Thread by @sailorrooscout

This is HUGE news! The FDA has officially approved Abrysvo, the first RSV vaccine designed for use in pregnant individuals to prevent lower respiratory tract disease (LRTD) AND severe LRTD caused by RSV in infants from birth through 6 months of age. Let’s talk about that! 🧵⬇️

On August 21st, the U.S. Food and Drug Administration approved Abrysvo (Respiratory Syncytial Virus Vaccine), the first vaccine approved for use in pregnant individuals to prevent lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV)

in infants from birth through 6 months of age. Abrysvo is approved for use at 32 through 36 weeks gestational age of pregnancy and is administered as a single dose injection into the muscle.

NOTE: The FDA approved Abrysvo in late May for the prevention of LRTD caused by RSV in individuals 60 years of age and older and is already available at certain Walgreens locations.
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•cnbc.com/2023/05/31/fda…
nejm.org/doi/full/10.10…

The safety and effectiveness of Abrysvo for immunization of pregnant individuals to prevent LRTD and severe LRTD caused by RSV in infants from birth through 6 months of age was evaluated in ongoing, randomized, placebo-controlled international clinical studies.

A clinical study evaluated the effectiveness of Abrysvo to prevent LRTD and severe LRTD caused by RSV in infants born to individuals who were vaccinated during pregnancy. Among approximately 3,500 pregnant individuals who received Abrysvo, compared to approximately 3,500 pregnant

individuals who received placebo, Abrysvo reduced the risk of severe LRTD by 81.8% within 90 days after birth, and 69.4% within 180 days after birth. In a subgroup of pregnant individuals who were 32 through 36 weeks gestational age, of whom approximately 1,500 received Abrysvo

and 1,500 received placebo, Abrysvo reduced the risk of LRTD by 34.7%, and reduced the risk of severe LRTD by 91.1% within 90 days after birth when compared to placebo. Within 180 days after birth, Abrysvo reduced the risk of LRTD by 57.3% and by 76.5% for severe LRTD.

Respiratory syncytial virus, or RSV, is a common respiratory virus that usually causes cold-like symptoms. Most people recover in a week or two, but RSV can be serious, especially for infants and older adults. RSV is the most common cause of bronchiolitis

(inflammation of the small airways in the lung) and pneumonia (infection of the lungs) in children younger than 1 year of age in the United States.

RSV can be dangerous for some infants and young children. Each year in the United States, an estimated 58,000 children younger than 5 years old are hospitalized due to RSV infection. Those at greatest risk for severe illness from RSV include:

RSV infections can be dangerous for certain adults as well. Each year, it is estimated that between 60,000-120,000 older adults in the United States are hospitalized and 6,000-10,000 of them die due to RSV infection. Adults at highest risk for severe RSV infection include:

If anyone is interested. This vaccine is PROTEIN BASED. NOT mRNA. Peer-reviewed. Out of NEJM. Results of the Phase 3 Trial:
•nejm.org/doi/full/10.10…

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•fda.gov/news-events/pr…
nbcnews.com/news/amp/rcna1…
cdc.gov/rsv/index.html
cdc.gov/rsv/high-risk/…
cdc.gov/rsv/high-risk/…