Moderna Stock (NASDAQ:MRNA)
During a phase 3 study in the Northern Hemisphere, Moderna (NASDAQ:MRNA) reported that its seasonal influenza (flu) vaccine mRNA-1010 did not collect enough cases at an interim effectiveness analysis to announce early success.
This month, Moderna will launch a confirmatory phase 3 study to see whether or if its updated version of mRNA-1010 improves the vaccine’s immunogenicity against influenza B strains.
Flu Vaccination Program
The business revealed conflicting findings for the flu vaccine in a phase 3 experiment called P301 conducted in the Southern Hemisphere and published in early February. The vaccine had not proven non-inferiority for either aim of seroconversion rates and geometric mean titer ratios for the influenza B/Victoria- and B/Yamagata-lineage strains.
On Tuesday, Moderna Stock updated investors and the public on its clinical projects, including the second Phase 3 study of mRNA-1010 in the Northern Hemisphere, codenamed P302, to assess the safety and non-inferior effectiveness compared to a licensed flu vaccine.
The company announced that the first interim analysis of efficacy had been completed by an independent Data and Safety Monitoring Board (DSMB), which had concluded that mRNA-1010 did not meet the statistical threshold required to declare early success and had recommended that the study continues with efficacy follow-up towards the subsequent analysis.
According to Moderna, the immunogenicity target of the P302 trial was not pre-specified.
Preliminary data on immunogenicity from a subset of trial participants showed that mRNA-1010 was superior to the licensed comparator against both influenzas A strains (A/H1N1 and A/H3N2) and was non-inferior to both influenza B strains (B/Victoria and B/Yamagata).
We are encouraged by the strong immunogenicity results against influenza A and titers consistent with non-inferiority against influenza B strains in the most recent Phase 3 trial of mRNA-1010, Moderna’s first investigational vaccine against seasonal flu, said CEO Stéphane Bancel.
The business revealed that it had five influenza vaccine candidates in clinical development.
RSV (Respiratory Syncytial Virus) Initiative
Moderna hopes to submit for approval of its experimental RSV vaccine mRNA-1345 this quarter.
ConquerRSV, a phase 2/3 study testing the vaccination in those aged 60 and over, is now underway.
Vaccine effectiveness (VE) of 83.7% against RSV-associated lower respiratory tract illness (RSV-LRTD) as characterized by two or more symptoms was achieved after evaluation by a Data Safety and Monitoring Board (DSMB), the firm said.
Portfolio of COVID-19 Vaccines
Moderna said its next-generation, refrigerator-stable COVID-19 vaccine mRNA-1283 has shown good results in numerous clinical studies and has just begun treating participants in a phase 3 study.
Commercial Updates
Six key vaccination product releases are anticipated by Moderna during the next several years. Moderna predicts the annual worldwide endemic COVID-19 booster market will be over $15 billion.
Sales of respiratory products are projected to reach between $8 billion and $15 billion in 2027, with a Respiratory operating profit of $4 billion to $9 billion. According to Moderna, this framework is backed by $6B to $8B in additional research and development expenditures over the next five years.
Moderna stock dropped 4.78% to $152.50 before the market opened on April 11.
Featured Image: Megapixl
Author Shariq Khan 
