Bavarian Nordic Fails Phase 3 Trial, Leaving the RSV Race

Bavarian Nordic, a Danish pharmaceutical company, suffered a significant setback in its quest to develop a vaccine for respiratory syncytial virus (RSV). The phase 3 trial of their vaccine candidate, MVA-BN RSV, yielded disappointing results in older adults, causing the company’s plans and stock price to plummet.

The VANIR study, which involved 20,000 adults aged 60 years and older, revealed that MVA-BN RSV failed to meet one of its two primary endpoints. The vaccine demonstrated only 42.9% efficacy in preventing more severe lower respiratory tract disease (LRTD). Despite achieving 59% efficacy in preventing at least two pre-defined lower respiratory tract disease (LRTD) symptoms, Bavarian Nordic completely abandoned its RSV program.

CEO Paul Chaplin expressed his disappointment in the outcome, acknowledging that it would impact the company’s short-term growth expectations. Despite the setback, he remained optimistic about the company’s unique commercial business.

However, investors were not as reassured, resulting in a 21% drop in the company’s stock value on the Copenhagen stock exchange. The decline wiped out 42.9 Danish kroner from its share price, falling from 190 kroner on Friday to 148.80 kroner on Monday.

The termination of the RSV vaccine program also meant that Bavarian Nordic would miss out on 195 million kroner ($28.9 million) in milestone payments from its Chinese partner, Nuance Pharma, intended for the vaccine’s launch in Asian markets. Despite this loss, the company asserted that its travel vaccine business, which included the typhoid fever vaccine Vivotif and cholera shot Vaxchora acquired from Emergent BioSolutions, would continue to experience robust growth and offset the financial impact.

The unsuccessful MVA-BN RSV vaccine employed five RSV antigens to trigger a comprehensive immune response against both subtypes of the virus, imitating the body’s natural reaction to an infection. Unfortunately, since the trial began in April 2022, the RSV landscape had transformed, with GSK obtaining the first-ever FDA approval for an RSV vaccine, followed by Pfizer. Moderna was also pursuing its RSV vaccine development, while Johnson & Johnson had abandoned its efforts.

Despite the disappointing efficacy reported for MVA-BN RSV, analysts from Jefferies noted that Bavarian Nordic was still on track to become a leading fully integrated vaccines company. They pointed to the possibility of “record deliveries” of the company’s mpox vaccine, Jynneos, driven by strong demand due to an mpox outbreak between April and July of the previous year.

Bavarian Nordic’s phase 3 failure in developing an RSV vaccine for older adults has shaken the company’s plans and led to a drop in its stock price. Despite this setback, the company remains hopeful about its future in the vaccines market and believes its travel vaccine business will help mitigate the financial impact. However, it faces stiff competition from other pharmaceutical companies that have already made strides in RSV vaccine development.

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