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On August 12, 2021, the FDA announced expanded Emergency Use Authorization (EUA) for a third booster dose of the Moderna or Pfizer vaccine for the immunocompromised.
The estimate is that means between nine to ten million vulnerable patients, or 2.7% to 3% of the USA population, will be eligible for the COVID-19 boosters.
The “hows” of the expanded EUA are just rolling out. Following the FDA’s EUA, the CDC quickly came out with their recommendation of a booster for the immunocompromised in their 8/13/2021 statement, COVID-19 Vaccines for Moderately to Severely Immunocompromised People:
- The CDC’s list of immune-compromised does not at first seem to include CLL patients who are not in active therapy. CLL Society understands their list to be only examples and that it is not meant to be all-encompassing. CDC is clearly recommending that “moderately to severely immunocompromised people receive an additional dose”. That would include any and all CLL patients who have a cancer of the immune system. Most CLL patients have not encountered any difficulty receiving the booster.
- CDC recommends the third dose be the same mRNA vaccine as the first two, but did say, “If the mRNA vaccine product given for the first two doses is not available or is unknown, either mRNA COVID-19 vaccine product may be administered.” Most pharmacies are asking which vaccine was used for the first two doses so they can use the same for the booster. Generally, a prescription or proof of being immunocompromised is not required.
- It is advised to wait at least four weeks after the second dose before receiving the booster. Sometimes more time between boosters improves the response. A fourth jab is not recommended.
- Testing for an adequate response after the initial dosing and before the booster is not mentioned and does not figure into their recommendations.
- There are no data and no recommendations as to what to do if one received the Johnson & Johnson COVID-19 vaccine.
- Reactions are not expected to be any different than with the first two doses. Though if it is similar to other vaccine boosters, more severe reactions may be seen. If one became sick after the 2nd dose of the COVID-19 vaccine, the same response might be expected after a third.
The “whys” have become increasingly apparent:
- Vaccines leave too many of the immunocompromised unprotected based on lack of antibody response. This is especially true for CLL patients.
- The fully vaccinated immune-compromised are at much higher risk for breakthrough infections and are at especially higher risk for hospitalization and death compared to the general population who have been vaccinated.
- Boosters, as the name suggests, boost the antibody response to where it becomes detectable (seropositive) in a significant percentage of the immunocompromised when before it was undetectable (seronegative) with the usual two shots.
- This success is variable and is not guaranteed. In CLL, we are waiting for more data, but we would be happily surprised if it was found that a booster could help more than half of those with blood cancers. Still, that would be a significant “boost”.
Here is the breaking news as it happened: FDA OKs third vaccine dose for the immunocompromised.
Here is the official FDA statement that was posted soon after: Coronavirus (COVID-19) Update: FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised Individuals.
The FDA states that “use of an additional dose in certain immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise”. That would include all CLL patients according to the CLL Society.
The FDA also took the opportunity of the announcement for the EUA of a booster vaccine to remind the immunocompromised of the value of a different therapy, anti-SARS-Cov-2 monoclonal antibodies.
“It is recommended that immunocompromised individuals discuss monoclonal antibody treatment options with their health care provider should they contract or be exposed to COVID-19. The FDA has authorized monoclonal antibody treatments for emergency use during this public health emergency for adults and pediatric patients (ages 12 and older weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. One authorized product includes use for preventative (prophylaxis) treatment after being exposed to SARS-CoV-2; however, this product is not a substitute for vaccination”.
The CLL Society strongly supports the booster recommendations and refers you to our COVID-19 Plan: Checklists for Chronic Lymphocytic Leukemia (CLL): Preparing for Pre and Post COVID-19 Exposure.
This is an evolving story and will be updated as we receive more information from the CDC and FDA.
Stay strong. We are all in this together.
Brian Koffman MDCM (retired) MS Ed
Co-Founder, Executive VP and Chief Medical Officer
CLL Society, Inc.