On November 10th, Operation Warp Speed published a “Playbook” for hospitals and healthcare providers for how monoclonal antibody therapeutics will be put to work to help combat COVID-19.
While this is ‘old news’, in the current moment of crisis we are facing, we felt it was a good time to put the spotlight on it, and talk about what else is urgently needed to actually make this effective in saving lives.
We Are Facing a Dire Situation
We are all familiar with the headlines. We are right back where we were in the Spring – but much worse. Now it’s nationwide, so the problem is many fold larger. Hospitals are once again on the verge of seeing their ICUs and general capacity overwhelmed. Our doctors, nurses and other caregivers are exhausted and being stretched well past their limits. When that happens, many of the gains we have made over the last 6 months in improving treatment and outcomes will be lost, and death rates will rise.
Meanwhile, between pandemic fatigue and the tragic politicization of public health response, much of the public continues to ignore the basic blocking and tackling that was and still is required to contain the epidemic. So now, states are going back into lockdowns, with all the negative impacts that has on our economy, lives and other health consequences.
Vaccines are Coming, But Not Soon Enough
Like everyone, we applaud the amazing speed with which safe, effective vaccines have been developed, and the herculean efforts being applied to get them manufactured and distributed at scale. This is clearly the tool for mass immunoprevention – i.e. how we get to herd immunity for the majority of the population. But the best case scenario remains the end of Q2, 2021 for vaccines to reach that target in the U.S. And there are several unknowns and problems with vaccines that will make this period particularly dangerous – and antibody therapeutics particularly needed.
- Historically, vaccines have often not been optimally protective for the elderly and people with pre-existing conditions. Sadly, with COVID-19 these are the exact groups most vulnerable to severe illness or death.
- As the vaccination program rolls out, people – especially young, healthy people that have little to fear from the virus but are known to be “super-spreaders” – will tend to lower their guard. So, there will be outbreaks in pockets.
- Some people will resist the vaccine, or get missed in the kinks of supply and demand. So, when there are outbreaks, there will be severe illnesses and deaths among the vulnerable. This is something we see every Flu season.
- If you are one of these unlucky individuals, a vaccine will not help you much if administered after you have already been infected or are showing symptoms.
So, vaccines are the most important tool, but we can’t count on them alone.
Antibodies Can Keep People Out of Hospitals – and Save Lives Now
The investigational monoclonal antibody therapeutic cocktail of casirivimab and imdevimab, from drug maker Regeneron, is not for COVID-19 patients who are already hospitalized, but instead for patients who have mild to moderate COVID-19 symptoms and who are at high risk of disease progression. According to the FDA, administration of casirivimab and imdevimab proved better than a placebo at reducing viral load in infected patients. Additionally, the FDA said, for high-risk patients, only 3% of those treated with the drug cocktail eventually required hospitalization or emergency room visits, versus 9% for those who received the placebo.
“Keeping patients out of the hospital with this therapeutic can reduce the strain on our healthcare system, help hospitalized patients receive better care, and in all likelihood, save lives,” Alex M. Azar, secretary of Health and Human Services, said during a conference call today.Warp Speed Readies to Distribute New Therapeutics for COVID-19, November 23, 2020
And Operation Warp Speed Published a Playbook of How
With thanks and credit for their transparency and communication, here are the slides and points that we think are most important to the discussion and action plans that now need to be implemented.
Early Identification and Treatment is Critical
The key to this is early identification and treatment. This requires rapid and frequent testing – with quick turn-around of results.
Focus On the Most Vulnerable
As we have explained here, we now have a strong epidemiological understanding and data set that COVID-19 is much more dangerous for the elderly and people with pre-existing conditions. But it is also unpredictable – many who are much younger with no health problems or conditions have died or suffered severe, long term illness. So we need to focus on the people prone to be vulnerable, but carefully monitor early progression of symptoms for all people.
Antibody Treatments Require Medical Support
Unfortunately, maBs generally and the Regeneron and Lilly cocktails must be administered via an intravenous infusion (IV). So they need to be done by qualified nurses, with other medical support, and can take 30 – 60 minutes.
And Should Be Given on an Outpatient Basis
The sub-title of the document is: Outpatient Administration Playbook. In fact, by the time a patient is sick enough to be hospitalized, antibody therapeutics should not be used, and are not authorized to be used under the EUA. The opportunity and purpose here is to treat people who are likely to get very sick early, and keep them out of the hospital. For that reason, they established flexible criteria to enable the creation of alternate sites for treatment. These can be set up in both portable facilities, and existing locations like urgent care clinics.
So, When Will This Start to Have an Impact?
The answer is now! Distribution of both antibody cocktails has begun, and is documented on this Web site. Alas, because funding for production of antibody therapies were paltry compared to vaccines, supplies are limited. But Operation Warp Speed has the option to order additional amounts under existing agreements, and certainly the funding and ability to support additional ramping of production.
And What Can We Do to Increase their Impact?
We will talk about that in detail in our next blog! Supplies are limited, and demand is far beyond capacity if used for everyone that could potentially benefit. So, the strategy must be very targeted. 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.
- Allocation by Casirivimab/Imdevimab (Regeneron) by Jurisdiction
- Lilly Bamlanivimab Antibody Playbook
- Allocation of Bamlanivimab by Jurisdiction