The world’s first vaccine for respiratory syncytial virus (RSV) has been approved by the Food and Drug Administration. The vaccine is called Arexvy and was developed by GlaxoSmithKline. It will be approved to prevent lower respiratory illnesses from spreading in those above it age 60.
RSV is a ubiquitous source of respiratory disease. Most of the time, the infection manifests itself as the common cold. But the virus can reach the lower respiratory tract and cause more serious complications such as pneumonia and bronchiolitis (swelling of the small air passages in the lungs). These complications can be life-threatening and are most likely to occur in very young children and the elderly, making RSV a serious public health problem. Somewhere in the estimated 60,000 to 160,000 Americans over 65 are hospitalized by RSV each year, according to Centers for Disease Control and Preventionwhile up to 10,000 may die.
Scientists have been trying to develop an RSV vaccine for more than 50 years, but it wasn’t until recently that these efforts finally came to fruition.
In the main, randomized, placebo-controlled, approved clinical trial, Arixvi appeared to significantly reduce people’s risk of developing lower respiratory tract disease from respiratory syncytial virus. The trial involved more than 24,000 people over the age of 60, half of whom were given a single dose of the vaccine. Compared to controls, those treated with Arexvy had an 86% lower risk of developing RSV-related lower respiratory tract infections. and 94% less likely to develop RSV-related lower respiratory tract infections.
“Today’s approval of the first RSV vaccine is an important public health achievement for preventing a potentially life-threatening disease and reflects the FDA’s continued commitment to facilitating the development of safe and effective vaccines for use in the United States,” said Peter Marks. , director of the Food and Drug Administration’s Center for Biological Evaluation and Research, in A statement from the agency.
There are still some important questions remaining regarding Arexvy. It is not yet clear how long the protection conferred by the vaccine will last. Clinical trial results have so far only looked at one RSV season, which typically runs from fall into winter in the United States, but the trial is still ongoing, Volunteers are expected to be tracked through three RSV seasons in total.
The most commonly reported adverse effects associated with the vaccine were mild to moderate and included injection site pain, fatigue, muscle aches, and headache. Joint stiffness/pain. But Arexvy may also pose a risk of rare but serious side effects.
In one smaller study, in which some people were also taking an approved flu vaccine at the same time, two people who took the vaccine combination developed acute disseminated encephalomyelitis (ADEM), a type of infection that affects the brain and spinal cord. One died after that. In another small study, one person taking Arixvi developed Guillain-Barre syndromeThis is a condition in which the immune system attacks nerve cells, resulting in muscle weakness and sometimes paralysis. Ten people in the larger trial developed atrial fibrillation, or an irregular heartbeat, after vaccination. compared to four in the placebo group.
Some vaccines are thought to pose a very small risk of causing Guillain-Barré, although the risk is often lower than it would be from catching the target naturally germas with Flu vaccination. At this point, though, it has not been proven whether Arexvy can cause Guillain-Barré or ADEM. The FDA authorizes GlaxoSmithKline to conduct aftermarket safety studies to assess these potential risks, and the company has also committed to tracking potential risks of atrial fibrillation.
While GSK’s RSV vaccine is the first to reach the public, it is unlikely to be the last. RSV Moderna Serum For seniors, it has yielded similarly promising results for Phase 3, as has Pfizer Issuance. Pfizer is also likely to get its products approved RSV maternal vaccine, which vaccinates mothers to pass protection on to their newborn babies during the first months of life. And it is expected that there will be vaccines for young children and antibody therapies aimed at preventing severe RSV along the way, too.