The United States has granted approval for the first-ever respiratory syncytial virus (RSV) vaccine, Arexvy by GSK, designed to protect older adults from the virus that poses significant risks to both infants and the elderly.
The FDA’s decision clears the path for adults aged 60 and above to receive vaccinations in the fall, pending a decision by the Centers for Disease Control and Prevention (CDC) on whether all seniors or only those at high risk should receive RSV protection. The CDC’s advisory panel is set to deliberate on this matter in June.
The approval of Arexvy marks a significant milestone in the pursuit of an RSV vaccine after decades of unsuccessful attempts. The medical community eagerly anticipates the availability of the vaccine, particularly in light of last fall’s virus surge that placed immense pressure on hospitals. In addition to Arexvy, Pfizer’s competing vaccine for older adults is under FDA review, while the company is also seeking approval to vaccinate pregnant women to confer protection to their newborns.
Currently, there is no vaccine available for children, but high-risk infants often receive monthly doses of a protective drug during RSV season. European regulators have recently approved a one-dose option, and the FDA is considering Sanofi and AstraZeneca’s one-shot medicine. With multiple potential RSV solutions on the horizon, it is an exciting time for the field.
RSV, which can cause life-threatening complications in very young children, the elderly, and individuals with high-risk health conditions, results in the hospitalization of approximately 58,000 children under the age of five in the U.S. each year, with several hundred fatalities. Among older adults, RSV leads to the hospitalization of up to 177,000 individuals and between 10,000 and 14,000 deaths annually.
The journey towards developing a viable vaccine has been a long and arduous one, primarily due to a significant setback in the 1960s when an experimental vaccine inadvertently exacerbated infections in children. Nevertheless, scientific advancements have led to improved methods for creating these vaccines, with modern candidates first being tested on adults.
GSK’s innovative vaccine for older adults, designed to bolster the immune system’s ability to recognize a protein on the surface of RSV, incorporates an adjuvant to further enhance the immune response. An international study involving approximately 25,000 individuals aged 60 and above revealed that a single dose of the vaccine was almost 83% effective in preventing RSV lung infections and reduced the risk of severe infections by 94%.
In order to determine the duration of protection, GSK is monitoring study participants for three years, comparing those who receive a single vaccination during that period with others who are administered a yearly booster. Typical vaccination side effects, such as muscle pain and fatigue, were observed in the study.
However, there were indications of a rare yet serious risk, including one case of Guillain-Barre syndrome, which can lead to temporary paralysis, and two instances of brain and spinal cord inflammation. Consequently, the FDA has mandated that the company continue investigating any potential connection to the vaccine.
Should the CDC ultimately advocate for the vaccination of some or all seniors, it would necessitate an additional shot during the fall season, in conjunction with the annual flu vaccine and potentially another COVID-19 booster. Dr. Schaffner, an infectious disease expert at Vanderbilt University, emphasized the need to inform the public about this lesser-known virus, which poses a significant health threat during the winter months.
