New York: After pressure from advocates in recent weeks, Moderna Inc. will now allow individuals living with HIV to be part of a late-stage clinical trial of its Covid-19 vaccine candidate.
Moderna had previously said it would exclude people with HIV from the trial.
The biotechnology company said Wednesday that it’s “committed to working with all communities who could benefit from our Covid-19 vaccine” and added those with “controlled HIV who are not otherwise immunosuppressed” to the protocols, after talking to government partners. Moderna said it planned to test the drug in people with HIV in a separate study.
Today, we are sharing an important update about our protocol for the Phase 3 COVE Study of mRNA-1273, our vaccine candidate against COVID-19. pic.twitter.com/jigTXUi9v2
— Moderna (@moderna_tx) August 5, 2020
“Aren’t we trying to help everybody here?” said Lynda Dee, executive director of AIDS Action Baltimore, who led the advocacy push, noting that people with health conditions are among the most at-risk from the novel coronavirus.
“It’s unconscionable to me that people who are going to die from this are excluded in any way, shape or form — explicitly or implicitly,” she said.
Dee and other advocates are also petitioning Pfizer Inc. to do the same with the late-stage trial of its vaccine partnership with BioNTech SE, according to a letter sent to a Pfizer executive on Wednesday. Their test protocols exclude people living with HIV, hepatitis B and hepatitis C.
Pfizer “has already been in the process of amending the protocol to clarify that people with stable HIV,” hepatitis B and hepatitis C can enroll, the drugmaker said Thursday. That will require regulators to sign off, according to the statement.
The clash shows how the Covid-19 crisis is bringing longtime tensions about representation in drug development to light, with the stakes higher than ever.
It’s well-established that certain groups like the elderly and those with pre-existing medical conditions are at higher risk for serious cases of Covid-19. But whether those populations will be adequately represented in initial studies of the vaccines and treatments being developed to treat it is anyone’s guess.
The U.S. Food and Drug Administration has told drug manufacturers that vaccine research should enroll those with other health conditions, racial and ethnic minorities and older individuals, and HIV advocates have highlighted that guidance. But so far there’s been few people of color included in research, suggesting the path ahead may still be strewn with challenges.
An estimated 1.2 million individuals in the U.S. have HIV. Short for human immunodeficiency virus, it’s known for assaulting and weakening the immune system, though the condition can be managed with medical treatments.
HIV is classified as a potential risk factor for severe Covid-19 illness by the U.S. Centers for Disease Control and Prevention. Many of those living with HIV are also Black or Hispanic, “people who are on the front lines and in the most danger of being infected,” said AIDS Action Baltimore’s Dee.
Including them in vaccine trials can help scientists understand how well the products work for those living with HIV, as well as what side effects they pose.
The latter is especially important because people with HIV “can often get big responses to vaccines,” said Rajesh Gandhi, a physician and chair-elect of the Infectious Disease Society of America’s HIV Medicine Association who was involved in the petition.
Enrolling those with HIV in separate trials, as Moderna had planned, can lead to delays and could bar those patients from receiving Covid-19 vaccines — or having them covered by health insurers, advocates argue.
When Gilead Sciences Inc.’s preventative HIV drug Descovy was approved last fall, for instance, the FDA said that since the trial had included only men and transgender women, the medication wasn’t advisable for cisgender women “because the effectiveness in this population has not been evaluated.”
A Moderna spokesperson said the company had planned for the HIV trial to be conducted in parallel with the late-stage study. It’s still assessing whether to run the separate study, the spokesperson said.
There’s precedent for the exclusion of those with HIV from medical research, including in cancer clinical trials, Dee and Gandhi said.
Before HIV could be controlled with medications, people with it “had impaired immune responses and could potentially be at greater risk for certain experimental medications,” Gandhi said.
“In the context of well-controlled HIV, we very much think and advocate that should no longer be the case,” he said.
Moderna is one of the early companies to have proceeded to late-stage clinical development. Advocacy groups want other developers that follow to also include individuals with HIV.
The issue was brought to them by Jeff Taylor, a 58-year-old activist in Palm Springs, California, who has been participating in clinical trials ever since they first got him access to HIV medications decades ago.
His physician told him the Moderna trial might exclude people with HIV, so Taylor tried signing up in mid-July. During the screening process, when he listed his medications, Taylor was told of the issue.
Even though Moderna has now changed the criteria, however, Taylor said he isn’t interested. He thinks other vaccine candidates are more promising. And the experience “left a bad taste in my mouth,” he said. – Bloomberg