My recommendation at this time is based on page 46 of the "Vaccines and Related Biological Products Advisory Committee Meeting" - December 10, 2020, FDA Briefing Document. Under section 8.2. 'Unknown Benefits/Data Gaps', 'Effectiveness in certain populations at high-risk of severe COVID-19':
Although the proportion of participants at high risk of severe COVID-19 is adequate for the overall evaluation of safety in the available follow-up period, the subset of certain groups such as immunocompromised individuals (e.g., those with HIV/AIDS) is too small to evaluate efficacy outcomes.
My recommendation for my providers is:
While the safety data is compelling enough to conclude, via a risk vs benefit analysis, that PLWH with multiple comorbidities should be advised to seek a vaccine, the efficacy data in a risk/benefit analysis for PLWH with a suppressed viral load and a strong CD4 and CD4/CD8 ratio with otherwise no additional comorbidities (or very few comorbidities that are well controlled) be advised at this time to await further clinical data supporting this vaccination in this patient population.
------------------------------
Christopher Wust
Byron GA
------------------------------
Original Message:
Sent: 12-09-2020 22:29
From: John Phoenix
Subject: COVID Immunizations in PLWH
I'm getting inquiries from patients about the safety of either of the 2 potential COVID 19 vaccinations.
I'm having a difficult time identifying any resources for this topic.
Recommendations would be greatly appreciated.
------------------------------
John Phoenix
Las Vegas NV
------------------------------