Resources to Help Navigate the Fast-Moving COVID-19 Vaccine R&D Landscape

In this update, you’ll find links to two new AVAC resources designed to support advocacy and accountability in the context of the search for a COVID-19 vaccine, and a link to the recording and slides from our webinar on the COVID-19 vaccine development pipeline.

We have developed these new tools in the context of unprecedented public and media attention to vaccine research and development. Every day, scientists, researchers and politicians make bold predictions—sometimes backed up with significant financial resources—about moving research with extraordinary speed. Speed is essential, but must not come at the expense of ethics, safety, robust engagement, equitable access, and scientific rigor including independent peer and regulatory reviews.

AVAC’s new resources are designed to help advocates fact-check, counter-balance claims in the media and their communities, and accelerate accountability-oriented action where needed. These two fact sheets—the first of a series—provide an overview of the pipeline and a primer on the risks and benefits of expedited vaccine research.

After reading and downloading these tools, we hope you will listen to an AVAC-hosted webinar presentation and discussion with Dr. Barney Graham, the Deputy Director of the NIH’s Vaccine Research Center (VRC). Dr. Graham reviewed the COVID-19 vaccine development pipeline and provided an update on the vaccine developed by Moderna and the NIH (mRNA-1273), which is currently being tested in a Phase III trial. Listen to the recording and download the slides here.

Trial Design in Focus

AVAC, since its inception, has pushed the need for people most impacted by HIV to be involved in the design and implementation of clinical trials. In recent years, we have heard a clear call for community input on the design of complex, next-generation HIV prevention trials, and—along with many partners—have taken that call seriously. In this update, we share the latest on this work and provide some advocate-focused resources on next-generation trial design.

Designing trials to test new HIV prevention modalities remains crucial; high rates of new infections persist in communities all over the world. Even with effective tools becoming more accessible, it’s clear no single option fits every need. But those same options make the design of future trials increasingly complex.

Bill Snow, AVAC co-founder and senior advisor, explores this issue in Designing a New Generation of Prevention Efficacy Trials. The report lays out basic concepts in innovations in trial design and an analysis of the implications for advocacy. Snow’s guide is a roadmap for advocates, who have a leadership role to play. Download it here.

We also hope you will look at a consensus statement that emerged from AVAC’s inaugural Trial Design Academy convened in September 2019. At that meeting, a group of around 20 HIV prevention advocates from across the globe explored technical issues related to trial designs, and engaged with researchers, statisticians and regulators to understand the decisions which must incorporate input from advocates. The statement—which includes the group viewpoints and stances on this new, complex generation of HIV prevention trials—was presented at AIDS 2020 Virtual: Advocates’ Perspectives on Next-Generation HIV Prevention Trial Design.

The Trial Design Academy cohort—a global group of HIV prevention advocates and community representatives, highly literate and engaged in these complex concepts—is ready to partner in decision-making to ensure that new, possibly controversial trial designs are understood, well-supported by communities and lead to the best results possible.

The world needs a strong pipeline of research and development for HIV prevention. Innovation in trial design must meet an ambitious agenda and advocates must lead the way. To join the conversation with AVAC’s Trial Design Academy reach out to avac@avac.org.

Aug 25 Webinar on NIH/Moderna mRNA-1273 Candidate and COVID-19 Vaccine Development

Please join AVAC next Tuesday, August 25, 10-11am EDT for a webinar presentation and discussion with Dr. Barney Graham, the Deputy Director of the NIH’s Vaccine Research Center (VRC).

Dr. Graham will review the rapid development timeline for COVID-19 vaccines and explore some of the recent and historic vaccine research developments that are being applied to this challenge. He will also provide a specific update on the mRNA-1273 vaccine—a vaccine developed by Moderna and the NIH—which is undergoing testing in a Phase III clinical trial launched last month.

Register here.

The webinar will be recorded and available on AVAC’s COVID-19 resources page.

And if you have any questions ahead of time, please be in touch!

The Weekly NewsDigest will return August 21

There will be no issue for the next week. The NewsDigest will return on August 21, 2020.

New Resources on AVAC.org! The ring, long-acting PrEP and more

In the midst of harrowing trends in COVID-19 and growing concerns about its impact on HIV, HIV research has brought welcome good news. From a positive opinion on the Dapivirine Vaginal Ring, efficacy data on long-acting injectable cabotegravir (although limited to MSM and transgender women), and advocacy opportunities to demand the integration of HIV services with sexual and reproductive health, HIV prevention is making important strides in 2020. This round-up of new resources on AVAC.org and PrEPWatch.org features tools and information to advance prevention advocacy right now.

A Giant Step for the Dapivirine Vaginal Ring, What’s Next?

Understanding the EMA Opinion and Next Steps for the Dapivirine Vaginal, AVAC’s primer on the status of the ring after the EMA’s positive opinion, background on the relevant research and advocacy for what must happen next.

A webinar on Wednesday, July 29 brought together leading advocates and representatives from the ring’s developer (IPM) and WHO to talk about next steps on the regulatory process and implications for rollout.

On AVAC.org’s dedicated page for the dapivirine vaginal ring find links to key resources for advocacy.

AVAC’s debut episode of Research Fundamentals, on our podcast Px Pulse, explores the concept of partial protection. What is Partial Protection, an 11-minute episode on how and why an intervention can offer imperfect but still useful protection.

CAB-LA Shows Efficacy in One Trial, Results Coming Soon in Another

On AVAC.org’s page on long-acting injectable cabotegravir find a background on the research to date, including two trials testing this long-acting PrEP option, HPTN 083 & 084. Put the research in context with a host of additional resources found there.

An Advocates’ Primer on Long-Acting Injectable Cabotegravir for PrEP, AVAC’s primer for understanding the results of HPTN 083 and the status of HPTN 084, explores unanswered questions and next steps for advocacy.

A Conversation About Long-Acting PrEP for Cisgender Women, this discussion between Sinead Delany-Moretlwe, HPTN 084 Study Chair and Awelani Neluonde, CAB Member, was part of AVAC’s Research Literacy Networking Zone at AIDS 2020.

A Conversation About Long-Acting PrEP for MSM & Transgender Women, this discussion between Raphael Landovitz, HPTN 083 Study Chair and AVAC’s Jessica Salzwedel was part of AVAC’s Research Literacy Networking Zone at AIDS 2020.

Priorities for Advancing HIV/SRH Integration

Visit www.srhintegration.org, a joint initiative between AVAC and FP2020, which features a video series One Expert, One Question, One Minute, with key stakeholders framing the priorities for integration. There’s also a recording of a July 30th webinar, One Year After ECHO: Innovation in the time of COVID. And find links to a host of resources to inform your advocacy.

Thinking About Better PrEP Rollout?

Easier and Equitable Access to PrEP: How DSD Can Help Get Us There, by AVAC’s Jessica Rodrigues, Director of Product Introduction and Access, and published on the IAS blog devoted to differentiated service delivery (DSD), makes the case for expanding PrEP access with this user-centered approach, and using DSD for PrEP as a model for future prevention products.

See data on PrEP uptake in a whole new way with AVAC’s Global PrEP Tracker, showing dynamic trends over time. Download the Excel version of the Tracker for additional information on targets, programs, drug registration status, all sortable by country. Updated quarterly.

A Look at the Pipeline

The Years Ahead in Biomedical HIV Prevention Research provides an updated snapshot of the status of key biomedical HIV prevention strategies in research and development.

At this moment in the epidemic of COVID-19, many people who need HIV prevention products and services are struggling, and the stakes are high—will the world lose hard-won gains against HIV? But stakeholders in research are persevering with success and advocates are leveraging the day-to-day challenges to continue to demand the products people need today and in the future. We hope you’ll use these resources to tell the story, protect the global gains against HIV and push for more at this critical time.

AVAC, ITPC, TAG and Global Partners Launch New COVID Advocates Advisory Board

Today, AVAC along with the Treatment Action Group (TAG) and the International Treatment Preparedness Coalition (ITPC) officially launched the COVID Advocates Advisory Board (CAAB), an urgently needed step to leverage civil society expertise and power to ensure ethical, inclusive and accelerated research on COVID-19 vaccines, treatments and testing. The CAAB website was also launched today.

The CAAB is working to create an open platform to amplify voices of individuals and groups most impacted by COVID-19 which is—like HIV—exacerbated by pre-existing racial, economic and structural inequalities. As immediate next steps, the CAAB will:

  • Continue to lobby for formal engagement with all four pillars of WHO’s ACT-Accelerator (ACT-A) and the US government’s Operation Warp Speed, ACTIV and CoVPN programs, in order to ensure civil society input into research and access planning, development, implementation, and dissemination of results;
  • Expand research literacy to support civil society input into COVID-19 research at community, national, regional and global levels;
  • Adapt and disseminate an approach to applying Good Participatory Practice Guidelines to COVID research;
  • Facilitate meaningful dialogue among research teams and communities so stakeholders’ perspectives are included in the design, planning, and implementation of clinical trials and there is open communication about research goals, processes, and results;
  • Advocate for equitable access to products developed through COVID-19 R&D to all people in need.

As co-conveners of the CAAB, we undertake these actions with the full understanding that research must earn the trust of the communities where products will be tested and eventually deployed. Without this, trials are slower, uptake of proven products is lower, and solutions that show efficacy in trials do not have impact in the real world. We also know that planning for equitable access starts well before data are available, and that people who need products most must, without fail, fight for that access.

There are multiple ways for advocates to be involved in the work of the CAAB. Please check out the announcement, visit the website to learn more, apply for involvement, and watch for regular updates.