What to Know About the RSV Vaccine, its Effectiveness and the Rare Serious Side Effects that can Occur

David Carney by David Carney, Partner of Green & Schafle

Information about the first FDA approved respiratory syncytial virus (RSV) vaccines effectiveness and rare serious side effects ADEM and GBS.

Respiratory syncytial virus (RSV) is a virus that is common among infants and young children but can also affect adults, in particular those with underlying health conditions, such as heart or lung disease or weakened immune systems. It is a major cause of upper and lower respiratory infections, including bronchiolitis and pneumonia. RSV is highly contagious and can spread easily through direct contact with infected secretions, such as saliva, mucus, and respiratory droplets. RSV is a seasonal virus, usually starting during the fall and peaking in the cold winter months. Last year, there were more than 126,000 cases reported between the months of October and November 2022, which is a 300% increase in cases compared with the previous year. Although most people recover from RSV without any treatment, the virus can cause serious illness in certain individuals, especially young infants and people with weakened immune systems. Symptoms of RSV include runny nose, dry cough, fever, and difficulty breathing. RSV can lead to severe complications such as pneumonia and bronchiolitis, a condition characterized by inflammation of the small airways in the lungs. On May 3rd 2023, the U.S. Food and Drug Administration (FDA) approved Arexvy, the first respiratory syncytial virus (RSV) vaccine for individuals 60 years of age and older. Older adults, in particular those with underlying health conditions, such as heart or lung disease or weakened immune systems, have been at a high risk for severe disease caused by RSV. In the FDA studies of the RSV vaccines safety and effectiveness, research concluded that the vaccine significantly reduced the risk of developing RSV-associated lower respiratory tract disease – with minimal side effects. The most commonly reported side effects by individuals who received Arexvy, were pain at the injection site, fatigue, muscle pain, headache and joint stiffness/pain. In some studies, after receiving the RSV vaccine, a couple participants developed a serious reaction called acute disseminated encephalomyelitis (ADEM), which is a rare type of inflammation that affects the brain and spinal cord. Another participant that received the RSV vaccine, developed Guillain-Barré syndrome (GBS), a rare disorder in which the body’s immune system damages nerve cells, causing muscle weakness and sometimes paralysis in the body. Although rare, these serious adverse reactions to the vaccine have prompted the FDA to require further studies to assess the indications of serious risks for [Guillain-Barré syndrome (GBS)](https://www.greenlegalteam.com/guillain-barre-syndrome-vaccine-injury-lawyer/) and [acute disseminated encephalomyelitis (ADEM).](https://www.greenlegalteam.com/adem-vaccine-injury-lawyer/) RSV is a serious virus that can cause severe illness in certain individuals. Fortunately, the public will now have access to a reportedly safe and effective vaccine. At Green & Schafle, our vaccine injury team will continue to follow updates on the RSV vaccines effectiveness and its impact on public health. For updates on new and existing vaccines, their potential serious adverse reactions and the latest regarding vaccine injury legal recourse, follow us on social media ([Facebook](https://www.facebook.com/GreenLegalTeam), [Instagram](https://www.instagram.com/greenlegalteam/), [LinkedIn](https://www.linkedin.com/company/the-green-firm)).
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