GSK, J&J and Pfizer vie for $10B RSV vaccine market, with Bavarian Nordic and Moderna hot on their trail
Covid-19 isn’t the only respiratory virus wreaking havoc around the world and pushing a bevy of drugmakers to invest in a vaccine.
Respiratory syncytial virus, or RSV, has also seen an unusual summer resurgence, and although it usually causes mild, cold-like symptoms, according to the CDC, RSV can be deadly, especially for infants and older adults.
In the US, the CDC estimates that more than 177,000 of adults over the age of 65 are hospitalized from RSV, and 14,000 of them die each year.
Driving the fight against this virus, in a field potentially worth up to $10 billion annually by 2030, are GlaxoSmithKline, J&J, and Pfizer, all of which will intensely compete for market share in the coming years, potentially as early as the end of 2023, according to a new report from SVB Leerink.
Last week, Pfizer kicked off its vaccine’s Phase III trial in older adults, expecting to enroll about 30,000 participants, which is likely to be larger than the nearly 25,000 participants planned in both GSK’s and J&J’s late-stage trials. The Pfizer trial’s pivotal readout could come as early as the first quarter of next year.
“We believe that PFE’s COVID vaccine commercial infrastructure will enable a rapid global launch if their RSV vaccine is approved and therefore represents significant competition to GSK’s program,” SVB Leerink analyst Geoffrey Porges wrote in an investor note on Monday.
GSK, meanwhile, said their pivotal trial results in older adults could come in the second half of next year, and it kicked off another Phase III study last February to evaluate its vaccine candidate’s immunogenicity, safety, reactogenicity and persistence.
J&J also launched its pivotal adult RSV vaccine trial last month, which could align the Big Pharma with Pfizer’s timeline.
“Given more or less equal timing, and the low probability of real differentiation between the programs, we have reduced our expected share for GSK and allocated share to PFE and JNJ who appear to be on a similar time course and also added limited share for BAVA and MRNA,” Porges wrote.
While not yet at frontrunner status, Bavarian Nordic last week released promising results from a small challenge trial, and Porges singled out how the candidate is different from the others.
Based on the Phase II challenge trial result, Bavarian Nordic “could have the first adult RSV vaccine to show efficacy not based on the F-protein antigen monovalent (single antigen) used by competitor programs,” Porges wrote.
Moderna, which is hauling in tens of billions from its mRNA Covid vaccine this year and next, early last month nabbed a fast-track designation from the FDA to try to take that mRNA platform into RSV. A Phase 1 study to evaluate the RSV vaccine candidate’s tolerability and reactogenicity in younger adults, older adults and children is ongoing.
None of the other companies’ pediatric development programs have advanced to pivotal trials yet, according to Porges, and GSK said in July that it’s discontinuing its RSV pediatric candidate “following assessment that target efficacy profile was unlikely to be met.”
But that doesn’t dampen SVB Leerink’s overall market projection, as it predicts that by 2030, 72% of the roughly $10 billion will come from the adult segment, 10% from maternal immunization, and 18% from infant prophylaxis.
Sanofi is also working with AstraZeneca on a monoclonal antibody that aims to protect infants entering their first RSV season, which could be ready for an FDA submission as soon as next year, and may hit blockbuster status by 2030.
“Of our total expected 2030 revenue, we expect GSK to capture 27% ($2.9bn), PFE 20% ($2.1bn), SNY 11% ($1.2bn), JNJ 16% ($1.7bn) and others 25% ($2.6bn),” Porges wrote.