NIH Statement on Lilly’s Bamlanivimab Creates Caution and Confusion Where There Should Be Urgency and Action

With the 3rd wave of the COVID-19 epidemic crashing up on the nation, literally tens of thousands of lives depend on the actions our government and public health leaders take over the next few critical weeks and months.

As chronicled on this site, the good news is that a new class of drugs which represent a game changing, life-saving new option in the battle against COVID-19 have arrived on the scene: antibody therapeutics.  Specifically, Eli Lilly’s Bamlanivimab and Regeneron’s REGN-COV2 have received Emergency Use Authorizations (EUAs) in the last week.  Nationwide distribution of stockpiles that were produced in advance has now started.

Unfortunately, the guidelines published by the NIH’s COVID-19 Treatment Panel on November 18th appear to be creating caution and confusion around the opportunity these therapies represent, rather than the urgency and action they deserve. To give on example, here in Vermont, at Governor Phil Scott’s twice-weekly press conference on Tuesday, Vermont Health Commissioner Dr. Mark Levine characterized these drugs as follows.

Health Commissioner Mark Levine said the drug “unfortunately received unfavorable reviews” from both the National Institutes of Health and the Infectious Disease Society of America. “The NIH felt that there was insufficient data to recommend for or against the use of this drug,” Levine said.

VtDigger.com, November 24, 2020

This in turn resulted in the following headline and article in the VtDigger.com:

It is understandable to be cautious with new therapies and drugs which still only have Phase 3 trial data, and we fully support all public health measures recommended by Dr. Levine, the FDA and CDC to reduce the spread of infection, and their leadership in this crisis. We also are cognizant that the initial supplies of these therapeutics are limited. But the stark realities of the death and severe illnesses that COVID-19 will wreak upon our nation in the very near term must be factored in to risk calculations. 

The NIH’s statement should also be weighed against the funding and effort both the FDA and NIH have put into this class of drugs since February.   Dr. Faucci, FDA Commissioner Hahn, and CDC Director Dr. Redfield – as well as former FDA Commissioner Dr. Gottlieb –  have all spoken repeatedly since then about the promise and importance of this approach.  We also note and applaud that the NIH and many other organizations have launched Phase 3 trials for the use of antibodies in prevention, not just treatment.

These are all important steps and solid data is critical. But we also must factor in the current extraordinary and grave situation the nation faces into calculations of risk, and bias towards action. Billions of dollars were invested to ramp up production while the Phase 3 trials were completed precisely because these had a strong probability of success and saving lives. So, now they have arrived – and we must not be afraid to use them!

The calculus is simple:

  1. For the elderly and persons with pre-existing conditions, the risk of severe outcomes is very high
  2. Applying antibodies to save lives and prevent infections has been used successfully for over a century, and this class of drugs also have successful track records. 
  3. The trials and data gathered for Bamlanivimab and REGN-COV2 clearly demonstrate a dramatic reduction in hospitalizations with no significant safety concerns.
  4.  Antibody therapies are also known to help protect the most vulnerable population groups for whom vaccines are often less than optimally effective.    

The key to success with these therapies, however, is rapid administration – while infections are still early and symptoms moderate to mild.   That in turn depends on awareness in the medical community, increased supply, and a rapid response system for delivery.

Therefore, we believe that government and public health leaders should be putting maximum effort increasing production, securing supplies and ensuring that that the processes for rapid identification and treatment of persons in vulnerable population groups those most likely to be helped can happen rapidly after confirmation of infection.  It is literally a matter of life and death.

Once that first goal is achieved, then the use of antibody therapies should be expanded to a broader group of vulnerable persons as a prophylactic measure prior to as a exposure. We repeat that while the new vaccines soon to arrive are the best possible tool for most adults, based on long experience with the Flu and Coronavirus cousins, there is significant risk that they will be less than optimally effective for the elderly and those with pre-existing conditions.

Vaccines are on the way, but antibodies are here now. We urge our leaders to put urgent focus and resources into bringing them into the fight to save lives and contain COVID-19 as rapidly as possible.

Further Reading:

The COVID-19 Treatment Guidelines Panel’s Statement on the Emergency Use Authorization of Bamlanivimab for the Treatment of COVID-19

NIH.gov: Clinical trials of monoclonal antibodies to prevent COVID-19 now enrolling

FDA Approves Eli Lilly’s Monoclonal Antibody Cocktail

Regeneron’s REGEN-COV2 Receives Emergency Use Authorization

NEJM: SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19

The History and Science of Antibodies

COVID-19 Prevention Network: The Science of COVID-19 Vaccines and Antibodies

Why COVID-19 kills some people and spares others. Here’s what scientists are finding

NIH Statement on Lilly’s Bamlanivimab Creates Caution and Confusion Where There Should Be Urgency and Action
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