Pictured: Respiratory syncytial virus vial and syringe/iStock, Manjurul

Bavarian Nordic’s portfolio has taken a hit as the company announced Saturday its respiratory syncytial virus vaccine candidate did not meet all primary endpoints in a Phase III study in older adults.

While the vaccine candidate showed 59% efficacy in preventing at least two pre-defined lower respiratory tract disease (LRTD) symptoms from RSV, that number dropped to below the co-primary endpoint for severe LRTD in patients 60 and older.

With the miss, Bavarian Nordic is discontinuing its RSV program. The decision also terminates its partnership with Nuance Pharma and chance for the coupled milestone payments of 195 million Danish kroner for developing and launching in select Asian markets.

Bavarian Nordic CEO Paul Chaplin said in the release that the outcome was “unexpected” and will impact short-term growth expectations.

However, the company said there is no impact on the financial guidance for 2023 as the loss of income potential is expected to be offset by the recently acquired travel vaccines purchased from Emergent BioSolutions in May for $380 million. Revenue-generating vaccines for cholera and typhoid fever were added to Bavarian Nordic’s offerings, plus a late-stage Chikungunya vaccine.

The Danish vaccine maker is the latest company to scrap its RSV program. Pharma giant Johnson & Johnson dropped its high-profile RSV program in March 2023 after “a review of the evolving RSV vaccine landscape,” a J&J spokesperson told BioSpace in an email at the time.

The landscape has certainly gotten more competitive this year as GSK made history in May with the first-ever FDA approval of an RSV vaccine. Arexvy’s efficacy numbers came in around 94% against severe RSV-LRTD for older adults and those with underlying medical conditions. Overall efficacy was 82.6%.

Pfizer followed shortly after in late May with approval for its shot, Abrysvo, in adults over 60. Results from the Phase III study showed 66.7% efficacy at preventing RSV-LRTD with at least two signs and symptoms.

While second to GSK in the older adult population, Pfizer is the frontrunner for getting its vaccine approved for the pediatric setting. The FDA’s decision is set for August for maternal inoculation with Abrysvo for infant immunization.

The global market for an RSV vaccine could surpass $10 billion by 2030, according to analysts. Bavarian Nordic’s stock was down more than 25% in Monday trading.

Source: bioSpace.com