Third Trimester Whooping Cough Vaccine Approved

The U.S. Food and Drug Administration (FDA) recently Approved the Boostrix vaccine for immunization during the third trimester of pregnancy to prevent pertussis. When the Boostrix vaccine is given during pregnancy, it boosts antibodies in the mother, which are transferred to the developing baby.

The FDA's approval of GlaxoSmithKline Biologicals' Boostrix vaccine (0.5-mL dose) has always included its use during pregnancy to protect the vaccinated individual. 

Today's approval is specific to use in pregnancy to prevent pertussis (whooping cough) in infants younger than two months.

According to the U.S. Centers for Disease Control and Prevention, 4.2% of pertussis cases reported in the USA in 2021 were in infants younger than six months of age, often requiring hospitalization.

"Pertussis disease is a highly contagious respiratory illness affecting all age groups. However, babies are at the highest risk for getting pertussis and having serious complications from it," said Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research, in a press release issued on October 7, 2022.

"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."

"This is the first vaccine approved specifically for use during pregnancy to prevent disease in young infants whose mothers are vaccinated during pregnancy." 

Boostrix was initially approved by the FDA in 2005 as a single dose for booster immunization against tetanus, diphtheria, and pertussis in individuals 10 through 18 years of age.

Subsequently, the FDA also approved Boostrix to include use in individuals 19 years of age and older and an additional dose nine years or more after the initial dose of a Tdap vaccine.

Since 2012, the CDC has recommended using Tdap vaccines during the third trimester of each pregnancy.

Note: This FDA announcement was manually curtaed for mobile ridership and is not paid content.