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Pfizer and BioNTech’s Covid-19 and flu vaccine failed to meet a key goal in a late-stage trial, jeopardising a highly anticipated product that would help the drugmakers to compete in the post-Covid jab market.
The drugmakers, which co-produced their top selling Covid vaccine during the pandemic, are developing a combination shot to protect against both flu and Covid.
On Friday, Pfizer and BioNTech said their product tested on 18 to 64-year-olds gave a more effective immune response against influenza A strain than a licensed flu vaccine and was as effective against Covid as their existing product. But the vaccine was inferior in targeting the less prevalent influenza B strain. The shot was tested on more than 8,000 adults.
The results throw the future of the product into doubt, and come after a competitor vaccine developed by rival Moderna met its goals in phase-three trials earlier this year, opening the door to US regulatory approval. Moderna expects its product could launch by the 2025 winter flu season.
The combination shots are both based on mRNA-technology behind the Covid vaccine, which can be more easily tweaked and upgraded for new flu and Covid variants in future seasons than egg-based flu vaccines.
While Covid is no longer the health threat it once was, developing a new vaccine that can tackle seasonal Covid and flu could prove a lucrative earner for jab-makers. Combination vaccines could also increase immunisation rates by being more convenient for patients to take and easier for health systems to administer.
Pfizer is expecting $5bn in revenue from its Covid vaccine Comirnaty in 2024, far below the $38bn of sales in 2022 but making it still a steady earner for the company.
The jab is also BioNTech’s only approved product and an important source of cash flow for the German company as it invests in developing cancer vaccines.
Airfinity, a health data provider, forecasts the G7 influenza market alone will reach $9.9bn by 2030. It expects the peak size of the G7 market for Covid-19 and flu combination vaccines to reach 114mn doses, with a peak of 70.5mn doses in the lucrative US market for each autumn and winter season, although the number of doses sold could be lower.
Pfizer and BioNTech’s share prices have fallen 52 and 78 per cent off their 2021 peaks respectively, when Comirnaty income boosted revenues.
The partners now risk falling further behind Moderna, which is also developing a combination shot incorporating protection against flu, Covid-19 and respiratory syncytial virus, another seasonal virus.
Pfizer and BioNTech said they were “evaluating adjustments to the candidate and will discuss next steps with health authorities”.
“The insights gained from this combination vaccine trial are highly valuable and will play a crucial role in guiding the further development of Pfizer’s and our combination vaccine programme against influenza and Covid-19,” said Uğur Şahin, BioNTech’s chief executive.
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