Finally, there’s a vaccine for respiratory syncytial virus (RSV), which infects more than 2 million Americans annually and leads to hundreds of thousands of hospitalizations.
This Wednesday, the U.S. Food and Drug Administration announced that it approved Arexvy, “the first respiratory syncytial virus (RSV) vaccine,” cleared for use in the U.S. This vaccine is only for adults age 60 and older to prevent RSV infection.
When Pfizer announced last November that it was working on its own RSV vaccine, the pharmaceutical company said there was “no” vaccine to prevent against the virus.
According to GSK, the pharmaceutical company that produces Arexvy, its vaccine “contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSK’s proprietary AS01E adjuvant.”
Per the U.S. Centers for Disease Control and Prevention, adjuvant refers to “an ingredient used in some vaccines that helps create a stronger immune response in people receiving the vaccine.”
“Today marks a turning point in our effort to reduce the significant burden of RSV,” said GSK Chief Scientific Officer Tony Wood Wednesday. “Arexvy is the first approved RSV vaccine for older adults, expanding GSK’s industry-leading vaccine portfolio, which protects millions of people from infectious diseases each year. Our focus now is to ensure eligible older adults in the US can access the vaccine as quickly as possible and to progress regulatory review in other countries.”
The FDA’s approval of Arexvy’s safety and effectiveness was based on analysis of data from an ongoing, randomized, placebo-controlled clinical study. Individuals age 60 and older both in the U.S. and internationally participated in the study.
“Participants will remain in the study through three RSV seasons to assess the duration of effectiveness and the safety and effectiveness of repeat vaccination,” said the FDA. “Data for a single dose of Arexvy from the first RSV season of the study were available for the FDA’s analysis.”
Approximately 12,500 participants received Arexvy through the study, and another 12,500 participants received a placebo. A “significantly reduced risk” of developing RSV-associated lower respiratory tract disease (LRTD) was observed in those who received the vaccine. Overall risk was reduced by 82.6% and risk of developing severe RSV-associated LRTD was reduced by 94.1%.
“Among a subset of these clinical trial participants, the most commonly reported side effects by individuals who received Arexvy were injection site pain, fatigue, muscle pain, headache and joint stiffness/pain,” said the FDA. “Among all clinical trial participants, atrial fibrillation within 30 days of vaccination was reported in 10 participants who received Arexvy and four participants who received placebo.”
Additionally, approximately 2,500 participants age 60 and older received Arexvy in two other studies.
“In one of these studies, in which some participants received Arexvy concomitantly with an FDA-approved influenza vaccine, two participants developed acute disseminated encephalomyelitis (ADEM), a rare type of inflammation that affects the brain and spinal cord, seven and 22 days, respectively, after receiving Arexvy and the influenza vaccine,” said the FDA. “One of the participants who developed ADEM died. In the other 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 Arexvy.”
According to the administration, it is requiring the company to conduct a post-marketing study to assess the signals of serious risks for Guillain-Barré syndrome and ADEM related to Arexvy. GSK also committed to assess atrial fibrillation in the post-marketing study, though it was not required by the FDA.
Every year, there are 60,000-160,000 hospitalizations of adults age 65 years and older in the U.S. due to RSV, as well as 6,000-10,000 RSV related deaths, according to the CDC. It also impacts young children, resulting in 58,000-80,000 hospitalizations among children younger than 5 years old, and 100-300 deaths of children younger than 5 years old.
“Older adults, in particular those with underlying health conditions, such as heart or lung disease or weakened immune systems, are at high risk for severe disease caused by RSV,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “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.”
Last month, “the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the vaccine for the prevention of LRTD caused by RSV in adults aged 60 years and older,” said GSK. A final regulatory decision is anticipated in the coming months and other regulatory reviews “are ongoing in Japan and several other countries,” according to the company.
Going forward, the Advisory Committee on Immunization Practices (ACIP) is expected to make recommendations on the appropriate use of the vaccine in the U.S. next month. GSK predicts Arexvy vaccines will be available for older adults before the 2023/24 RSV season.
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