GSK Plc announced on Wednesday that the Respiratory Syncytial Virus (RSV) vaccine has received approval from the U.S. Food and Drug Administration. It is the first injection to be cleared for use in protecting against a common respiratory condition that can be fatal for older people.
According to the manufacturer, those 60 and older are eligible for the vaccination.
By 2030, analysts predict that the market for RSV vaccines will reach $10 billion.
Prior to the approval on Wednesday, GSK’s Chief Commercial Officer Luke Miels told Reuters that the company anticipates having the vaccine on the market before the upcoming RSV season in the United States.
When given the results of a study, he claimed that the cost of the vaccine would be higher than $120 per shot.
Some facts related to the RSV vaccine.
It is the first such approval on a worldwide scale, and Pfizer and other manufacturers are expected to release comparable vaccines in the near future.
According to senior US Food and Drug Administration (FDA) official Peter Marks,
“Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening.”
RSV often only causes minor, cold-like symptoms, but in persons with weakened immune systems, it can be life-threatening.
The US Centres for Disease Control and Prevention estimate that it causes 60,000 to 120,000 hospital admissions and 6,000 to 10,000 fatalities among people 65 and older.
Based on 25,000-person research that showed a single dose of the vaccine was 83 percent effective against RSV sickness and more than 94 percent effective against severe disease, the vaccine was authorized for use in persons 60 and older.
The most frequent side effects were joint stiffness, muscular soreness, headaches, and pain at the injection site.
Out of 10 subjects who took Arexy and 4 persons who received a placebo experienced an abnormal heartbeat.
Know more about RSV
The Respiratory Syncytial Virus (RSV) is a member of the family Pneumoviridae, order Mononegavirales, and genus Orthopneumovirus. The human RSV, bovine RSV, and murine pneumonia virus are all members of this genus. Human RSV is divided into two main antigenic subtypes (A and B), which are primarily dictated by antigenic drift and duplications in RSV-G sequences but also by genome-wide sequence divergence, including within RSV-F.
In all age groups, human RSV is a common cause of lower respiratory tract infections worldwide. The initial RSV infection in newborns and young children may result in severe bronchiolitis, which can occasionally be deadly.
Repeated upper respiratory tract infections, which can vary from asymptomatic illness to symptomatic upper respiratory tract disease, are prevalent in older children and people without comorbidities.
Along with the pediatric burden of disease. RSV infection causes an increase in hospitalization rates for people 65 and older and an increase in mortality rates among the frail elderly that are approaching those found with influenza.
RSV is becoming more and more recognized as an important pathogen in older persons. Adults with underlying chronic pulmonary disease, circulatory issues, functional limitations, and higher viral loads are more likely to experience severe disease.
RSV poses a nosocomial risk to young newborns, immunocompromised people, and other susceptible groups. RSV infection has been linked to high mortality rates in patients who have undergone lung or bone marrow transplants.
Other RSV vaccines are on the way.
The European Medicines Agency, which oversees medicines for the European Union and whose recommendations are typically formally adopted by the European Commission, has recommended that GSK’s Arexy be approved.
According to Pfizer, a decision from the FDA regarding its over-60s RSV vaccine is anticipated in May.
Moderna expressed anticipation in January that their RSV vaccine will be authorized and accessible for the upcoming winter in the Northern Hemisphere.
A prophylactic antibody treatment for RSV was licensed by the EU last year and was created by the British-Swedish pharmaceutical company AstraZeneca and the French company Sanofi.