FDA approves third-trimester vaccine to prevent pertussis in infants younger than 2 months
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The FDA announced it approved a vaccine administered during the third trimester of pregnancy to prevent pertussis — whooping cough — in infants younger than 2 months of age.
When the vaccine (Boostrix, GlaxoSmithKline Biologicals) is administered, it boosts antibodies in the pregnant mother, which are transferred to the developing baby, according to a press release from the FDA.
“Pertussis disease is a highly contagious respiratory illness affecting all age groups. However, babies are at highest risk for getting pertussis and having serious complications from it,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in the release. “While vaccination is the best method for providing protection, infants younger than 2 months of age are too young to be protected by the childhood pertussis vaccine series. This is the first vaccine approved specifically for use during pregnancy to prevent a disease in young infants whose mothers are vaccinated during pregnancy.”
The vaccine was previously approved by the FDA in 2005 as a single dose Tdap booster immunization against tetanus, diphtheria and pertussis for individuals aged 10 to 18 years. Since 2012, the CDC has recommended the use of Tdap vaccines during the third trimester of each pregnancy, according to the release.
The approval is based on real-world data from 108 cases of pertussis in infants younger than 2 months of age and 183 control infants without pertussis in which researchers observed 78% rate of effectiveness in preventing pertussis when administered during the third trimester of pregnancy.
Another prior trial did not identify any vaccine-related adverse effects on pregnancy or on the fetus/newborn, according to the release.
The most common side effects included pain, redness at the injection site, headache, fatigue and gastrointestinal symptoms.
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