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Shares of Moderna MRNA declined nearly 8% yesterday after it announced that it had voluntarily withdrawn a regulatory filing seeking the FDA’s approval for mRNA-1083, its investigational mRNA-based combination vaccine against influenza and COVID. Per the company, the decision was taken in consultation with the agency.
This announcement did not come as a surprise since MRNA had already announced earlier this month, alongside its Q1 results, that the FDA had requested ‘Phase 3 flu efficacy data.’ This setback derailed the company’s initial plans to secure a potential FDA approval for the vaccine before this year’s end.
Moderna plans to resubmit this filing later this year after vaccine efficacy data from the ongoing phase III study on its investigational seasonal influenza vaccine, mRNA-1010, is available. Interim data from this study is expected this summer.
This decision also comes a day after the FDA issued new guidance for COVID vaccine boosters. As part of this guidance, COVID vaccine makers will be required to conduct randomized, placebo-controlled clinical studies demonstrating the real-world benefit of yearly COVID vaccine boosters in individuals aged under 65 years.
The initial FDA filing, which sought approval for use in older adults aged 50 years and above, was supported by data from a phase III study announced last year. Data from this study showed that mRNA-1083 elicited higher immune responses against influenza and COVID compared with licensed standalone influenza and COVID vaccines.
MRNA Stock Price Performance
Year to date, Moderna’s shares have plummeted 38% compared to the industry’s 4% fall.
Image Source: Zacks Investment Research
Other Players Developing COVID-Flu Combination Shots
Apart from Moderna, Novavax NVAX, Pfizer PFE and Sanofi SNY are also developing their respective COVID/flu combination vaccines.
NVAX started a late-stage study last year evaluating its experimental COVID-influenza combination (CIC) vaccine candidate. This study is comparing the immunogenicity and safety of the CIC vaccine against separate administrations of Novavax’s currently authorized COVID vaccine and a licensed seasonal influenza vaccine. Initial data from this study is expected later this year.
Pfizer suffered a major setback in this space last year when it reported data from a phase III study on its investigational mRNA-based COVID/flu combination vaccine. The study missed one of its two primary immunogenicity objectives. PFE is currently evaluating adjustments to its combination vaccine program to improve immune responses against influenza B and plans to discuss the next steps with health authorities. Pfizer is developing this vaccine in collaboration with BioNTech.