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The COVID-19 pandemic is a global health emergency that will disproportionately impact the health and economies of low- and middle-income countries (LMICs). The only solution to the pandemic is global vaccination, coupled with annual vaccination for years to come. This scenario has the potential to create catastrophic health inequities in the global south and must be addressed.
The media reports daily on the progress of the front runner vaccines, many of which are being advanced by developed countries for their own populations. While these vaccine technologies can be incredibly innovative and cutting edge, many require specialized manufacturing capabilities, significant capital investment and costly sub-zero storage / transportation. These vaccines, that ultimately must pass their costs on to the consumer, are not suitable for long term, low-cost, mass vaccination campaigns, which is what is needed if we are to control COVID-19 in the decades to come.
To address these looming health inequities, we partnered with research partners and developed a vaccine (NDV HxP-S) based on the well-established influenza vaccine that was created over 70 years ago. NDV HxP-S has performed well in preclinical trials, has a very high yield (large volumes can be made in a short amount of time), and has shown to be very stable during storage and transportation. Most importantly, this vaccine can leverage the billions of dollars of global infrastructure that has been established to manufacture the annual influenza vaccine.
To enable long term supply for LMICs, we have given royalty-free licenses to 3 large influenza vaccine manufacturers in the global south: Vietnam (IVAC), Thailand (GPO) and Brazil (Butantan). These manufacturers alone will be able to produce more than half a billion doses on an annual basis. To put some context behind this, one must consider that even with the ongoing colossal effort by global vaccine manufacturers, there will be a shortage of over two billion doses/year for annual vaccination programs.
We estimate that NDV HxP-S will have a long-term cost of $2-3 per dose. A low price is a critical element of access, and although many manufacturers have agreed to offer low cost doses to LMICs, these agreements are short term and only valid until WHO declares an end to the pandemic, which, by their own estimates, is likely a year or less from now.
The initial push for NDV HxP-S, which included development and preclinical (animal) trials, has been funded by a large global foundation. Now, Phase 1 (safety) and Phase 2 (efficacy) trials need to occur, followed by a large-scale Phase 3 clinical trial. Currently, however, virtually all global resources are focused on Phase 3 trials for this “first wave” of vaccines that will be distributed, for the most part, in developed countries. These global funders require vaccine producers to ship 20% of this initial wave to LMICs, but as mentioned above, the demand will greatly outweigh the supply and the long-term price will rise and greatly limit access. NDV HxP-S is considered to be a “second wave” vaccine and one that would be utilized for years to come.
A key aspect of our strategy is to conduct Phase 1 and Phase 2 clinical trials within these manufactures’ local markets and seek funding from local entities. In this way, distribution of the vaccine in that country (and neighboring countries) will take first priority and 100% of the production will go to LMICs. The governments of Vietnam and Thailand have each contributed to this effort and the manufacturers will cover all associated internal costs. There is a funding gap, however, of approximately US$500K for Vietnam, US$500K for Thailand and $2.3M for Brazil.
We are inviting interested parties to contact Carmen Forsman at email@example.com for more information.