COVID-19 Vaccine Trial Will Include People Living With HIV

In the wake of protest from activists, biotech company Moderna has agreed to include HIV-positive people in trials for its COVID-19 vaccine.

Moderna has begun administering its mRNA-1273 vaccine to volunteers in a phase III trial, but it initially would not accept anyone with HIV, thinking the virus would interfere with their response to the vaccine, Science reports. But HIV activists and researchers objected strenuously; they pointed out that most HIV-positive people who are on antiretroviral treatment have a normally functioning immune system, so HIV would have no effect.

“There is no clinical justification for excluding people with HIV from COVID-19 vaccine trials,” stated a petition from several HIV organizations, led by AIDS Action Baltimore, on Change.org. “Thanks to the advent of triple combination antiretroviral therapy (ART) in the mid-1990’s, HIV infection has not been synonymous with an ‘immunodeficient state’ for over two decades. For this reason, routine immunizations are recommended for people with HIV, with the only caveat being withholding of certain live vaccines if the CD4 T cell count is below 200.”

The exclusion would mean there would be no data on the Moderna vaccine’s safety and efficacy in HIV-positive people, and “there will probably not be [a Food and Drug Administration] indication for people with HIV or payer reimbursement as a result,” the petition noted.

The petition was directed at the National Institutes of Health, a federal government agency that is assisting with some of the vaccine trials. The HIV Medicine Association and its parent organization, the Infectious Diseases Society of America, also contacted the NIH, sending a letter saying, “There is no clinical justification for excluding people with treated, well-controlled HIV from COVID-19 vaccine trials.”

Moderna responded via Twitter Wednesday, saying it would accept volunteers “with controlled HIV and who are not otherwise immunosuppressed.”

Activists targeted Moderna as soon as they learned about the exclusion, but they want other companies that are making COVID-19 vaccines to include HIV-positive people in trials as well. Lynda Dee, executive director of AIDS Action Baltimore, told Bloomberg News that her organization and others had contacted another drugmaker, Pfizer, about including people with HIV in the late-stage trial of the vaccine it’s developing with BioNTech SE.

Pfizer “has already been in the process of amending the protocol to clarify that people with stable HIV,” hepatitis B, and hepatitis C can participate in the trial, officials with the company told Bloomberg Thursday. Regulators must also approve the change, Pfizer spokespeople said.

To sign up for the Moderna trial, visit the Coronavirus Prevention Network’s website or go to ClinicalTrials.gov and search identifier NCT04470427.