After 2023 COVID sales landed at the low end of Moderna’s estimates, company executives and investors alike are turning their attention towards tantalizing late-stage programs, namely respiratory syncytial virus (RSV) and cytomegalovirus (CMV).
That was the vibe on the Flagship breadwinner’s fourth-quarter earnings call Thursday, with the company slated to hear back from the FDA on its RSV vaccine by the middle of May. This year is also expected to mark the first tranche of efficacy data on Moderna’s CMV vaccine, though the timing is contingent on case accrual.
President and head of R&D Stephen Hoge, M.D., explained on the call that the first interim analysis will be triggered once 81 cases of infection have been accrued. If the study hasn’t reached statistical power at the first analysis, then it will carry on until a final analysis, marked by 112 cases. Based on the current pace, Hoge expects the study “will have more than enough cases this year.”
“We are therefore pretty confident that we're going to be seeing a readout from the interim analysis, possibly even a final analysis for efficacy in 2024,” he said. But since these readouts are event-driven, he cautioned that “we just have to bide our time.”
As for Moderna’s RSV prospect, Hoge said that he and the team continue to feel “really enthusiastic” about the data and described the vaccine’s durability as “quite encouraging.” Earlier this month, Moderna reported that MRNA-1345 had an overall efficacy of 63.3% in patients 60 years and older with a median follow-up of 8.6 months, down from 84% efficacy at the 3.3-month mark. GSK’s Arexvy had a 67.2% efficacy over two seasons, while the efficacy of Pfizer’s Abrysvo fell from 66.7% to 49% across the two seasons.
Hoge said he does not expect CDC advisers to have different administration recommendations for the three vaccines, should Moderna’s be approved at the agency’s June meeting.
“We would suspect that they will continue to view the products as more similar than not and therefore continue with consistent recommendations,” he said.
The potential for a new marketable vaccine along with late-stage CMV data and investors' excitement around Moderna's Merck-partnered melanoma treatment may have been behind the almost 9% rise in the company's share price, from $87.59 to $95.26 by 10.40 am ET on Thursday.
It's a positive start to the year after dwindling COVID sales diminished the stock price by more than $60 per share over the course of 2023. Moderna CEO Stéphane Bancel described 2023 as a "year of transition" in the latest earnings announcement.