Moderna races ahead in flu and Covid-19 combo vaccine race with Phase III win – Clinical Trials Arena

The journey towards a combined flu and Covid-19 vaccine just got one step closer following Modernas announcement of positive data from a Phase III trial of its mRNA vaccine candidate.

Compared to two individual vaccine administrations, a single shot of the combined vaccine elicited a stronger immune response against both diseases.

Named mRNA-1083, Modernas jab comprises a seasonal influenza vaccine candidate, mRNA-1010; and a next-generation Covid-19 vaccine prospect called mRNA-1283, both of which have fared well in their own respective Phase III trials.

Now, in a Phase III trial (NCT06097273) for mRNA-1083, Moderna said the candidate brought about statistically significantly higher immune responses compared to existing vaccines on the market. The trial met its primary endpoints, Moderna said in a 10 June press release.

The study evaluated the safety, reactogenicity and immunogenicity of the vaccine in around 8,000 participants, equally split into two independent age cohorts one with adults aged 65 years and older and the other with adults aged between 50 to 64 years. In the older age group, Modernas candidate was pitted against the companys Covid-19 vaccine Spikevax and Sanofis flu vaccine Fluzone HD. In the younger age group, Fluzone HD was substituted for GSKs Fluarix, whilst Spikevax remained.

Moderna stated that a single dose of mRNA-1083 was non-inferior versus the co-administered comparators. According to Moderna, those who received the combined vaccine showed an improved immune response compared with those who had the flu and Covid vaccines separately. The drugmaker added that the immune response was seen across three influenza virus strains (H1N1, H3N2, and B/Victoria) and against SARS-CoV-2.

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As for safety, mRNA-1083 was in line with licensed vaccines used in the trial. The most common adverse reactions included injection site pain, fatigue, and headache.

The most recent flu season in the UK had a great deal more cases than previous years. Englands National Health Service (NHS) revealed that flu cases in late January were up 75% from the same period last year. At some of the highest levels in winter, data showed an average of 2,226 patients were in hospital each day with flu, three-quarters up from the same week in January 2023.

Modernas CEO Stphane Bancel said: Combination vaccines have the potential to reduce the burden of respiratory viruses on health systems and pharmacies, as well as offer people more convenient vaccination options that could improve compliance and provide stronger protection from seasonal illnesses.

While other companies are developing their own combined Covid-flu vaccine, Moderna is ahead of the competition being the only one testing in Phase III trials. Pfizer and BioNTech, for example, announced positive data from a Phase I/II trial in October 2023.

Bancel stated that Moderna is the only company with a positive Phase III flu and Covid combination vaccine.

Although Moderna has not published the full dataset from the Phase III trial, it plans to present the results in more detail at an upcoming medical conference, in addition to a submission for publication. The company said it will engage with regulators on next steps.

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Moderna races ahead in flu and Covid-19 combo vaccine race with Phase III win - Clinical Trials Arena