Moderna Inc. may have risen to prominence during the pandemic with its messenger RNA (mRNA)-based COVID-19 vaccine, but it’s now casting a net far larger and wider. The company said on July 5 that it is readying international approval for its second mRNA vaccine called mRNA-1345 for respiratory syncytial virus (RSV)-associated acute respiratory disease based on positive interim data from the ongoing Conquer RSV study in individuals 60 and older.
Moderna Inc. may have risen to prominence during the pandemic with its messenger RNA (mRNA)-based COVID-19 vaccine, but it’s now casting a net far larger and wider. The company said on July 5 that it is readying international approval for its second mRNA vaccine called mRNA-1345 for respiratory syncytial virus (RSV)-associated acute respiratory disease based on positive interim data from the ongoing Conquer RSV study in individuals 60 and older.
With GSK plc’s Arexvy approved in the U.S. as the first respiratory syncytial virus (RSV) vaccine, several other developers are lining up for what in five years could be a $10 billion market. Their aim is to provide lasting protection for those most susceptible to the endemic virus, particularly young children and those older than 60. Behind GSK is Pfizer Inc. with PF-06928316, which has a U.S. FDA PDUFA date set for this month, and Sanofi SA’s nirsevimab, for which FDA action is expected in the third quarter.
In its first markup of the 118th Congress May 2, the Senate Health, Education, Labor and Pensions (HELP) Committee, under the new leadership of Sen. Bernie Sanders (I-Vt.), devolved into a brief mutiny of sorts as the committee members started to take up four bipartisan bills aimed at taming prescription drug prices.
Moderna Inc.’s mixed results in mid-February from a trial with its mRNA influenza vaccine served to emphasize the need for a more comprehensive preventer of the still problematic-for-many seasonal bug – a space where Vir Biotechnology Inc. has been busy and is slated to report closely watched phase II data from the study called Peninsula in late spring or early summer of this year.
The latest U.S. FDA emergency use authorizations to fall by the wayside, as COVID-19 continues to evolve, are the ones for the first Moderna Inc. and Pfizer Inc.-Biontech SE’s mRNA vaccines.
Combining the personalized cancer vaccine mRNA-4157 (V-940, Moderna Inc.) with Keytruda (pembrolizumab, Merck & Co. Inc.) significantly extended recurrence-free survival in patients with stage III/IV resected high-risk melanoma in the randomized phase II KEYNOTE-942/mRNA-4157-P201 trial. Compared to Keytruda alone, adding the vaccine cut the risk of recurrence or death by 44% 18 months after treatment, lead investigator Jeffrey Weber reported at the opening clinical trials plenary of the 2023 annual meeting of the American Association for Cancer Research (AACR).
On Vaccine Day, Moderna Inc. had to tell the world there weren’t enough flu cases to get a good reading in one of its two phase III vaccine studies. The northern hemisphere clinical trial of mRNA-1010, a seasonal quadrivalent vaccine, did not meet the statistical threshold because there were not enough sick participants to test to determine an interim efficacy analysis.
