Pfizer’s Vaccine Approved by the US FDA to Prevent Respiratory Syncytial Virus in Older Adults
The US Food and Drug Administration (FDA) has given an approval to Pfizer’s vaccine ‘ABRYSVO’ for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in people aged 60 years or older.
Important Milestone for Public Health
For more than half a century, a vaccine to help prevent RSV has been a challenging objective for public health officials. However, now with the approval of the ‘ABRYSVO,’ the vaccine has been considered a crucial milestone.
Annaliesa Anderson, Senior Vice President, and Chief Scientific Officer of Vaccine Research and Development at Pfizer stated, “’ABRYSVO’ will address a need to help protect older adults against the potentially severe consequences of RSV disease.”
Groundbreaking Phase 3 Clinical Trial
The FDA’s decision was dependent on data obtained from the pivotal Phase 3 RENOIR clinical trial, a global, randomized, double-blind, placebo-controlled study designed to evaluate the vaccine’s efficacy and safety in people aged 60 years or older.
‘RENOIR’ has recruited approximately 37,000 participants who were randomly chosen in a 1:1 ratio to receive either the vaccine or a placebo. The recently published results in the prestigious scientific journal ‘The New England Journal of Medicine’ revealed the vaccine’s efficacy, immunogenicity, and safety.
The Ongoing Fight Against RSV
Respiratory Syncytial Virus, commonly known as RSV, is beyond any doubt a contagious virus. It is also a common cause of respiratory illness across the world, and it can severely affect the lungs and airways of an infected person. The severity of the RSV disease escalates with age and the presence of comorbidities such as asthma, chronic obstructive pulmonary disease, and congestive heart failure.
The RENOIR trial is ongoing, and efficacy data will be collected in the study’s second VRS season. The vaccine’s approval is considered a significant contributor to the ongoing efforts to fight RSV globally.