People with HIV no longer barred from COVID-19 vaccine trial
Lynda Dee at the 2017 amfAR Institute Cure SummitAfter sustained pressure from advocates, Moderna Therapeutics has announced that its COVID-19 vaccine trial will no longer exclude people living with HIV. On August 5, the biotechnology company stated that it had heard the community and would now include “people living with controlled HIV who are not otherwise immunosuppressed.”
A major victory for the HIV community, the reversal comes just as Moderna is beginning a Phase III clinical trial to test the effectiveness of its coronavirus vaccine in 30,000 participants.
Bowing to pressure from activists, Pfizer is also expected to abandon a similar exclusion clause in its own COVID-19 vaccine trial.
“This should never have happened,” said Lynda Dee, the AIDS Action Baltimore Executive Director and former member of the Community Advisory Board for the amfAR HIV Cure Research Institute, who led the advocacy campaign. “The trial was opening on July 27 and we found out about it about three days before. So that’s really not optimal. We need to make sure they get community engagement in protocol development.”
“Our gang, we don’t beat up easily. We might be beat up for an hour or so, but we always come rattling right back.”The moment they learned that people living with HIV would be excluded from participation, Dee and a group of veteran AIDS activists swung into action. Dee co-signed a letter with Mark Harrington and Richard Jefferys of Treatment Action Group—with the support of several advocacy organizations—urging U.S. National Institutes of Health Director Francis Collins to ensure that sponsors of COVID-19 clinical trials did not exclude people living with HIV.
"It was like an octopus with tentacles everywhere: The FDA, NIH, Congress, the drug companies, inside of different institutes—NIAID,” said Dee, describing the advocacy effort. “It was a huge amount of work, but it was really a concerted effort and we did it together. It was very successful and done at lightning speed.”
The pressure worked, as it has many times before when the activist community worked in concert to make sure people living with HIV were included in clinical trials and had access to potentially lifesaving treatments.
“It’s really helpful to have a positive result so quickly and for people to feel empowered, especially at this point in time because everybody’s pretty beat up,” said Dee. “But our gang, we don’t beat up easily. We might be beat up for an hour or so, but we always come rattling right back.”