Moderna’s combined Covid-19 and flu vaccine matched the efficacy of single shots in late-stage trial results published on Monday, opening the door for the mRNA vaccine maker to seek approval for its third product.
In a phase three trial studying antibody responses in more than 8,000 adults aged 50 and over, Moderna said its combination vaccine proved as effective as its Covid shot administered separately alongside two popular seasonal flu jabs, Fluzone and Fluarix, which were given selectively to different age groups.
The combined shot also showed higher efficacy when targeting three specific seasonal flu strains, including H1N1 swine flu.
Moderna plans to publish the interim data in a peer-reviewed journal and then submit it for US regulatory approval later this year.
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Moderna anticipates an approval decision could be handed down by the US Food and Drug Administration as early as next summer, potentially allowing it to launch the first combined Covid and flu shot by the 2025 winter season. Moderna said its combined shot also showed an “acceptable tolerability and safety profile”.
With its share price down about 67 per cent on its pandemic peak in late 2021, Moderna is trying to convince investors that it can diversify its pipeline beyond Covid products, putting its messenger RNA-based vaccine platform to work against other viruses and diseases, including cancer.
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Moderna’s chief executive Stéphane Bancel said the launch of the first combined shot would give the vaccine maker access to the $8 billion (€7.4 billion) seasonal flu jab market, which is larger than the market for Covid jabs, as well as allow it to outcompete single Covid shots because of the added convenience.
“When you talk to doctors, they love the idea of combinations as they will result in higher uptake as it appeals to people who don’t like needles,” said Mr Bancel.
Pfizer and BioNTech are also collaborating on a combined shot being studied in late-stage trials, and Novavax and Sanofi are developing a dual-acting jab.
Flu vaccine coverage in the US was more than double that of Covid shots in the latest season, with 48.5 per cent of all adults aged 18 and over receiving a flu shot, far outstripping the 22.5 per cent of adults who received a Covid jab, according to the Centers for Disease Control and Prevention.
Global sales of Moderna’s Covid jab are projected to total $3.9 billion this year, down 40 per cent on revenues of $6.6 billion last year.
Mr Bancel said the biotech – whose first approved product was its blockbuster Covid vaccine – had proved through its pipeline that mRNA shots enabled “speed of development, combo shots and vaccines that could tackle complex biology”. “Those are huge proof points for our platform,” he added.
Moderna last month received US regulatory approval for its second-ever product: a vaccine targeting respiratory syncytial virus.
In previously published notes, Michael Yee, an analyst at Jefferies, said the key test for Moderna’s combined jab was it proving “non-inferior” to separately administered shots. He also said that positive phase three data from its combined shot trial could be a “nice catalyst” for the stock.
Moderna’s share price is up 37 per cent so far this year, giving the company a market value of $57 billion. The uptick has been driven by investor interest over the biotech’s H5 pandemic flu vaccine candidate which could be used to combat the US bird flu outbreak if it were to spill over from animals into humans.
The improving share price has also prompted traders who have shorted Moderna’s stock to close their positions pushing the share price yet higher. – Copyright The Financial Times Limited 2024
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