Ever since the COVID-19 pandemic began to ease, Moderna has weathered a sharp revenue downturn. But a new FDA approval shows that the company's scientific engine is no one trick pony.
Moderna's mRESVIA has secured FDA approval to protect adults ages 60 years and older from lower respiratory tract disease caused by respiratory syncytial virus (RSV) infection. The company plans to launch the product in time for the 2024-2025 RSV season, which typically starts in the late fall in the U.S.
The nod marks Moderna's second FDA approval after the agency's 2022 thumbs up for COVID-19 vaccine Spikevax. Like Spikevax, mRESVIA is based on Moderna's messenger RNA platform.
While mRESVIA is not the first RSV vaccine to secure FDA approval—that designation went to GSK's Arexvy—Moderna's offering is the first mRNA shot against RSV.
In a large phase 3 trial in 22 countries, Moderna's vaccine was associated with an 83.7% rate of efficacy against RSV-associated lower respiratory tract disease after 3.7 months of median follow-up.
Besides Moderna's impending commercial showdown with GSK, Pfizer is also present in the market with Abrysvo.
GSK, Pfizer and Moderna's vaccines each boast FDA approvals in older adults, while Pfizer's offering can also be used as a maternal vaccination to protect newborns.
So far in the RSV clash, GSK's Arexvy has generated 1.2 billion pounds ($1.5 billion) while Pfizer's Abyrsvyo has pulled down about $1.03 billion.
Besides COVID-19 and RSV, Moderna is testing mRNA candidates against influenza, HIV, Lyme disease, Zika, and many other diseases. The company's Merck& Co.-partnered cancer vaccine has gained particular attention in recent months as the companies shore up their development plans.