FDA Has Given the Green Light for the World's First RSV Vaccine To Prevent Common Virus From Causing Life-Threatening Illness

GSK's vaccine for respiratory syncytial virus (RSV) has received approval from the US Food and Drug Administration (FDA) for use in individuals aged 60 years and older. This milestone marks the first approval of an RSV vaccine anywhere in the world, and researchers are celebrating its potential impact.

Barney Graham, the senior adviser for global-health-equity trials at Morehouse School of Medicine in Atlanta, Georgia, said that having options available to prevent RSV disease is a significant achievement. Pending a recommendation from the US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices, the vaccine could be available to seniors as early as this fall.

RSV Vaccine 60 Years in the Making

GSK, a global biopharmaceutical company, has received approval from the US Food and Drug Administration (FDA) for the first-ever RSV vaccine to protect people aged 60 and over. It has taken scientists almost six decades to make their initial attempt at an RSV vaccine and has finally succeeded.

In the study, titled "Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults" published in the New England Journal of Medicine, researchers said that the vaccine, marketed as Arexvy, was found to be 83% effective in preventing lower respiratory tract disease caused by RSV in a clinical trial of nearly 25,000 older adults.

Moreover, the trial also showed that the vaccine was 94% effective at preventing severe disease in seniors who needed supplemental oxygen or mechanical help to breathe, such as a ventilator. No approved RSV vaccines have existed until now.

According to CNN's report, the RSV vaccine is developed using a protein, known as the fusion (F) protein, which sticks out on the surface of the virus and helps it attach to and infect cells in the upper airways of the body. It uses a potent pre-fusion form of the protein that was discovered a decade ago by researchers at the National Institutes of Health.

Furthermore, the RSV vaccine includes an adjuvant, which boosts immune activity. The protection it provides appears to last for about a year, but researchers will continue to evaluate vaccine efficacy over time.

The vaccine is effective in preventing lower respiratory tract infections in vulnerable seniors with underlying health conditions, such as chronic obstructive pulmonary disease (COPD), heart failure, or heart disease, at a rate of 94%.

The vaccine's most common side effects were pain at the injection site and fatigue, which could be relieved within one to two days. The FDA has required GSK to monitor the vaccine's safety signals as it rolls out to a wider population and to study the risk of adverse events, including Guillain-Barré syndrome and acute disseminated encephalomyelitis.

Race for RSV Vaccines

Experts are hopeful that more pharmaceutical companies will develop RSV vaccines after the approval of GSK's vaccine, Nature reported. RSV is a common respiratory infection that can be severe in young children and older adults.

Pfizer has a protein-based RSV vaccine for pregnant women and people over 60, which is expected to be approved by the FDA this month. Moderna also has an mRNA-based vaccine for RSV prevention in adults 60 and older that is under expedited review with the agency.

Since babies have high risk from RSV, Pfizer has adopted the strategy to immunize pregnant people a few months before birth, as newborns' immune systems do not respond robustly to many vaccines. GSK's RSV vaccine is also expected to be approved in Europe soon, and the CDC's Advisory Committee on Immunization Practices will weigh in on its use in the US in June.

Development of Respiratory Syncytial Virus (RSV) Vaccine and Monoclonal Antibodies Underway

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