FDA Approves First Respiratory Syncytial Virus (RSV) Vaccine

Arexvy is the first respiratory syncytial virus (RSV) vaccine to receive approval from the U.S. Food and Drug Administration. Arexvy has been given the go-ahead to prevent lower respiratory tract illness in people 60 years of age and older caused by RSV.

About the disease/condition

RSV is a highly contagious virus that affects people of all ages by infecting their lungs and breathing systems. The seasonality of RSV circulation normally begins in the autumn and peaks in the winter. RSV is a frequent contributor to lower respiratory tract disease (LRTD), a lung condition that can lead to life-threatening pneumonia and bronchiolitis (inflammation of the tiny airways in the lungs), in older persons.

Symptoms

• fever
• congestion
• cough
• runny nose
• sneezing

Less common symptoms include:

• wheezing
• difficult, short, or fast breathing
• bluish skin (note that this may not be visible on darker skin tones)

Causes

RSV is a viral infection that can be passed via close contact with someone who has it. If you’re standing next to someone with RSV and they cough or sneeze, there’s a chance you might get the virus.

It’s also possible to get the virus by touching something, such as a toy or a doorknob, that was touched recently by someone who has the virus.

Safety and effectiveness of the vaccine (Arexvy)

Based on the FDA’s examination of data from an ongoing, randomized, placebo-controlled clinical investigation of people 60 years of age and older conducted in the U.S. and globally, Arexvy has been found to be safe and effective. Arexvy’s primary clinical research was created to evaluate the safety and efficiency of a single dose given to people 60 years of age and older. Three RSV seasons will pass before participants are removed from the trial in order to evaluate the effectiveness’s longevity as well as the benefits of repeated immunization. The FDA’s analysis was allowed to use data for a single Arexvy dose from the study’s first RSV season.

Reference: https://www.fda.gov/news-events/press-announcements/fda-approves-first-respiratory-syncytial-virus-rsv-vaccine?utm_medium=email&utm_source=govdelivery