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Abstract
An urgent need exists for a universal flu vaccine to be more effective than current vaccines, yet there is no such vaccine in the market and no regulatory guideline for its approval. This report proposes a stepwise process for regulatory and marketing approval for such a vaccine. As a first step, the universal vaccine will be tested as a primer to existing HA-based vaccines. Regulatory approval and conditional marketing authorization will be granted based on safety assessments and improved hemagglutination inhibition antibodies (as a marker for efficacy) for the vaccines used in combination. Permanent market authorization will be granted next, based on clinical efficacy data, accumulated during several years, and ultimately the new vaccine will be approved as a standalone vaccine.
Financial & competing interests disclosure
All authors are either employees or related to the BIONDVAX pharmaceuticals company that is developing M-001. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
No writing assistance was utilized in the production of this manuscript.