Moderna sprints toward RSV podium behind GSK, Pfizer, with eyes on combo vax

The race to nab the first FDA approval of an RSV vaccine is largely a two-horse sprint between Pfizer and GSK. But, in an interview with Fierce Biotech Tuesday, Moderna CEO Stéphane Bancel maintained confidence that his company's shot would stand out even as the development process lags months behind.  

Moderna is among those working toward a coveted podium spot in the potentially $10 billion market, with a shot of its own in a phase 3 trial slated to read out likely in the first quarter. The company's previous timeline said a readout was expected in "the winter," assuming that RSV attack rates resulted in enough cases to measure clinical efficacy, which Bancel says is happening. 

“As we've said before, we believe the product will be competitive,” Bancel said, couching the expectation with the fact that the company will wait for the data. He added that given Moderna’s shot codes for the same protein in Pfizer and GSK’s competitors, he has no reason to believe that it will be any less effective. 

But to Bancel, approval for an RSV shot is just the tip of the needle, per se. He’s instead veering attention toward the company’s efforts to group together vaccines for respiratory diseases, including one asset, mRNA-1230, that’s a three-in-one COVID-19, flu and RSV vaccine. However, the reality remains that Moderna would need regulatory signoff of flu and RSV before they’d accept a triple-action substitute. Still, Bancel says that’s where the company is set to distinguish itself. 

“What I'm really excited about is the ability to combine RSV and COVID through the single shots, because that's something that the other guys won't be able to do,” he said. As of the company’s third-quarter earnings report, that triple combo vaccine had started phase 1 trials. 

Even with the phase 3 trial in older adults slated to read out soon, Moderna will have to wait to tack on pediatric patients, which are currently being tested in a fully enrolled phase 1 trial. According to the Centers for Disease Control and Prevention, there are 2.1 million outpatient visits for RSV each year among kids younger than 5.