Bavarian Nordic to scrap RSV vaccine after study setback

2023-07-24

疫苗临床3期临床结果

Dive Brief:

Bavarian Nordic will stop developing an experimental vaccine for respiratory syncytial virus, or RSV, after the shot failed to meet one of the key goals of its Phase 3 trial.

Study results disclosed on Saturday showed the vaccine was only about 43% effective at preventing severe instances of respiratory disease caused by RSV, defined as including at least 3 symptoms, in adults 60 years of age or older. The vaccine was more protective against more mild cases that included at least two symptoms, but Bavarian Nordic nonetheless intends to stop development, including an ongoing partnership with Nuance Pharma.

The Danish biotechnology company believes the revenue generated from a portfolio of travel vaccines it recently acquired from Emergent BioSolutions can help offset the loss of milestone payments it could’ve received from Nuance. Still, shares lost more than a quarter of their value in Monday trading, falling to their lowest levels since May 2022.

Dive Insight:

The bar for a successful RSV vaccine has been raised significantly in the last few months.

Since May, Pfizer and GSK have both brought RSV vaccines to market, and AstraZeneca and Sanofi have followed with a protective antibody drug.

Moderna has brought a shot to regulators as well, highlighting the fierce competition Bavarian Nordic has been up against. Already, one competitor, Johnson & Johnson, has bowed out despite having a vaccine in late-stage development. The Danish biotech is now following suit.

Its decision comes as the result of a Phase 3 study in more than 20,000 adults at least 60 years of age, a similar group to the one now cleared to receive Pfizer and GSK’s vaccines. The shot did meet one of its study goals, proving 59% effective at preventing at least two lower respiratory tract disease symptoms. But missing its other goal “was unexpected,” said the company’s president and CEO, Paul Chaplin, in a statement.

While the outcome “will impact our short-term growth expectations, we continue to have a unique commercial business and given the recent strong brand and market growth, this provides a solid foundation for profitable growth in the years to come,” Chaplin said.

The company sells a portfolio of vaccines already, including shots for tick-borne encephalitis, smallpox and monkeypox, and acquired other products from Emergent for typhoid fever and cholera. As a result, it’s not expecting the study failure to have any impact on its financial projections for 2023.

The company could also add to its product portfolio shortly. A vaccine for chikungunya virus recently succeeded in a late-stage study. There aren’t any shots or treatments available for chikungunya virus infections.

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