FDA Approves Adacel Vaccine During Pregnancy to Protect Infants Against Pertussis

The vaccine was 88% effective in preventing whooping cough in infants under 2 months of age when administered in the third trimester.

The FDA has approved third-trimester Adacel (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine; Tdap) to protect against whooping cough in infants less than 2 months of age.

The Adacel vaccine is FDA-approved for active booster against tetanus, diphtheria, and pertussis in individuals aged 10 to 64 years. It is the first vaccine in the world approved for use during pregnancy to prevent whooping cough in young infants.

Whooping cough is a highly contagious respiratory infection. Very young infants are most at risk of complications from whooping cough because their immune systems are still developing, and nearly half of infants under 6 months with whooping cough may require hospital care. There is a nature. In addition, 1 of her 100 infants hospitalized with whooping cough dies.

Although it can be prevented by vaccination, whooping cough is often undiagnosed. It can cause serious and sometimes life-threatening health problems, including exacerbation of chronic medical conditions such as asthma. For children and adults, the first symptoms usually appear 7 to 10 days after exposure and are similar to the common cold. The next stage of the disease is characterized by frequent attacks of paroxysmal cough and inspiratory whooping cough.

CDC recommends Tdap vaccination during all pregnancies. Adacel given in the third trimester of pregnancy helps pregnant women create antibodies against the bacteria that cause whooping cough and pass it on to their infants before birth. These antibodies help protect infants from whooping cough during the first few months of life.

According to a press release, the efficacy of Adacel when administered in the third trimester to prevent whooping cough in infants under two months of age was established in a groundbreaking real-world data clinical study. rice field. That study found the efficacy of the vaccine to prevent whooping cough to be 88%.

From retrospective passive surveillance studies and available safety data from ongoing pregnancy registries in the third trimester of pregnancy, no vaccine-related adverse effects on pregnancy or the fetus or infant were evident.

said Michael Greenberg, MD, MPH, Sanofi’s North American Medical Director, Vaccines. in a press release. “We pursued label expansion to be fully consistent with long-standing health agency recommendations to provide Tdap vaccination to all women in all pregnancies. Tdap vaccination coverage during pregnancy. I hope that will get higher and fewer babies will get whooping cough.”


The FDA has approved Adacel for vaccination during pregnancy to protect young infants from whooping cough. news release. Sanofi; January 17, 2023. Accessed January 17, 2023. – Toddler – vs whooping cough

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