UPDATE Aug. 6, 2020: After key HIV advocates wrote a letter of concern to federal health officials and got over 1,000 signatures on a petition crying foul, Moderna agreed to reverse its ban on people living with well-managed HIV in its Phase 3 trials of its COVID-19 vaccine. Other drugmakers working on COVID-19 vaccines, including Sanofi, NovaVax and J&J, will also include people living with HIV in their trials, according to Lynda Dee of AIDS Action Baltimore, one of the advocacy groups that wrote the complaint letter.
Our original story, which published on July 30, continues below.
On July 27, representatives from a dozen prominent HIV nonprofits, including Treatment Action Group, National Minority AIDS Council, and Latino AIDS Commission, sent an open letter to National Institutes of Health (NIH) leadership urging them to demand that drugmaker Moderna undo its exclusion of people living with HIV from the third and final, largest phase of its trial of a vaccine for COVID-19, which opened for enrollment on the same day.
“Our letter is occasioned by the exclusion of people with HIV in the mRNA-1273 Moderna Phase 3 COVID-19 vaccine trial according to ClinicalTrials.Gov,” reads the letter. “We are extremely dismayed to learn that a COVID-19 vaccine candidate developed with significant contributions from researchers at the NIH excludes people with HIV with no scientific basis. We want to be sure you are aware of this situation, will do everything in your power to intercede with Moderna to reverse this exclusion and ensure that such an exclusion never happens again. This matter is particularly urgent and requires your immediate attention as this trial opened to enrollment on July 27, 2020.”
The letter goes on to say that there is no evidence that people on HIV treatment with undetectable virus and a stable to healthy CD4 count (generally seen as above 200) should react to a vaccine any differently from other trial participants—including those with preexisting conditions, such as asthma or diabetes, that appear to make people more vulnerable to COVID than well-managed HIV.
The letter is publicly readable here on this change.org petition, which has garnered 347 signatures as of the evening of Wednesday, July 29, demanding that Moderna allow people with HIV into the trial.
Secondarily, the letter charges that trial administrators have not reached out to the HIV community for help enlisting people to enroll in the trial. “The HIV community was promised that there would be community representation in all aspects of COVID-19 clinical trials development,” the letter reads.
“But all we see,” it continues, “is procrastination which now appears to be purposeful. Many of us surmised that community involvement would occur via the already established NIAID Community Advisory Board (CAB) networks which are already in place and well-established with seasoned committed members with many years of dedicated service. ... Unfortunately, we have learned that you intend to create community engagement structures for COVID-19 and all other diseases. What we do not need here is another level of underfunded bureaucracy which will take long to implement.”
Another COVID-19 vaccine trial, conducted in the United Kingdom by Oxford University and AstraZeneca, excludes people with “any confirmed or suspected immunosuppressive or immunodeficient state” but does not exclude people merely for having HIV.
That phrasing makes sense, says Lynda Dee of AIDS Action Baltimore, one of the letter signers. “I can see if you’re talking about someone who is not on HIV meds, whose HIV is not controlled, and who has really low CD4s,” she says. “But to exclude the whole HIV population is ridiculous. There’s no age limit on the trial. Someone who is 90 can get in, but someone with well-managed HIV cannot? That’s crazy.”
Dee said that Carl Dieffenbach, Ph.D., director of NIAID’s division of AIDS within the NIH, is fighting Moderna “tooth and nail” to drop the exclusion. “The American taxpayer is funding this,” she said, meaning that Moderna alone should not have all the decision-making power.
She said she suspects that Moderna is “trying to take out anything that would complicate their analysis. In other words, [who cares about] people with HIV—we wanna make sure this works.”
Reps from Moderna did not reply, in a window of 12 hours, to queries from TheBody as to why they were excluding people with HIV, or whether they planned to drop the exclusion.