On Friday, the FDA approved Boostrix, a vaccine administered during the third trimester of pregnancy to prevent pertussis in infants under 2 months of age.
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On Friday, GlaxoSmithKline won FDA approval for a whooping cough vaccine that can be used in infants under the age of two months.
Boostrix (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed [Tdap]) is a vaccine that is administered during the third trimester of pregnancy to prevent pertussis, commonly known as whooping cough. The approval marks the first Tdap vaccine for infants approved by the FDA specifically for use during pregnancy, GSK said.
Boostrix is designed to boost antibodies within the mother. Those are then shared with the baby, providing it with a level of protection when it emerges from the womb.
GSK submitted a supplemental Biologics License Application to the FDA that included evidence in support of the maternal immunization indication. This included a re-analysis of Boostrix-relevant data from an observational case-control study of Tdap vaccine effectiveness.
Approval for Boostrix was based on a re-analysis of Boostrix-relevant data from an observational case-control study of Tdap vaccine effectiveness, the FDA noted in its announcement. That data showed that Boostrix delivered a 78% efficacy in preventing pertussis in children under the age of 2 months when the medication was administered prenatally.
The regulatory agency said the data provided real-world evidence to support the approval in this indication.
The study did not identify any vaccine-related adverse effects on pregnancy or on the fetus or newborn, the FDA noted. In earlier clinical programs, the most common side effects were pain at the site of injection, as well as headache, fatigue or gastrointestinal symptoms.
In a brief statement, Roger Connor, president of vaccines and global health for GSK, said the approval of Boostrix for this indication should protect more infants from the “potentially life-threatening implications of whooping cough.”
Pertussis is a common respiratory disease that results in frequent outbreaks, and in infants younger than two months, pertussis is often life-threatening. According to the CDC, 4.2% of 2021 U.S. pertussis cases reported were in infants younger than 6 months of age. Of those, approximately 31% required hospitalization.
The History of Boostrix
Boostrix was originally approved by the FDA in 2005 as single-dose booster against tetanus, diphtheria and pertussis in juveniles ages 10 to 18. The vaccine has also been approved for use in adults over the age of 19.
The FDA approval always allowed for use during pregnancy, and for the past 10 years, the CDC has recommended the use of Tdap vaccines during the third trimester of each pregnancy. In its own announcement, the FDA said the latest approval is specifically to prevent pertussis in infants under 2 months.
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement that infants under the age of 2 months have been unable to be protected against pertussis by other available vaccines for childhood pertussis.
Sanofi and Merck have a six-disease combination vaccine that includes pertussis that can be administered to children beginning at 2 months of age, but Boostrix is the first vaccine approved specifically for use during pregnancy to prevent disease in young infants whose mothers are vaccinated during pregnancy, Marks said.
