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FDA Approves Second COVID-19 Bivalent Booster Dose Along with Additional Specific Guidance for the Immunocompromised

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On April 18th, the FDA announced that certain groups are now eligible for another dose of the bivalent COVID-19 vaccine. Here is a summary of the updated guidance:

  • Those 65 and older can now get a second bivalent dose as long as at least four months have passed since their initial bivalent dose. The FDA commented that a second bivalent dose for this age group is supported by data showing that immunity wanes in this older population over time but that an additional dose restores it.
  • Anyone who is immunocompromised can get an additional bivalent booster dose if at least two months have passed since their initial bivalent dose.
  • Guidance for additional future doses of the bivalent vaccine for those who are immunocompromised was issued. Regarding any additional doses in the future to be allowed “at the discretion of the healthcare provider, who can also determine the interval at which these additional doses are received.”

What we take that to mean is that going forward, a healthcare provider can independently recommend the timing of future boosters based on their patient’s circumstances. So those who are immunocompromised are now eligible for booster doses potentially every two months in consultation with their healthcare provider. It is important to remember that you do not need to provide any proof of being immunocompromised, as the CDC changed this guidance over a year to self-attestation.

In June 2023, the FDA will hold a meeting to discuss what COVID-19 strain the fall booster dose will consist of. Much like the FDA does yearly with the influenza vaccines, the agency will seek input from the committee on which SARS-CoV-2 variants and lineages are most likely to circulate in the upcoming year. Once the specific variant strains are selected for the fall COVID-19 vaccines, the FDA expects manufacturers to make updated formulations that will be available starting in the fall.

The CDC has approved and signed off on the FDA’s additional booster dose recommendations. Additionally, the American Medical Association (AMA) is also recommending those who are eligible get the booster when they qualify.

CLL Society recommends all of those diagnosed with CLL / SLL schedule a second bivalent booster dose if at least two months have passed since their initial bivalent dose, as everyone living with CLL / SLL is considered moderately to severely immunocompromised regardless of treatment status.

It is always important to discuss your vaccination schedule with your healthcare provider.

Keep learning and stay well.

Robyn Brumble, MSN, RN
Director of Scientific Affairs & Research

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.