Signs are seen outside the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, August 29, 2020.
Andrew Kelly | Reuters
The Food and Drug Administration on Friday approved a vaccine for use in the third trimester of pregnancy to prevent whooping cough in newborns.
The vaccine, called Boostrix, is made by GlaxoSmithKline. It’s the first syringe the FDA has approved for use during pregnancy to prevent illness in young infants from their mothers’ needles, said Dr. Peter Marks, the agency’s senior vaccine officer.
The vaccine, which is given as a single dose, was 78% effective in preventing whooping cough in newborns when given to mothers in the third trimester, according to data evaluated by the FDA. No side effects on the pregnancy, the fetus or the newborn have been observed.
The most common side effects in people receiving the vaccine are injection site pain, headache and tiredness.
Pertussis, better known as whooping cough, is a highly contagious respiratory disease that can cause serious health complications in babies. Infants younger than two months are not old enough to be protected against the disease by the normal childhood vaccine series.
The new vaccine will allow mothers to protect their newborns by getting vaccinated during pregnancy. While whooping cough can affect all ages, most cases of hospitalization and death occur in infants younger than two months, according to the FDA.
The FDA had previously approved Boostrix for use during pregnancy to protect the mother from disease, but had not specifically approved it to prevent whooping cough in newborns. The vaccine was first approved in 2005 to protect against whooping cough in people aged 10 to 18, and later for everyone aged 19 and over.
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