The World Health Organization cites vaccine hesitancy, or the reluctance to receive vaccines, as a “growing challenge for countries seeking to close the immunization gap.” There are many factors driving hesitancy, including misinformation, patient complacency, vaccine cost, geographic barriers, and scheduling concerns. Multi-purpose vaccines, which provide immunization against multiple diseases, help address several of these factors by allowing patients to receive protection from multiple diseases with a single shot.
In one recent example, the European Commission granted marketing authorization in the European Union for Moderna’s combination messenger RNA (mRNA) vaccine, dubbed mCombriax. The authorization was announced in a press release on April 21. The vaccine is specifically designed to protect people aged 50 years and older against both seasonal influenza and SARS-CoV-2, the virus that causes COVID-19. By creating a vaccine that protects against both illnesses, Moderna takes a significant step toward overcoming barriers to vaccine access.
Combined Flu and COVID-19 Vaccine Could Point to a Healthier Future
While most cases of seasonal flu and COVID-19 are mild or moderate, severe cases do occur. These cases are particularly prevalent in older individuals and individuals with compromised immune systems. Furthermore, co-infection (becoming infected with both the influenza virus and SARS-CoV-2) can result in more severe disease in older adults. mCombriax has the potential to prevent both viruses. Beyond that, the vaccine represents a new frontier of convenience for patients.
How mRNA Drives the Combined Vaccine
Per the press release, mCombriax builds on the advances from the clinical development of mRNA-1010, Moderna’s investigational seasonal influenza vaccine, and mNEXSPIKE, Moderna’s COVID-19 vaccine. mCombriax was designed to protect against both seasonal influenza and COVID-19 by preparing the body’s immune system to recognize and respond to both viruses.
The vaccine contains mRNA, which provides instructions for producing proteins found in seasonal influenza viruses type A-H1N1, type A-H3N2, and type B of the Victoria lineage. The mRNA also provides instructions for cells to temporarily produce proteins found in SARS-CoV-2, the virus that causes COVID-19. The proteins are recognized by the immune system as foreign, which prompts the initial production of antibodies and protective white blood cells. The mRNA from the vaccine is naturally broken down and removed from the body after vaccination, but the effects linger: If the vaccinated person is later exposed to either virus, their immune system can respond more rapidly, helping to prevent serious illness and co-infection.
Evidence supporting the vaccine’s effectiveness includes a pivotal study involving approximately 8,000 adults aged 50 years and older. In the study, mCombriax was found to generate antibody levels against both influenza and SARS-CoV-2 that were statistically non-inferior to those produced by the combination of either Fluzone HD or Fluarix, which are both licensed influenza vaccines, and Spikevax, a licensed COVID-19 mRNA vaccine.
Combined Vaccines and Clinical Development
mCombriax’s impact may be far-reaching.
First, it appears to be a promising immunization candidate against seasonal influenza and COVID-19 in Europe. Seasonal influenza alone causes up to 50 million symptomatic cases each year in the European Economic Area (EEA), while COVID-19 continues to produce a steady stream of hospitalizations and deaths, a burden that, like severe flu, falls hardest on older adults. A strong vaccine contender may go a long way toward quelling both.
Second, the vaccine will also test developers’ capabilities to move nimbly in an evolving disease landscape. For example, the influenza strains targeted by the vaccine were based on the WHO’s 2023/2024 recommendations. As with existing vaccines targeting influenza and COVID-19 separately, the composition of mCombriax will need to be updated regularly to match evolving viral strains.
The vaccine also presents an interesting possibility from a messaging perspective. mCombriax has been deemed safe and is currently approved for active immunization in individuals 50 years of age and older across all European Union member states, as well as Iceland, Liechtenstein, and Norway. The most common side effects are relatively mild, ranging from injection site pain to headache, chills, and nausea. However, the medical community already struggles to reach patients who may be vaccine-averse due to fear of side effects. Developers will need to carefully craft messaging around potential post-vaccine downtime, emphasizing the fact that, by effectively serving the purpose of two vaccines in one, mCombriax may reduce vaccine recovery time. It is, undeniably, a simpler approach.
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“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,” said Moderna CEO Stephane Bancel in the press release. “mCombriax offers an important new option for Europeans, while also aiming to strengthen the resilience of healthcare systems across Europe.”
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