Health

FDA approves vaccine to prevent pertussis in newborns by vaccinating mother in third trimester

This vaccine prevents whooping cough in infants under 2 months of age. It can be safely administered to mothers in the third trimester of pregnancy.

The FDA has approved tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine, sorbent (Tdap) (Boostrix; GlaxoSmithKline) for vaccination of mothers in the third trimester of pregnancy. Although approved for infants younger than 2 months of age, vaccination of mothers during the third trimester of pregnancy can protect infants from whooping cough at birth. This approval indicates that Tdap can be administered to patients in a 0.5 mL dose and is the third in a series of FDA approvals for whooping cough over the past 20 years.

Since children under 2 months of age are not eligible to receive the actual vaccine themselves, giving the mother the Tdap vaccine boosts her antibodies, which she then transfers to her developing fetus. It can boost an infant’s immune system.

“Infants are most at risk of contracting whooping cough and serious complications from it,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release.

Whooping cough, better known as whooping cough, is a highly contagious but common respiratory disease that can affect all ages in the United States, Marks said in a press release. Whooping cough comes from the “whooping cough” sound of trying to hold your breath after suffering a coughing fit.

Only 4.2% of U.S. cases occur in this age group, but 31% of infants under 6 months with the disease go to the hospital because of the illness, according to the CDC.

To assess the efficacy and safety of Tdap in this population, researchers conducted a randomized, placebo-controlled trial enrolling pregnant women who had not given birth. In this study, researchers identified her 680 pregnant women who were in their third trimester. Of the participants, 340 received her non-US Tdap formulation and 340 received a saline placebo. After delivery, placebo patients received the international Tdap vaccine.

Non-U.S. formulations are primarily believed to be similar to U.S. formulations. Therefore, as the safety of the non-U.S. formulation has been evaluated and approved in previous clinical trials, the safety of the U.S. formulation also provided further data supporting FDA approval.

After the study, no women reported vaccine-related adverse effects on the newborn, fetus, or pregnancy itself. Symptoms reported.

The FDA first approved Tdap in 2005 as a single booster for tetanus, diphtheria, and pertussis for children ages 10 to 18. The FDA has since approved his Tdap for individuals over the age of 19. In this second approval, the FDA allowed an individual to receive her second dose of Tdap if nine years had passed since he received the first vaccination.

“This is the first vaccine specifically approved for use during pregnancy to prevent illness in young infants whose mothers are vaccinated,” Marks said in a press release.

reference

US Food and Drug Administration. The FDA has approved a vaccine for use during the third trimester of pregnancy to prevent whooping cough in infants under 2 months of age. October 7, 2022. FDA website. Accessed October 7, 2022. -two?utm_medium=email&utm_source=govdelivery

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FDA approves vaccine to prevent pertussis in newborns by vaccinating mother in third trimester