Flu vaccine did not meet criteria for early success in late-stage trial: Moderna

The U.S. biotech company at its vaccine day meeting in Boston also said it expects to have six major vaccines on the market in the next few years. Its COVID-19 shot is currently the company's lone marketed product.

The company is banking on its respiratory vaccine candidates to help offset the expected steep fall in revenue from its hugely successful COVID-19 vaccine. Analysts have forecast 2023 Moderna COVID vaccine sales of around $7 billion, far less than the $18.4 billion windfall in 2022, due to decreasing demand.

That has increased investor scrutiny of Moderna's experimental mRNA-based shots for flu and respiratory syncytial virus (RSV).

The company is testing whether its experimental flu shot, mRNA-1010, is comparable to an approved flu vaccine in preventing the illness.

Moderna said there was not enough available data to determine if the flu vaccine would succeed, and it is not clear whether it will accrue enough information from the trial during the current flu season.

"We have not included enough cases to date at the interim analysis to declare early success," said Moderna executive Raffael Nachbagauer at the meeting.

Moderna President Stephen Hoge in an interview said he expected to start generating revenue from the flu vaccine in 2024, although the amount would depend on timing of the launch.

Moderna's decision to continue the trial comes months after data from an earlier trial showed the shot generated a strong immune response against influenza A strains, but failed to generate a similar response as the approved vaccine for less-prevalent influenza B.

Oppenheimer analyst Hartaj Singh said Tuesday's update removes some near-term optimism around Moderna's flu vaccine.

Moderna's pipeline includes an mRNA-based cancer vaccine, which has been shown to work against melanoma in a mid-stage study. The company is expected to share full data for that vaccine later this week at a medical conference.

The company's RSV vaccine was shown to be 84% effective at preventing at least two symptoms in older adults. Moderna expects to launch the RSV vaccine next year, the first of several it hopes to have approved in coming years.

Chief Financial Officer James Mock said he expected Moderna to set up one to two partnerships per quarter to help the company develop its mRNA platform, bring partner products to market or break into new therapeutic areas.

"We want to continue to invest in our platform, and so that does mean partnerships," he told Reuters.

Moderna forecast sales in the range of $8 billion to $15 billion in 2027 from its RSV and influenza vaccines and next-generation COVID-19 shot.

SVB Securities analyst Mani Foroohar in a note said: "We remain dubious of the company's ability to reach stated respiratory vaccine franchise guidance."

Moderna estimates that the COVID-19 booster shot market will be about $15 billon globally, assuming the same vaccination rate as annual flu shots in older populations.