The Food and Drug Administration(FDA) authorized Arexvy, the world’s first respiratory syncytial virus (RSV) vaccine, on Wednesday. This scientific achievement had taken 60 years to come to fruition.
According to the New York Post, the pharmaceutical firm GSK created the single-dose shot to protect people aged 60 and up against lower respiratory tract disease caused by RSV.
“Our focus now is to ensure eligible older adults in the US can access the vaccine as quickly as possible and to progress regulatory review in other countries,” Tony Wood, the chief scientific officer at GSK, said in a statement.
RSV, which typically causes mild, cold-like symptoms, can be fatal in elderly persons and young children.
According to the Centers for Disease Control and Prevention, the highly contagious virus is responsible for more than 60,000 hospitalizations, 6,000 or more deaths among persons 65 and older in the United States, and 100 to 300 deaths among children under the age of five each year.
The CDC also forecasts that RSV will hospitalize up to 80,000 children under the age of five each year.
Arexvy vaccine reduces risk of severe respiratory illness in clinical trial, according to FDA evaluation
The FDA evaluated data from a clinical trial in which Arexvy was given to 12,500 participants while a placebo was given to the same number. According to the study, immunization reduced the risk of severe RSV-associated LRTD by 94% and RSV-associated LRTD by 83%.
“With this vaccine, Americans over the age of 60, and particularly those with underlying health conditions like COPD, asthma or congestive heart failure, will have a vaccine to help protect against potentially serious outcomes from RSV,” Dr. John Kennedy, the president of the American Medical Group Association, said a statement.
The most commonly reported side effects of the immunization include injection site soreness, tiredness, muscular pain, headaches, and joint stiffness. GSK promises to make RSV immunization available to senior folks ahead of the RSV season, which is slated to begin in the autumn.
Other RSV vaccines are on the way
Researchers expected Pfizer’s RSVpreF vaccine to be approved by the FDA as the first RSV vaccine. The shot, the first RSV vaccine for expectant moms, could be administered to pregnant women in their late second or third trimesters if the agency approves. This is expected to occur in August.
