Given the global impacts of the COVID-19 pandemic, there is enormous pressure to speed vaccine development and approval. However, if approval appears to have been influenced by politics, or if the process skips important steps, public faith in vaccines will be damaged, resulting in decreased uptake for COVID-19 vaccines, and, potentially, other immunizations.

To help advocates lead the push for science—not politics—in the decision-making about possible vaccine approvals, AVAC has just published a Regulatory Approval Primer for Vaccine Advocates to help all stakeholders understand the regulatory process and points along the way to hold authorities accountable.

AVAC developed this checklist, outlining what to watch in the regulatory review of COVID-19 vaccines, to demand and protect a process that is unbiased, swift and thorough.

This new resource, along with our recently released COVID-19 Vaccine Pipeline Cheat Sheet, Advocates’ Guide: The risks and benefits of expedited COVID-19 vaccine research, and a new COVID-19 Vaccine Pipeline PowerPoint presentation, can now be found on the recently redesigned COVID-19 webpage on avac.org. The new page showcases resources and materials to help advocates make sense of the rapidly evolving research landscape.

Finally, if you missed last month’s webinar with Dr. Barney Graham, the Deputy Director of the NIH’s Vaccine Research Center (VRC), you can watch the recording here. Dr. Graham reviewed the COVID-19 vaccine development pipeline and put a spotlight on the vaccine developed by Moderna and the NIH (mRNA-1273), currently being tested in a Phase III trial.

We are scheduling additional webinars with other vaccine developers to explore the full pipeline, and to plan advocacy efforts to drive a response to COVID-19 based on the science.

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.

• COVID-19 Vaccine Pipeline Cheatsheet – This two-pager offers advocates an at-a-glance view of the funders, platforms, research phase and considerations for some of the front-runner candidates.
• Advocates’ Guide: The risks and benefits of expedited COVID-19 vaccine research – This guide highlights the strategies being implemented to shorten the COVID-19 vaccine development timeline and the benefits, risks and key takeaways for each.

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.

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 [email protected].

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!

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

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.

All of us at AVAC are deeply saddened by the untimely demise of Inviolata Mwali Mmbwavi, a fearless leader who devoted her life to fighting for the right to treatment and dignity for people living with HIV in Kenya. She brought this same spirit as a passionate advocate for HIV prevention.

“I would not wish HIV infection to happen even to my worst enemy. I will do whatever it takes within my ability to speak out and support prevention efforts to stop any single HIV infection where I can,” Inviolata told guests at an HIV Vaccine Awareness Day event in Nairobi last May.

Invio, as she was fondly known, worked closely with AVAC around HIV prevention for women, mentoring an AVAC Fellow, advocating for HIV vaccine research and lately around the COVID-19/HIV intersection. At a media webinar this year she presented the results of interviews she had conducted among Kenyan women living with HIV on how the COVID-19 pandemic was impacting their access to treatment.

As one of the first people in the country to publicly declare her HIV-positive status, Inviolata used her oratory gifts to fight HIV stigma and discrimination, from the rural villages of Kenya to the highest national political levels. She became a role model for positive living for youth and adults alike. Her actions contributed directly to the gradual shift in attitudes and HIV policies in the country.

In her life, Inviolata endured HIV stigma, opposition, ridicule and bouts of life-threatening illness, but always rose again to come back to her life’s work for the benefit of Kenya’s women.

Inviolata was the National Coordinator of the International Community of Women Living with HIV- Kenya Chapter (ICW-K). She launched a 3-year strategic plan for the organization in 2018, and worked tirelessly to fundraise and implement its holistic approach to HIV/AIDS care and treatment for women.

We echo the statement by NEPHAK, where she earlier served as founding executive director: “The history of the response to HIV in Kenya will not be complete without the mention of Inviolata Mmbwavi.”

AVAC sends sincere condolences to Inviolata’s beloved daughter and extended family.

Rest in peace and power, Invio.

Earlier this month, the first ever virtual International AIDS Conference played out over the course of a week. Out of it came both exciting news (injectable PrEP works really well for MSM and transwomen and so does oral PrEP) and disappointing data (we are definitely missing the targets)—all of which will inform AVAC’s advocacy for the months and years to come. For many of us here at AVAC, the week was a whirlwind of adjusting to the new online space, finding the virtual equivalent of a hallway conversation and tracking the firehose of news and session updates from the conference (not unique to the virtual experience).

In this update, we’ve put together news highlights, and links to some of our work at the conference, including recordings of some fun pop-up chats with researchers that were part of AVAC’s Research Literacy Networking Zone (RLNZ) programming. The conversations were a highlight for us—and we hope you find them useful, too!

And please bookmark our AIDS 2020 page, which we’ll update with links to the various session recordings as they become available.

Conference highlights

News and session highlights follow—with the news links courtesy of our friends at aidsmap. For their complete coverage of the conference, click here.

• Greg Millett’s plenary address on on a host of disparities that affect the HIV epidemic, the drivers and proposed solutions is essential watching for everyone.
• Access to PrEP is a powerful tool to bring down incidence at the population level, new data from the SEARCH study show.
• Injectable cabotegravir is highly effective in reducing HIV risk in men who have sex with men and transgender women. Participants in both study arms had low rates of HIV infection, but the difference in infection rates support the conclusion that CAB-LA is “superior” to oral TDF/FTC in terms of HIV risk reduction.
• Need a refresher on HIV prevention research? UCSF’s star researcher Susan Buchbinder provided a fantastic 20-minute lesson in plenary address on why, despite high efficacy, oral PrEP alone can not meet the world’s prevention needs, Biomedical HIV prevention: Beyond daily oral PrEP.
• Confirmation of preliminary data from the ADVANCE trial, which showed significantly higher weight gain in participants (and especially in women), who were in the treatment arm that included TAF. A separate study showed weight gain before and after a switch from TDF to TAF for treatment.
• More data on ARV use and effects in pregnant and breastfeeding women, including a meta analysis of different treatments and additional data from the Tsepamo study on neural tube defects (NTDs) in women using dolutegravir-based (DTG) regimens. Additional data from the Tsepamo study suggest a decreased difference in the number of NTDs between women who do and do not use DTG, compared to earlier study findings. The findings confirm the call for access to DTG-based regimens for all women.
• Study data showed that gay men and other men who have sex with men (MSM) in sub-Saharan African countries where homosexual activity is severely criminalized face nearly five times the risk of HIV acquisition compared to countries that don’t criminalize homosexuality.
• Additional data show that on-demand “2-1-1” PrEP is highly effective for MSM and transgender women.
• The Treatment Action Group (TAG) released its annual Pipeline Report, looking at HIV vaccines, antibodies, PrEP and microbicides.

RLNZ Pop-Up Chats

Click below to view sessions with researchers and advocates who discussed hot topics of the day. Have a topic you’d like to see featured in a future pop-up? Let us know!

• <href=”https://www.youtube.com/watch?v=Y9J3cmm4gck&t=1515s”>Long-Acting PrEP for Cisgender Women, featuring Sinead Delany-Moretlwe, Wits RHI
• Long-Acting PrEP for MSM & Transgender Women, featuring Raphael Landovitz, UCLA
• A Look at the Broadly Neutralizing Antibody Pipeline: What happens after AMP results?, featuring Devin Sok & Olayinka Fagbayi, IAVI
• A Conversation with Advocates on Preparing for AMP Trial Results, featuring Shelly Karuna, Fred Hutch Cancer Research Center
• HIV Cure Research, featuring Thumbi N’dung’u, Africa Health Research Institute
• Do Africans Need COVID-19 Research? A Conversation with Advocates and Researchers, featuring Dr. Kathy Mngadi, Aurum Institute, Dr. Sherman Padayachee, Setshabsa Research Centre, Xolani Mndaweni, Klerksdrop CAB, Former Participant
• Advocates Reflect on the Latest UNAIDS Report: What does it mean for research and access?

The satellite recordings aren’t yet up on the AIDS 2020 website, but the conversation at an HIV & SRH integration satellite, co-convened by AVAC and FP2020, was so good that we decided to continue it on a webinar this week. Please watch the recording of One Year After ECHO: Integration in the Time of COVID. And in the meantime, to hear more from the experts on SRH integration, check out our One Expert/One Question/One Minute Campaign mash-up video, and additional videos and resources at SRHintegration.org.

Read about work from AVAC and our partners in various sessions below!

• • Ending the HIV epidemic: Optimism, realism and disparities symposium
  • How did they do it? What successful communities can teach all of us about making dramatic progress against HIV

epidemics and what this means in the age of COVID symposium

• How policy affects practice: policy barriers to provision of HIV biomedical prevention services in Sub-Saharan Africa
• Transnational activism for an effective, comprehensive HIV response: Lessons from the coalition to mobilize power activism, strategy, solidarity (COMPASS) Africa
• Advocates’ perspectives on next-generation HIV prevention trial design
• Understanding ‘silenced health experiences’ of young people accessing HIV services through Body-Map Storytelling

We’ll keep adding new resources and links to our AIDS 2020 page as they become available, and remind you when they’re loaded up! If you have questions, or want to share with us your personal highlights, be in touch—we love hearing from you!

In our latest COVID Action Alert, we put today’s news of a Phase III trial launched by the biotech company Moderna in context. Larger trials mean an even greater need for robust community engagement to support the research and plan for uptake of an eventual vaccine. HIV vaccine and prevention advocates can lead the conversations that pave the way for ethical trials and swift implementation. How so? Read on.

On Monday, Moderna announced that enrollment has begun in a 30,000-person Phase III study of its mRNA SARS-CoV-2 vaccine candidate (mRNA-1273). The Moderna study is one of five large-scale, randomized, controlled efficacy trials currently slated to be conducted in partnership with the new NIH-funded COVID Prevention Trials Network (CoVPN) and with US government funding. At the same time, four other vaccine candidates have already entered into efficacy trials in Brazil, China, South Africa and the UK, and at least five more are expected to progress to Phase III by the end of this year. This work is being conducted through a number of global research collaborations, including the CoVPN.

The Moderna study will be conducted exclusively in the US in individuals “whose locations or circumstances put them at appreciable risk of exposure to SARS-CoV-2 and COVID-19.” The other Phase III trials planned with the CoVPN are expected to be conducted in the US and various international locations.

Anyone can get COVID-19. However, faultlines of racial and socioeconomic disparity run through this pandemic, as with HIV. In order to conduct research in communities and individuals that have been failed by the state and its health system, trials need robust community engagement—meetings with leaders and community members to share information, develop messages, address concerns and answer questions about eventual access plans. As HIV prevention activist Rob Newells said in a Washington Post story over the weekend, “… we have to engage people early in the research end of it, so by the time something gets approved, it’s not something brand new. I think it’s going to take time to talk to people about vaccine research.”

Moderna Phase III participants will be enrolled at 89 sites across the US, 24 of which are affiliated with the CoVPN, which includes groups and researchers with a long history of community-based research engagement. The remaining sites will be enrolled via a clinical research organization called PPD whose commitment to engagement is unknown.

Advocates and activists can take action by:

• Responding to recruitment announcements with a request for information on the local advisory mechanisms.
• Working with communities to develop priorities to inform engagement with research. This can include information on future access and health care for individuals in the trials.
• Push for community-driven inclusion and exclusion criteria. Both the Moderna and Pfizer Phase III protocols indicate that individuals with HIV are not eligible for participation. Many groups, including AVAC, have joined together to raise urgent concerns about how this data gap will impact access for PLHIV, demanding that the trial sponsors review and change the criteria. The trials also exclude pregnant women, raising yet more concerns about how this research will replicate gender gaps that have hindered public health equity for years. Sign-on letters on both issues are in process.
• Sharing experiences. The world needs a COVID-19 vaccine; activists and advocates can help make sure that speedy research is safe, ethical and inclusive by rapidly disseminating what’s working and what isn’t—because if the research process does not build community trust and confidence now, then future vaccine access will be severely jeopardized.

To help ensure these and other steps happen effectively and efficiently, AVAC, ITPC, TAG and other partners have established a global COVID Advocates Advisory Board (the CAAB), that seeks to connect advocates, build power and elevate core issues. If you’re interested in learning more, please email us at [email protected].

More about the Moderna candidate

The Moderna candidate uses an mRNA platform. mRNA is “messenger” ribonucleic acid, a single strand of genetic material that contains instructions for a specific protein. The Moderna vaccine contains a synthetic mRNA sequence that teaches the body to produce a protein found on the outside of SARS-CoV-2. The instructions don’t teach the body how to make the whole virus; there is no chance that the vaccine itself will cause SARS-CoV-2. In smaller trials, people who received this candidate made antibodies against SARS-CoV-2 that blocked viral activity in test tubes. This trial will help evaluate whether the vaccine-induced immune responses do the same in humans. Scientists are enthusiastic about the promise of mRNA vaccines, as they would be relatively easy to manufacture quickly and in large numbers. However, there are no licensed mRNA vaccines as of yet.

In July, Moderna published Phase I data from 45 volunteers, split evenly between men and women, at sites in Seattle and Atlanta. The data showed that the vaccine was safe, though it caused side-effects (chills, fatigue, headaches, etc) in many volunteers, particularly at higher doses. The vaccine was shown to elicit neutralizing antibodies; after two doses volunteers had more neutralizing antibodies than most individuals who have recovered from COVID-19. It is important to note that the level and duration of antibodies required for protection is not yet known. Phase II trials are ongoing, but the data were sufficiently promising to warrant launching the Phase III trial, which will randomize volunteers to receive either a placebo or the vaccine. The trial will primarily be looking to see if the vaccine prevents symptomatic COVID-19 disease, but researchers are also interested to see if it prevents severe disease.

For a snapshot of the larger COVID-19 vaccine pipeline, check out this update done in collaboration with TAG, and stay tuned for details on upcoming webinars on this and other COVID-19 vaccine candidates in development.