Whooping Cough Vaccine Gets Green Light

FDA approves Boostrix to protect newborns from whooping cough

(RxWiki News) The US Food and Drug Administration (FDA) has approved a vaccine to protect newborns from whooping cough.

This vaccine is found under the name Boostrix (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed [Tdap]).

It is to be given to women during the last trimester. Boostrix is approved to prevent pertussis (whooping cough) in babies younger than 2 months of age.

Pertussis is a common respiratory disease. You may often hear about outbreaks.

Pertussis is also referred to as whooping cough because of the “whooping” sound when individuals are trying to get air after coughing.

In some cases, pertussis may result in hospitalizations and even death.

The Centers for Disease Control and Prevention (CDC) reported that 4.2 percent of the total cases of pertussis in the United States in 2021 were in babies younger than 6 months of age.

The agency also reported that approximately 31 percent of these cases required hospitalization.

“Babies are at highest risk for getting pertussis and having serious complications from it,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a press release. “While vaccination is the best method for providing protection, infants younger than two months of age are too young to be protected by the childhood pertussis vaccine series. This is the first vaccine approved specifically for use during pregnancy to prevent a disease in young infants whose mothers are vaccinated during pregnancy."

Dr. Marks also noted that this vaccine boosts antibodies in the mother during pregnancy, which then are transferred to the baby.

Since 2012, the CDC has recommended the Tdap vaccine during the third trimester of each pregnancy.

In other words, Boostrix was given to protect the mother. This recent approval is specifically to prevent pertussis in infants younger than 2 months of age when given to women during pregnancy.

What do we know about Boostrix?

Boostrix was initially approved by the FDA in 2005. It was initially approved as a single-dose vaccine (as a booster) to protect against tetanus, diphtheria and pertussis in those between the ages of 10 and 18 years of age. Later, the FDA approved Boostrix for those over 18 years old.

In previous clinical studies, the most commonly reported side effects included pain, redness at the injection site, headache, fatigue and stomach symptoms.

The FDA granted the approval of this vaccine to GlaxoSmithKline Biologicals.