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FDA Greenlights Pfizer’s Maternal RSV Vaccine for Infant Protection


The US Food and Drug Administration (FDA) has approved the first vaccine to protect newborns from respiratory syncytial virus (RSV). The vaccine, called Abrysvo, is made by Pfizer and is given to mothers during the third trimester of pregnancy. It provides protection to infants through their first six months of life.

What is RSV?

RSV is a common respiratory virus that can cause mild to severe illness in infants, young children, and older adults. It is the leading cause of hospitalization for infants under 1 year old in the United States. The last RSV season was longer and more severe than usual, overwhelming children’s hospitals.

Abrysvo: A Major Breakthrough

A clinical trial of more than 7,000 pregnant women and their infants found that the vaccine Abrysvo reduced the risk of infants needing to see a doctor or be admitted to the hospital for RSV infection.

The trial found that infants born to mothers who received Abrysvo were 55% less likely to need to see a doctor for RSV infection and 74% less likely to be hospitalized for RSV infection. The vaccine was also 70% effective at preventing severe RSV disease in infants during their first six months of life.

The results of the trial are a major breakthrough in the fight against RSV. The approval of Abrysvo is a major breakthrough in the fight against RSV. The vaccine is safe and effective, and it has the potential to save lives. It is especially important for infants born during the RSV season, which typically runs from fall to spring.

Abrysvo is the first vaccine that has been shown to be effective at preventing severe RSV disease in infants. The vaccine is expected to be available in the United States in the coming months.

Pfizer’s RSV Vaccine

Pfizer’s RSV vaccine could prevent up to 16,000 hospitalizations and more than 300,000 doctor’s visits due to RSV each year. The FDA’s vaccine advisers voted unanimously that the vaccine is effective and 10-4 that data supports its safety.

Pfizer plans to conduct a large post-market safety study to help evaluate the safety of the vaccine in a larger population. The company is also studying the vaccine in higher-risk children and adults.

The approval of the RSV vaccine is a major breakthrough in the fight against this common and serious respiratory virus. The vaccine has the potential to save lives and reduce the burden of RSV on families and healthcare systems.

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