Europe—not US—first to authorize Moderna's combo mRNA flu-COVID vaccine

At a glance:

• Europe Commission greenlights Moderna's mRNA-1083 mCOMBRIAX combo vaccine for flu and COVID-19, first in world
• US still shelved; European Medicines Agency committee gave positive review in February
• Phase III trial with 4,000 adults showed mCOMBRIAX spurred higher immune responses vs. standard/high-dose flu vaccines
• CEO Stéphane Bancel calls it 'important new option for Europeans' and a 'resilience booster' for healthcare systems
• mRNA-1010 investigational flu vaccine component still under review in Europe

What happened

Moderna's mRNA-based combination vaccine against both flu and COVID-19 has received its first regulatory approval outside the United States, marking a significant milestone in the global fight against respiratory viruses. This week, the European Commission authorized Moderna to market the vaccine, mRNA-1083 or mCOMBRIAX, making it the world’s first authorized combination shot for the two respiratory viruses. The decision follows a positive review in February from a key European Medicines Agency’s committee, which paved the way for the approval. This move comes as Europe grapples with the dual threat of influenza and COVID-19, diseases that have repeatedly caused outbreaks and overwhelmed healthcare systems. The authorization of mCOMBRIAX represents a potential game-changer in immunization strategies, offering a single-dose solution to protect against two significant respiratory viruses.

Why it matters

The approval of mCOMBRIAX by the European Commission is a testament to the potential of mRNA technology in vaccine development. Moderna CEO Stéphane Bancel welcomed the news, stating, "By combining protection against two significant respiratory viruses in a single dose, our vaccine aims to simplify immunization for adults, particularly those at high risk," Bancel said in a press release. "mCOMBRIAX offers an important new option for Europeans, while also aiming to strengthen the resilience of healthcare systems across Europe." This combination vaccine addresses a critical need in public health, particularly for populations that are vulnerable to both flu and COVID-19. By providing protection against both viruses in a single dose, mCOMBRIAX could potentially reduce the burden on healthcare systems and improve the quality of life for millions of people in Europe.

How it works

mCOMBRIAX combines Moderna’s COVID-19 vaccine with an investigational influenza vaccine called mRNA-1010, which is still under review in Europe. The combination shot was authorized based on findings from a Phase III clinical trial of around 4,000 adults. The trial contained two groups, one with participants aged 50 to 64 that included a comparison of a standard flu vaccine, and another aged 65 and up that included a comparison of a high-dose flu vaccine. In both groups, mCOMBRIAX spurred statistically-significant higher immune responses against common flu strains (A/H1N1, A/H3N2, and B/Victoria) and against SARS-CoV-2 than the comparator vaccines. These results suggest that mCOMBRIAX could provide robust protection against both viruses, potentially reducing the need for multiple vaccinations and improving the overall effectiveness of immunization efforts.

What's next

While the European Commission has authorized mCOMBRIAX, the vaccine is still not available in the European market. Moderna is working to ensure that the vaccine meets all regulatory requirements and is ready for distribution. The company has also launched a public education campaign to raise awareness about the benefits of the combination vaccine and to encourage uptake among eligible populations. In the United States, mCOMBRIAX remains shelved due to regulatory and commercial considerations. However, Moderna is exploring opportunities to bring the vaccine to the US market in the future.

The bigger picture

The approval of mCOMBRIAX by the European Commission highlights the growing role of mRNA technology in vaccine development. Moderna's success with the COVID-19 vaccine has paved the way for the company to explore other applications of mRNA technology, including combination vaccines like mCOMBRIAX. This development has significant implications for public health, particularly in the context of ongoing respiratory virus outbreaks. By combining protection against two significant respiratory viruses in a single dose, mCOMBRIAX could potentially reduce the burden on healthcare systems and improve the quality of life for millions of people in Europe and beyond.