HIV Vaccine Awareness Day 2023: Hard lessons, innovation & new directions

May 18th is recognized as HIV Vaccine Awareness Day (HVAD), and this year it is a time of deep reflection and potential. Three major HIV vaccine trials have ended in no efficacy since 2020, but the field knows more than ever that a vaccine is still needed for a durable and sustainable end to the pandemic – and has new insights into possible vaccine strategies that might one day effectively protect against HIV.

This year, AVAC and CASPR partners are casting a spotlight on the many issues and opportunities for HVAD 2023. Check it all out here! And read on for details about a wide range of new resources.

New PxPulse Podcast Episode!

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Listen to the newest PxPulse podcast, “Evolving Strategies for an HIV Vaccine: One researcher explains where the field is going and why,” featuring Katy Stephenson of Harvard Medical School, Beth Israel Deaconess Medical Center, and the Center for Virology and Vaccine Research. In conversation with AVAC’s Jeanne Baron, Katy provides an accessible breakdown of where the field of HIV vaccine research is, including details on recent trial results that proved ineffective and what’s next (and exciting) in HIV vaccine advocacy and research.

Save the Date for Two Upcoming Webinars!

save the date advertisement for these upcoming webinars

What’s All the Buzz About: mRNA, manufacturing, vaccines access

Thursday, June 1 at 10am ET / 4pm SAST
Featuring Caryn Fenner of Afrigen Biologics, Ike James of Medicines Patent Pool, and Mike Frick of Treatment Action Group. Register here.

To bNAb or not to bNAb? The case for broadly neutralizing antibodies

Wednesday, June 7 at 10 AM ET / 4 PM SAST
Featuring Slim Abdool Karim of CAPRISA, Pervin Anklesaria of Bill & Melinda Gates Foundation, Khadija Richards of Wits RHI, and Huub Gelderblom of HIV Vaccine Trials Network (HVTN). Register here.

CASPR Partner and Collaborator HVAD Events

Communities across the globe will be engaged in a wide array of events focused on HIV vaccine awareness in the coming days. Here, we provide details on activities the Coalition to Accelerate & Support Prevention Research (CASPR) partners are leading – be sure to watch AVAC’s Twitter for real-time highlights!

New Series of Advocate Briefs

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In the weeks to come, we’ll release From the Lab to the Jab, a series of briefs on next generation vaccine research and development; the basics of mRNA technology; initiatives that support local manufacturing; and understanding and overcoming barriers that undermine equitable access to vaccines. Each brief also highlights the advocacy needed to keep these efforts on track and in line with what communities need and want.

New Resources

AVAC has updated our recent HIV vaccine primers. And we’re sharing a viewpoint written in the Journal of the International AIDS Society.

As the science continues to advance, we hope these resources inform our collective advocacy. With the knowledgeable voices of advocates guiding the response, scientific successes will not be squandered, communities won’t be left behind, programs will be people-centered, and epidemics will end.

United States Government Listening Session Ahead of World Health Assembly 76

The US Department of Health and Human Services (HHS) is charged with leading the US delegation to the 76th World Health Assembly, and convened a Stakeholder Listening Session on May 3, 2023. The Stakeholder Listening Session is designed to seek input from stakeholders and subject matter experts to help inform and prepare for US government engagement with the World Health Assembly.

AVAC’s Samantha Rick, Manager: Multilateral/Pandemic Preparedness and Response (PPR) Advocacy Specialist, delivered these remarks orally at the Listening Session.

“I am speaking as a representative of AVAC, an international non-profit organization that leverages global partnerships to accelerate ethical development and equitable delivery of effective HIV prevention options, as part of a comprehensive and integrated pathway to global health equity.

As the document for the World Health Assembly for this topic has not been released, we reference the document provided for the EB earlier this year. In regard to the proposals for strengthening the Health Emergency Preparedness, Response and Resilience (HEPR) framework, we have some concerns about implementation. The governance piece relies on the development of the Pandemic Accord under the Intergovernmental Negotiating Body (INB), and the current draft text does not have sufficient accountability measures to ensure that Member States adhere to the provisions set out for actions in health emergencies. In addition, the suggested textual edits, particularly by the US, weaken any language that could compel Member States to take actions for the global good by inserting ‘voluntary’, ‘suggest’, ‘should’, and ‘intend to’ in front of many of the agreements. These negotiations give us less hope that the HEPR framework governance reforms will be effective.

The systems proposals are intriguing, but can only be implemented if there is a recognition that in order to have strong surveillance and reporting mechanisms, we must also guarantee access to benefits of these mechanisms, namely through true access to medical countermeasures developed from the data shared in the course of collaborative surveillance. The EB document references ACT-A as an example of access to medical countermeasures – this is concerning, as the ACT-A system did not provide access broadly, in a timely manner, or in an equitable fashion and relied heavily on voluntary donations. An end-to-end system for access to medical countermeasures must be based on need (both financially and degree to which an outbreak is acute and posing national and regional risk).

Proposal 10 also needs some significant additional thought. The reputation of the WHO within countries and globally is at a low point and more creative communication strategies to strengthen WHO’s position in the center of the HEPR architecture are needed. To that end, a more inclusive WHO would go a long way. The exclusion of NSAs and civil society from the INB negotiations is a glaring example of squandering an opportunity to open up proceedings and dispel any misinformation around the process. Within the WHO, civil society organizations are treated the same as philanthropies and corporations. Expanding the pool of CSOs would help to gain trust in the WHO as a central coordinating body for health emergencies. A key lesson from US support for both PEPFAR and the Global Fund has been the essential role of civil society in governance and accountability, and we now look to the US to champion civil society inclusion in WHO processes.”

About the World Health Assembly

The World Health Assembly is the decision-making body of WHO. It is attended by delegations from all WHO Member States and focuses on a health agenda prepared by the World Health Organization Executive Board. The main functions of the World Health Assembly are to determine the policies of the Organization, appoint the Director-General, supervise financial policies, and review and approve the proposed programme budget.

Celebrating One Year of The Choice Agenda

HAPPY ANNIVERSARY! It was one year ago that we introduced The Choice Agenda (TCA) with Jim Pickett in the hopes of creating a space to continue the discussion, debate, and information sharing that has been core to four decades of HIV advocacy and activism in HIV treatment and prevention – and is central to global health equity.

In its first year, we’ve seen close to 1,000 threads on a list serve of 1500+ subscribers covering a broad range of topics from HIV prevention research to sexual health, STIs, PrEP implementation, pleasure, LGBTQIA+ rights, public health, human rights, abortion rights, funding, politics, pandemic preparedness and so much more. We also hosted 18 webinars on an exciting range of topics – with many more to come.

We take this moment to honor the life and work of two of our first subscribers who died this year – the US CDC’s Dawn Smith and Italian activist Giulio Maria Corbelli – each highly consequential, deeply-involved, community-focused and adored.

Today, as we work to make complex science accessible, identify where advocacy and action are needed and pursue bold agendas that improve global responses to HIV and prepare to prevent future pandemics, the TCA’s agenda-setting conversations are more important than ever.

Thank you to everyone who started with the TCA a year ago, who has been a part of the discussion and debate along the way and who are using this platform to continue and who have been part of the discussions and debate.

Take a minute to review our archived resources and webinars, and be sure to sign up for our next two upcoming webinars. Also, if you are interested in joining The Choice Agenda’s global discussion list, reach out to Jim at jimberlypickett@gmail.com.

PrEP (In)equity: Documenting, measuring, and flipping the script towards justice
Tuesday, May 9 at 9:00 AM–10:30AM ET
Featured Speakers: Leisha-McKinley Beach, National HIV/AIDS Consultant, Michael Chancley, PrEP4All, and Patrick Sullivan, Emory University
Register

PrEP That Booty: The latest on rectal microbicide research for the back door
Thursday, June 29 at 9:00 AM–10:30AM ET
Featured Speakers: Jonathan Baker, #RectalRockstar, Craig Hendrix, Johns Hopkins, Juan Michael Porter II, The Body, and Sharon Riddler, University of Pittsburgh
Register

New Px Pulse Episode on LGBTQIA+ Advocacy in Uganda

Our latest podcast, LGBTQIA+ Advocacy in Uganda: Facing down fear and fighting for justice, is available now!

This episode looks at Uganda’s just-passed anti-homosexuality bill, that now awaits final action from President Museveni. The broad-reaching legislation further criminalizes LGBTQIA+ people and is part of a wave of anti-gay hate laws and actions by authorities that are sweeping across the region with recent crackdowns in Ghana, Kenya, Rwanda, Tanzania and Zambia.

The Ugandan bill would make it a crime to even identify as lesbian, gay, bisexual, transgender or queer, with sentences up to life imprisonment. It gives authorities wide powers to crackdown on anyone who does not report on same-sex couples or who promote gay rights, including prohibitions on news coverage and media. And the law could impose death sentences in some cases, including for the transmission of HIV. Uganda’s President Museveni has the power to stop the bill. But so far he is issuing statements for other African countries to follow Uganda down this path.

This podcast episode features several leading Ugandan advocates, whose fierce and imperiled voices are readying to fight for LGBTQIA + people in Uganda, but at AVAC, we know they are fighting for all of us. Listen as they dig into the specifics of how these attacks have gained momentum and their ties to US-based religious extremists. For the full podcast episode, resources to learn more on the issue, and the archive of previous episodes, visit avac.org/px-pulse. And subscribe on Apple Podcasts, Spotify or wherever you get your podcasts!

Uganda-based advocates are urgently organizing and raising money to challenge this law. You can donate to SMUG and Chapter Four Uganda.

Catch Up on the Advocacy for IP Waivers, Tech Transfers and PPPR

In case you missed it, highlights from our April 6 webinar, Global PPPR Equity: Why do we need agreements on IP and tech transfers?, are a must read. Panelists, bringing a range of expertise, explored lessons learned from the HIV/AIDS epidemic on IP and tech transfer advocacy and what’s next in the fight for global equity in pandemic prevention, preparedness and response (PPPR).

Featured speakers included:

-Fifa Rahman, ACT-A CSO and Health Poverty Action
-Brook Baker, Northeastern University and Health GAP
-Fitsum Lakew, WACI Health
-Esteban Burrone, Medicines Patent Pool

Listen to the webinar to learn:

-Why patents matter for diagnostics, despite assertions from industry that they do not
-The impact of intellectual property monopolies during COVD-19
-About the need for rapid scale up of manufacturing in African countries and more

“There are five key reasons we need licensing and tech transfer: they reduce prices, accelerate access to new and innovative treatments and other technologies, enable production of greater volumes, contribute to supply security, and support geographical diversification of manufacturing.” – Esteban Burrone, Medicines Patent Pool

Check out our summary of the webinar, watch the recording, download the slides and find links to a host of resources on PPPR, including an Advocate’s Guide to PPPR and two recent podcasts on the global architecture being put in place to make investments and coordinate resource sharing.

With pandemic prevention, preparedness and response an area of increasing investment and planning, these voices are sharing insights and messages that are instrumental for collaboration and advocacy. Tell us what you think and contact Samantha@avac.org to get involved!

AVAC at the 2023 Biomedical HIV Prevention Summit

The Biomedical HIV Prevention Summit, now in its seventh year, will be held in Las Vegas, Nevada, on April 11-12. This annual meeting focuses on biomedical interventions for treatment and prevention of HIV and approaches to implementation of these tools to end the epidemic.

This year’s theme highlights the role of sex and pleasure and includes a plenary featuring advocacy to right the wrongs of a failed US federal PrEP response with a US National PrEP Program.

AVAC and partners are involved in a number of sessions and activities; scroll down for information on these and click here to check out the full conference agenda.

And finally, be sure to follow our Twitter feed, @HIVpxresearch, Tuesday, April 11, when our Senior Program Manager for Policy, John Meade Jr., takes it over to report on the meeting live from Las Vegas.

AVAC and Partners at the Biomedical Prevention Summit

Tuesday, April 11:

10:30 to 12:00 PM PDT: No Data No More: A research scorecard for transgender inclusion
Session 1 Workshop
If we are to end the epidemic, we need biomedical research data that are representative of transgender communities. AVAC has designed a Scorecard tool with which to hold researchers accountable for the meaningful inclusion of transgender people in all HIV clinical trials. Join this session to learn how milestone HIV studies from 1991-the present have scored on transgender inclusion—and how you can ensure “No Data No More.”

4:30 to 6:00 PM EDT: Long-Acting Injectables: Revolutionary prevention drugs require revolutionary adaptations in delivery
Session 3 Workshop
Current delivery models for longer-acting injectable (LAI) PrEP require consumers to travel to outpatient settings and be seen by providers qualified to deliver injections. Yet, many providers serving HIV-impacted populations do not have sufficient capacity to offer LAI PrEP at the volume necessary to end the epidemic. Additionally, structural barriers and serious inequities within the United States healthcare system prevent many from engaging in HIV prevention. This workshop will explore how the HIV prevention community can draw lessons from other fields to successfully develop, advocate for, and implement alternative delivery models for LAI to increase access, and realize the promise of these revolutionary interventions.

4:30 to 6:00 PM PDT: PrEP in Black America: An equity movement in HIV prevention
Session 3 Workshop
Black people in the US bear a disproportionate burden of HIV, representing approximately 13 percent of the population while comprising more than 40 percent of incident HIV diagnoses in 2019. Despite this, biomedical HIV prevention tools remain underutilized by Black people and more than 90 percent of those who can benefit from PrEP have not been prescribed PrEP. The PrEP in Black America Summit (PIBA) was convened by a cadre of Black HIV activists, advocates, leaders, and public health professionals to address these frustrating factors on the 10th anniversary of the Food and Drug Administration’s approval of the first medication for biomedical HIV prevention. Summit leaders gathered more than 150 individuals, in person and virtual, in the spirit of confronting the historical injustices and race-based discrimination that continue to drive HIV and other sexual health inequities experienced by Black communities to develop a Black-focused agenda or “roadmap” for HIV prevention.

Wednesday, April 12:

10:30 to 12:00 PM PDT: CAB 4 PrEP: Opportunity for advancing equity and improving access
Session 4 Workshop
Injectable PrEP uptake in the US has the potential to reduce HIV infections, but only if its introduction can address the impediments to its implementation. Participants will engage with panelists that have experience with injectable cabotegravir in this workshop.

Challenging a Season of Hate in 2023

A look back at the last few weeks brings a heavy heart, and, for us at AVAC, a renewed determination to fight back against a sea of reactionary policies that jeopardize healthcare and dismantle civil liberties around the world.

As our Executive Director Mitchell Warren recently told the TheBodyPro, “This is, frankly, a global pandemic. Right-wing politics, moralizing legislatures, and moralizing judicial systems are putting people’s lives at risk.”

Extremist courts and legislatures in the US and in many other countries are pursuing laws that will, at the very least, turn back time in our progress against HIV and at worst destroy the lives of whole segments of society.

In the last two weeks alone, AVAC has had to issue three statements condemning unjust, dangerous and deeply flawed legal maneuvers.

On March 24, we condemned Uganda’s Anti-Homosexuality Bill of 2023, a more poisonous version of a 2014 attempt to further criminalize the LGBTQIA+ community. It’s also just one of condemned Uganda’s Anti-Homosexuality Bill of 2023 several draconian anti-gay bills sweeping across Africa and the US. As Brian Kanyemba of Advocacy for Prevention of HIV and AIDS (APHA) told TheBodyPro, it’s a “Homophobic Spring”. (Watch this space for a podcast in the coming days with stunning reports from Uganda-based advocates on the fight against Uganda’s proposed anti-homosexuality law.)

Two US court rulings have since come down, each attacking access to fundamental healthcare. On March 30th, a US federal judge in Fort Worth, Texas, struck down a section of the Affordable Care Act that requires insurance coverage for many preventive services, including HIV testing and the provision of PrEP. This ruling reinforced an earlier decision that ruled PrEP provision may violate individual religious freedom. AVAC’s statement condemned this ruling that endangers access to PrEP, as well as other life-saving prevention services.

And today, we are again condemning a court ruling from a different US federal judge, this time based in Amarillo Texas, who has issued an unprecedented preliminary injunction suspending the US Food and Drug Administration’s (FDA) approval of mifepristone, a safe and effective abortion medication approved more than 20 years ago. If this decision is allowed to stand, it will restrict access to the most widely used method of abortion and undermine the FDA’s authority on drug regulation generally.

“This decision throws open the door to reversals of other drug approvals based on one individuals’ personal or political beliefs rather than science and evidence. It’s yet another blow in a campaign to roll back bodily autonomy and human rights and cannot be allowed to stand,” said Warren. “In solidarity, we stand with the millions of individuals and families who will be affected by this highly political decision, and we stand with science and medical evidence, which is increasingly under attack in the US.”

In what has become a season of hate, we turn our eyes to the work ahead. We call on the Biden administration to take immediate action to safeguard access to every aspect of sexual, reproductive and preventive healthcare, including PrEP, mifepristone and other abortion services. We call on political leaders and health leaders in every corner of the globe to take action in solidarity with LGBTQIA+ people to protect and expand their civil rights. When fear and reaction gather momentum, we must recommit to an advocacy agenda that champions evidence-based and science-informed policy. We must join together, with clarity and solidarity, to face down the hate and build a world for all of us that is safe, healthy and just.

AVAC Condemns Court Decision that Tramples Human Rights, Endangers Evidence-Based Medical Care and Sets a Dangerous Precedent

As a global organization dedicated to health as a human right, to social justice, and to individual autonomy and choice, AVAC strongly condemns the decision by a federal judge in Texas who issued an unprecedented preliminary injunction that suspends the US Food and Drug Administration’s (FDA) approval of mifepristone, a safe and effective abortion medication approved more than 20 years ago. If this decision is allowed to stand, it will restrict access to the most widely used method of abortion and undermine the FDA’s authority on drug regulation generally.

A counter ruling issued shortly after the Texas decision by a judge in Washington state called for the FDA to maintain access to mifepristone. It is unclear how these competing rulings will play out, but it is assumed this will force the issue to the Supreme Court where it is uncertain how a conservative majority may rule.

“The Texas decision throws open the door to reversals of other drug approvals based on one individuals’ personal or political beliefs rather than science and evidence. It’s yet another blow in a campaign to roll back bodily autonomy and human rights and cannot be allowed to stand,” said Mitchell Warren, AVAC’s executive director. “In solidarity, we stand with the millions of individuals and families who will be affected by this highly political decision, and we stand with science and medical evidence, which is increasingly under attack in the US.”

More than 20 years ago, the FDA reviewed the scientific evidence and approved mifepristone for medication abortion as a safe and effective product. In the intervening time, a tremendous amount of additional evidence has been added to the safety and efficacy profile of the drug, and its effective use outside of a clinic setting.

“The FDA’s job is to evaluate reams of scientific evidence and conduct unbiased, stringent review of new drugs and devices.” said Suraj Madoori, AVAC’s director of policy advocacy. “Friday’s ruling would take decision-making out of the hands of experts and put it into the hands of misguided activist judges, endangering access to other FDA-approved medications. AVAC is especially concerned about implications for access to contraception, treatments used by transgender individuals and HIV prevention drugs.”

“The FDA is recognized as the global leader in stringent, objective review of drugs and devices. Today’s ruling not only endangers public health and access to safe, effective medication, it jeopardizes our national standing and well-earned respect for our regulatory body,” said Madoori.

AVAC calls on the Biden Administration to take immediate action to safeguard access to mifepristone and to the sanctity and credibility of the nation’s drug approval process. AVAC also calls for appellate courts and the Supreme Court to uphold the FDA’s jurisdiction over drug regulation.

“This decision cannot be allowed to stand. AVAC commits to working with our partners and allies to ensure that the right to access evidence-based medical care is not infringed and that the right to abortion, and reproductive rights overall, are protected for all,” Warren added.

Webinar Recording on Global PPPR Equity

Global PPPR Equity: Why do we need agreements on IP and tech transfers?

Over the past two decades, HIV advocates have engaged in hard battles for equitable access to HIV/AIDS drugs and prevention options and have had some big wins. The process of these negotiations has led to strong relationships that have enshrined certain equity provisions as standard in clinical trials and manufacturing of HIV drugs. Through these battles, we’ve learned clear lessons on the necessity for such agreements and what’s required to secure them.

Throughout global PPPR agreements in 2023, governments and advocates in the Global South are asking for provisions on equity in the form of temporary IP waivers, mandatory tech transfer, and mandatory licensing for pandemic tools.

This panel discussed lessons from the HIV epidemic and explore why governments of the Global South and advocates think we still need to address ‘the IP question’.

Featured Speakers included Fifa Rahman, Brook Baker, Fitsum Lakew, and Esteban Burrone

Watch the recording here.

A Look Ahead of Webinars in 2023

Mark your calendars! We have a number of webinars and events coming up, including three this week, that you won’t want to miss. And scroll down for links from our archived webinars.

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This week!

Braidwood v. Becerra and PrEP Access: Emergency town hall
Tuesday, April 4, 2023, 6:00 PM ET
Register here
Especially if you live in the US, join PrEP4All, AVAC, HIV Medicine Association, Center for HIV Law & Policy, Lambda Legal, and other leading advocacy organizations , for an emergency virtual town hall to help the community better understand the implications of a recent US ruling that would block insurers from covering a range of critical preventive services such as PrEP, HIV testing, STI screening, and more. Read AVAC’s statement on the issue.

DRM Learning Collaborative
Thursday, April 6, 2023, 8:00 AM ET / 3:00 PM EAT
Register here
The Learning Collaborative is a virtual space that brings together global health advocates, civil society organizations and other key stakeholders from Africa to engage in peer-to-peer learning. This webinar will discuss the landscape including challenges and opportunities, and identify priority advocacy towards expanding local manufacture of vaccines, diagnostics, and therapeutics.

Global PPPR Equity: Why do we need agreements on IP and tech transfers?
Thursday, April 6, 2023, 9:00 AM ET / 2:00 PM GMT / 4:00 PM EAT
Register here
Throughout global PPPR agreements in 2023, governments and advocates in the Global South are asking for provisions on equity in the form of temporary IP waivers, mandatory tech transfer, and mandatory licensing for pandemic tools. This webinar will discuss lessons from the HIV epidemic and explore why governments of the Global South and advocates think we still need to address ‘the IP question’. Featured speakers include Fifa Rahman, Brook Baker, Fitsum Lakew, and Esteban Burrone.

Later in April and beyond from The Choice Agenda
:

How to Communicate about Sexual Health and STIs: Sex positivity vs. risk-based language
Thursday, April 20 at 9:30 AM ET
Register here
Our language matters especially when discussing our sexual health. Join The Choice webinar for a conversation focused on sex positivity and risk-based language when discussing sexual health and STIs. Featured speakers include Keosha T. Bond, Joseph Cherabie, and Alison Footman.

HIV Prevention Plus Plus: Developing options that meet the full range of our sexual and reproductive health needs
Tuesday, April 25, 2023 at 9:00 AM ET
Register here
With a growing number of PrEP options already, what will it take to bring a new MPTs (Multipurpose Prevention Technology) to market? This webinar from The Choice Agenda will explore what we’ve learned so far on R&D, marketing, counseling and delivery for MPTs – and discuss what we can do now to prepare prevention markets to include new MPT options. Featured speakers include Ruth Akulu, Gregorio Millet, and Thesla Palanee-Phillips.

PrEP (In)equity: Documenting, measuring, and flipping the script towards justice
Tuesday, May 9, 2023, 9:00 AM ET
Register here
Disparities in PrEP awareness, access, and uptake are stark in the United States, and play out along lines of race, gender, age, and geography. This webinar from The Choice Agenda will break down some of the existing inequities and key calls to action on how we can better strive for PrEP justice in the US. Featured speakers include Leisha-McKinley Beach, Michael Chancley, and Patrick Sullivan.

PrEP That Booty: The latest on rectal microbicide research for the back door
Thursday, June 29, 2023 at 9:00 AM ET
Register here
Researchers and advocates for years have been working on HIV prevention products specifically for the back door (rectum) to provide protection during anal intercourse. This webinar from The Choice Agenda will investigate some of this newfound research with experts working closely in the field. Featured speakers include Jonathan Baker, Craig Hendrix, Juan Michael Porter II and Sharon Riddler.

Past Webinars
Be sure to check out recent webinars including Mpox – Sexual Networks, HIV and Activism, a comprehensive recap of this year’s CROI meeting, Been There, Did That – Research Reflections from CROI 2023, and Making PrEP accessible: Updates on long-acting injectable options from International AIDS Society (IAS).