FDA Approves Tdap Vaccine for Pregnant Mothers to Prevent Pertussis in Young Infants


The agency licensed the new indication for Sanofi’s Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed [Tdap]) shot for immunization during the third trimester of pregnancy.


This week, the FDA approved the ADACEL (Tdap) vaccine in pregnant mothers to prevent pertussis (whooping cough) in infants younger than two months of age—which offers protection for the neonates before their recommended age of the first dose of the vaccine (at two months of age.)

The vaccine is manufactured by Sanofi Pasteur, and on their website they point to studies that have validated the benefit of the vaccine in this population. “Tdap vaccination in pregnancy reduces the risk of pertussis infection by approximately 90% in a newborn’s first two months of life and reduces pertussis-related deaths by 95% in infants of vaccinated mothers.”1

With this most recent approval, the vaccine is indicated for the following:

  • active booster immunization against tetanus, diphtheria and pertussis. Adacel is approved for use in persons 10 through 64 years of age.
  • immunization during the third trimester of pregnancy to prevent pertussis in infants younger than 2 months of age.

The vaccine can be administered to pregnant mothers who are in their third trimester and it is administered as a single, intramuscular injection shot.

According to the Centers for Disease Control and Prevention (CDC), pertussis start like a common cold, but differs in that patients can develop a cough that can last for weeks or months. Pertussis symptoms of whooping cough usually develop within 5 to 10 days after you come into contact with the bacteria that cause it. Sometimes symptoms do not develop for as long as 3 weeks.

This respiratory virus can be more severe for infants compared to teens and adults who develop pertussis.

“Many babies with whooping cough don’t cough at all,” the CDC wrote on its site. “Instead it may cause apnea and turn blue or struggle to breathe. It may seem like a common cold for the entire illness, not just the beginning.”

CDC estimates there are 24.1 million cases of pertussis and about 160,700 deaths worldwide per year. The agency also says on its website that it is highly contagious, and the infection can transmitted to infants from family members. And 80% of pertussis-related deaths occur in infants younger than three months old, the CDC reports.


1. Amirthalingam G, Campbell H, Ribeiro S et al. Sustained effectiveness of the maternal pertussis immunization program in England 3 years following introduction. Clin Infect Dis. 2016;63(S4):S236 S236–S243.

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