FDA Expands Use Of GSK’s Pertussis Vaccine To Cover Pregnancy

The US FDA has approved GlaxoSmithKline’s Boostrix for immunization during the third trimester of pregnancy to help prevent pertussis, commonly known as whooping cough, in infants less than two months of age. 

Pertussis is a common respiratory disease in the US. According to the Centers for Disease Control and Prevention (CDC), 4.2% of pertussis cases in the US were in infants younger than six months, and around 31% required hospitalization. 

Boostrix was initially approved in 2005 to protect against Tdap (tetanus, diphtheria, acellular pertussis) in patients aged 10 to 18. The FDA has since expanded its use to adults and the elderly. Since 2012, the CDC has recommended Boostrix during the third trimester of each pregnancy. 

“We’re immensely proud to have the first-ever Tdap vaccine approved by the FDA specifically for this use during pregnancy,” said Roger Connor, President, Vaccines and Global Health, GSK. 

“We believe this approval may help protect more infants from the potentially life-threatening implications of whooping cough.”

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How Does Boostrix Work?

Boostrix contains a small dose of bacteria or a protein from the bacteria, which stimulates the body’s immune response against the disease. 

When the Tdap shot is given during pregnancy, it boosts antibodies in the mother, which are transferred to the infant. 

The new approval for Boostrix is based on re-analyzed data from a study that showed that the vaccine was 78% effective in preventing pertussis. The study included around 680 pregnant women, half of whom received Boostrix while the other half received a saline placebo. 

Common side effects reported in the study include pain, redness at the injection site, headache, fatigue, and GI symptoms. These were in line with results from previous clinical studies. The recent study did not find any vaccine-related adverse events in pregnancy or on the newborns. 

Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, explained that 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,” he said.

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Joy Lin

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