The US Food and Drug Administration (FDA) could approve Pfizer Inc's (NYSE:PFE) new respiratory syncytial virus (RSV) vaccine this summer after the regulator accepted a fast-track licence application for the new product.
The jab is given to expectant mothers late in the second or third trimester and helps to protect infants from RSV. The antibodies triggered by the vaccine are passed on to the foetus, helping to protect against RSV from birth through the first six months of life.
Pfizer's clinical trial found that the vaccine was 82% effective in preventing severe disease from RSV in newborns during the first 90 days of life.
RSV is the leading cause of hospitalisation for infants in the US, causing inflammation of small airways in the lungs and pneumonia. It affects almost all children before they reach two years old, but infants are particularly vulnerable.
Pfizer’s is one of a number of new RSV vaccines set for review in the coming months. Moderna, GSK, J&J, and Janssen are all working on new drugs.
Others working in the field are aiming to protect another at-risk group - the elderly, especially those with underlying health conditions such as heart or lung disease, or weakened immune systems.
The symptoms of RSV in adults can range from mild to severe and may include coughing, sneezing, a runny nose, sore throat, and a fever. In some cases, RSV can lead to more serious complications such as pneumonia or bronchitis, which can be life-threatening for elderly individuals.