Here come the respiratory syncytial virus (RSV) vaccines from a crowded field of contenders, including Pfizer and GSK. But until they arrive, there’s a way to defend against RSV with a single dose, at least in Europe.
On Friday, the European Medicines Agency approved Sanofi and AstraZeneca’s Beyfortus (nirsevimab) to prevent RSV lower respiratory tract disease in infants.
The antibody treatment is the first and only single-dose protective option for infants for the seasonal virus which is highly contagious, infecting virtually all children before the age of 2. Beyfortus can be given to all infants, regardless of health conditions or if they were born preterm.
Nearly all babies get the virus and experience symptoms similar to a mild version of the flu. But some infections reach the lower tract. Of the estimated 33 million such infections worldwide in 2019, 3 million led to hospitalizations, with roughly 100,000 deaths.
“Today is a landmark day for RSV prevention, as decades of research and development come together in the world’s first approval of a broadly protective option against RSV disease,” Sanofi’s vaccine chief Thomas Triomphe said in a release.
Beyfortus previously earned a blessing from Europe’s Committee for Medicinal Products for Human Use (CHMP). In a trial, the drug reduced RSV-associated lower respiratory tract infections compared with placebo.
Analysts differ on the commercial potential of Beyfortus. While Jefferies has pegged its peak sales at $3 billion, Evaluate Vantage has a more tempered view, forecasting 2026 sales at $700 million.
The companies have also submitted for approval in the United States and are targeting the fall of 2023 for launch, Sanofi said.
Threatened by the approval for Beyfortus is AZ’s Synagis, which has been on the market for 24 years, offering passive protection against RSV by way of monthly injection. The advantage of Beyfortus is comparable protection provided in a single dose throughout the five-month RSV season. Formerly a blockbuster, Synagis’ sales reached (PDF) $410 million in 2021.
Looking forward, the forthcoming availability and convenience of vaccines should grow the market considerably, according to Global Data, which projects annual average growth of 30% through 2030.
Among the vaccine competition, GSK appears to be moving fastest toward the finish line in the U.S. and recently gained a priority review from the FDA. But the company also had a trial setback with its shot in infants.
As for Pfizer, the company is nearing a submission for its RSV shot in those 60 and older. The company also has scored in testing its shot on pregnant women to protect their newborn babies, with a submission for approval planned by the end of this year.