New Resources on AVAC.org and PrEPWatch.org

The latest estimates for COVID-19 anticipate a death toll approaching 2.8 million by year’s end. Economies are stuttering on every continent. Controversy surrounds how vaccines will be allocated, with ten leading candidates racing to show efficacy without sacrificing rigor. All this, as global health leaders of every stripe struggle to sustain the gains against HIV, TB, malaria, other preventable diseases and unintended pregnancies. Advocates must be armed with information and tools to demand transparency, and to get effective interventions for both HIV and COVID-19 developed and distributed equitably. Read on for recently produced resources to help get the job done.

HIV Prevention Moves Forward

AVAC’s latest episode of its Px Pulse podcast looks at critical next steps for the Dapivirine Vaginal Ring, which received a positive opinion in July from the European Medicines Agency. Hear five different perspectives on what must happen next and what it means for cisgender women.

Fill out our survey on tools for PrEP rollout! AVAC is evaluating how the PrEPWatch site is used at the global and country level to inform PrEP planning and introduction. Your responses will be kept confidential. The survey should take about 5 minutes to complete.

Designing a New Generation of Prevention Efficacy Trials is a report by AVAC founder Bill Snow that lays out basic concepts for innovation in trial design and offers an analysis of their implications for advocacy. And check out this Consensus Statement that emerged from AVAC’s inaugural Trial Design Academy, convened in September 2019.

COVID-19 On the Ground

Catch up on the conversation about how COVID-19 is impacting countries across Africa and learn about the collective response in this recorded webinar with the heads of Africa CDC and WACI Health. Hosted by WACI Health, AVAC and Friends of the Global Fight Against AIDS, TB and Malaria.

Science—Not Politics—in the COVID-19 Response

Help lead the push for evidence-based decision-making in COVID-19 vaccine development and approvals with these two resources:

The COVID-19 Vaccine Pipeline

  • Check out COVID-19 Vaccine Pipeline Cheat Sheet for a snapshot on leading vaccine candidates for COVID-19.
  • COVID-19 Vaccine Pipeline PowerPoint presentation offers advocates a detailed view of the funders, platforms, research status and key considerations for some of the front-runner candidates.
  • An August webinar included an overview of the COVID-19 vaccine pipeline with the Deputy Director of the NIH’s Vaccine Research Center Barney Graham, and a special focus on the Moderna/NIH candidate (mRNA-1273), which is currently being tested in a Phase III trial.
  • AVAC’s recently redesigned COVID-19 webpage on avac.org houses all these resources and more to help advocates make sense of the rapidly evolving research landscape.

Science, Not Politics, Must Lead to COVID Vaccine Approvals

This post first appeared in Science Speaks. Uché Blackstock, MD, is the Founder & CEO of Advancing Health Equity, and Mitchell Warren, is the Executive Director of AVAC.

COVID-19 has devastated communities and health systems around the world – but it has also created an historic global effort leading to the unprecedented development of more than 165 potential vaccines against COVID-19. Equally impressive innovations are speeding vaccine testing within a rigorous scientific framework, while manufacturing and transportation capacity are being scaled up to distribute millions of doses of future COVID vaccines to those who need them most.

These advances require scientific collaboration and logistical coordination on a scale never seen before, and enormous investments of private and taxpayer money. All of that hard work, innovation and investment is endangered, however, if the public loses faith in a critical step in the process: the independent, unbiased review by regulatory agencies, such as the US Food and Drug Administration, of data demonstrating that a vaccine is safe and effective.

Vaccines are among the most powerful tools we have to reduce health disparities and advance health equity – but only if they are trusted and used. Government approval of any potential vaccine must be based on a process that is transparent, scientifically rigorous and free from political pressure. This is especially true as misinformation and conspiracy theories about vaccines circulate, and public confidence in vaccines falls. The consequences of any vaccine approval that appears to have been influenced by politics would be particularly grave for Black and Latinx communities, who have real reasons to distrust both politicians and drug testing processes, and who are also at significantly increased risk for COVID infection and illness.

That’s why it’s particularly worrying that politicians are wading into the vaccine testing and approval process. In the United States, government officials, perhaps with the November election in mind, are discussing granting emergency approval to one or more COVID vaccines as early as October – well ahead of the completion of essential Phase III vaccine testing. Concerns over the potential political manipulation of the vaccine approval process are so grave that last week nine pharmaceutical companies issued an unprecedented public pledge that they would not seek approval of any vaccine without extensive safety and effectiveness data.

How the US approaches vaccine approval will have global implications. FDA has provided a gold standard in the review and approval of drugs and vaccines – so much so that its decisions are often adopted by other countries. The idea that political pressure could lead FDA to alter its vaccine approval standards should send shockwaves not only through the US, but through global health systems as well.

The rush-to-approval dynamic is not limited to FDA, however. The Chinese military began using a COVID vaccine in July, long before advanced testing was complete. And in Russia, the release of a vaccine that has not undergone critically important Phase III testing has produced broad concern, with only 24 percent of physicians there saying they would give it to their patients.

Large Phase III studies are the only way to determine how well potential vaccines work, including whether they produce side effects unnoticed in smaller studies. To be truly effective, those studies must enroll not only enough people, but also the types of people who are most affected by COVID-19, including older people, people of color, and people with illnesses that may make them particularly susceptible to severe disease.

Any reliable vaccine study must also meet clear criteria, published in advance, for when and how the study is stopped. And all data for any prospective vaccine must be peer-reviewed and published in a transparent process that gives the public unshakable faith that the vaccine is being approved for scientific, and not political reasons.

Global efforts to speed COVID vaccine testing could produce a successful vaccine faster than any previous effort. Testing timelines can only be accelerated to a certain point, however, before we lose vital knowledge about how well a vaccine really works. The Russian example proves that vaccines won’t be used if people don’t understand or trust the testing and approval process.

That doesn’t mean that politicians will stop pressuring researchers and regulators to accelerate testing, sometimes with their own political fortunes in mind. This was most recently evidenced by the US Health and Human Services Secretary’s troubling memo which bans FDA (and other health agencies) from signing new rules regarding medicines. But it does make it more important than ever that researchers, regulators, public health professionals and community advocates raise our voices to prevent the politicization of science.

We’ve already seen the power of public pressure to compel product developers to publish their data analysis plans, stopping rules, statistical assumptions, and the membership of their independent review boards. Now that same energy should be focused on product developers, the FDA, and HHS to ensure that Phase 3 trials are able to accrue adequate safety and efficacy data before any decisions regarding approval are made.

Detailed guidance for COVID vaccine developers, issued by FDA in June, provides a roadmap for advocates to monitor and evaluate the vaccine approval process. Organizations such as AVAC have produced materials to help advocates and the public understand both the innovations that are helping to speed safe testing of COVID vaccines and the essential steps that must be completed before any COVID vaccines should be approved and licensed.

The rapid development of safe and effective COVID vaccines could help end this pandemic, and strengthen faith in vaccines worldwide. But that can’t happen unless we take the signals of diminishing public faith in the process seriously, and eliminate any sign of political interference in vaccine testing or approval. To protect health in the US and around the world, and advance health equity, we must insist on a COVID vaccine effort that is fast, transparent, thorough and safe, and guided by science, not politics.

New Report: Global Investment in HIV Cure Research and Development

2020 has brought unprecedented catastrophe and uncertainty—from droughts, storms and wildfires related to climate change, to short-sighted, self-serving political manipulations, and a pandemic ravaging global health and the world economy—but those committed to the research enterprise in HIV have persevered with important advances. Efficacy results for one trial on long-acting injectable PrEP and a positive opinion allowing the Dapivirine Vaginal Ring to continue toward regulatory approval, right? These results have won inspiring news headlines, and HIV cure research is no exception: Has someone just been cured of HIV with a cheap, simple drug regimen? Promising results for vesatolimod in monkeys and humans. Brazilian man in long-term HIV remission – without a stem cell transplant. HIV and COVID-19 research must continue, and advocacy for funding is imperative. This just released report from AVAC and the International AIDS Society, the Global Investment in HIV Cure Research and Development in 2019, tracks the latest investment data and provides an analysis of funding trends. Read on for a recap of the findings and also check out AVAC resources on funding for COVID-19 research here.

Key Findings in Cure R&D Funding for 2019

Investments in HIV cure research, including therapeutic HIV vaccines (for treatment), increased approximately 1 percent, from US$323.9 million invested in 2018 to US$328.2 million in 2019.

Compared to the US$88.1 million invested since tracking began in 2012, 2019 investments represent a 272 percent increase. But these 2019 figures also represent a much smaller year to year increase than seen in previous years.

The public sector accounted for the majority of funding, at US$306.7 million, with the remaining US$20.7 million invested by philanthropies such as amfAR, the Bill & Melinda Gates Foundation and Institut Pasteur.

The smaller year to year increase may reflect research funding cycles or even the challenges of funder reporting in the midst of the COVID-19 pandemic, and may not reflect a broader trend. But another report, the Fiscal Year (FY) 2021 NIH HIV/AIDS Professional Judgment Budget: Catalyzing Partnerships for HIV Prevention, released by the National Institutes of Health (NIH) Office of AIDS Research (OAR) on August 4, 2020, adds an additional dimension to consider.

The Professional Judgment Budget provides guidance to the US Administration and US Congress on underfunded research in HIV. It’s a sort of wish list for HIV research at the NIH. For FY21, the OAR recommended a 9.2 percent increase for HIV cure research at the NIH, an amount significantly smaller than other areas of research addressed in the Professional Judgment Budget. This budget suggests that the largest funder of HIV cure research by far, the NIH, sees both opportunities for growth, but also limits to new research opportunities as compared to other research.

As advocates, it will be important to continue to highlight the importance of HIV cure research and areas where research should focus. This report should serve as a tool for advocacy and to inform public policy that accelerates scientific progress in cure research. We thank all of the individuals who contributed data to the report and who gave time and effort as trial participants.

If your organization is a funder or recipient of HIV cure grants, and we don’t know you already, please contact us at analysis of funding trends for HIV prevention research at large, due out early in 2021.

New Episode of Px Pulse! A Leap Forward For the Dapivirine Vaginal Ring, the Next Steps Are Critical

A fresh episode of AVAC’s Px Pulse podcast is ready for download, looking at what the Dapivirine Vaginal Ring means for women and for HIV prevention from several perspectives.

The ring is the first woman-initiated HIV prevention option to receive a positive regulatory opinion since the female condom in 1993.

In this episode, Zeda Rosenberg, founder and chief executive officer of the International Partnership for Microbicides (IPM)—the ring’s developer—walks us through next steps for securing access now that the European Medicines Agency (EMA) has released a positive regulatory opinion. Cleopatra Makura, a 2019 AVAC Fellow and HIV prevention youth advocate leader in Zimbabwe, Sharon Hillier, head of the Microbicide Trials Network (MTN), and Benny Kottiri, Research Division Chief in the Office of HIV/AIDS at USAID, discuss the work of advocates, why the ring is a promising new option and the need for continued investment in ring rollout. And Lori Heise, professor of social epidemiology at the Johns Hopkins Bloomberg School of Public Health and an early champion of microbicides research, draws on powerful lessons from the past to guide what must come next in rolling out the ring.

Check out AVAC.org’s dedicated page for the Dapivirine Vaginal Ring, as well as the ring page on PrEPWatch for the full background and status of the ring, including resources for advocacy and access.

Want to learn more? Please join this webinar hosted by the PrEP Learning Network on Thursday, September 24, 2020 9:00 AM EDT | 15:00 CAT | 16:00 EAT, providing an overview of the Dapivirine Vaginal Ring and the regulatory process, a framework for ring introduction as part of combination prevention, and national considerations for introduction in Zimbabwe and Kenya.

For the full podcast episode, highlights and more resources, visit avac.org/px-pulse. And subscribe on Apple Podcasts, Spotify or wherever you get your podcasts!

COVID-19 in Africa: Webinar with Africa CDC, WACI Health and Civil Society

On Wednesday, September 16, WACI Health, AVAC, and Friends of the Global Fight Against AIDS, TB and Malaria hosted a virtual dialogue to discuss how COVID-19 is impacting Africa and learn about the collective response in different countries. Panelists included Dr. John Nkengasong, Director of the Africa Centres for Disease Control and Rosemary Mburu, Executive Director of WACI Health and Lwazi Mlaba, a Global Fund Champion working in HIV, TB and GBV, a COVID-survivor and the founder of the an African COVID-19 Support group. Dr. Elizabeth Bukusi, Principal Research Officer at KEMRI and Co-Director of the KEMRI-UCSF Infectious Disease Research Training Program and AVAC’s Maureen Luba moderated the converstation. The conversation explored:

  • The status of COVID-19 in Africa and its impact on AIDS, TB and malaria programming.
  • The role of African researchers in the development of COVID-19 therapeutics and vaccines.
  • The role of global donors to support an Africa-led COVID-19 response.

The webinar was recorded and is available on AVAC’s COVID-19 resources page.

Science—Not Politics—in COVID-19 Vaccines: How to watchdog the regulatory process

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.