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July 15, 2021

**Update: On Friday, July 16, the FDA granted a priority review for Pfizer’s application for full approval of its COVID-19 vaccine, which is expected within two months. This will give doctors the option of administering a vaccine booster to immunocompromised individuals.

Current status 

Immmunocompromised individuals, especially those taking treatments which further compromise the immune system, have a very poor response to the two-dose Pfizer and Moderna COVID-19 vaccinations. Very low levels of antibodies (even zero) develop, which is obviously very disappointing and leaves individuals vulnerable. 

This means that myeloma patients receiving immune therapies, such as anti-CD 38 antibodies or BCMA-targeted therapies, must behave as if unvaccinated and take precautions using masks, social distancing and the like to stay safe. This is one of the topics addressed in the new video in the IMF’s IMWG Conference Series: ASCO/EHA 2021. Also in the news this week is an Op-Ed in the L.A. Times that summarizes and analyzes the current situation and spells out how a third booster shot can potentially provide immunocompromised individuals with an answer.

The Washington Post reported today that CDC advisers will meet July 22 to consider additional doses of COVID-19 vaccine for immunocompromised patients. This is good news and, hopefully, we will see some positive steps moving forward.

Experience with boosters 

There are no data yet to indicate the benefit of a booster for myeloma patients. A new study is just starting in Greece to gather information and assess the value. However, a recent French study showed that nearly half of test subjects in parallel situations responded well to a booster shot. Of 59 patients who lacked antibody response after two shots, 44% showed positive results after a 3rd shot. In the U.S., benefit has also been shown for a small number of patients who have managed to get a 3rd shot.

France and Israel have already approved boosters for immunocompromised people and the U.K. has announced intentions to do the same. 

Options in the U.S.

The Pfizer and Moderna vaccines are available through the Emergency Use Authorization (EUA). This means that giving a third shot would violate the current CDC Provider Agreement. In addition, there are currently many hurdles to starting clinical trials of a third shot in this setting, despite deep concerns about new COVID-19 surges in states across the country due to the Delta variant.

Two solutions discussed by Jennifer and Robert Mnookin in their L.A. Times Op-Ed are: 

  • Full approval of the vaccines (Pfizer/Moderna), which apparently can be expected fairly soon. This would allow doctors to use their “clinical judgement” to provide a third booster shot. 
  • FDA approval for a third shot of the Pfizer vaccine under its current EUA agreement. 

Bottom line 

With the Delta variant threatening to put many myeloma patients across the country at risk of critical infection, the U.S. can follow the lead from France, Israel and the U.K. to authorize doctors to use their best judgement to provide a third booster shot. The safety of the current two-shot vaccines is not in question and the lifesaving potential is enormous. Let’s all advocate for rapid action for immunocompromised individuals, who represent 3-to-5% of the population, several million people in all. There is enough vaccine to spare right now for this humanitarian cause. 

Translations:

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Image of Dr. Brian G.M. DurieDr. Brian G.M. Durie serves as Chairman of the International Myeloma Foundation and serves on its Scientific Advisory Board. Additionally, he is Chairman of the IMF's International Myeloma Working Group, a consortium of nearly 200 myeloma experts from around the world. Dr. Durie also leads the IMF’s Black Swan Research Initiative®.

 

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