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Moderna Falls as Early Flu Vaccine Data Show No MRNA Miracle
Robert LangrethSat, December 11, 2021, 12:31 AM·4 min read
(Bloomberg) -- Moderna Inc. investors are learning that just because a vaccine is made with messenger RNA, that doesn’t mean it will produce miraculous results.
The Covid-19 vaccine maker’s shares dropped as much as 14% Friday after the first human trial results from its experimental seasonal flu shot fell short of Wall Street’s expectations. The Moderna shot raised antibodies against influenza as much as a high-dose vaccine from Sanofi that’s already on the market.
Seasonal flu shots could become a valuable new revenue stream for Moderna, which gets all of its sales from its Covid vaccine. Jefferies Financial Group analysts said before Friday’s news that they generally expected positive results in seasonal flu with a large-scale trial in 2022 and potentially a quick path to regulatory approval.
The market reaction shows how expectations have grown for mRNA shots that turn the body’s cells into vaccine factories. While researchers anticipate the technology that speedily provided Covid vaccines will one day allow scientists to improve upon the efficacy of existing flu shots, it may be a long, complicated task.
Getting there may require new components that aren’t in existing flu shots. Moderna’s initial flu vaccine, called mRNA-1010, is essentially an mRNA version of existing four-strain flu shots, with no new components or flu strains that might help better match the vaccine to what’s circulating in the real world.
What Bloomberg Intelligence Says:
“The ‘ok’ data from the Phase I trial of Moderna’s flu shot show it to be similar to that of Sanofi’s already marketed flu vaccine, but perhaps with worse side effects. It illustrates that broadening its business outside its Covid-19 vaccine may be tougher than most had expected.”
-- Bloomberg Intelligence analyst Sam Fazeli. Read the research here.
In a statement, the drugmaker said its first-generation flu vaccine boosted antibodies against all four flu strains tested in an early-stage trial of younger and older adults. The results appeared in-line with those of Sanofi’s widely used Fluzone HD, a high-dose shot for people ages 65 and older.
“We believe the market was looking for data which supported clearly better efficacy,” Morgan Stanley analyst Matthew Harrison said in a note.
Executives Grilled
On a 90-minute conference call on Friday, analysts grilled Moderna executives about what the results meant, and why the immune response data wasn’t better. Company officials faced repeated questions about the shot’s side effects, which some analysts said appeared to be worse than existing shots.
Moderna President Stephen Hoge said on the call it was too early to make direct efficacy or safety comparisons, as that will only be done in later trials. The goal of the first-generation flu shot is to at least match existing vaccines, he said, and the company is working on follow-up versions that could contain added components to make them superior.
The goal of the current program “is to be at least as good as the best,” he said. “Then show how you improve.”
The results represent only the first steps from Moderna in flu, Chief Executive Officer Stephane Bancel said on the call, and show they’re already matching one of the strongest shots on the market. The company also reiterated its commitment to developing a shot that would combine Covid boosters with flu shots. Eventually, Moderna is working to make a combination vaccine that would include protection against Covid, flu and a third major respiratory virus called RSV.
Tough Competition
New messenger RNA technology unlocked vaccines for Covid-19 that were developed in record time with high levels of effectiveness. But Moderna and other companies betting heavily on the technology will have to compete with older, proven medications that are already widely used and often less expensive.
Sanofi gained 3% in Paris after Moderna’s statement. About 16% of the French drugmaker’s 2020 revenue came from vaccines against flu, meningitis and other diseases. GlaxoSmithKline Plc, which got almost 21% of its sales from vaccines last year, rose 0.8% in London.
In the Moderna study, few differences were seen across three dosing levels, and the company suggested it could explore even lower doses. An interim analysis of the next stage of testing is expected early next year, and the company is seeking advice from global regulators on the larger-scale testing needed for marketing approval.
©2021 Bloomberg L.P.
