FDA approves Moderna’s RSV vaccine, its second licensed product
The Food and Drug Administration on Friday approved Moderna’s vaccine to protect older adults against respiratory syncytial virus, or RSV, making this the company’s second licensed product.
The Moderna RSV vaccine, which will be marketed under the name mResvia, was approved for adults 60 and older. It is made using the same messenger RNA platform as Moderna’s other licensed product, its Covid-19 vaccine Spikevax.
“The FDA approval of our second product, mResvia, builds on the strength and versatility of our mRNA platform,” Moderna CEO Stéphane Bancel said in a statement.
In a pivotal Phase 3 trial involving nearly 37,000 people in 22 countries, mResvia was shown to have a vaccine efficacy of 83.7% against lower respiratory tract disease caused by RSV.
The company said a follow-up analysis of the primary endpoint was performed during the FDA review; it included cases that started before the primary analysis cut-off date but that were not confirmed until afterward. Those results were similar to the primary analysis, showing a vaccine efficacy of 78.7%, which was not statistically different from the earlier result.
The statement said follow-up of participants from the trial showed protection lasted over 8.6 months. When a vaccine is new, it takes time to determine how long its protection lasts.
The vaccine arrives on the market a year after two competitors, GSK’s Arexvy, and Pfizer’s Abrysvo, which were both approved for the same age group. (Pfizer’s vaccine has a second approval for pregnant people as well.) Both of those companies have since applied to the FDA for license extensions, arguing the vaccines should be offered to younger adults who are at high risk of severe illness from RSV infection.
GSK, which used a priority review voucher to speed its application through the approval process, expects to hear whether Arexvy can be targeted at people 50 and older by June 7. Pfizer is seeking a more ambitious extension, applying to be able to market Abrysvo to adults 18 and older who are at high risk from RSV.
