2023-10-24 14:09:00
The first ‘2 in 1’ vaccine against influenza and Covid could arrive in 2025. American Moderna today announces the start of phase 3 – the last step of clinical trials – for the mRna-1083 vaccine candidate. The first dose was administered today, the company informs. The trial is expected to enroll approximately 8,000 adults in the Northern Hemisphere. Moderna, we read in a note, “continues to target potential initial regulatory approval for the combined vaccine in 2025.”
The phase 3 study – explains Moderna – will evaluate the “immunogenicity, safety and reactogenicity” of mRna-1083 compared to an active control, i.e. compared to the co-administration of vaccines already authorized against influenza and Sars-CoV-2. There will be two independent cohorts of adults on which the combined vaccine candidate will be tested: 4 thousand people over 65 and 4 thousand aged between 50 and 65.
The trial – recalls the company – follows the phase 1-2 study in which mRna-1083 showed “strong immunogenicity against influenza and Covid-19, with an acceptable reactogenicity and safety profile, compared to approved single vaccines” . In more detail, technically the product “achieved hemagglutination inhibition antibody titers similar to or greater than those of both authorized quadrivalent influenza vaccines, and Sars-CoV-2 neutralizing antibody titers similar to the Spikevax* bivalent booster”.
For Moderna, “mRna-1083 has the potential to effectively reduce the overall burden of acute viral respiratory diseases by providing simultaneous protection against influenza viruses and Sars-CoV-2, with a single injection.” The ‘2 in 1’ vaccine candidate also offers “greater convenience” and could increase adherence to vaccination, thus leading to “greater compliance with the recommendations” on the share of the population to be protected. Ultimately, “this approach could bring benefits to public health, synergistically increasing coverage rates against influenza viruses and Sars-CoV-2”.
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