FDA approves first vaccine against Respiratory Syncytial Virus

2023-05-04 01:00:59

• The first vaccine against Respiratory Syncytial Virus is called Arexvy and was developed by GlaxoSmithKline Biologicals.
• The biologic is indicated for the prevention of the disease in people 60 years of age or older.
• The main side effects reported during clinical trials were pain at the injection site, fatigue, muscle pain, headache, and stiff/painful joints.

In an unprecedented move, the US Food and Drug Administration (FDA) authorized the first vaccine against Respiratory Syncytial Virus in history. One of the clear objectives is to offer a new alternative for the population and thus reduce the number of fatalities.

In the first instance, immunization is considered one of the most important health strategies in the world. The application of biologicals prevents between 1.5 and 3 million deaths on the planet. Although if the coverage were greater then even more lives could be saved.

First vaccine against Respiratory Syncytial Virus

While now is the time to talk about a fact of great relevance. The FDA approved Arexvy, developed by GlaxoSmithKline Biologicals and which is the first vaccine against Respiratory Syncytial Virus. So far it is the only one of its kind that can be applied in the United States. The biologic is indicated for the prevention of the disease in people 60 years of age or older.

“Older adults, particularly those with underlying health conditions such as heart or lung disease or weakened immune systems, are at high risk of severe illness caused by Respiratory Syncytial Virus. Today’s approval is a major public health achievement,” said Peter Marks, FDA director.

He Respiratory syncytial virus It is highly contagious causing lung and respiratory tract infections in people of all ages. Its circulation is seasonal and generally begins during the fall and peaks in the winter.

In older adults it is a common cause of lower respiratory tract disease that affects the lungs and can cause life-threatening pneumonia and bronchiolitis.

The safety and efficacy of Arexvy are based on the FDA’s analysis of data from an ongoing, randomized, placebo-controlled clinical study conducted in the United States in people 60 years of age and older.

Today we approved the first respiratory syncytial virus (RSV) vaccine, approved for use in the U.S., to prevent lower respiratory tract disease caused by RSV in individuals 60 years and older.

Learn more: https://t.co/V6ChIMKcYt pic.twitter.com/DgmkzjIR42

— U.S. FDA (@US_FDA) May 3, 2023

The main clinical study of Arexvy was designed to evaluate the safety and efficacy of a single dose administered to people 60 years of age and older. Participants will remain in the study for three seasons to assess duration of protection.

Efficacy and side effects

In this study, approximately 12,500 participants received the Arexvy vaccine and 12,500 participants received a placebo. Among the participants who received the immunization, a decrease of 82.6% was observed for the Respiratory Syncytial Virus.

Among a subset of these clinical trial participants, the most commonly reported side effects by people receiving Arexvy were injection site pain, fatigue, muscle pain, headache, and joint stiffness/pain. Among all clinical trial participants, atrial fibrillation was reported within 30 days of vaccination in 10 participants receiving Arexvy and 4 participants receiving placebo.

Also read:

RSV, second most frequent cause of mortality in children under one year of age

Nutritionist recommends these foods to prevent respiratory diseases

Respiratory Syncytial Virus: Tips to prevent infections