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FDA Grants Approval for RSV Vaccine to Provide Newborns with Immunity Through Pregnant Women

The Food and Drug Administration on Monday granted approval to Pfizer’s vaccine against the RSV virus for pregnant women. This vaccine allows pregnant women to pass on immunity to their newborns, protecting them from respiratory diseases caused by RSV.

Pfizer’s vaccine, called Abrysvo, should be administered to pregnant women between 32 and 36 weeks of pregnancy. It is expected to provide protection to infants for the first six months of their lives, reducing the risk of RSV infection.

RSV is a common illness in infants, with nearly all children contracting it by the age of 2. This vaccine aims to reduce the incidence of respiratory diseases and improve outcomes for infants infected with RSV.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, stated, “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. This approval provides an option for healthcare providers and pregnant individuals to protect infants from this potentially life-threatening disease.”

Each year, approximately 500,000 to 600,000 infants experience lower respiratory tract disease from RSV, making it a leading cause of hospitalization in children under the age of 1.

Earlier this year, the FDA approved the Pfizer vaccine for adults ages 60 and older, who are at higher risk for severe outcomes from RSV, especially if they have underlying health conditions.

The Pfizer vaccine for older adults was approved weeks after another vaccine from GlaxoSmithKline was approved to combat RSV in this age group.

As the fall immunization season approaches, drugmakers are promoting RSV shots alongside COVID-19 boosters and flu shots.

While RSV has been around for a long time, the virus gained increased attention after a particularly severe season last fall.

The FDA’s approval of the vaccine was based on late-stage trials involving more than 7,000 pregnant women and their infants, totaling 14,000 participants.

The trials demonstrated that Pfizer’s vaccine reduced the risk of severe disease from RSV by 81.8% within 90 days of birth and 69.4% within 180 days of birth.

Annaliesa Anderson, a senior vice president and chief scientific officer for vaccine research and development at Pfizer, said, “Today, a long-sought-after goal to deliver a maternal vaccine that will help protect infants six months of age or younger — when they are at greatest risk of possible serious consequences from RSV — has been achieved.”

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