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The US Food and Drug Administration (FDA) has granted approval to GlaxoSmithKline (GSK) for Arexvy, the world’s first vaccine designed to protect older adults against respiratory syncytial virus (RSV). RSV is a common respiratory virus that can cause serious illness, particularly in adults over 65 years of age, and in infants and young children. It is responsible for up to 177,000 hospitalizations and 14,000 deaths annually in the US alone.
JoinAStudy.ca would like to highlight the efforts of our investigators Dr. Peter Dzongowski, Dr. Michael Jones, Dr. James Lai and Dr. Sean Peterson who all took part in the series of trials leading to this approval. We would also like to thank their dedicated patients and study volunteers, whose participation in Phase 3 of this study was integral in gathering the necessary data to confirm the efficacy and safety of Arexvy.
Arexvy is a single-shot vaccine that is designed to stimulate the immune system to produce antibodies against the RSV virus. It contains a protein found on the surface of the virus, which triggers an immune response from the body. The vaccine has been shown to be safe and effective in clinical trials, with a high level of protection against RSV infection and related hospitalizations.
The approval of Arexvy is an important development in the fight against RSV. Until now, there has been no vaccine available to protect human beings against the virus. The approval of Arexvy represents a significant milestone in the development of RSV vaccines and is likely to have a major impact on the health and well-being of older adults around the world.
The vaccine is expected to be available in the US in the coming months. GSK has also announced plans to seek approval for the vaccine in other countries, including Europe and Japan.
In addition to its use in seniors, Arexvy is now also being studied in other populations at serious risk of complications from RSV, including infants and pregnant women. RSV is a common cause of respiratory illness in infants and young children, and there is currently no vaccine available to protect them against the virus. The development of a vaccine for this population could have a significant impact on public health, particularly in developing countries where RSV is a major cause of childhood mortality.
Overall, the approval of Arexvy is a major step forward in the fight against RSV. With its high level of protection and potential use in multiple populations, the vaccine has the potential to save thousands of lives and prevent serious illness in millions of people around the world.