Correct Answer :   USFDA

The US Food and Drug Administration (FDA) has approved GSK’s vaccine against respiratory syncytial virus (RSV) for use in people aged 60 years and older. This is the first RSV vaccine to gain approval anywhere in the world, and researchers are celebrating.

* “It’s a very big deal to have options available to prevent RSV disease,” says Barney Graham, senior adviser for global-health-equity trials at Morehouse School of Medicine in Atlanta, Georgia.

* RSV usually causes mild symptoms similar to those that arise during a common cold. But for older people, it can be deadly. According to the US Centers for Disease Control and Prevention (CDC), each year RSV kills approximately 6,000 to 10,000 adults in the United States who are 65 years or older, and sends 60,000 to 160,000 to hospital. People in this age group with comorbidities such as chronic obstructive pulmonary disease, asthma or congestive heart failure are especially at risk.

* The FDA approved GSK’s RSV vaccine, to be sold as Arexvy, on the basis of phase III clinical-trial data submitted by the pharmaceutical company, which is based in London.

* Those data showed that the shot reduced the risk of people aged 60 and older developing lower respiratory tract disease from RSV by 82.6% and that of developing severe disease by 94.1%...

Source : Nature