Moderna

Moderna racks up Phase III RSV success

Published: Jan 18, 2023

By Cory Renauer

BioSpace

People worried Moderna may be a one-hit wonder can rest a little easier.

Wednesday, Moderna announced positive topline results from a Phase III trial with older adults and a vaccine candidate aimed at preventing respiratory syncytial virus (RSV) called mRNA-1345. This candidate employs the same lipid nanoparticle envelope as the company’s COVID-19 vaccine, Spikevax.

“These data are encouraging, and represent the second demonstration of positive Phase III trial results from our mRNA infectious disease vaccine platform after, Spikevax, our COVID-19 vaccine,” said Stéphane Bancel, Moderna’s CEO in a statement.

The ConquerRSV trial enrolled 37,000 patients who were at least 60 years old. Investigators conducted an interim analysis once there were 64 cases of RSV-associated lower respiratory tract disease (RSV-LRTD) as defined by two or more symptoms.

They found 55 cases among patients to receive a placebo and nine cases among participants who received mRNA-1345, which suggests the vaccine candidate is 84% effective.

At this year’s J.P. Morgan Healthcare Conference, Moderna officials told investors that COVID-19 vaccine sales reached an unaudited $18.4 billion. Company representatives expect this figure to shrink to $5 billion in 2023 based on existing purchase agreements.

Moderna’s RSV vaccine candidate is a few steps behind the competition.

In November, the FDA granted priority review to GlaxoSmithKline’s RSV vaccine candidate for older adults.

The FDA recently began reviewing RSV vaccine candidates from Pfizer and BioNTech; they will likely decide whether to approve them in May.

Source: BioSpace