When can we expect the Respiratory Syncytial Virus (RSV) vaccine to be approved and available?

Several vaccines against respiratory Syncytial Virus (RSV) are in development and at least two are in the final stages of clinical testing and will undergo priority review by the US Food and Drug Administration (FDA) (GSK November 2022; Pfizer December 2022). If successful, the first approval could be granted in May 2023 for use in the US. Phase 3 trials have been completed in adults over the age of 60 years and it’s likely that the vaccines will first be approved for use in this age group (GSK October 2022; Pfizer August 2022). A Phase 3 trial for a vaccine to be given to pregnant women reported in November 2022 with 82% efficacy against severe RSV for infants from birth to 90 days and 70% through to 6 months (Pfizer November 2022). Timelines for approval of this vaccine are not yet available.

RSV is a common seasonal virus that causes lower respiratory tract infection. The virus tends to cause most infections in the late autumn and early winter months. While most RSV infections are mild and self-limiting, severe illness with need for hospitalisation may occur following infection, particularly in vulnerable groups including the very old and the very young. Severe illness can also occur in healthy adults and infants with no risk factors. There are no specific treatments for RSV infection and this means that vaccination is critical to drive a reduction in cases and consequently in severe infections. In older adults, risk for severe disease is due to age-related decline in immunity. Chronic conditions, including those affecting the respiratory system, also increase the risk of severe infections. In infants, the greatest risk for severe disease is during the first months of life and is greatest in preterm babies and those with congenital heart or lung disease.