Moderna wins second approval with vaccine targeting RSV infection

Moderna has received its second drug approval from US regulators for an RSV vaccine in older adults, a step forward in the biotech’s efforts to convince investors of its path back to growth after the Covid-19 pandemic.

The US Food and Drug Administration approved the vaccine to protect adults aged 60 and over from complications such as lower respiratory tract disease and pneumonia resulting from respiratory syncytial virus, Moderna said on Friday.

The decision hands Moderna its second-only product approval to date after its Covid jab, which has generated more than $40bn in revenue. Its blockbuster Covid shot propelled the Boston-based biotech to a valuation of more than $160bn at the height of the pandemic, but investors have since soured on the vaccine maker, with the stock down 65 per cent from its peak.

The mRNA-based vaccine works in the same way as Moderna’s Covid jab, by prompting the immune system to create proteins that battle disease. RSV is only the second illness to have an mRNA vaccine approved for its treatment.

Between 60,000 and 160,000 US adults are hospitalised with RSV every year, and 6,000 to 10,000 die from it annually, according to data from the US Centers for Disease Control and Prevention.

The approval “builds on the strength and versatility of our mRNA platform”, Stéphane Bancel, Moderna’s chief executive, said.

Moderna’s RSV jab, known as mRESVIA, will face stiff competition from rival shots from GSK and Pfizer, which have had about a year’s head start after gaining FDA approval last year.

Moderna’s shot is projected to generate $4.6bn in worldwide sales over the next five years, compared with $13.8bn for GSK’s vaccine and $9.6bn for Pfizer’s over the same period, according to analysts’ consensus estimates. Moderna has also filed for regulatory approval in multiple other territories.

Bancel claimed Moderna’s jab has a competitive advantage over rival shots as it is the only vaccine that comes in a pre-filled syringe, “designed to maximise ease of administration, saving vaccinators’ time and reducing the risk of administrative errors”.

In an effort to diversify away from Covid, Moderna has put its mRNA vaccine technology to work in late-stage trials targeting melanoma, a type of skin cancer, and CMV, a common virus that can infect babies during pregnancy. It is also studying a combined Covid and flu shot in phase-three trials. The company has nine late-stage trials in its pipeline.

Michael Yee, an analyst at Jefferies, said after two years of the market being “extremely bearish” about Moderna, the RSV approval “will help them stabilise revenues and re-grow again from here and other products may help them get to break-even by 2026-2027 to continue to fund the pipeline”.

“This could set Moderna up for an investor upside surprise if they can execute this year and deliver on their easier pre-filled syringe,” Yee added.