FDA clears vaccine to prevent whooping cough in newborns by giving shot to mother during pregnancy

The Food and Drug Administration on Friday approved a vaccine for use in the third trimester of pregnancy to prevent whooping cough in newborn infants.

The vaccine, called Boostrix, is made by GlaxoSmithKline. It is the first vaccine the FDA has approved to prevent a disease in young infants by giving the shot to their mothers during pregnancy, said Dr. Peter Marks, the agency’s chief vaccine official.

The vaccine, which is administered as a single dose, was 78% effective in preventing whooping cough in newborns when given to mothers during the third trimester, according to data evaluated by the FDA. No side effects on the pregnancy, fetus or newborn were observed.

The most common side effects for people who receive the vaccine are pain at the injection site, headache and fatigue.

Pertussis, more commonly known as whooping cough, is a highly contagious respiratory disease that can lead to serious health complications in babies. Infants younger than two months are not old enough to receive protection through the normal childhood vaccination series for the disease.

The vaccine allows mothers to protect their newborns by getting the shot while they are pregnant. While whooping cough can affect all age groups, most cases of hospitalization and death occur infants younger than two months old, according to FDA.

The FDA had previously approved Boostrix for use during pregnancy to protect the mother against disease, but had not cleared it specifically to prevent whooping cough in newborns. The vaccine was first approved in 2005 to protect people ages 10 to 18 years old against whooping cough and then later for everyone ages 19 and older.