FDA Approves First Pertussis Vaccine for Use During Pregnancy
The FDA has approved the first vaccine – Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Absorbed Tdap [boostrix]) – to be administered during the third trimester of pregnancy for the prevention of pertussis in infants aged younger than 2 months.
The vaccine was previously approved as a booster dose for the prevention of Tdap in individuals aged 10 through 18 years, and later for use in individuals aged 19 years or older. The vaccine is also approved as a booster dose to be administered 9 years or more following an initial dose of a Tdap vaccine.
While the vaccine has always been approved for use during pregnancy and recommended by the CDC since 2012, the FDA’s latest approval focuses on the impact for this pediatric population.
“… While vaccination is the best method for providing protection, infants younger than 2 months of age are too young to be protected by the childhood pertussis vaccine series,” said the director of the FDA’s Center for Biologics Evaluation and Research, Peter Marks, MD, PhD. “This is the first vaccine approved specifically for use during pregnancy to prevent a disease in young infants whose mothers are vaccinated during pregnancy.”
The efficacy of the vaccine was evaluated in a re-analysis of an observational case-control study of Tdap vaccine effectiveness. The preliminary results indicated that the vaccine was 78% effective in preventing pertussis among this patient population. Similarly, the safety of the vaccine was assessed in a randomized, placebo-controlled study. The rates of reported adverse events among those who received the vaccine during pregnancy were consistent with the rates of those who received the vaccine after childbirth.
The vaccine is to be administered in a single dose of 0.5 mL. While no vaccine-related adverse events on pregnancy or for the fetus/newborn were identified, prior clinical studies reported pain, redness at the injection site, headache, fatigue, and gastrointestinal symptoms.
—Leigh Precopio
Reference:
FDA approves vaccine for use during third trimester of pregnancy to prevent whooping cough in infants younger than two months of age. News release. US Food and Drug Administration; October 7, 2022. Accessed October 21, 2022. https://www.fda.gov/news-events/press-announcements/fda-approves-vaccine-use-during-third-trimester-pregnancy-prevent-whooping-cough-infants-younger-two