An FDA approval for Pfizer’s Abrysvo respiratory syncytial virus (RSV) vaccine is likely to threaten GSK’s current hold on the market, according to GlobalData.
GSK received approval by the European Commision (EC) for its vaccine Arexvy, which targets the prevention of lower respiratory tract infections (LRTI) caused by RSV in adults 60 years of age and older. It was the first RSV vaccine to be made available across the EU and was also approved by the FDA in May, making it the first RSV vaccine to be authorised in the US.
Now, GSK’s dominance is under threat by Pfizer, as the company has recently received approval for its own RSV vaccine, Abrysvo. Abrysvo has one key advantage over GSK’s Arexvy, in that it is currently under review by the FDA, with the organisation assessing it as a maternal vaccine to protect infants against RSV at birth. The FDA’s Vaccine Advisory Committee has voted in favour of approving Abrysvo as a maternal RSV vaccine and a Prescription Drug User Fee Act (PDUFA) date has been set for this August.
Nancy Jaser, Pharma Analyst at GlobalData, said: “While Arexvy was first to gain US approval, which marked the first time a vaccine was authorised for use against RSV in any population, anywhere in the world, Pfizer’s Abrysvo was approved by the FDA quickly after, allowing sufficient time for both vaccines to be available for US launch around the same time this fall, prior to the winter RSV season. Therefore, GSK is not likely to experience a significant first-mover advantage for market share in the US. However, Arexvy may still benefit from a first-mover advantage in the EU as Pfizer’s Abrysvo has yet to gain approval for use by the EC. A decision is expected later this year.”
Jaser added: “Abrysvo will likely be the first approved RSV vaccine to protect infants worldwide, potentially leading to a higher market share than its competitors. It is currently the only vaccine candidate in late-stage development that targets multiple patient segments.”
Further competition is expected from Moderna’s RSV vaccine, mRNA-1345 which has received positive Phase III date in older adults. The company is planning to file for US approval in the first half of 2023.
Jaser commented: “mRNA-1345 is likely to be the first mRNA-based RSV vaccine to reach the market. As an RNA virus, RSV is capable of rapid mutation to escape attack by new pharmaceuticals. Novel RSV variants could emerge as a result, requiring adjustments to vaccine targets. Moderna’s vaccine would likely see higher success in this situation, as the mRNA platform allows for quick modification of antigens to target potential new viral strains.”