If approved by regulators, the RSV vaccine will represent Moderna’s second commercial product. And while the vaccines launch in different situations – COVID-19 during a pandemic and RSV instead taking on a long-established virus – there are many parallels between the two markets and launch pathways.
Both COVID-19 and RSV vaccines will primarily targeting a similar patient group, with Moderna's existing COVID-19 commercial infrastructure in place for the RSV launch, says the company.
And as with COVID-19, Moderna’s RSV vaccine is likely to be one of the first to be approved: with a number of unknowns about the size, evolution and long-term booster potential of the market.
In-place commercial infrastructure from COVID-19
mRNA-1345 has followed a speedy line of development: going from Phase 1 start to Phase 3 data in 24 months. In January, Moderna reported that the vaccine met the primary efficacy endpoints in its Phase 3 trial: reporting efficacy of 83.7% against RSV-associated lower respiratory tract disease in older adults.
Moderna now expects to file for regulatory approval within the first half of this year. With the option of using a priority review voucher, it expects it could see a regulatory decision in late 2023 or early 2024.
“The RSV launch will leverage the existing commercial infrastructure that is already in place for COVID and we will continue to invest to support it, ensuring strong execution,” Arpa Garay, Chief Commercial Officer, Moderna, told investors at the company’s FY2022 earnings call.
“Both COVID and RSV markets overlap considerably as we look at our target customers as well as potential target patients and audiences, and we will leverage this overlap between the two markets. We will ensure awareness of RSV disease and the associated economic burden of RSV in older adults across key stakeholders such as healthcare providers and payers. Upon approval of our RSV vaccine, we will educate consumers on key attributes of our vaccine.
“These planned activities will be initiated in 2023 and in full force upon approval. We have the added benefit of an in-place commercial infrastructure built for COVID.”
Furthermore, many of these resources can be leveraged for a future launch of the company’s influenza vaccine, which is currently in Phase 3 trials, added Garay.
Four player market
While Moderna’s RSV vaccine launch will represent a milestone for the company and for mRNA technology, it is unlikely to be the first RSV vaccine to market: with both Pfizer and GSK neck-and-neck as they both expect to hear a decision on their candidates from the FDA by May this year.
Add in J&J’s candidate and that makes a four player market. So how does Moderna see its vaccine performing in a market suddenly flooded with entrants?
Stephen Hoge, Moderna’s president, champions the efficacy of the mRNA vaccine. “We have seen very high efficacy 83%, which we really think is among the best. And that efficacy actually holds up beautifully as you look at older populations, those over the age of 70, as well as those with high-risk comorbidities. Those would drive the majority of the expense associated with caring for patients, older adults with respiratory disease from RSV.
“So overall, it's very difficult, obviously, to do cross-trial comparisons. And ultimately, it will fall for public health officials to make those decisions, but we are really encouraged by both the efficacy and tolerability profile of mRNA-1345, and look forward to filing and ultimately to the commercialization of that product.”
Long-term RSV vaccine market
As with the COVID-19 vaccine, expectations of the RSV market are likely to evolve as the picture of the competitive landscape becomes clearer.
The frequency of dosing, too, is – like the early days of COVID-19 vaccines – currently an unknown. At this point none of the three leading RSV vaccine candidates have a clear answer on the durability of protection: although the assumption is that immunity will wane after time as it does against natural RSV infections.
“It is not yet clear on how frequently people will need an RSV vaccine,” said Hoge. “It's a seasonal virus, a seasonal epidemic of disease that shows up. Most of us have been exposed to RSV all over a dozen times over the course of our life. And what really happens from a biology perspective is as we get older, our ability to maintain high neutralizing titers to protect us goes down, and what we have is breakthrough disease and ultimately, a disease leads to substantial cost and morbidity and even some mortality in older adults.
“We do not yet have approved vaccines, and so what we don't yet know is what's the frequency of vaccination. Is it going to be seasonal every year, or is it going to be less than seasonal every couple or few years?
"But what's pretty clear, from my perspective, based on the epidemiology of RSV infection, is that we do see RSV fairly regularly as adults, and unfortunately, over time, it breaks through more frequently, and so there probably will need to be repeated boosting to protect against RSV.
"At the end of the day, the initial recommendations will come from ACIP as well as from regulators around that frequency, and we will have to defer to them on how they want to administer and roll out the RSV vaccines.
"Whether they want to follow a flu model, which would be annual to make sure that we get the broadest amount of protection, or that they want to initially roll out RSV vaccines and then follow over time for the durability of that efficacy.”