After a winter marked by a rise in hospitalisations due to the RSV, the FDA has granted its first approval for an Respiratory Syncytial Virus (RSV) vaccine to Arexvy for adults ages 60 years and above. This vaccine specifically prevents RSV-related lower respiratory tract disease (LRTD).
The approval comes after an FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously of Arexvy鈥檚 effectiveness and safety. Furthermore, in April 2023, the European Medicines Agency鈥檚 Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion in support of the vaccine鈥檚 approval. These recommendations and the FDA approval were based on . Results from the trial showed a statistically significant and clinically meaningful overall efficacy of 82.6% against RSV-LRTD in adults ages 60 years and over. Additionally, efficacy in reducing the risk of severe RSV-associated lower LRTD was 94.6% in older adults with at least one underlying medical condition of interest like certain cardiorespiratory and endocrine-metabolic conditions. The study will continue for three RSV seasons to test the duration of effectiveness and the safety and effectiveness of repeat vaccination.
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By GlobalDataArexvy contains a combination of a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) and 鈥檚 proprietary AS01E adjuvant. 骋厂碍鈥檚 vaccine is one of a cohort of RSV vaccines that has reached later stages of development this year. RSV vaccine will soon also face a US regulatory decision with an upcoming Prescription Drug User Fee Act (PDUFA) date later in May. and are also running Phase III trials with their RSV vaccine candidates.
In June, the Advisory Committee on Immunization Practices (ACIP) will give guidelines on the appropriate use of the vaccine in the US. , GSK also announced that the vaccine will be available for older adults before the 2023/24 RSV season. RSV season usually begins in autumn and peaks in the winter months in the Northern hemisphere.
, the director of the FDA鈥檚 Center for Biologics Evaluation and Research Dr. Peter Marks said, 鈥淭oday鈥檚 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鈥檚 continued commitment to facilitating the development of safe and effective vaccines for use in the United States鈥�.
