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Update to the FDA Fact Sheet for Healthcare Providers: Emergency Use Authorization for Evusheld

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On October 3, 2022, the FDA updated the guidance offered to healthcare providers concerning Evusheld (the cocktail of two COVID-19 monoclonal antibodies, tixagevimab, and cilgavimab). Evusheld is currently the only authorized Pre-Exposure Prophylaxis (PrEP) against COVID-19 for the immunocompromised, including those with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), in whom protection provided by the COVID-19 vaccine is unpredictable and less robust.

CLL Society wants to take a moment to explain these changes to our community, and we promise to share more information as we learn more from our meetings with the FDA, CDC, ASPR, and AstraZeneca (the manufacturer of Evusheld).

Let’s start with the bottom line.

CLL Society still recommends that everyone with CLL / SLL consult their healthcare team about receiving Evusheld. This is because when this article was written it remained active against the dominant circulating variant, BA.5, which makes up approximately 81% of all COVID-19 cases in the US. Based on the available data, CLL Society continues to believe that Evusheld is the best option for preventing severe COVID-19 disease and death for those with CLL / SLL, regardless of their treatment status.

It is important to note that for the first time the FDA has stated (and we are quoting directly from section 5.3 of the Fact Sheet): “Certain SARS-CoV-2 viral variants may not be neutralized by monoclonal antibodies such as tixagevimab and cilgavimab, the components of Evusheld. Therefore, Evusheld may not effectively prevent COVID-19 caused by these SARS-CoV-2 viral variants.”

It is reassuring that while higher levels of Evusheld may be needed to neutralize other specific variants, neutralization can still be reliably achieved at the present recommended dosing.

We also echo the FDA’s strong message in the updated fact sheet: “If signs or symptoms of COVID-19 occur, test early for COVID-19 and seek medical attention, including starting treatment for COVID-19 as appropriate.” Early treatment is critical for those with CLL / SLL.

Reviewing the data provided by the FDA on the fact sheet, the most resistant and worrisome variant appears to BA.4.6. However, there are a couple of important things to consider when reviewing this data. First, it is important to keep in mind that testing was performed using a pseudovirus and not the more reliable authentic virus. So these testing results from the pseudovirus need to be confirmed once the authentic virus is available. And second, BA.4.6 currently represents only 12.8% of COVID-19 cases on average in the US. However, its proportion is growing week by week. If you are someone who has received Evusheld, please keep a close eye on how predominant BA.4.6 is in the area you live by frequenting the CDC’s variant tracker, specifically scrolling down to the map of the United States on that webpage and click on your region. For example, BA.4.6 makes up only 5% of COVID-19 cases in California. By contrast in Missouri, BA.4.6 makes up 21.9% of COVID-19 cases there.

What does this mean for those with CLL / SLL?

CLL Society’s recommendations remain the same as always:

  1. Make sure you are up-to-date on COVID-19 vaccines and get boosted with the new bivalent COVID-19 vaccine as recommended for the immunocompromised. The good news is that both the Moderna and Pfizer new bivalent boosters are still protecting against all the circulating variants in the US, including BA.4.6, for those who respond to the vaccine. It is also important to remember that even if you have not previously had a robust measurable COVID-19 antibody response, that does not mean that the vaccine has not stimulated other parts of your immune system (i.e., the T-cells) that are very important in fighting off infection.
  2. Obtain Evusheld every six months as recommended. Again, it still retains activity against BA.5, which was still the most dominant variant when this article was written.
  3. Consider being even more careful and consistent right now about wearing a well-fitted N95 or KN95 mask, continue to practice good hand hygiene, and avoid high-risk environments such as crowded or poorly ventilated indoor spaces.
  4. Keep an eye on the level of community spread (number of cases) in your area and check the CDC variant tracker weekly in your area to gauge what variant is dominant where you live.
  5. Make sure you keep your COVID-19 Action Plan updated and revisit it periodically to remind yourself what you should do.

Unfortunately, the pandemic is not over for those with CLL / SLL, but we can still be part of the world with appropriate precautions.

There is some relatively good news about the updated information in the FDA fact sheet on Evusheld. First, it is important to remember that the FDA has not pulled Evusheld’s emergency use authorization as it has done previously with other monoclonal antibodies (such as Regen-COV and sotrovimab) because it still offers valuable protection to high-risk individuals against the dominant circulating variant, BA.5.

However, the updated fact sheet serves to prepare healthcare providers to be aware of the rate of BA.4.6 in case it begins to outperform BA.5 in the US in the coming weeks or months.

Also, the FDA included the updated language by the NIH in the fact sheet, which included those with CLL / SLL as individuals who should be considered immunocompromised and eligible for Evusheld (located on page 4). CLL Society has been advocating hard on behalf of our community for these language changes with various government agencies for well over a year, so we are thrilled to see the FDA using the inclusive NIH language.

Please keep checking CLL Society’s website. This is a developing story, and we will share any ongoing updates with our community as they occur. What we know for sure by now at this point in the pandemic is that the only consistent thing about COVID-19 has been ongoing change and updates as new data are available.

Our Chief Medical Officer, Dr. Brian Koffman, made this recording for those who prefer their news via video.

Stay strong. We are all in this together.

CLL Society

CLL Society - COVID-19

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.