A recent study published in the journal Eurosurveillance has provided interim results on influenza vaccine effectiveness (VE) estimations for the 2022/2023 season, with data obtained from primary care, emergency, and hospital settings across six European countries. VE was found to be only 27%–44% for influenza A and ≥50% for influenza B, highlighting a longstanding unmet need for more effective seasonal influenza vaccines.

Prior to the start of each influenza season, the strains that are predicted to be dominant in the upcoming months are selected to be included in seasonal influenza vaccines. Therefore, current vaccines do not protect against all strains, particularly as the dominant strains can change during the time required to produce and distribute the vaccines. However, research into universal influenza vaccines, which have the potential to protect against a much wider variety of strains—including unanticipated strains—is gaining precedence, as several of these candidates have reached clinical development.

The concept behind universal influenza vaccines is that they are created to provide protection against more strains of the virus than the quadrivalent influenza vaccines. The antibodies produced as a result of these universal influenza vaccinations should be able to recognise conserved epitopes on the surface of various influenza strains. This would be particularly advantageous in the event of an influenza pandemic arising from a new strain.

GlobalData estimates that in 2022, the lab-confirmed seasonal influenza mortality rate across all ages was estimated to be 1.24 per 100,000 in the US. However, a universal vaccine that confers immunity against a wide range of influenza strains could drastically reduce influenza-related hospitalisation and mortality. Several candidates have already reached Phase II trials, including Imutex’s FLU-v and Osivax’s OVX-836. In a Phase IIb trial, FLU-v demonstrated positive results in protecting against the intranasal challenge of wild-type (H1N1)pdm09 influenza A virus, with mild-to-moderate influenza disease significantly reduced in the FLU-v treatment arm compared to placebo.  Additionally, in a Phase IIa trial, OVX-836 demonstrated a strong safety profile and protective efficacy in reducing polymerase chain reaction (PCR)-confirmed influenza-like illnesses by 78%. The vaccine continues to be evaluated in further Phase II studies.

Additionally, the first mRNA-based universal vaccine, H1ssF-3928 mRNA-LNP, which was designed by the Vaccine Research Centre (VRC) of the National Institute of Allergy and Infectious Diseases (NIAID), has also recently advanced to Phase I clinical development in the US. This open-label trial will test the safety and immunogenicity of the H1ssF-3928 mRNA-LNP vaccine against an approved quadrivalent seasonal influenza vaccine. The study will aim to recruit three groups of ten participants who will be vaccinated with either 10μg, 25μg, or 50μg of H1ssF-3928 mRNA-LNP to determine the optimum dose, which will then be administered to a further ten participants. In addition, an active comparator group of ten participants will be vaccinated with the most recent seasonal influenza vaccine. The advantage of designing an mRNA-based universal influenza vaccine is that it could potentially be tested and produced quickly at a large scale, resulting in faster distribution to larger numbers of patients.

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