The US Food and Drug Administration (FDA) has approved Arexvy, the respiratory syncytial virus (RSV) vaccine, making the United States the first country in the world to do so. The Federal body approved the vaccine for the prevention of lower respiratory tract disease caused by RSV in people who are above 60 years old. The respiratory disease in question usually causes mild symptoms similar to those that arise during a common cold. However, the disease can prove to be severe among older people and can even turn deadly.
“Older adults, in particular those with underlying health conditions, such as heart or lung disease or weakened immune systems, are at high risk for severe disease caused by RSV,” said Peter Marks, M.D., PhD, director of the FDA’s Center for Biologics Evaluation and Research. “Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening and reflects the FDA’s continued commitment to facilitating the development of safe and effective vaccines for use in the United States,” he added. RSV is a highly contagious virus that causes infection in the lungs and issues breathing passages among individuals in all age groups.
The infection kills thousands of people in the US every year
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. Most of them are above 65 years or older and around 60,000 to 160,000 people usually have to go to the hospital. The CDC also stated that people with chronic obstructive pulmonary disease, asthma or congestive heart failure are especially at risk of getting affected by the virus. “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,” the FDA stated in a statement.
The federal body also stated in a statement that the vaccine has been almost 60 years in making. Back in the 1960s, two children died during a clinical trial of the vaccine. Not only this 80% of the participants in the first trial, eventually ended up in hospital. The Federal body expedited the approval of the GSK vaccines last November, during a period when the country was grappling with a “tripledemic” of people suffering from RSV, influenza or COVID-19. The body also stated that an advisory panel will convene on 18 May to consider the safety and effectiveness of Pfizer’s RSV vaccine.