This site was founded based on insights and understandings about the importance of antibodies in the fight against COVID-19 that were first published in June, 2020: COVID-19 and SARS Coronavirus 2: Antibodies for the Immediate Rescue and Recovery Phase. Sadly, that opportunity to scale the production of antibodies back then, which would be saving lives right here and now in the peak of the third wave was missed. Therapeutics in general, and antibody therapeutics in particular, have suffered from gross underinvestment and lack of focus and urgency from the very earliest days of this epidemic. Dr. Scott Gottleib, former FDA Commissioner for the Trump Administration, put it this way:
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
But it’s not too late for antibodies to play an important role going forward. As Dr. Gottlieb put it, antibodies can be a COVID insurance policy for 2021. And more.
Where We Stand Now
First, let’s revisit where we stand right now.
- Antibodies have a 100+ year track record of success as a strategy to reduce infections and disease in epidemics, and should have been a top priority for development and production.
- In September and October, the first data from clinical trials by Regeneron and Eli Lilly and others demonstrated efficacy with no significant safety concerns.
- In November, both Regeneron’s Casirivimab and Imdevimab and Eli Lilly’s bamlanivimab received EUAs and have are in nationwide distribution (see: Casirivimab / Imdevimab; bamlanivimab, and both the NIH and FDA specifically highlight the use of antibody therapeutics – subject to the physician’s judgement – for early treatment of at-risk individuals.
- The 3rd wave of the epidemic is once again overwhelming our hospitals and healthcare staff – which is of course leading to a surge in deaths and the rate of deaths per hospitalization, as well as incalculable new economic damage and stress.
- Vaccines are rolling out, but our best case scenario for reaching herd immunity is the end of Q2, 2021, and we cannot be sure they will be fully protective of vulnerable population groups.
How Can We Maximize the Benefit of What We Can Produce in the Short Term?
Supplies are limited, and demand is far beyond capacity if used for everyone that could potentially benefit. But there are also some silver linings that we can leverage. We know:
- what population groups generally are at highest risk of severe illness or death;
- how to monitor individuals that do not fall into these groups, but are showing a progression of symptoms that indicate they are at risk for severe disease or death; and
- how and when to treat at risk patients with antibody therapeutics to reduce their risk of hospitalization and death.
All of this is laid out in by in Operation Warp Speed’s Playbook:
So, with a targeted strategy matching antibodies to those who will most benefit, we can maximize the benefit.
We Need a Strategy for Focused Protection with Antibodies
The public health and medical community should set the specifics of enacting this, but it will also take support from our political leaders and the public. We must have supply, knowledge, awareness and action working in concert to match antibody therapeutics to the right patients at the right time: a strategy of Focused Protection.
The details are critical, but, we think this would be a good place for each state to start.
- Demand funding and action from Congress and Operation Warp Speed to increase production and expedite distribution of antibody therapeutics.
- Implement a communications campaign to the public so that people who are in vulnerable population groups are aware that this therapy exists, and that early action is critical to their effectiveness.
- Set up a registry of these people, as well as a self service Web site for proactive people that would like to determine if they are vulnerable, and be able to develop a concrete plan of action for what they should do if they are infected.
- Set up a hotline and brief physicians / clinics / healthcare networks so that they know what to do with patients in their population that are at risk of severe outcomes from COVID-19.
With this action plan at the state and local level, we could start to empower citizens and public health leaders to work together in a smart, focused way to stay safe and re-open our economy more quickly over the first half of 2021.