Moderna will recruit 56 HIV-negative adults to enroll in Phase I. It will be testing two mRNA-based vaccines. Moderna’s and Pfizer’s COVID vaccines are mRNA-based, while Johnson & Johnson’s is not.

In the 37 years since HIV was identified as the virus that causes AIDS, no vaccine against it has ever been approved. That’s not for lack of trying: Five HIV vaccines have made it through clinical trials as far as Phase 3, the final step toward the Food and Drug Administration approving a drug as safe and effective.

But three of those five failed to protect from infection. The fourth vaccine, RV144, was developed in Thailand and was deemed only about 31 percent effective. A fifth attempted to follow up RV1444’s progress, but ultimately proved ineffective, too. Each initiative cost over $100 million.

The variability of HIV in a single person can be higher than the variability of a seasonal flu virus across the entire world.

A significant barrier is the complexity of the virus itself. “HIV is continually evolving within a single infected individual to stay one step ahead of the immune responses,” Ronald C. Desrosiers, a pathology professor at the University of Miami, wrote in The Conversation. “[T]hrough natural selection a mutated virus variant appears that is no longer recognized by the individual’s immune system. The result is continuous unrelenting viral replication.”

So the HIV virus can become highly variable within the same human body. The variability of the HIV virus in a single person can be higher than the variability of a seasonal influenza virus across the entire world.

The United Nations Programme on HIV/AIDS estimated that in 2020, close to 38 million people globally were living with HIV, and 1.5 million became newly infected. More than 36 million people have died of AIDS-related complications since the epidemic began in the 1980s.

Currently, sub-Saharan Africa is the part of the world hardest hit by the virus. Lesotho, South Africa, and Mozambique lead the world in deaths from HIV by population. HIV is the leading cause of death in South Africa, Mozambique and Botswana.

The US federal government spends over $28 billion per year responding to HIV/AIDS, spread between prevention, care, research and mandatory spending on programs like Medicare and Medicaid. Overall, US expenditures on HIV/AIDS have risen over the past 30 years—but have remained flat since 2010, and are actually declining when adjusted for inflation. Private investment reached a high of $680 million in 2016, but is concentrated in a small pool that primarily funds research.

Meanwhile, local governments across the country are increasingly targeting syringe service programs that have helped keep HIV prevalence under control, even as historic outbreaks emerge and new clusters are identified across multiple states. Many are also increasing police funding, despite policing itself being associated with spikes in HIV.

Advocates hope that in addition to breaking new ground on a vaccine, the pandemic will catalyze more drastic political action.

Photograph of AIDS worker in Indonesia via Flickr/Creative Commons 2.0

The post The Pandemic Is Bringing Us Closer to the First HIV Vaccine appeared first on Filter.

Pfizer’s COVID vaccine was approved by the FDA on December 11. A second vaccine, from Moderna, was approved on December 18. Nevertheless, it will be some time before the supply matches the demand, meaning that for the next few months at least access to the vaccines will have to be triaged.

Earlier this month, the Advisory Committee on Immunization Practices (ACIP)—the independent committee that routinely advises the Centers for Disease Control and Prevention on all immunization schedules—released an interim recommendation outlining “Phase 1a,” the groups of people that should receive the first available vaccines. ACIP reserved Phase 1a for residents of long-term care facilities and for health care personnel, defined as including “all paid and unpaid persons serving in healthcare settings who have the potential for direct or indirect exposure to patients or infectious materials.”

“Of course people working in syringe exchanges meet that definition.”

ACIP’s additional subcategorization—for instances when vaccines among eligible groups are in short supply—describes health care personnel with “direct patient contact and thus who are unable to telework, including those who work in inpatient, outpatient or community settings, who provide services to patients or patients’ family members or who handle infectious materials.” Infectious materials, of course, would include blood—a regular source of exposure for SSP workers, hepatitis C testers and harm reductionists helping with, say, abscess care.

“I read that and I say, ‘of course people working in syringe exchanges meet that definition,’” Dr. Jennifer Kates, director of global health and HIV policy at the Henry J. Kaiser Family Foundation, told Filter. “But it’s not clear yet whether they’ll be included.”

On December 20, a subsequent panel vote confirmed that “Phase 1b” would comprise essential workers and people over the age of 75. “Essential workers” is a definition that currently varies widely between the states, but generally includes police officers, firefighters and first responders; school and childcare staff; food, agricultural and grocery workers; corrections officers; United States Postal Service employees; and public transit workers. The vote also defined “Phase 1c” as pertaining to Americans over the age of 65 and with underlying health conditions. Vaccinations of phases 1b and 1c should begin in January and February, respectively.

Almost all 50 states and the District of Columbia are currently following the ACIP guidelines, in most cases more or less verbatim. None of those plans (or, in the absence of publicly accessible plans, public statements made to their effect) reviewed by Filter makes specific mention of SSPs or peer outreach workers. However, most do mention general criteria for Phase 1—whose members have either already begun receiving vaccinations or are scheduled to do so before springtime—that would imply the inclusion of frontline harm reductionists. New Mexico’s plan notes that the state has partnered with harm reduction organizations to facilitate the vaccination of residents experiencing homelessness.

Alabama’s vaccination plan, for instance, specifies that its Phase 1a includes “first responders [and] persons working in critical healthcare services who have direct contact with the general public, such as pharmacists.” Delaware specifies that its Phase 1c includes “Public health and community health support workers.” Idaho specifies “Public health and emergency management response workers who are unable to telework,” Illinois specifies “local health department staff who interact with patients at test sites, health clinics or provide direct patient care,” and so on.

New Hampshire’s plan includes a straightforward flowchart that would seem to indicate frontline harm reductionists are eligible for its Phase 1a, whether or not its creators realize it. The CDC has offered Indigenous tribal governments the option of receiving their vaccine allotments through the Indian Health Service (IHS) or through local jurisdictions; the IHS plan does not specify inclusion of any frontline harm reductionists.

Some states, like North Carolina, reserve their Phase 1a vaccines for health care workers treating COVID specifically, but still address other types of health care workers by no later than Phase 1b.

“I think it’s going to vary a lot by state,” Kates said. “There are some states more supportive of syringe programs, and maybe their health departments will be more forward-looking. But I think there’s going to be others that … because of their own views and policies about syringe access might make different decisions. And in that case, yes, that group might be farther down the line simply because of that, and not because they’re at lower risk, which would be unfortunate.”

Non-Hospital Harm Reductionists May Have to Advocate for Their Place in Line

There are two factors at play here. The first is cultural—whether harm reduction providers like SSPs will be deprioritized by the states because of historical bias. The second, though, is logistical—how to vaccinate any of the various kinds of health care workers who work outside hospital settings.

“It’s more about, where does the vaccine go? How are they going to get it there?” Kates said. “That’s going to really vary, because initially most states are having the vaccine sent to hospitals. That’s a defined facility where the vaccine can be administered. So I think health care workers that work in [community] settings, there’s some big questions about how they will be reached.”

For non-hospital health care workers—which includes most harm reductionists—states that care to include them now face the issue of where to ship those vaccinations, where to store them (both the Pfizer and the Moderna vaccine need to be refrigerated at very low temperatures) and ultimately where to administer them.

This is what we’ll see play out over the next few weeks. Many local and state governments are making efforts to reach community-based health care workers, if not harm reductionists specifically. A number of the state plans reviewed by Filter, like North Dakota’s, had made provisions for non-hospital community health care workers in their Phase 1 tiers. Some states, including the District of Columbia, are now building online registration systems so that health care workers who operate outside hospital settings are able to submit their names for early vaccination.

A number of states, such as Florida and Iowa, are planning to reach nursing home and other long-term care residents by shipping doses to local pharmacies (CVS and Walgreens), which have been approved by the US Department of Health and Human Services to administer the vaccine. In some locations, Osco and Walmart will have access to the vaccine as well. As of publication time, that arrangement remains specific to nursing home and assisted living facilities. In Maine, officials referenced “thinking about ways that we can use others in the community who are trusted and known to community members” to oversee pop-up vaccination sites by late spring, though again harm reduction facilities such as SSPs were not mentioned by name.

“A lot of frontline harm reduction workers work for community-based organizations, which are not being included in these first rounds.”

David, a San Francisco-based peer counselor who works on a street-crisis response team and whose name has been changed at his request, received his vaccination on December 19. He works on an ambulance rig, but was able to get vaccinated at San Francisco General Hospital after the management staff of his program submitted his team’s names to the city and county for early eligibility.

“It was a little chaotic, but they had a system going,” David told Filter of his vaccination experience. “You come in and register and wait in the queue, and then they walk you through the process explaining what’s in [the vaccine] and asking if you’re allergic to anything that’s in it … I feel a little tired and [have] some injection-site soreness, but that’s it.” His second dosage has been scheduled for early January.

According to David, he and his team might have been uniquely helped by the fact that they’re registered as Disaster Service Workers with the city. “I think that a lot of these frontline harm reduction workers, peer outreach workers, work for a lot of CBOs [community-based organizations],” he said. “And those aren’t really being included in these first rounds.”

Photograph via Pixnio

The post Frontline Harm Reductionists Qualify for Early Vaccination—Will They Get it? appeared first on Filter.