by Mike Andrew -
SGN Staff Writer
As the first COVID-19 vaccines are rolled out around the world, HIV-positive people may wonder whether the vaccines are safe for them to take.
The answer seems to be a qualified yes.
Neither Pfizer nor the CDC has stated that its vaccine is unsafe for people with HIV. On the other hand, neither has affirmed that it is safe, either.
The inconclusive statements arise from the fact that 120 people with HIV participated in the Phase 2 and Phase 3 trials, but Pfizer did not present separate data for them, stating that the sample population was too small to draw conclusions.
In a December 10 meeting, the FDA's Vaccines and Related Biological Products Advisory Committee said the Pfizer vaccine was safe but declined to say it would be effective for people living with HIV.
"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," their report said.
The official Emergency Use Authorization (EUA) allowing the vaccine to be distributed does not list HIV as one of the contraindications. In other words, being HIV-positive is not a reason to avoid taking the vaccine.
On the other hand, the EUA contains the warning that "immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 vaccine."
In FDA communications, the term "immunocompromised" is used to describe people living with HIV but not for people with an undetectable viral load or high CD4 count.
That caveat does not exempt immunocompromised people from getting the vaccine, according to both the CDC and Pfizer.
In a meeting of the CDC's Advisory Committee on Immunization Practices (ACIP) on December 12, CDC medical officer Dr. Sarah Mbaeyi stated that, unless there is a contraindication, people living with HIV should get the COVID-19 vaccine, especially given that "people with HIV infection, or other immunocompromising conditions, or who take immunocompromising medications or therapies, might be at increased risk for severe COVID-19."
Both Mbaeyi and Pfizer stated that the EUA warning should not be considered as a contraindication.
Although the FDA is requiring follow-up studies to collect more data about the effect of the COVID-19 vaccine on people with HIV, it did not say that this additional research is required to ensure safety in people living with HIV.
Tim Horn, a longtime HIV advocate who is the director of medication access and pricing at NASTAD, recommends accepting the safety of the vaccine.
"While there's no indication of any safety signals involving people living with HIV and certainly no contraindication that would stand in the way of people living with HIV from getting the Pfizer vaccine, we just don't know if there are any efficacy differences compared with those without HIV," he said.
"We will need to live with this unknown, at least until Pfizer provides an analysis of the HIV-positive individuals that participated in their phase 3 trial and additional, population-level data are available."