Moderna MRNA reported positive interim data from an ongoing phase I/II study evaluating mRNA-1083, its investigational combination vaccine against influenza and COVID-19, in older adults (50 years and older).
Data from the study showed strong immunogenicity against influenza and COVID-19 when compared with licensed standalone influenza and COVID-19 vaccines.
Per management, mRNA-1083 generated antibodies similar to or greater than two quadrivalent influenza vaccines: GSK’s GSK Fluarix and Sanofi’s SNY Fluzone HD. About COVID-19, the vaccine generated neutralizing antibodies similar to the previously approved/authorized Spikevax bivalent booster.
Based on this data, Moderna intends to advance mRNA-1083 to late-stage development. The company intends to start a phase III study in older adults before this year-end. Management expects a commercial launch for this vaccine in 2025.
In an interview with Yahoo Finance, Moderna CEO Stéphane Bancel stated that mRNA-1083 will be refrigerator-stable. Unlike the first-generation mRNA-vaccines, it will not require to be frozen and will be stable in average fridge storage.
Per Moderna, the global influenza vaccine market volume is around 500-600 million doses, with nearly 150 million doses administered alone in the United States. Management expects the fall 2023 COVID-19 market size in the United States to be around 50-100 million doses, depending on vaccination rates. Over time, Moderna anticipates the COVID-19 market to catch up with the influenza market in the country, given the similar nature of both diseases.
In the year so far, shares of Moderna have declined 42.0% compared with the industry’s 18.2% fall.
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mRNA-1010 combines the company’s influenza vaccine and its next-generation refrigerator-stable COVID-19 vaccine candidates, mRNA-1010 and mRNA-1083, respectively.
Last month, Moderna provided a positive interim update from a phase III immunogenicity study (P303) on mRNA-1010 in older adults. Data from the study showed that mRNA-1010 elicited higher immune responses across all four A and B strains of influenza than GSK’s Fluarix. In a separate phase I/II head-to-head study, mRNA-1010 elicited a higher antibody response than Sanofi’s Fluzone HD. The P303 study is expected to support Moderna’s filing for mRNA-1010, with a commercial launch anticipated next year.
Both GSK and Sanofi currently dominate the influenza vaccine market space. The GSK vaccine is approved for use by the FDA in individuals six months and older, while the Sanofi vaccine is approved for use in older adults 65 years and above.
Last month, Moderna announced that the phase III study evaluating mRNA-1283 has completed enrolment. Management expects to launch this vaccine by 2025.
Apart from mRNA-1083, Moderna is also evaluating multiple combination vaccines in separate clinical studies, including mRNA-1230 (COVID + flu + RSV) and mRNA-1045 (flu + RSV). It also intends to launch mRNA-1230 by 2028.
Another company working on a combination vaccine for COVID-19 and influenza is Novavax NVAX. In May, Novavax reported top-line results from a phase II study evaluating its COVID-19-influenza combination (CIC) candidate. Results from the study showed that the vaccine achieved antibody levels similar to Seqirus’ Fluad quadrivalent influenza vaccine and Sanofi’s Fluzone HD. Based on this data, NVAX has decided to make strategic stage gate investments in 2023 and 2024 to advance the CIC vaccine to late-stage development. Novavax intends to enter into strategic collaborations and/or available financing alternatives to finance the late-stage development of the CIC candidate.
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Moderna currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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