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Inside the fight to include HIV-positive people in Covid vaccine trials

By adminvertexpublic / Published on Tuesday, 29 Dec 2020 17:48 PM / Comments Off on Inside the fight to include HIV-positive people in Covid vaccine trials / 68 views



When Jeff Taylor, a longtime AIDS advocate and survivor, learned about clinical trials for the new Covid-19 vaccine in his hometown, Palm Springs, California, he leapt at the opportunity to participate.

“I always want to be the first person to try something,” he said.

But Taylor’s enthusiasm was short-lived. As soon as he told a recruiter over the phone that he was HIV-positive, Taylor was informed that he was ineligible to join.

“I argued with him, but he said: ‘I don’t make the rules. This is what our sponsor told us to do,'” Taylor, 58, said.

Taylor understood, in a sense, why they were rejecting him. As head of the HIV + Aging Research Project-Palm Springs, he had read plenty of studies that excluded people who were immunocompromised or on immune-modularity drugs.

“It’s something that happens all time,” Taylor said.

A study published this year in the Journal of Clinical Oncology found that 73 percent of over 1,090 analyzed cancer immunotherapy trials specifically excluded patients with HIV.

Not including a sample for the estimated 1.2 million HIV-positive people in the U.S. in the most significant vaccine trial in a generation seemed to him unwise. On July 18, Taylor notified a private listserv for HIV activists and researchers called IBT-Cure. Shortly thereafter, he got a response from Lynda Dee, executive director of AIDS Action Baltimore, another heavyweight in the HIV advocacy world who has been agitating for an AIDS vaccine since the 1980s.

Dee immediately recognized that someone running the trials had failed to include people with HIV. But, having long been an advocate for more inclusive medical trials, she also knew that the experiments were sprawling operations with plenty of opportunities for routine error.

“Vaccine protocols change, and there are usually 20 iterations before they actually get sent to the FDA for approval,” she said. “Someone must have stuck [the HIV exclusion] in there.”

She speculated that researchers didn’t want to include a population that they thought could compromise their results.

“Somebody must have thought: ‘Well, this is about immune systems. I don’t want to confound the data by including someone with HIV,’” she said. “They had no idea what something like that looks like and what hell they were going to get from people like us.”

Lynda Dee is an attorney and the executive director of AIDS Action Baltimore. Courtesy Lynda Dee

Alarmed by Taylor’s story, Dee put together a group of activists — including representatives from the Latino Commission on AIDS and the National Minority AIDS Council — and sent a letter to Dr. Francis Collins, director of the National Institutes of Health.

Written with a palpable urgency and more than a whiff of anger, the letter, which the activists also posted to Change.org, said the agency was shooting itself in the foot by excluding HIV-positive people from Covid-19 vaccine trials. Black and Latino residents of the U.S. had been disproportionately affected by both HIV/AIDS and Covid-19, the letter said, and now both communities were the most likely to express skepticism about the coronavirus vaccine.

The activists also pointed out that people with HIV who were responding well to antiretroviral therapy weren’t considered so “immunodeficient” that they were barred from getting other vaccines. (The Centers for Disease Control and Prevention doesn’t recommend certain live vaccines for people with HIV whose CD4 white blood cell count is below 200.)

Dee said she also reached out to her contacts in the U.S. government, including Carl Dieffenbach, director of the Division of AIDS at the National Institute of Allergy and Infectious Diseases. She said Dieffenbach was able to quickly begin discussions with Moderna, because the drugmaker was using government-run clinical trial networks to test its vaccine. (Pfizer didn’t rely on funding from the U.S. government’s Operation Warp Speed.)

Dieffenbach did not respond to a request for comment.

On Aug. 5, about eight days after Dee posted the letter on Change.org, Moderna changed course and announced plans to drop its exclusions. Moderna recruited 176 people living with HIV out of 30,000 participants, according to data on the FDA’s website. Of those with HIV, one who received the placebo and none who received the vaccine developed Covid-19, according to the data.

Pfizer made a similar announcement a day later and ended up enrolling a relatively small number of HIV-positive people — 120 out of 43,000 participants — in the last phase of its trials, according to information on the FDA’s website. An efficacy rate for the HIV-positive participants in Pfizer’s vaccine is not yet available.

The CDC’s website says people with HIV “may receive the vaccine” but notes that the safety data specific to this population “is not yet available.” The agency adds that people with weakened immune systems “should also be aware of the potential for reduced immune responses to the vaccine, as well as the need to continue following all current guidance to protect themselves against COVID-19.”

Even though Dee was able to exert pressure on much of the hulking bureaucracy that decides who gets injected first, she still laments that it took so long for the vaccine makers to change their rules.

“We got ’em in,” she said, “but my God, what a mistake,” she said of the initial exclusion of those with HIV.

Neither Pfizer nor Moderna responded to multiple requests for comment.

Dr. Larry Corey, a virologist who was chosen by Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, to run vaccine testing operations for Operation Warp Speed, said the pressure on Pfizer and Moderna has been immense, “similar to playing Wimbledon Center Court.”

“I think there were an overwhelming number of priorities and things to do, and it just fell off the radar,” he said.

Corey said there was never “any worry” in the advocacy world that people successfully managing their HIV infections on antiretroviral therapy would have bad responses to the Covid-19 vaccine. Other experts at the Joint U.N. Program on HIV/AIDS, the British HIV Association and Aidsmap have also said the Covid-19 vaccine should be considered safe and effective for people with HIV.

Now, Dee and others are working to amend CDC guidelines and prioritize HIV-positive people for vaccination after the elderly and essential workers, as Germany has done. Some data have emerged that suggest that people living with HIV are also at an increased risk of severe Covid-19 (although more research is needed), and nearly half of Americans who are HIV-positive are over age 50 and thus more likely to live with co-existing conditions that can complicate the course of the illness, like diabetes or cardiovascular disease.

Dee, who watched all of her friends die of AIDS in the ’80s, said she’s ready for this next fight.

“I’m a pushy old broad, and I’ve been doing this for 33 years,” she said. “People know me, they trust me, and they’re often a little afraid of me because I’m this East Coast battle-ax, and I say what I think.”

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