The combined influenza and Covid-19 vaccine from Moderna has demonstrated comparable effectiveness to individual vaccinations in late-phase trial findings disclosed on Monday. This signals the potential for the mRNA vaccine producer to pursue authorisation for its third offering.
The efficacy of Moderna’s dual vaccine was confirmed in a phase 3 experiment that analysed antibody reactions in a sample size of more than 8,000 individuals aged 50 or above. The company found that its combined vaccine had an efficacy rate similar to that of standalone Covid vaccinations when administered with prominent seasonal influenza vaccines Fluzone and Fluarix, dispensed to different age brackets based on necessity.
In relation to three specified seasonal influenza strains, such as the H1N1 swine flu, the combined injection demonstrated superior efficacy. Moderna intends to present this initial data in a peer-reviewed scientific journal prior to sending it for American regulatory approval later in the year.
The combined Covid and flu vaccine could, in Moderna’s estimate, receive a judgement from the US Food and Drug Administration as early as the summer of the forthcoming year. This timeline would enable the launch of the first combined flu and Covid vaccination in time for the winter season of 2025. The tolerability and safety profile of the combined vaccine has also been deemed satisfactory by Moderna.
Amid a 67% decrease in its stock price from its pandemic zenith in late 2021, Moderna is seeking to assure investors of its strategy for product diversification beyond Covid-19, utilising its messenger RNA-based vaccine technology in the combat against various other pathogens and ailments, including cancer.
CEO of Moderna, Stéphane Bancel, stated that the release of the dual vaccine would provide the company entry into the seasonal flu vaccine market, valued at $8 billion or €7.4 billion. This market surpasses the Covid vaccine market and offers an opportunity not only to supersede single Covid vaccinations through added convenience but also to capitalise on a greater share of the market.
Pfizer and BioNTech, in addition to Novavax and Sanofi, are also partnering to develop a combined vaccine, which is currently undergoing late-stage trial evaluations.
According to the Centers for Disease Control and Prevention, influenza vaccination rates in the United States were over twice as high as those for Covid in the most recent season, with nearly half (48.5%) of adults 18 and older receiving the flu vaccine, significantly surpassing the mere 22.5% who got a Covid vaccination.
In globally projected sales, the profits from Moderna’s Covid vaccine is expected to reach $3.9 billion this year, a 40% decrease from last year’s total revenue of $6.6 billion. Mr Bancel, representing the biotech company whose debut product was its highly successful Covid vaccine, stated that their portfolio has demonstrated that the mRNA vaccines provide quick development, combination vaccines and have the capacity to handle complex biological challenges. He hailed these as major validating factors for their platform.
The US authorised Moderna’s second product, a vaccine for respiratory syncytial virus, just last month. Michael Yee, an analyst from Jefferies, in previous note publications suggested that for Moderna’s combined vaccine, the crucial assessment would be its ability to demonstrate it’s ‘non-inferior’ to isolated vaccines. Additionally, he mentioned that encouraging results from trials of its combined vaccine could provide a favourable momentum for its stock.
This year, Moderna’s share values have risen by 37%, raising the company’s market worth to $57 billion. The rise has been stimulated by investors’ intrigue towards the company’s H5 pandemic flu vaccine candidate, seen as a potential remedy for a US bird flu outbreak if transmitted from animals to humans.
The escalating share price has also provoked traders to cease shorting Moderna’s stocks, subsequently driving prices even higher. – The Financial Times Limited 2024.