Moderna Doses First Patient in Study of Flu mRNA Vaccine Candidate

Moderna recently announced that the first patient has been dosed in the Phase 1/2 study of its quadrivalent seasonal flu mRNA vaccine candidate.

mRNA-1010 is Moderna’s first seasonal flu vaccine candidate to enter clinical trials. It targets lineages recommended by the World Health Organization (WHO) to prevent the flu, including influenza A H1N1, H3N2, and influenza B Yamagata and Victoria. 

The randomized, observer-blind study will evaluate the safety, reactogenicity, and immunogenicity of the vaccine candidate, mRNA-1010, in 180 healthy adults 18 years of age and older in the US.

“We are pleased to have begun this Phase 1/2 study of mRNA-1010, our first mRNA seasonal flu vaccine candidate to enter the clinic. We expect that our seasonal influenza vaccine candidates will be an important component of our future combination respiratory vaccines,” Stéphane Bancel, chief executive officer of Moderna, said in the announcement. 

“Respiratory combination vaccines are an important pillar of our overall mRNA vaccine strategy. We believe that the advantages of mRNA vaccines include the ability to combine different antigens to protect against multiple viruses and the ability to rapidly respond to the evolution of respiratory viruses, such as influenza, SARS-CoV-2 and RSV,” Bancel continued. 

Seasonal flu epidemics vary in severity each year, causing respiratory illness and putting a significant burden on the healthcare system. About three to five million severe cases of the flu and 290,000 to 650,000 flu-related respiratory deaths occur each year globally.

Additionally, the economic burden of the flu is nearly $11 billion per year.  

Flu vaccines are only about 40 to 60 percent effective. Moderna stated that it plans to explore potential combination vaccines against the flu, COVID-19, respiratory syncytial virus (RSV), and human metapneumovirus (hMPV). 

A November 2020 Kaiser Family Foundation report found that 52 percent of the US population six months and older received the seasonal flu vaccine in 2019. 

Rates for flu vaccination were the highest in the Northeast (57 percent), followed by the Midwest (54 percent), the South (52 percent), and the West (51 percent). But in 12 states, less than half of the population received a flu vaccine. 

Overall, the national annual flu vaccination percentage was well below the Healthy People 2030 target of 70 percent for all racial groups. 

“Our vision is to develop an mRNA combination vaccine so that people can get one shot each fall for high efficacy protection against the most problematic respiratory viruses. We look forward to advancing our core modality of prophylactic mRNA vaccines so that we can continue to make an impact on global public health,” Bancel said in the recent announcement.