The Food and Drug Administration on Friday approved a third vaccine for respiratory syncytial virus, clearing a shot from biotechnology company Moderna one year after granting a green light to vaccines from GSK and Pfizer.
The vaccine, dubbed mResvia, is for the prevention of disease caused by respiratory syncytial virus, or RSV, in adults 60 years of age and older. Experts from the Centers for Disease Control and Prevention are expected to meet next month to provide recommendations on the shot’s use. Moderna had said it expects the vaccine to be available in time for the fall immunization season in the U.S.
RSV can cause severe disease in infants, the elderly and immunocompromised individuals, in some cases leading to death. The virus typically circulates during the fall and winter in the Northern Hemisphere, similar to the seasonal pattern for influenza and COVID-19.
“RSV is finally being appreciated as an adult disease with a considerable morbidity, mortality, and impact on hospital capacity,” said Amesh Adalja, an assistant professor at the Johns Hopkins Bloomberg School of Public Health and an infectious disease physician, in a May interview. “The virus is finally being taken seriously, hopefully, more vaccine options will increase uptake.”
Scientists for decades struggled to develop a safe and effective vaccine for RSV. Their efforts were unsuccessful until a breakthrough in 2013 paved the way for development of the current crop of vaccines that are now reaching the market.
British drugmaker GSK was the first to gain approval in the U.S. with its vaccine Arexvy cleared for use in older adults last year. Pfizer followed weeks after with its shot Abrysvo. Later last summer, the FDA granted Abrysvo an additional approval for maternal use
Demand has been high. In the first year it was approved, Arexvy brought in 1.2 billion pounds, or about $1.5 billion, for GSK, growing the company’s vaccine business. Pfizer’s shot has also done well, although sales haven’t been as strong as GSK’s. The company reported $515 million in Abrysvo sales in 2023.
Moderna plans to compete. It will have to, as declining sales of its popular COVID vaccine have put pressure on the company to deliver growth from other products.
Like its COVID shot, mResvia is built around messenger RNA. It trains the body to recognize the “prefusion” F protein of RSV, similar to Pfizer’s and GSK’s vaccines.
Moderna points to mResvia’s preparation and delivery as advantages versus the competition. On a recent earnings call, Moderna CEO Stéphane Bancel said the shot could ease “personnel burden on pharmacies” with a prefilled syringe formulation versus its competitors’ more-complex-to-administer shots.
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