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FDA Authorizes Revisions to Evusheld Dosing

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If we have learned anything during this pandemic, we have learned that much of our knowledge quickly becomes obsolete. This is because it’s constantly being swept up in the flood tide of new viral mutation and scientific research.

The pandemic has indeed humbled many, including me.

On 2/24/2022, the FDA announced it recommends doubling the dose of Evusheld to protect the immunocompromised better, including those with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) against all variants of SARS-COV-2, the virus that causes COVID-19.

The FDA wants to do all it can to protect the immunocompromised against all the strains of COVID. They believe that a double dose is more likely to prevent infection against the present Omicron subvariants BA.1 and BA.1.1. In addition, it is effective against the emerging BA.2 or the “stealth Omicron” that is expected to soon be the dominant strain in the US. I also understand any breakthrough infections did not drive this. The FDA is simply being proactive and quick to respond, and for that, I am grateful.

I hope they will quickly share the data that drove this decision.

This dosing change won’t be easy to implement.

There is already a haphazard approach to Evusheld distribution. This will complicate matters in the short term as there will now be two groups who will benefit from another dose, those needing a “top up” to the newly recommended dose and those who have yet to receive a dose. It’s going to be tricky sailing for a while. I am anticipating many frustrated folks who would benefit from either a first or second dose and will have trouble accessing what they need,

The line has just gotten much longer with no clear rules in place about how Evusheld should be prioritized between those who have received what is now recognized as a partially recommended dose and those who have not.

It also raises serious questions about the supply, which has just been effectively halved.

Here is the FDA’s official statement: FDA authorizes revisions to Evusheld dosing.

I have more to say about this that you can find quoted in this article by CNN that also features some of our advocate friends in other immunocompromised communities: FDA doubles dosage of Covid-19 monoclonal antibody, raising concerns about access and supply.

CLL Society is very pleased that CNN and others in the press listen to other advocates and us and let the public know about our needs.

Brian Koffman MDCM (retired) MS Ed
Co-Founder, Executive VP, and Chief Medical Officer
CLL Society, Inc.

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When appropriate, the CLL Society will be posting updates and background information on the present Coronavirus pandemic focusing on reliable primary sources of information and avoiding most of the news that is not directly from reliable medical experts or government and world health agencies.