- Johnson & Johnson's experimental vaccine for respiratory syncytial virus, or RSV, prevented complications in people 65 and older, with the company reporting Saturday treatment reduced cases of lower respiratory tract disease by 80% in a mid-stage trial.
- J&J said last week it has initiated a large Phase 3 trial of its shot, making it one of several companies testing an RSV vaccine ahead of seeking regulatory approval. Pfizer has already started a late-stage trial, while GlaxoSmithKline and the smaller player Bavarian Nordic could begin work soon.
- RSV causes 177,000 hospitalizations a year in the elderly and 58,000 in children younger than 5. SVB Leerink analyst Geoffrey Porges estimates that combined revenue from selling RSV vaccines could exceed $6 billion by 2025 and $10 billion by 2030.
Development of coronavirus vaccines has dominated the spotlight for the past 18 months, and seasonal flu shots tend to be the focus of attention in non-pandemic times. Still, drugmakers continue to develop and improve preventive shots for other infectious diseases like pneumococcal disease, for which Merck and Prizer both just won approval for new vaccines.
RSV, however, has never had a vaccine approved. Experimental candidates in the 1960s stimulated non-protective antibodies and a type of immune response that made the disease worse. Some treatments exist, such as the older antiviral ribavirin. A synthetic antibody called Synagis sold by Swedish Orphan Biovitrum can also prevent disease in high-risk babies.
But vaccines could help reduce cases and hospitalizations, and J&J's vaccine may eventually be a part of that immunization campaign, if further testing proves positive.
The J&J vaccine is composed of two parts: the adenovirus vector used in its coronavirus vaccine but carrying genetic material that stimulates production of a protein which stimulates antibodies to RSV, and a synthetic version of the same protein. The company said the combined DNA and protein vaccine was created for "induction of a more optimal immune response."
A Phase 2 study called CYPRESS — data for which were released at the IDWeek 2021 conference — compared the vaccine to a placebo shot in 5,782 volunteers aged 65 years and older in the U.S. through a single RSV season. Cases of lower respiratory tract disease caused by RSV were reduced by 80% in participants who received the vaccine when compared to a placebo, and cases of any RSV-related respiratory infection were reduced by 70%.
Investigators also evaluated immune response in vaccine recipients, who experienced a "substantial increase" in RSV neutralizing antibodies when measured 14 days after their single shots of the vaccine, J&J said.
Last week, the company announced it was starting the Phase 3 EVERGREEN trial, positive results from which could help it win Food and Drug Administration approval. The study will enroll 23,000 people aged 60 and older, and measure prevention of RSV-related lower respiratory tract disease as its primary goal.
The trial puts J&J just weeks behind Pfizer, which will evaluate its RSV vaccine in the RENOIR trial that aims to enroll 30,000 people and generate data in 2022. GSK, meanwhile, has begun a Phase 3 trial to study safety and immune response, but hasn't announced plans for a large efficacy trial.
Bavarian Nordic has reported efficacy of 79% in a human challenge study and expects to provide further details on its Phase 3 plans before the end of the year.
In a Sept. 7 note to clients, Porges predicted that GSK will win 27% of the market, while Pfizer and J&J will get 20% and 16%, respectively.