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Following a reported rise in RSV cases in the US, leading data and analytics company GlobalData notes that the country should test COVID-19-free patients that are showing symptoms for RSV in order to address this worsening issue.

Nancy Jaser, PharmD/MBA, Pharma Analyst at GlobalData, comments:

“The recent reported surge in RSV cases in the US was hardly unexpected, as similar situations occurred in Australia and New Zealand, where the summer season occurred earlier than in the US. Healthcare professionals should now be testing SARS-CoV-2 negative patients with respiratory symptoms for RSV to prevent further complications and deaths.”

RSV vaccines and prophylaxis have been largely overshadowed by the ongoing COVID-19 pandemic. Very few cases were seen in the winter of 2020, compared to the normal annual case count. With the prevalence of cases today, companies are now able to resume trial enrolments in a race to bring improved therapies and the first ever vaccines to market.

Jaser continues: “It is clear that vaccines are a much-needed weapon to tackle RSV, however, new monoclonal antibody nirsevimab has demonstrated major advantages in clinical trials involving infants over the current standard of care, Synagis (palivizumab).”

Nirsevimab, developed by AstraZeneca and Sanofi, has an extended half-life of up to 117 days, compared to the 20-day half-life of Synagis. A single dose can provide protection for at least five months, which covers an entire RSV season. Further, Synagis has a high price tag of up to $9,000 per year, providing an opportunity for price competition. Synagis is limited to use in high-risk pre-mature infants, while nirsevimab is intended to be used in all infants. Nirsevimab is currently in late stage pivotal trials and with FDA breakthrough designation and positive Phase 3 results, is on track to become the first new intervention approved for RSV in 23 years.*”

Jaser continues: “While the awareness of RSV in the general population remains low, pharmaceutical companies are still working rapidly to provide the FDA with pivotal trial data to submit their vaccines and prophylactic treatments for approval. This new generation of vaccine candidates use an improved ‘pre-fusion’ RSV F-protein antigen. Currently, GlaxoSmithKline is on track to bring the first older adult RSV vaccine to market, while Pfizer is closest to a maternal vaccine approval. Until new interventions enter the market, it remains important to use Synagis in high-risk infants to prevent disease and associated healthcare costs.”

*Qing Zhu et al, A highly potent extended half-life antibody as a potential RSV vaccine surrogate for all infants