US Becomes 1st Country To Approve Vaccine For Pregnant Women To Prevent RSV In Infants

The United States on Monday became the first country to approve a vaccine for pregnant women that prevents severe disease caused by Respiratory Syncytial Virus (RSV) in their babies.

New York: The United States on Monday became the first country to approve a vaccine for pregnant women that prevents severe disease caused by Respiratory Syncytial Virus (RSV) in their babies. The Pfizer shot known as “Arexvy”, which was already approved for use in older adults, has now been greenlighted for use at 32 through 36 weeks of pregnancy, to protect infants from birth through six months, a statement by the Food and Drug Administration said.

The shot becomes the second RSV vaccine, and third new intervention against the disease this year. In May, the FDA approved the Abrysvo vaccine for preventing RSV in people 60 years and older. The same vaccine is now approved for pregnant people in their third trimester. And in July, the agency approved nirsevimab, an antibody-based injection that protects babies immediately after birth from RSV.

The Approval

The approval follows a clinical trial involving some 7,000 pregnant women, which showed Pfizer’s vaccine, called Abrysvo, reduced severe disease caused by RSV by 82 percent in babies from 0-3 months, and 69 percent from 0-6 months.

Abrysvo was previously approved by the FDA for adults aged 60 and over, as was another vaccine by drugmaker GSK, called Arexvy.

According to FDA, the safety and effectiveness of Arexvy is based on the FDA’s analysis of data from an ongoing, randomized, placebo-controlled clinical study conducted in the U.S. and internationally in individuals 60 years of age and older. The main clinical study of Arexvy was designed to assess the safety and effectiveness of a single dose administered to individuals 60 years of age and older.

Researchers have targeted an RSV vaccine since the 1960s, but the spate of shots that are emerging now were made possible thanks to a scientific breakthrough a decade ago. “RSV is a common cause of illness in children, and infants are among those at highest risk for severe disease, which can lead to hospitalization,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

About Respiratory Syncytial Virus

RSV is a highly contagious virus that causes infections of the lungs and breathing passages in individuals of all age groups. RSV circulation is seasonal, typically starting during the fall and peaking in the winter. In older adults, RSV is a common cause of lower respiratory tract disease (LRTD), which affects the lungs and can cause life-threatening pneumonia and bronchiolitis (swelling of the small airway passages in the lungs). According to the U.S. Centers for Disease Control and Prevention, each year in the U.S., RSV leads to approximately 60,000-120,000 hospitalizations and 6,000-10,000 deaths among adults 65 years of age and older.

An estimated 58,000-80,000 children younger than five years are hospitalized due to RSV infection, according to the Centers for Disease Control, making it the leading cause of hospitalization among infants.