The Way Forward for HIV Vaccine Development

HIV vaccine science is at a crossroads. New science, new findings from recent phase III trials that ended without efficacy, innovations learned from COVID-19 vaccines, and new approaches to trial design are all contributing to a period of innovation and transition in HIV vaccine development. AVAC’s latest blog, An HIV Vaccine: The challenges ahead, frames these issues and draws highlights from a webinar series AVAC convened earlier this year.

In July, the Treatment Action Group (TAG) released its 2022 annual overview of research and development in HIV, Hepatitis and TB; it included a specific report on HIV vaccines and passive immunization, or bNAbs. This pipeline report provides added context to our blog.

And for more on HIV vaccines, read the May JIAS Viewpoint, HIV vaccines in 2022: where to from here?; AVAC’s backgrounder on experimental medicine vaccine trials (EMVTs), and AVAC’s fact sheet of early phase trials testing mRNA-based HIV vaccines—a one-stop sheet including a expanded snapshot of up-to-date mRNA trials and additional resources to explore and learn more.

A few highlights from these resources include:

  • Research using mRNA technology for an HIV vaccine is in very early stages. This innovation could speed the research process, but cannot alone answer some of the most crucial questions bedeviling the advance of HIV vaccine research.
  • The development of quick, iterative trial designs has become crucial, as the field continues to try and answer a fundamental question: what immune response needs to be triggered for effective protection against HIV. The use of innovative trial designs, including experimental medicine vaccine trials (EMVTs) hold promise and potential, and should be prioritized.
  • Re-invigorated collaboration, recognizing the quest for an HIV vaccine as one of the greatest scientific challenges of the modern era, is essential to analyse closely what the field has learned to date, develop clarity on the critical scientific challenges and agree on a coordinated strategy to pursue answers.

Stay tuned for more updates on HIV vaccine R&D after next month’s bi-annual HIV Vaccine Trials Network meeting.

Now Accepting Applications for Global Online Course

Join the hundreds of global learners – from more than 20 countries since 2014 – who have benefitted from the Good Participatory Practices (GPP) Course, a unique online learning opportunity about the criticality of stakeholder engagement as part of the research process.

The 10-week online course—running from October 17 – December 16—provides research implementers and advocates with a foundational knowledge of the Good Participatory Practice (GPP) Guidelines. The course draws from lessons learned from various infectious disease areas, the rollout of new interventions, and COVID-19 research to date. Insights from these efforts will be used to foster participants’ capacity to develop quick and responsive stakeholder engagement in research and beyond. Participants who complete the course will finish with a customized stakeholder engagement plan that reflects the landscape of their local environment.

Apply Here to participate in the course today!

Participants will benefit from a combination of interactive online modules, video webinars, written assignments, discussion forums, and a suite of specially curated resources. Learners will customize the course topics and resources that meet their needs. Global GPP experts will discuss high-impact models of engagement and help synthesize theory into easy-to-understand actionable steps. Participants will spend 2-4 hours per week on the course, culminating in a GPP action plan that aligns with their specific work and role in the field.

Applications are due by October 12, 2022.

As always, please reach out out with any questions.

About the GPP Online Course:

More than 10 years ago, UNAIDS and AVAC published the Good Participatory Practice Guidelines for Biomedical HIV Prevention Trials (GPP). Created to provide a consistent global standard for stakeholder engagement across the research life-cycle, GPP has emerged as a point of reference for how to engage stakeholders. It has also given rise to a robust community of practice.

HIV Vaccines: The challenges ahead

Just two years ago, AVAC highlighted the connections between COVID-19 and HIV, and outlined their implication. Two years later, those insights on Platforms, Process, Partnerships, Payers and Participatory Practices that Drive Vaccine Development remain critical. The field has continued to build on those insights as it considers priorities for the HIV vaccine field today—and tomorrow.

Because recent results from major HIV vaccine trials have had disappointments and reframed the questions the field must ask, AVAC hosted a 2022 webinar series on the progress in HIV vaccines in light of a rapidly changing research landscape. This document provides highlights from the presentations and discussions as part of this series to help advocates understand and mobilize around an agenda for HIV vaccine research and access.

graphic promoting our HVAD webinar series

Reclaiming the Meaning of Choice

This week we are reminded of the importance of sexual and reproductive health and rights as we marked World Contraception Day (Sept. 26) and International Safe Abortion Day (Sept. 28). All of our voices must be heard to protect and expand access to real choices for everyone who needs them. Especially when it comes to sexual health, which is so often stigmatized and often profoundly under threat.

At AVAC, we are thinking about how to be a champion for choice. Wherever our work takes us. Here are a couple of things we are working on and we invite you to be a part of.

The idea of reclaiming choice played a major role in the International AIDS Conference this year, especially around the dapivirine vaginal ring (DVR) and the dual prevention pill (DPP)—both of which could improve the landscape of prevention for adolescent girls and young women (AGYW) and pregnant and lactating populations (PLP). Get updates on both the ring and DPP in these webinars:

Private Sector Delivery Opportunities for the Dual Prevention Pill (DPP): Lessons from family planning (FP) for the introduction of multi-purpose prevention technologies (MPTs)

Wednesday, October 12 at 7:30am ET

AVAC and FP2030 will explore new findings on private sector opportunities for the DPP in Kenya, South Africa and Zimbabwe. With anticipated rollout of the DPP just two years away, planning for where to introduce the DPP in the private sector will be critical for ensuring access, but will hinge on where PrEP delivery is already permitted. Learn more about the webinar and register here.

The Choice Agenda hosted a conversation around the latest in DVR advocacy last week: RINGing the Bell for Choice: Actions and Solutions on Dapivirine Ring Access.Watch the webinar, explore up-to-date resources on DVR hereexplore up-to-date resources on DVR here, and sign-up for The Choice Agenda listserv (a growing community of over 700 prevention advocates and counting).

And save the date for:

Doxycycline for STI prevention: Evidence and Current Research

Webinar: Friday, October 7, 2022 at 10:00AM ET

Join The Choice Agenda for the latest scientific data and discussion around a new STI prevention strategy, doxycycline as post-exposure prophylaxis (dPEP) to reduce chlamydia, syphilis, and possibly gonorrhea. Join us to hear the implications for policy and program. Register here.

A Guide to This Year’s Global Fund Replenishment

The Global Fund’s Seventh Replenishment conference begins this weekend in New York City. Held every three years, these conferences bring governments, philanthropies and the private sector together to pledge their investments to the largest global grant-making source for health systems in low- and moderate-income countries.

The UNAIDS Report released in July showed us that we are off-track in reaching global targets for HIV, and the field of global health knows the world is similarly off-track with TB and malaria targets. At least US$18 billion for the Global Fund’s Seventh Replenishment would save 20 million lives, cut the death rate from HIV, TB and malaria by 64 percent and build resilient and sustainable systems for health, and to strengthen pandemic preparedness.

The US government already committed $6 billion over the next three years. Now, the rest of the world needs to step-up with their support for the Global Fund. Plus the US needs to ensure that PEPFAR is robustly funded. Next year, PEPFAR will be up for Congressional reauthorization, allowing advocates opportunities to influence and sustain PEPFAR’s priorities. These priorities must advance pandemic preparedness and be defined by what impacted communities need and want.

The Global Fund and PEPFAR together constitute a core foundation for pandemic preparedness and global health security. Investing in both is fundamental to making full use of existing platforms and expanding them to achieve global health security and equity. Read our latest P-Values blog, What does multilateralism mean and why it’s right for the future, from AVAC’s Senior Policy Manager, John Meade for more.

And check out other resources and background to inform your Replenishment advocacy.

Global Fund and PEPFAR’s Essential Collaboration

What does multilateralism mean and why it’s right for the future

COVID-19 was declared a Public Health Emergency of International Concern by the WHO in January 2020. There was unprecedented speed and urgency at the start of the pandemic that resulted in rapid development of diagnostics and vaccines to combat the spread of disease. It was a terrific example of multilateralism at work—when nations recognize a shared threat or interest, and come together toward a common purpose.

However, as the pandemic progressed, decisions around COVID-19 vaccine distribution revealed deep and enduring inequalities that prioritized nationalism over multilateralism. Citizens of high-income countries have access to third and fourth rounds of shots while citizens of low-to-middle income countries are still fighting for their first doses. This nationalist approach in the midst of an emergency is the basis for catastrophic failure in any pandemic response, as shown over the last two years.

Multilateral organizations—those jointly supported by multiple governments and other partners—with a shared aim of health as a common good, are instrumental to global health security, overcoming health inequities, and building resilient health systems around the globe.

One of the world’s most important multilateral efforts is The Global Fund, which has made possible a groundswell of innovative and community-centered initiatives. These programs set up a bulwark against HIV, TB and malaria, while addressing COVID-19. Models of innovation at the ground-level such as these represent essential preparation for future epidemics and pandemics. Human-created borders cannot be allowed to constrain this work.

Link to more info on protection global gains dot org

To succeed, the Global Fund works interdependently with The President’s Emergency Plan for AIDS Relief (PEPFAR), a country-to-country (bilateral) program that represents the world’s largest investment in delivering HIV treatment and prevention. Each makes the other stronger.

COLLABORATIVE FUNCTIONS PEPFAR <-> GLOBAL FUND
Coordination These two organizations coordinate closely. Liaison representatives from each organization participate in relevant planning and coordinating meetings. For PEPFAR it’s a process known as the Country Operational Plans (COPs), and the Global Fund works through Country Coordinating Mechanisms (CCMs).
Geographical Representation Global Fund operates in 78 countries where there’s no PEPFAR presence, drawing lessons from PEPFAR experience, expertise and technical assistance. Refer to the first image below.

In the countries where PEPFAR works, Global Fund is shoring up health systems and buttressing the supply chain.
Procurement PEPFAR is one of the world’s largest procurers and donors of HIV treatment and prevention commodities.

Global Fund provides essential funding to coordinate and supplement PEPFAR funding, as well as helps procure non-HIV tools that address health needs, such as TB or malaria, which are endemic among communities where HIV is prevalent.
Technical Assistance PEPFAR exchanges country-specific and scientific expertise in HIV to help strengthen and boost Global Fund activities.

Global Fund support strengthens the overall systems that are essential to a robust HIV response, significantly increasing the impact of PEPFAR’s more targeted actions in treatment and prevention programming. Global Fund grants to health systems support strategic program planning a reliable supply chain, and program innovation for resilient health systems.

HIV is a constant threat to global health, leaving millions all the more vulnerable to other diseases, and demanding vigilance and steadfast, fully-funded strategies to end it as a global epidemic. Global Fund operates in 78 countries where there’s no PEPFAR presence, drawing lessons from PEPFAR experience, expertise and technical assistance. In the countries where PEPFAR works, Global Fund is shoring up health systems and buttressing the supply chain.

Geographic Reach of PEPFAR and the Global Fund to Fight AIDS, TB and Malaria

(Source: Kaiser Family Foundation)

Source Funding by Commodity Type in 2019

(Source: Kaiser Family Foundation)

Political Will and the Future of Global Health

The Global Fund’s Seventh Replenishment, taking place the week of September 18th, is an opportunity to rise to the challenge and raise essential funding. The minimal need required to get back on track to reach global targets for HIV, TB, and Malaria (that were derailed by COVID-19 and nationalistic policies) is pegged at $18 billion. But this figure will leave a $28 billion gap, spurring demands from civil society to go further.

The US government has committed to investing $2 billion in fiscal year 2023, and $6 billion over three years. Although this is a major win for the U.S investment in multilateralism, the Biden Administration requested a $20 million cut for PEPFAR that will impair HIV programming around the globe. This blow comes as new leadership at PEPFAR holds great promise to extend the reach of one of the single most effective programs in the history of global health.

This year PEPFAR welcomed its first African-born leader, Ambassador John Nkengasong. As he charts the course for the agency’s global HIV/AIDS programming, his extensive experience in pandemic preparedness and response as the head of Africa CDC provides the opportunity for a fresh vision that looks toward the future of global health security and global health equity, while scaling-up successful prevention interventions and shifting control to local organizations and institutions, strengthening PEPFAR’s impact.

Now is not the time to pull back. Next year, PEPFAR will be up for Congressional reauthorization, giving advocates an opportunity to push PEPFAR’s priorities to better align with pandemic preparedness and what impacted communities need and want, transforming the US’s response to HIV/AIDS and global health at large.

Call to Action: Fully Fund PEPFAR and GF

This interdependent relationship between the Global Fund and PEPFAR must continue, and be strengthened and leveraged. Investing in one over the other is detrimental, irresponsible, and will have adverse consequences for reaching global targets against HIV, TB and malaria and will undermine global health security.

Advocates and civil society organizations have an important role to play in ensuring that Global Fund and PEPFAR are both fully funded, working together and recognized as essential platforms for pandemic preparedness and response. Here are some specific calls to action that advocates can take to get involved:

  1. Work with policymakers to maximize donor country contributions to Global Fund replenishment.
  2. Raise awareness that Global Fund and PEPFAR together constitute a core foundation to pandemic preparedness and global health security.
  3. Highlight to policymakers how PEPFAR and Global Fund work in coordination with each other, how that coordination saves money, and how fully investing in PEPFAR is not redundant.

No organization or country can address these complex epidemics alone. Now, the world is facing a turning point where overcoming nationalism with political commitments to fully fund the Global Fund and PEPFAR could decide the fate of global health for years to come. Will the global community be prepared for emerging pandemics while responding effectively to a current one (COVID-19) and protecting global gains against long-standing epidemics (such as HIV, TB and Malaria)?

The actions of world leaders in the weeks to come will tell the story. AVAC and our partners will be watching. Stay tuned for updates and further opportunities to join the fight.

Global Fund Replenishment Coming Up

September is a big month for global health, for the HIV response, for pandemic preparedness and equitable access to care around the world. The Global Fund will be hosting its seventh replenishment conference the week of September 18th in New York City. Held every three years, these conferences bring nations and the private sector together to pledge their investment to the largest global grant-making source for health systems in low and moderate income countries.

The Global Fund is seeking $18 billion, from 2024-2026, to address HIV, TB, & malaria with investment in frontline health workers, disease surveillance, robust supply chains and program innovation for resilient health systems. Advocates have been scrutinizing the numbers, raising questions, and framing demands. Budget targets and donor commitments must meet the need, and reflect the crucial role of the Global Fund within a larger picture.

Global health resilience includes full funding to Global Fund and PEPFAR, and a bottom-to-top, beginning-to-end commitment to people-centered approaches. AVAC will be at the conference September 19th, when pledge commitments will be made public, to watch and report.

In the meantime, check out the Global Fund Advocates Network (GFAN) Communications Toolkit, which outlines key advocacy ahead of the conference.

Follow our coverage on Twitter at @HIVpxresearch and watch this space in the days to come for more resources.

AVAC Condemns Court Decision that Tramples Human Rights, Reinforces Homophobia and Denies Life-Saving PrEP Drugs to Individuals in Texas

As a global organization dedicated to health as a human right, to social justice, and to individual autonomy and choice, AVAC condemns the decision by a federal judge in Texas who ruled in favor of a historically homophobic, misogynistic, and discriminatory plaintiff. A conservative activist sued on behalf of a Texas company claiming that adhering to a provision of the Affordable Care Act requiring employers to provide coverage for HIV pre-exposure prophylaxis (PrEP) drugs violates their religious rights.

“This shocking ruling defies evidence, logic, public health and human rights and sets back enormous progress made in the fight to end the HIV epidemic in the US and globally,” said Mitchell Warren, AVAC’s executive director. “It is a blatantly homophobic and misogynistic ruling that will endanger the lives of many gay men and others who rely on PrEP to protect themselves from HIV.”

“This ruling is the latest blow in a campaign to roll back bodily autonomy and human rights for a wide swathe of the American people. The Supreme Court overturning of Roe v. Wade earlier this year was a wake-up call that individual rights are under attack by the far right,” Warren added. “This decision likely won’t be the last we see in a campaign to impose some individuals’ religious beliefs on the broader population. Access to contraception, vaccinations, routine health screenings, prevention services and patient privacy are all under attack.”

While this latest decision is for now limited to the Northern District of Texas, it has ramifications for the rest of the country and for global programs to provide PrEP to people of all genders and sexual orientations who need and want to use it. These kinds of decisions often test the ground for cases that go to the Supreme Court, where the current makeup of the court means such a decision may be upheld and even expanded upon nationally.

“Deciding to use PrEP is a decision between an individual and their healthcare provider, no one else. Another person’s religious beliefs have no place in determining the right to use a safe, highly effective, FDA-approved, life-saving drug,” said Suraj Madoori, AVAC’s director of policy and advocacy.

“Daily oral PrEP was approved by the US FDA a decade ago and still has not reached nearly all of those who would benefit from its use. This decision throws up another substantial barrier between a life-saving intervention and individuals and communities most vulnerable to HIV, further capping the untapped potential of an important prevention option,” Madoori added.

This decision creates enormous, unnecessary barriers for LGBTQ+ people in Texas, as well as heterosexual women who are HIV-vulnerable, from the healthcare they need and is yet another example of oppressive or criminalizing policies in countries around the world that set barriers to health and human rights. We know these barriers drive poverty, epidemics and disenfranchisement from civil society. Policies like this don’t advance anyone’s freedom to live full, healthy lives; rather they undermine community resilience, individual autonomy and public health.

“At a time when science has given us the tools to advance towards the end the HIV epidemic and rational evidence-based public health policies and programs can implement those tools to save millions of lives around the world, one judge’s biased and discriminatory decision could endanger programs and lives far beyond northern Texas,” Warren added. “As advocates, activists and citizens, we at AVAC stand in solidarity with those whom this decision affects. We firmly believe that the ruling must be called out as homophobic and dangerous and that every effort must be made to ensure that it does not stand.”

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About AVAC: Founded in 1995, AVAC is a non-profit organization that uses education, policy analysis, advocacy and a network of global collaborations to accelerate the ethical development and global delivery of HIV prevention options as part of a comprehensive response to the pandemic. Follow AVAC on Twitter @HIVpxresearch and find more at www.avac.org and www.prepwatch.org.

Upcoming TCA Webinars On CROI And The Ring!

The Choice Agenda, a global forum for advocacy on the latest in HIV prevention, has two webinars coming up you won’t want to miss:

the Choice Agenda logo

CROI and Community and YOU – Preparing for CROI 2023
Wednesday, September 7 at 10:00-11:00am ET; 2:00-3:00pm GMT

Register here.

Join the conversation with co-chairs of the Conference on Retroviruses and Opportunistic Infections (CROI), as well as researchers, advocates, community educators and members of the Community Liaison Subcommittee. The discussion will touch on what to expect at CROI 2023, which features some of the most consequential research on HIV, monkeypox, SARS-CoV-2 and more. The webinar will also cover how to apply for a Community Scholarship, and key dates and deadlines for engaging with the conference. Remarks from:

  • Dawn Averitt, Member of the Community Liaison Subcommittee
  • Dr. James Hoxie, Chair of the 2023 CROI Planning Committee
  • Drs. Diane Havlir, Vice-Chair of the 2023 CROI Planning Committee
  • Landon Myer, Vice-Chair of the 2023 CROI Planning Committee
  • Jim Pickett, Member of the Community Liaison Subcommittee
  • Ntando Yola, Member of the Community Liaison Subcommittee

RINGing the bell for Choice: Actions and Solutions on Dapivirine Ring Access
Thursday, September 22 at 9:00-10:30am ET; 1:00-2:30pm GMT

Register here.

This webinar will offer the latest from African advocates leading efforts to demand access to the dapivirine vaginal ring. In recent weeks, advocates have been pressing PEPFAR and others to do more to deliver the ring to women who want it. The Population Council will also discuss their plans for moving forward a full agenda for ring technology, including rolling out the approved monthly PrEP Ring, and continuing research on a three-month ring and multipurpose technology. In July, the Population Council announced it had acquired the ring technologies from the International Partnership for Microbicides, the ring’s developer. Speakers include:

  • Yvette Raphael, Advocacy for Prevention of HIV and AIDS, South Africa
  • Leonard Solai, IPM, South Africa
  • Erica Gollub, Pace University
  • Chris Obermeyer, The Global Fund

For previous webinars from The Choice Agenda, check out our archive here! And join more than 600 advocates on the TCA listserve by reaching out to Jim at jimberlypickett@gmail.com.

AVAC’s August Reading List

Yesterday we heard that Dr. Anthony Fauci will step down from his role leading the US National Institute of Allergy and Infectious Diseases (NIAID) after a half a century of public service. His vision, passion and commitment to ending the AIDS epidemic and advancing global health equity has been an inspiration to AVAC and to so many. As we contemplate the huge leadership gap Dr. Fauci leaves, we look forward to working with him and all stakeholders to ensure that hard fought gains in public health under his leadership are not lost and are further built upon.

This August reading (and listening) list is a great place to start building on the legacy of Dr. Fauci and taking charge of the work ahead. As Dr. Fauci reminds us: “much accomplished; much still to do”.