads to severe coughing spells, which can last for many weeks or even months.
