The Food and Drug Administration (FDA) gave its approval to GlaxoSmithKline's (GSK) vaccine called Arexvy, which offers protection against respiratory syncytial virus (RSV). This marks the first time that an RSV vaccine has been authorized for use in the United States.
The vaccine, developed by the British pharmaceutical company GSK, is specifically designed for people aged 60 years and above, who are more susceptible to RSV infection. With just one shot, the vaccine could be ready for distribution to seniors as early as this autumn.
FDA Approves First RSV Vaccine
Dr. Peter Marks, the director of the FDA's Center for Biologics Evaluation and Research, emphasized that older adults, especially those with underlying health conditions, are at a higher risk of experiencing severe symptoms caused by RSV. He stated that the approval of the first RSV vaccine is a significant public health accomplishment that demonstrates the FDA's dedication to supporting the development of safe and effective vaccines.
CNN reported that GSK's RSV vaccine employs a small portion of the virus known as the fusion protein, which protrudes from the virus's surface. This protein helps the virus to latch onto and infiltrate cells in the body's upper respiratory system. The vaccine utilizes lab-created protein fragments produced by specially engineered cells to trigger the body's immune system.
The vaccine is based on research findings made ten years ago by scientists at the National Institutes of Health (NIH), who played a crucial role in developing COVID-19 vaccines.
The F protein is usually flexible, shifting and altering its shape after fusing with a cell. However, the NIH scientists discovered how to immobilize the protein in its pre-fusion shape, allowing the body to produce robust antibodies against it.
GSK's vaccine employs this pre-fusion form of the protein, which is highly effective, in combination with an immune-boosting adjuvant.
Aside from GSK, the FDA is also anticipated to render a verdict on Pfizer's RSV vaccine, which is a contender for the same age range, according to Axios.
Moreover, both Pfizer and GSK vaccines received the support of an agency panel of experts who affirmed their safety and efficacy.
Medical Trial of GSK's RSV
According to the Centers for Disease Control and Prevention, the respiratory syncytial virus (RSV) causes cold-like symptoms and infects nearly everyone by the age of two.
However, RSV is the primary cause of hospitalization among newborns and young children, with between 58,000 and 80,000 hospitalizations reported annually among those under five years old. RSV also affects older adults, causing over 177,000 hospitalizations and 14,000 fatalities each year.
The main clinical trial of GSK's Arexvy vaccine focused on the safety and efficacy of a single dose in individuals aged 60 and over. The trial subjects will be monitored over the course of three RSV seasons to evaluate the period of effectiveness and the safety and efficacy of receiving the vaccine multiple times.
Based on the FDA, data from the first RSV season of the trial were available for the FDA's analysis, indicating that the vaccine significantly reduced the risk of RSV-associated LRTD by 82.6% and severe RSV-associated LRTD by 94.1%.
Approximately 12,500 participants received the vaccine, while another 12,500 received a placebo. During the trial, individuals who received the vaccine reported experiencing injection site pain, muscle pain, headaches, fatigue, and joint stiffness or pain as the most common side effects.
The FDA has mandated that the company conduct a post-marketing study to determine if there are any significant risks associated with Guillain-Barré syndrome and ADEM.
While this is not an FDA requirement, the company has committed to analyzing atrial fibrillation in the post-marketing study.
