The Food and Drug Administration has authorized the first-ever vaccine against the ubiquitous winter insect Respiratory Syncytial Virus.
In clinical trials, Arexvy was more than 84% effective against lower respiratory tract infections and 94% effective against severe disease.
The immune system produces high amounts of antibodies after being exposed to viral proteins.
The Respiratory Syncytial Virus (RSV) kills approximately 10,000 American adults annually and can also cause severe illness in infants and toddlers. Scientists have struggled for decades despite numerous failed attempts to develop a vaccine against it.
Today, the FDA gave its approval for the vaccination to be administered to adults aged 60 and older.
Before it can be made available to the public, the Centres for Disease Control and Prevention (CDC) must recommend its use. This is anticipated to occur at a meeting of advisors next month.
It was unclear whether approval would be extended to children, but other RSV vaccines are in development for children. One manufactured by Pfizer is anticipated to be approved by the end of the year.
Arexvy was created by the British pharmaceutical behemoth GSK and is administered to patients in a single dose to provide protection.
It targets only one of the two genotypes of RSV, RSV A. But research demonstrates that it provides nearly equivalent protection against both strains.
Arexvy or placebo was administered to 25,000 patients in a study that led to FDA approval.
The study is scheduled to span three RSV seasons, with approval contingent on findings from the initial year of research.
It was unclear whether participants would be offered stimulants in the future.
The injection caused pain at the injection site, fatigue, muscle pain, migraines, and stiffness in the joints.
Ten recipients of the vaccine were also diagnosed with atrial fibrillation or an irregular heartbeat.
In two other studies of the vaccine, two participants experienced brain inflammation, and one participant suffered from Guillain-Barre syndrome, an uncommon condition in which the immune system damages cells.
In announcing the drug’s approval, Dr. Peter Marks, director of the FDA, referred to it as a “significant public health achievement.”
GSK will start selling the vaccine in the US and other nations.
In the coming months, it anticipates approval from the United Kingdom, the European Union, Canada, and several other nations.
Work on an RSV vaccine has been plagued by multiple clinical trial failures for decades.
In a 1960s trial, children given an experimental vaccine experienced worse sickness than those given a placebo. Two children under the age of two have passed away.
Later research determined that this was because the vaccine targeted a variant of the virus’s protein that forms after the virus fuses with a cell, meaning that it did not provide protection against the disease and may have hindered the immune response.
RSV infections typically peak from late autumn to early spring.
The virus typically causes a cold in adults, manifesting as a runny nose, loss of appetite, congestion, and fever.
In older individuals and those with weakened immune systems, however, it can lead to lung infection and pneumonia.
This year, the virus returned with a vengeance due to a lack of Covid restrictions that allowed infections to rebound.
Dr. Marks stated, “Older adults, especially those with underlying health conditions such as heart or lung disease or weakened immune systems, are at a greater risk for RSV-caused severe disease.”
The FDA’s continued dedication to facilitating the development of safe and effective vaccines for use in the United States is reflected in the approval of the first RSV vaccine today, which is a significant public health achievement to prevent potentially fatal disease.
