We Have an Answer, and It’s NOT Let It Be. Bam Bam and REGN-COV2 are Here!

Marla Keller, MD, infectious diseases, Albert Einstein School of Medicine

Vice Chair for Research, Department of Medicine & Associate Director, Block Institute for Clinical and Translational Research

Member, COVID-19 Treatment Guidelines Panel, National Institutes of Health

Rumors of shortages of the Regeneron and Eli Lilly monoclonal antibodies that treat COVID-19 are exaggerated; many hospitals are now adequately supplied. The problem is, these are I.V. administered medications, yet should be given in the first week after symptom onset (10 days maximum), before the disease becomes severe enough to require hospitalization.

According to CNN,

There are very few drugs that prevent people with early Covid-19 from progress to severe disease, but monoclonal antibodies may be among them. Early study results show they may reduce the rate of hospitalizations by up to 70% if they are taken in time, which can be life-saving, especially among people who are at high risk of getting very sick.

But it seems that the word is not getting out to those who need the medications the most, or their health care providers.

Eli Lilly's monoclonal antibody, called bamlanivimab, received an emergency use authorization from the US Food and Drug Administration in early November. Less than two weeks later, the agency granted an EUA to Regeneron's monoclonal antibody cocktail, made up of two monoclonal antibodies, casirivimab and imdevimab, and called REGN-COV2. It was given to President Trump when he got infected at the start of October. Former New Jersey Gov. Chris Christie and Housing and Urban Development Secretary Ben Carson were also treated with monoclonal antibody therapy.

FDA authorizes emergency use of the antibody cocktail given to Trump to treat Covid-19

According to the FDA, monoclonal antibodies should be given as soon as possible after symptoms emerge and a person tests positive for infection. And, because of limited supply, the authorizations are limited to high-risk patients, such as people 65 and older, those who have a BMI (body mass index) of 35 or greater and those with other health conditions like diabetes, cardiovascular disease or chronic kidney disease.

"The monoclonal antibodies we've authorized seem to work best for preventing hospitalization in outpatients early in their disease — typically within 10 days of the onset of symptoms, if you are a high-risk individual. So, over the age of 65, or over the age of 55 with a comorbidity, or… some preexisting illness to put you at risk," FDA Commissioner Dr. Stephen Hahn told CNN's Dr. Sanjay Gupta in mid-December.

"These antibodies, for the last month since authorization, have been distributed around the country. So, they should be available locally, and it's under state jurisdiction," Hahn said.

[To read the rest of the CNN story above, which we recommended, use this link.]

People recently diagnosed with COVID-19 can receive these antibodies by I.V., but need to do so right away, as outpatients. This has forced hospitals to set up “access sites”, the locations of which have not been made public. Your doctor, RN, or physician assistant (PA) should have a phone number they can call to make arrangements for you if you meet some broad eligibility criteria, and may be able to put you on a reserve list if you don’t. If they don’t have this information, suggest they call one of the numbers at the end of this article.

In an appearance on This Week in Virology, Dr. Daniel Griffin of Columbia and The ProHealth Network said:

I’m now starting to see a significant number of people who go for this. The first person I saw got it on day 4, two days later felt great, another gentleman got it on day 9, didn’t notice much, ended up in the hospital. The suggestion is that if you get these monoclonal antibodies within the first week, there’s about a 70% reduction in progressing to hospitalization. The U.S. government is actually distributing 65,000 doses every week, but only about 20% are getting used.

Ways for health care professionals to request monoclonal antibody therapeutics:

Via the channel they have been directed to use by their employer or the New York State Department of Health
By calling 516-918-6089 (administered by Northwell)
By contacting Eli Lilly at 855-545-5921 or 800-545-5979
By contacting Regeneron at 844-734-6643

Montefiore and Jacobi may have information, but we have not been able to verify it.

Their websites are:

https://covid19.montefiore.org/home

https://www.nychealthandhospitals.org/jacobi/