The stock rose after the company announced strong results from a major trial of its respiratory syncytial virus vaccine, adding new drama to the clash of biopharmaceutical titans.
get ready to compete.
RSV is a common virus that usually causes mild symptoms, but it can cause severe disease in older adults and young children. Cases have been particularly widespread in the United States this fall. To date, no vaccine has been approved to prevent the disease.
(ticker: MRNA) said Tuesday that an experimental messenger RNA-based RSV vaccine known as mRNA-1345 is 83.7% effective in preventing less severe disease and 82.4% effective in preventing more severe disease in adults 60 and older. The company released only the topline results and said it would submit the full data for publication in a scientific journal.
direct comparisons with
(GSK) Previous trials of RSV vaccines are difficult because the vaccines have not been tested against each other and The definitions of severe and less severe disease used in the studies do not match.
Still, at first glance, Moderna’s effectiveness at preventing less severe disease appears to be higher than that reported by the other two firms, while its vaccine appears to be slightly less effective at preventing more severe disease.
Moderna shares rose 7.9% to $205.84 in intraday trading Wednesday after the company announced test results.
Moderna said 4% of people who received the vaccine reported a serious systemic adverse reaction, such as fever, compared with 2.8% of those who received a placebo. Adverse vaccine reactions have been an area of some concern, given the fever and headaches that have affected some people after vaccination with the mRNA-based Covid-19 vaccine.
The results look strong enough to make Moderna a contender in the nascent RSV market next year. In the near term, they serve as further evidence of the value of Moderna’s mRNA technology beyond the Covid-19 vaccine. In late December, the company announced strong results in a trial of Moderna’s cancer treatment, mRNA-4157.
“I think this bodes well for the platform and what the platform means for society,” said Moderna CEO Stéphane Bancel. test results in an interview on Tuesday.
Moderna’s Covid-19 vaccine remains the company’s only product, although it is developing a long list of others, including a flu vaccine and combination vaccines to protect against influenza, Covid-19 and RSV.
“It’s just validation with clinical data that we really have a platform,” Bancel said. “That ability to periodically turn around, change the code and get another product is something really unique in the industry.”
Moderna shares have fallen more than 50% since peaking in mid-2020, but shares have rebounded in recent months. Shares are up nearly 64% since early October
Companies and analysts expect strong demand for RSV vaccines: In an October note, SVB Securities analyst David Risinger said he expects $7 billion in total annual sales for RSV vaccines for older adults.
The Food and Drug Administration is set to decide in May whether to approve Pfizer and GSK’s RSV vaccines for the elderly, and the Centers for Disease Control and Prevention’s recommendations and potential rollout could come in June.
If Moderna’s RSV vaccine is approved, it won’t join the fray until next year. Bancel said Moderna would seek FDA approval of the vaccine “as soon as possible” and that the company could use a priority review check that would speed up the FDA’s review. That could be an FDA decision in late 2023 or very early 2024, Bancel said.
Moderna’s vaccine is similar to the company’s Covid-19 vaccine, using the same lipid nanoparticles to deliver the mRNA sequence. The Pfizer and GSK vaccines use a more traditional protein-based approach rather than mRNA-based ones.
Complicating the comparison of the three RSV vaccines is how the companies defined severe infections in their trials. Moderna’s job definitions most closely match those used by Pfizer. In Pfizer’s Phase 3 study, its vaccine was 66.7% effective against cases meeting its less severe definition and 85.7% effective against cases meeting its more severe definition.
Moderna’s higher efficacy against less severe cases, 83.7%, may be an advantage for the vaccine. Low efficacy against more severe cases, 82.4%, but may be deficient.
GSK’s Phase 3 study, meanwhile, showed 71.7% efficacy against cases meeting the least severe condition definition; 82.6% effective against more severe cases; and 94.1% effective against cases meeting the most severe case definition.
Much depends on how the data is digested by the CDC’s powerful vaccine advisory committee, which makes recommendations on vaccine use in the US and can recommend one vaccine over another.
Email Josh Nathan-Kazis at firstname.lastname@example.org