FDA Approves GSK's Vaccine For Use In Pregnancy To Prevent Whooping Cough In Infants

(RTTNews) - The FDA has approved GSK plc's (GSK) Boostrix vaccine for immunization during the third trimester of pregnancy to prevent pertussis, commonly known as whooping cough, in infants younger than two months of age.

The agency noted that Boostrix (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed [Tdap]), when given during pregnancy, boosts antibodies in the mother, which are transferred to the developing baby. Boostrix is administered as a single 0.5-mL dose.

Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, noted that this is the first vaccine approved specifically for use during pregnancy to prevent a disease in young infants whose mothers are vaccinated during pregnancy.

Pertussis is a common, highly contagious respiratory disease, resulting in frequent outbreaks. It is also called whooping cough for the "whooping" sound that someone makes when gasping for air after a fit of coughing.

Infants younger than two months of age are too young to be protected by the childhood pertussis vaccine series. Due to this, babies are at highest risk for getting pertussis and having serious complications from it including hospitalizations and deaths.

According to the Centers for Disease Control and Prevention or CDC, in the total cases of pertussis reported in the United States in 2021, 4.2 percent were in infants younger than 6 months of age and around 31 percent required hospitalization.

Boostrix was initially approved by the FDA in 2005 as a single dose for booster immunization against tetanus, diphtheria and pertussis in individuals 10 through 18 years of age.

Later, the agency approved the vaccine to include individuals 19 years of age and older and to include use of an additional dose 9 years or more after the initial dose of a Tdap vaccine. The Boostrix approval has always included its use during pregnancy to protect the vaccinated individual.

The latest approval is specific to use in pregnancy to prevent pertussis in infants younger than 2 months of age. The agency noted that the CDC has recommended the use of Tdap vaccines during the third trimester of each pregnancy since 2012.

The approval was based on a re-analysis of the Boostrix-relevant data from an observational case-control study of Tdap vaccine effectiveness. As per the data, Boostrix was 78 percent effective in preventing pertussis among infants younger than 2 months of age, when administered during the third trimester of pregnancy.

This preliminary estimate of effectiveness was updated using data from published observational studies.

The safety of Boostrix administered during the third trimester of pregnancy was also assessed in a randomized, placebo-controlled study with a non-U.S. formulation of Boostrix. The study did not identify any vaccine-related adverse effects on pregnancy or on the fetus/newborn. For More Such Health News, visit rttnews.com