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FDA approves Tdap vaccine for prenatal pertussis prevention

FDA approves Tdap vaccine for prenatal pertussis prevention

 


FDA the first vaccine delivered to the fetus by the pregnant mother For protection in the first two months of life.

Boostrix, a tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine, is administered during the third trimester of pregnancy to deliver antibodies to the developing baby. Approval was based on an estimated efficacy of 78% for Boostrix in preventing whooping cough in infants under 2 months of age when administered in this setting.

“Vaccination is the best way to provide protection, but infants younger than 2 months are too young to be protected by the childhood pertussis vaccine series,” said Peter Marks, FDA Center for Biologics Evaluation and Research. MD, PhD said: press release. “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 cited CDC data showing that infants under 6 months of age will account for 4.2% of pertussis infections in 2021. These infants required hospitalization in nearly one-third of cases.

“Pertussis is a highly contagious respiratory disease that affects people of all ages, but infants are most at risk of contracting whooping cough and suffering serious complications,” Marks said. said.

The 78% efficacy of Boostrix was observed in 108 infants with whooping cough before 2 months of age (including 4 mothers who received Boostrix in the third trimester of pregnancy) and 183 who were not infected with pertussis. infants (18 mothers who received Boostrix in the third trimester).

In randomized, placebo-controlled studies, excess side effects for pregnancy or babies were not associated with prenatal Tdap vaccination. Side effects reported were pain, injection site redness, headache, fatigue, and gastrointestinal symptoms.

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    Ingrid Hine Staff writer for MedPage Today on Infectious Diseases. She has been a medical reporter for over ten years. follow

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2/ https://www.medpagetoday.com/pediatrics/vaccines/101125

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