FDA approves Tdap vaccine for prenatal pertussis prevention

The U.S. Food and Drug Administration announced approval of the first vaccine to be delivered to an unborn baby by a pregnant mother to provide protection during the first two months of life.

The tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine Boostrix will be given in the third trimester to provide antibodies to the developing baby. Approval is based on Boostrix’s estimate of 78% effectiveness in preventing pertussis in infants under 2 months of age in this setting.

“While vaccination is the best way to provide protection, two younger infants, Peter Marks, MD, of the FDA’s Center for Biologics Evaluation and Research, said in a news release that two Month-olds are too young to be protected by the childhood pertussis vaccine series. “This is the first vaccine specifically approved for use during pregnancy to prevent disease in young infants whose mothers are vaccinated during pregnancy. “

The FDA cites data from the CDC showing that infants younger than 6 months account for 4.2 percent of pertussis infections in 2021. In nearly one-third of cases, these infants require hospitalization.

“Pertussis is a highly contagious respiratory disease that affects all age groups. However, infants are at the highest risk of developing whooping cough and serious complications from it,” Marks said.

Boostrix’s 78% effectiveness was calculated based on a real-world study , which compared the age of 108 infants with pertussis before 2 months (including 4 mothers who received Boostrix in their third trimester) and 183 infants without pertussis (18 mothers who received Boostrix in their third trimester).

There were no excessive adverse effects on pregnancy or the baby and was associated with prenatal Tdap vaccination in a randomized, placebo-controlled study. According to the FDA, the most commonly reported Side effects were pain, injection site redness, headache, fatigue, and gastrointestinal symptoms.

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  Ingrid Hein is a staff writer for Medicine Today covering infectious diseases. For over a decade, she has been a A medical reporter. Follow