Moderna said on Tuesday that it has initiated a late-stage clinical trial of its experimental bird flu vaccine in the U.S. and the U.K., marking the first time an mRNA-based pandemic influenza vaccine has entered Phase 3 testing.
The company’s vaccine, mRNA-1018, will be evaluated in around 4,000 healthy adults aged 18 years and older.
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It is backed by a $54 million investment from the Coalition for Epidemic Preparedness Innovations, a global partnership focused on accelerating the development of vaccines against epidemic and pandemic threats.
CEPI’s investment in December came after U.S. Health Secretary Robert F. Kennedy Jr. decided in May to cancel more than $700 million in contracts with Moderna for developing a bird flu vaccine aimed at protecting against a potential future pandemic.
The technology, which was previously used in COVID-19 vaccines, is considered a faster approach for developing vaccines against emerging viruses with pandemic potential.
Moderna Chief Executive Stephane Bancel said bird flu remains a pandemic threat and that the study marks an important step in efforts to improve preparedness for future outbreaks.
The company said any future filing for regulatory approval of mRNA-1018 would also be supported by positive data from its separate seasonal flu vaccine candidate, mRNA-1010, which is under review in the U.S., the European Union, Canada and Australia.
Under its agreement with CEPI, Moderna said that if the vaccine is approved and a flu pandemic is declared, it will reserve 20% of its manufacturing capacity to supply low- and middle-income countries at affordable prices.
