Pfizer recently received approval from the U.S. Food and Drug Administration (FDA) for ABRYSVO®, its respiratory syncytial virus (RSV) vaccine. This approval expands the vaccine’s use to individuals between 18 and 59 years old with an elevated risk of RSV-related lower respiratory tract disease (LRTD). ABRYSVO is now the most broadly applicable RSV vaccine for adults, encompassing those 60 years and older. It maintains its unique standing as the sole RSV vaccine approved for pregnant individuals between 32 and 36 weeks of gestation, offering protection for infants from birth to six months.
This FDA decision stems from findings in the MONeT Phase 3 clinical trial, which studied the vaccine’s safety, tolerability, and how it affects the immune system in adults susceptible to RSV complications due to pre-existing health conditions. Pfizer plans to share these results with the scientific community through peer-reviewed publications and upcoming conference presentations.
Statistics highlight the significance of this approval: a notable portion of U.S. adults aged 18 to 49 have underlying conditions like obesity, diabetes, or respiratory illnesses that make them vulnerable to RSV-associated LRTD. This percentage increases in the 50 to 64 age group.
RSV poses a widespread health concern as a common respiratory virus. It can lead to severe illness and even death by affecting the lungs and airways. Various chronic conditions, such as cardiovascular disease, lung disease, compromised immunity, diabetes with complications, and severe obesity, heighten an individual’s risk of experiencing severe RSV.
ABRYSVO is a bivalent vaccine engineered to provide comprehensive protection against RSV-LRTD, regardless of the specific RSV subgroup. The vaccine targets the RSV fusion protein in its prefusion state, which is crucial for the virus’s ability to infect cells, making it a key target for neutralizing antibodies.
In addition to this recent approval, ABRYSVO has garnered approvals for use in older adults and pregnant women to protect infants in multiple countries. Its journey includes recommendations from key advisory committees for its use in various age groups and risk categories.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
