The Race for an RSV Vaccine Approval
Last week, Moderna published some strong top-line results from its large-scale trial of its respiratory syncytial virus (RSV) vaccine. The RSV vaccine aims to protect against RSV-associated lower respiratory tract disease (LRTD). This success positions Moderna as another competitor in the biopharmaceutical giants’ race to receive the first FDA approval of an RSV vaccine, with Pfizer and GSK already in the running.
Moderna’s vaccine, known as mRNA-1345, uses lipid nanoparticles to deliver an mRNA sequence, the same technology used in their COVID-19 vaccine. By contrast, Pfizer and GSK’s proposed vaccines both use a standard protein-based approach. Direct comparison of the three vaccines’ efficacy is difficult since they have not been tested against each other. Moreover, the parameters used to define “severe” and “less severe” cases of RSV-associated LRTD varied between studies.
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Nonetheless, a simple comparison of figures suggests that GSK’s vaccine is most effective at preventing “severe” LRTD cases in adults over 60, with 94.1% efficacy. In “less severe” cases, Pfizer appears to come out on top; their vaccine was 85% effective at preventing LRTD, versus Moderna’s 83.7% and GSK’s 82.6%.
When asked about the data in an interview with Fierce Biotech, Moderna CEO Stéphane Bancel said that the results from the mRNA-1345 trial “bode well” for Moderna’s mRNA platform. The data should also be strong enough to make Moderna a serious contender in the budding RSV vaccine market, which has the potential to be quite sizeable, with estimates suggesting it could be worth $10 billion.
The FDA is set to give their decision over Pfizer and GSK’s vaccines in May, with recommendations from the CDC (and perhaps even vaccine rollout) potentially coming in June 2023. Both companies were granted priority reviews, which is at least in part due to the current lack of an RSV vaccine.
Bancel said that Moderna will seek FDA approval “as soon as [they] can”, but unlike their competitors, they were not granted priority review. They may use one of two priority reviews available to them, one which they purchased and one which they received thanks to their COVID vaccine. If they do so, we could see an FDA decision for mRNA-1345 as soon as the end of 2023 or early 2024. Fundamentally, the future state of the RSV vaccine market rests on FDA approval and how the CDC vaccines advisory committee responds to the data.
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