FDA Approves Abrysvo to Protect Infants from RSV

August 23, 2023

The US Food and Drug Administration (FDA) has granted approval for the groundbreaking vaccine Abrysvo, designed to protect infants from birth to 6 months of age against lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV). This approval marks the first vaccine of its kind. Abrysvo was earlier approved for individuals aged 60 years and older to prevent LRTD caused by RSV. RSV is highly contagious and poses a significant risk, especially to infants, leading to severe respiratory illness and hospitalization.

Abrysvo is administered to pregnant women during gestational weeks 32 to 36 via a single-dose injection. While the vaccine demonstrated effectiveness, certain side effects were noted, including pain at the injection site, headache, muscle pain, and nausea. However, a rare hypertensive disorder called pre-eclampsia occurred more frequently among those receiving Abrysvo compared to the placebo.

What is the significance of the FDA approval for Abrysvo?

The FDA approval of Abrysvo is groundbreaking as it is the first vaccine designed to safeguard infants from lower respiratory tract disease (LRTD) and severe LRTD caused by therespiratory syncytial virus (RSV). It provides a crucial preventive measure for pregnant women to protect their infants from the potentially life-threatening effects of RSV.

What is RSV, and who is most susceptible to its effects?

RSV (respiratory syncytial virus) is a highly contagious virus that causes respiratory infections across age groups. Infants are particularly susceptible to severe respiratory illness caused by RSV, often requiring hospitalization.

What are the potential side effects of Abrysvo for pregnant women?

Side effects observed among pregnant women who received Abrysvo included pain at the injection site, headache, muscle pain, and nausea. Additionally, a rare hypertensive disorder called pre-eclampsia occurred more frequently in those receiving Abrysvo compared to the placebo.

What are the results of Abrysvo’s effectiveness in preventing LRTD and severe LRTD?

Abrysvo showed an 81.8% reduction in severe LRTD risk within 90 days after birth and a 69.4% reduction within 180 days. For pregnant individuals at 32 to 36 weeks gestational age, Abrysvo led to a 34.7% reduction in LRTD risk and an impressive 91.1% reduction in severe LRTD risk within 90 days after birth. At the 180-day mark, Abrysvo demonstrated a 57.3% reduction in LRTD risk and a 76.5% reduction in severe LRTD risk compared to the placebo.

Why were pregnant women susceptible to preterm birth kept out of Abrysvo’s clinical studies?

Pregnant women highly susceptible to preterm birth were generally excluded from Abrysvo’s clinical studies, likely to mitigate potential risks and complications associated with preterm birth.

What potential impact could Abrysvo have on infant health and well-being?

Abrysvo’s approval offers a significant advancement in protecting infants from severe respiratory illnesses caused by RSV. By reducing the risk of lower respiratory tract disease, especially in the critical early months of life, the vaccine has the potential to enhance infant health and well-being.

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