NPR ran a good story yesterday on the current surprising low demand and usage of the new game-changing antibody therapeutics from Regeneron and Eli Lilly. They point out that after the successful treatment of President Trump, Governor Christie and other prominent people, the initial expectation was there would be a shortage of these drugs given the surge in need with the 3rd wave of the epidemic.
There should be a shortage because these are the first effective treatments that can help to prevent severe disease or death in the midst of an epic wave of infections, and supply is much more limited than vaccines. So the initial fear was there would be overwhelming demand and rationing needed. Ironically, and increasingly tragically, however, because of the confusing guidance, these treatments are sitting on the shelves in many places. As the NPR story highlights, this is much to the consternation of the FDA, HHS and Operation Warp Speed, which have provided clear guidelines for how to leverage them to reduce hospitalizations and save lives.
The NIH’s guidance leaves the question of use up to physicians and their patients – but also specifically highlights their availability and value when used early in disease progression for high risk individuals. While that may be appropriate in normal circumstances, given how overwhelmed physicians and healthcare network are currently, the equivocal phrasing has resulted in confusion and hesitancy in the medical community. Some states and healthcare networks are moving forward aggressively in using them – with great success – and others are not.
These antibody therapeutics leverage the same basic biological mechanisms as the new vaccines – and are based on 100+ years of success with antibodies-based treatments for viral diseases. They have demonstrated strong efficacy in clinical trials as treatment to help prevent hospitalization and deaths and have been made available – in consultation between patients and their physicians – under the same Emergency Use Authorization as vaccines currently being deployed to tens of millions of people.
There are two key criteria.
- At risk individuals – the elderly, and others that are compromised with pre-existing conditions – who are at high risk for hospitalization or death from COVID-19.
- Early detection & treatment – must get within 3 – 10 days after infection, when symptoms are still mild.
We hope that those physicians and providers that are leading the way with the proactive use of antibody therapeutics to reduce hospitalizations and save lives will share their best practices and experiences to the benefit of citizens across the nation. As Dr. Eric Daar of UCLA Medical Center, in an Infection Disease Society of America Podcast dedicated to Monoclonal Antibodies for COVID-19 put it:
The most important thing is that institutions that have access to this therapy . . . have put in a great deal of thought to make sure that any provider or patient that wants to take advantage of this opportunity through the EUA, that they do indeed have access to it.Dr. Eric Daar of UCLA Medical Center, in IDSA Podcast: COVID-19