A vaccine for another respiratory illness will soon become available.
The Food and Drug Administration has approved the very first RSV vaccine. The FDA announced that the vaccine, known as Arexvy, received federal approval for those aged 60 and older in early May.
Respiratory syncytial virus, or RSV, is a common respiratory illness known to cause cold-like symptoms. It is the most common cause of bronchiolitis and pneumonia for infants younger than 1 year of age.
Those who contract the illness normally recover within a week or two, but the virus poses a distinct threat to infants, adults aged 65 and up, and adults with chronic heart disease, lung disease, or compromised immune systems.
The National Institute of Allergy and Infectious Diseases reported that the illness results in the deaths of 14,000 U.S. citizens aged 65 or older annually. RSV reached overwhelming prevalence alongside COVID-19 and the flu in a public health crisis that experts dubbed the “tripledemic,” as previously reported by The Dallas Express.
Experts hope that the development of the vaccine will limit cases of RSV.
“Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening 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 FDA’s Center for Biologics Evaluation and Research, in the announcement.
The FDA approved this new vaccine after assessing data from an ongoing, randomized clinical study conducted on Americans aged 60 and up. Researchers conducted the study by administering Arexvy to 12,500 participants, while another 12,500 were given a placebo.
Officials were able to determine that the vaccine was effective.
“Among the participants who have received Arexvy and the participants who have received a placebo, the vaccine significantly reduced the risk of developing RSV-associated LRTD [lower respiratory tract disease] by 82.6% and reduced the risk of developing severe RSV-associated LRTD by 94.1%,” said FDA officials in the announcement.
Patients did, however, experience side effects in the form of fatigue, muscle pain, injection site pain, and stiffness.
Additionally, studies conducted combining this vaccine with others have yielded more drastic consequences.
Scientists conducted studies on an identical sample but this time administered Arexvy at the same time as a flu vaccine. Two patients in one study developed acute disseminated encephalomyelitis (ADEM), while one patient in another study developed Guillain-Barré syndrome.
One of the patients who developed ADEM died.
The FDA will require that the manufacturer of Arexvy conduct a “post-marketing study” to determine risk factors for these illnesses.