One can have differing opinions and positions on the wisdom of various strategies that have been pursued by different nations and governments to contain and respond to the COVID-19 epidemic over the course of 2020. The world has served as a trial laboratory for just about every path that is possible. But there is one thing that is now certain:
- While the epidemic rages in the US and Europe, and various countries consider returning to lockdowns or less draconian measures, antibody-based therapeutics remain grossly underfunded and underprioritized.
As Dr. Scott Gottleib, former FDA Commissioner for the Trump Administration, commented yesterday:
From @BARDA shows prioritization of Covid vaccines over therapeutics by feds. Antibody drugs could be a critical bridge to a vaccine; but supply is sharply limited. It’s not too late to surge new manufacturing; improve distribution of drugs to maximize benefit.Dr. Scott Gottlieb, October 27, 2020
What Can We Do to Change This?
Immunoprevention.org remains dedicated to changing this, with more urgency than ever! There are three tracks that need to be pursued aggressively in parallel.
1. Building awareness and avenues to connect people in vulnerable population groups that have been infected to rapid treatment with antibody-based drugs
This is something that can start saving lives in the very short term, if we are proactive in taking advantage of it. Given that for the short term, antibody-based drugs will be in very short supply, and the Federal government will follow its current practice and leaving distribution entirely up to each state, this is an opportunity for action on a local level. If you work in public health or the healthcare response to COVID-19 in your state or community, or are just a concerned citizen that can help with our outreach, please:
2. Ramping up production to address the prevention use case – not just treatment
Unfortunately, our manufacturing capacity is limited, and there has been no national effort thus far (as of October 26, 2020) to change that. In the short term, we can produce with existing capacity – which is substantial, with plans for millions of doses per month by Q1 2021. Given the current rates of infection, this will limit use to only high risk population groups. However, with focus and action now, the Federal government can play a critical role in 3 areas (for those with interest, see Duke Margolis Center for Health Policy: COVID-19 Manufacturing for Monoclonal Antibodies) to change capacity for both the mid and long term:
1. capital investment – or covering the risks of these – to ramp production;
2. coordination of supplies and production with existing facilities – as Operation Warp Speed is doing now for vaccines; and
3. expand manufacturing on a relatively short timeframe using replicate single-use modular platforms or by identifying and bringing online mothballed facilities.
If you would like to support and participate in this effort, you can:
3. Developing Innovative Models to Make Them Accessible While Still Gathering Good Data
We have partnered with Clinical Trial Media to develop an innovative Phase 4 Trial model to support this, and are approaching the leading Pharma/BioTech developers (Regeneron, Lilly, AstraZeneca, etc.) to discuss how it can be implemented. If you would like to support and participate in this effort, you can:
Want to Help?
Companies, non-profits, institutions, and community-based organizations are essential partners for Immunoprevention.org to help America and the world beat Covid-19. We can provide a digital infrastructure, focus and plan, but it is ultimately the actions and work of our partners that will win this war. If you would like to help, please: