There is the first vaccine against RSV

- The elderly, especially those with conditions such as heart or lung disease or a weakened immune system, are particularly vulnerable to a severe form of RSV disease. The approval of the first RSV vaccine is an important step for public health. This vaccine prevents a disease that can be fatal," said Dr. Peter Marks director of the Center for Biologics Evaluation and Research at the FDA.

RSV is a highly contagious virus that causes lung and respiratory infections in people of all ages. The season of illness caused by RSV usually begins in autumn and peaks in winter. In the elderly, RSV is a common cause of lower respiratory tract disease (LRTD), which can cause fatal pneumonia and bronchiolitis (swelling of small airways in the lungs). According to the U.S. Centers for Disease Control and Prevention, each year in the U.S. RSV leads to about 60,000-120,000 hospitalizations and 6,000-10,000 deaths among seniors 65+.

Data on the safety and efficacy of the new vaccine come from an ongoing, randomized, placebo-controlled clinical trial conducted in the U.S. and internationally in people 60 years of age and older. Participants will remain in the study for three seasons to evaluate the duration of protection and the efficacy and safety of the booster dose.

Approximately 12,500 study participants received the tested prepratate, while 12,500 received a placebo. The vaccine reduced the risk of developing RSV-related LRTD by 82.6% and reduced the risk of developing severe LRTD by 94.1%.

The most commonly reported adverse reactions in people who received the vaccine were pain at the injection site, fatigue, muscle aches, headaches and stiffness or joint pain. Atrial fibrillation within 30 days of vaccination was reported in 10 people who received the vaccine and in four people who received placebo.

In another study, in which some participants received the new formulation at the same time as the flu vaccine, two people developed acute disseminated encephalomyelitis (ADEM). One of the participants who developed ADEM died. In another study, one participant developed Guillain-Barré syndrome (a rare disorder in which the body's immune system damages nerve cells, causing muscle weakness and sometimes paralysis) nine days after receiving the new RSV vaccine.

The FDA requires the manufacturer to conduct a post-market study to assess the risk of Guillain-Barré syndrome and ADEM. In addition, although it is not an FDA requirement, the company has committed to assessing the incidence of atrial fibrillation in those vaccinated in the post-market study.

Source: FDA