Press Release

Immunizing Against Misinformation and Shortsightedness: AVAC Report Injects a Dose of Reality into the Debate on the State of AIDS Vaccine Research

New York, NY , The AIDS Vaccine Advocacy Coalition (AVAC) today released a new report that provides a comprehensive review of recent developments in AIDS vaccine research. AVAC Report 2008: The Search Must Continue explores the issues that have been raised in the wake of the failure of Merck’s vaccine candidate and provides context for the events and major changes of the last year in HIV prevention research.

In the Report’s opening letter, AVAC Executive Director Mitchell Warren says “Enough is enough,” with regard to the misinformation that has crept into some of the public conversations about AIDS vaccine research. In the report, AVAC argues that continuing to move forward with AIDS vaccine research and testing is imperative and lays out recommendations for the AIDS vaccine and HIV prevention field.

AVAC’s 11th annual Report on AIDS vaccines also looks at the comparative advantages of major players, including the U.S. National Institutes of Health and the International AIDS Vaccine Initiative, and analyzes the current environment for decision-making about future clinical trials. The report is available online at www.avac.org/reports.htm.

The AVAC Report comes at a critical time for HIV prevention research. Over the past 12 months, several trials, including vaccine, microbicide, cervical barrier method and herpes-treatment trials, have yielded disappointing results of no efficacy. Recently, a slew of editorials and media coverage have spotlighted AIDS vaccine research and, in some instances, included calls to end public funding or to reapportion funding away from AIDS vaccine research toward existing HIV treatment or prevention interventions. At the same time, there are ongoing discussions at the NIH about whether to launch another vaccine efficacy trial using a strategy developed by the NIH’s Vaccine Research Center.

“With recent pessimistic headlines and the creation of na�ve and false dichotomies between research and clinical trials or between treatment and prevention or existing interventions and new research, we at AVAC say enough is enough,” said Mitchell Warren, executive director of AVAC. “An AIDS vaccine is possible, and it is essential.”

“It’s been a challenging year for the AIDS vaccine field and for HIV prevention research generally, but the recent spate of statements that seem to revise the history of the past few years of AIDS vaccine research are deeply troubling,” said Warren. “Now more than ever, we must maintain momentum in AIDS vaccine and other HIV prevention research while simultaneously continuing to ramp up provision of existing treatment and prevention options for all those who need them.”

“We were all disappointed with the results from the trials of Merck’s vaccine candidate last year,” said Pontiano Kaleebu, Assistant Director of the Uganda Virus Research Institute, Chairperson of the African AIDS Vaccine Programme, and an AVAC board member. “But we must now reclaim the narrative of what happened with trials of that vaccine and of what they mean for the future of AIDS vaccines and HIV prevention. Here in Uganda and throughout Africa and the world, we still desperately need an AIDS vaccine and we are committed to continuing the search.”

“There have been major changes in the AIDS vaccine field and in biomedical HIV prevention research in the last year. The AVAC Report provides a comprehensive and sensible guide to where the vaccine field stands now and where it needs to go,” said Alan Bernstein, executive director of the Global HIV Vaccine Enterprise.

In The Search Must Continue, AVAC makes several key recommendations for moving the AIDS vaccine and HIV prevention research fields forward, based on a comprehensive review of recent events in the field and future plans of the major players in AIDS vaccine and HIV prevention research as well as conversations with researchers, funders, policy makers and community representatives. These recommendations include:
Ensure that the scientific data from the STEP trial are fully assessed and used to inform the design of improved immunization strategies.
Articulate the human discovery trials agenda and balance vaccine discovery and development.
Structure the vaccine field so that there are career paths for young investigators.
Prepare for results of the Thai prime-boost vaccine efficacy trial.
Systematically improve community engagement strategies, especially as decisions are made around the design of the PAVE 100 vaccine trial.
Clearly communicate and manage expectations of prevention research trials and results.
Increase support for pre-exposure prophylaxis (PrEP) research as well as community stewardship of this promising area of research.
Engage in meaningful dialogue around the scaling-up of male circumcision programs that adequately address HIV testing and gender-specific issues in program rollout.
Expand community engagement with and critique of the microbicides science agenda.
Reconsider how clinical trials infrastructure is sustained and clinical research agendas are developed, in discussion led by developing country voices.

The Report is being released ahead of HIV Vaccine Awareness Day, May 18th, which commemorates U.S. President Bill Clinton’s call for a concerted effort to develop an AIDS vaccine within a decade. Today, it is a global observance to recognize and thank the thousands of volunteers, community members, health professionals, researchers and scientists who are working together to find a safe and effective AIDS vaccine.

“Yes, we have all been surprised and disappointed in the results of the Merck vaccine candidate,” Warren said. “But that is the nature of the scientific process. To acknowledge failure of a candidate vaccine is in no way to concede overall defeat. We all now have a tremendous opportunity to learn from these setbacks and to be better for them, better, even, than we might have been without them. This year, as we commemorate HIV Vaccine Awareness Day, AVAC remains committed and cautiously optimistic.”

# # #

About AVAC: Founded in 1995, the AIDS Vaccine Advocacy Coalition (AVAC) is a non-profit, community and consumer-based organization that uses public education, policy analysis, advocacy and community mobilization to accelerate the ethical development and global delivery of AIDS vaccines and other HIV prevention options. For more information, visit http://www.avac.org/.

Px Wire January-March 2008, Vol. 1, No. 1

This is the first issue of our new quarterly, PxWire, which tracks key developments in the field of HIV prevention research, including the launch of new trials, results of ongoing studies and an up-to-date tally of trials going on worldwide. PxWire is designed to complement AVAC’s other publications and to help advocates stay on top of the ever-changing field of HIV prevention research. It is the first one-stop source for information on the full range of HIV prevention research going on worldwide, including vaccines, microbicides, pre-exposure prophylaxis (PrEP), herpes simplex virus-2 treatment, male circumcision, cervical barrier methods and partner treatment.

Press Release

AIDS Vaccine Advocacy Coalition Issues Report on Tenofovir Prevention Trials: Calls for coordinated response to ensure trials continue

 NEW YORK – The AIDS Vaccine Advocacy Coalition (AVAC) today released a report on issues surrounding clinical testing of the antiretroviral drug tenofovir as pre-exposure prophylaxis (PREP) – a possible once-a-day pill for prevention of HIV.

Legitimate ethical concerns raised by some advocates have led to cancellations and delays in some of the PREP trials. The AVAC report, “Will a Pill a Day Prevent HIV? Anticipating the Results of the Tenofovir “PREP” Trials,” examines the issues surrounding the tenofovir trials and makes recommendations for ensuring that trials are carried out ethically and that provisions are made for dealing with the results of the trials when they are available. The report also calls for more concerted coordination and advance planning to accelerate evaluation, licensing and access to PREP.

“The concerns raised about the trials are serious, and there is a need for thorough and unbiased investigation,” said Mitchell Warren, AVAC Executive Director. “But all of the concerns raised are solvable. AVAC calls on researchers, communities and advocates to work together to ensure that ethical concerns are addressed, solutions are found, and the trials go forward.”

The AVAC report calls for a coordinated effort from the World Health Organization, UNAIDS, the trial sponsors and other organizations to ensure that research and trials are coordinated and progress in an accelerated fashion, and that additional research is carried out in an expedited fashion, to ensure that we will know as soon as possible if tenofovir is a safe and effective biomedical prevention intervention.

Warren added, “We need as many HIV prevention tools as possible, so research on vaccines, microbicides and other potential interventions must also be accelerated whether or not tenofovir proves appropriate for PREP.” “AVAC remains committed to our mission of accelerating development of an AIDS vaccine, but we are also committed to working in partnership with other advocates and researchers to advance ethical prevention research and ensure that the benefits are shared globally.”

The report is available online at www.avac.org and in print on request from avac@avac.org.

About AVAC
Founded in 1995, the AIDS Vaccine Advocacy Coalition (AVAC) is a non-profit, community- and consumer-based organization that uses public education, policy analysis, advocacy and community mobilization to accelerate the ethical development and global delivery of vaccines against HIV/AIDS.

This special report and AVAC’s continuous policy analysis, advocacy, education and outreach work are made possible by the dedicated labor of AVAC advocates and support from the Bill & Melinda Gates Foundation, Broadway Cares/Equity Fights AIDS, the Ford Foundation, the International AIDS Vaccine Initiative, the Overbrook Foundation, Until There’s a Cure Foundation, the WHO-UNAIDS HIV Vaccine Initiative, and many generous individuals who have become AVAC Members. AVAC is an IRS-certified 501(c)3 tax exempt organization, and donations are tax deductible.

Press Release

A public statement from the Global Campaign for Microbicides and the AIDS Vaccines Advocacy Coalition on the impact of stopping Tenofovir trials in Cambodia and Cameroon

Recently clinical trials have been launched in Africa, Asia and the United States to explore the potential use of oral Tenofovir as a “once a day” pill to prevent HIV in uninfected individuals – an intervention known as pre-exposure prophylaxis (PREP). Yet concerns from a few activists opposed to these efforts have resulted in government decisions to halt the trials in Cambodia and Cameroon.

The decisions to halt the trials have generated a firestorm of controversy in the HIV/AIDS treatment, prevention, advocacy, and research communities. In both countries, the public allegations criticizing the trials were not completely evidence-based, and the media’s coverage was highly provocative. As a result, government decisions to stop the trials may have been premature.

Left unchecked, these forces threaten to undermine future trials. The cost is paid in people’s lives – the lives of those who might benefit from new technologies or treatments. This is not to say that unethical research should proceed. But derailing trials without high levels of evidence to support the claim that they are unethical, is a costly practice.

The Global Campaign for Microbicides and the AIDS Vaccines Advocacy Coalition (AVAC) are international networks of advocates who have worked to forge meaningful collaborations between researchers, communities and activists. Both organizations are committed to ensuring that as science proceeds, the public interest is protected and the rights and interests of trial participants, users, and communities are fully represented and respected. Good prevention research must be accelerated, must be ethical, must involve communities and must result in products accessible and acceptable to the people who need them most.
We are convinced that the concerns raised by those who oppose the trials are solvable and need not have resulted in stopping trials. Issues can and should be addressed by researchers and sponsors working collaboratively with local communities and governments. Controversy over the ethics of research is an opportunity to engage communities in partnership. As Gregg Gonsalves of Gay Men’s Health Crisis recently noted, shutting down an HIV prevention study “is not a victory – it is a defeat. A victory would have been to be able to craft a solution to fix the local study.”

In this spirit, the Global Campaign and AVAC are planning to generate various materials that accurately reflect current events, assist all stakeholders with working though these issues and provide specific recommendations to accelerate ethical development of new technologies. Among the materials we will produce are:
�    A fact-sheet designed to correct some of the common misperceptions and errors of fact that have been made in the course of public discussion of these trials. This fact sheet will be available on our websites (http://www.global-campaign.org/ and http://www.avac.org/) in the next few weeks.
�    A background document that attempts to articulate the basics about Tenofovir, the current PREP studies and the various issues involved will be available in early March.
�    Two on-the-ground case studies to document what actually happened in Cambodia and Cameroon from each sector’s perspective, to identify lessons learned that could help prevent similar situations in the future. This project is already underway, and we hope to have these materials available in the coming three months.

The following key principles are pivotal:
1.    The HIV pandemic creates an incredibly urgent demand for additional safe and effective tools with which to treat HIV infection and stop transmission. This can only be achieved by responsible, credible scientific studies.
2.    Research to create these tools must be done in a way that protects the rights of vulnerable populations and contributes to overcoming the global imbalance in access to health care resources.
3.    Communities affected by research must be actively involved in its conceptualization and implementation.
4.    The rights of trial participants should be respected and participants should be admired for their contribution to helping others.
5.    Researchers and funding agencies must be held accountable for their studies, and advocates must demand that problems be resolved.
6.    AVAC and the Global Campaign are dedicated to developing effective collaborations among a broad range of civil society actors, researchers and sponsors.
We cannot combat AIDS effectively without research and development of new technologies. Without clinical trials, we cannot know what does and does not work – or how different drugs and interventions work in various populations and settings. This means wrestling, collectively and collaboratively, with the complexities of designing trials that are simultaneously ethical and scientifically rigorous. Simply objecting to existing trial designs and shutting down trials is not a solution. We must, instead, proceed with the much harder job of shaping a research standard we can support and then demanding that trials be designed and adequately funded to meet that standard.

For more information:
�    AIDS Vaccine Advocacy Coalition (AVAC): Mitchell Warren, Executive Director, mitchell@avac.org, +1 (212) 367-1084, http://www.avac.org/

�    Global Campaign for Microbicides: Lori Heise, Executive Director, lheise@path-dc.org, +1 (202) 822-0033, http://www.global-campaign.org/

2003 AVAC Report: 4 Years and Counting: How do you Fight a Disease of Mass Destruction?

When America became frightened by the bio-terror threat, Congress and the Administration moved swiftly to put funding and incentives in place. That same kind of decisive action is needed to accelerate research and ensure an AIDS vaccine is available to all who need it. This Report looks at the bioterror model, and provides the results of our new industry survey.

2002 AVAC Report: 5 Years and Counting: Science, Urgency and Courage

Five years away from the date former President Bill Clinton set as a goal for finding an AIDS vaccine, there are more candidate vaccine products in development than ever before. No one knows if any of the current experimental vaccines will work. No one even knows what immune response a vaccine needs to elicit to prevent HIV disease. The only way to obtain answers is to ask tens of thousands of altruistic and courageous participants to participate in dozens of trials. The only way to obtain answers is to invest hundreds of millions of dollars to fund these trials.

2001 AVAC Report: 6 Years and Counting: Can a Shifting Landscape Accelerate an AIDS Vaccine?

In 1996, AVAC was the first organization to demand that development of an AIDS vaccine become a national goal. President Clinton set that goal in May 1997, calling for a successful vaccine by 2007. We are now six years away from the goal and counting. None of the challenges are insurmountable. The optimism that characterizes HIV vaccine research today should drive policy makers and researchers to grapple effectively with the issues that remain. An HIV vaccine is possible. The question is how soon we find it, and who gets it when we do.

2000 AVAC Report: 7 Years and Counting: How Can We Overcome Obstacles to an AIDS Vaccine?

The last year was one of great activity across US agencies and throughout the world. This Report documents the steadily increasing activity in the quest for a vaccine against HIV. We have also identified several actions necessary to accelerate development of HIV vaccines, and we outline all of this in the AVAC Report for 2000.

1999 AVAC Report: 8 Years and Counting: What Will Speed the Development of an AIDS Vaccine?

This Report urges government, industry, and community to dedicate themselves to the development of a safe and effective HIV vaccine. If the goal for 2007 cannot be achieved, then we need to know what will be accomplished over the next eight years toward a vaccine that could bring the HIV pandemic under control. With 16,000 new HIV infections each day, the world can afford no delay. This Report describes what each of these sectors has accomplished during the past year and outlines what each can do to speed the search for a preventive vaccine.

1998 AVAC Report: 9 Years and Counting: Will We Have an HIV Vaccine by 2007?

This report surveys the public- and private-sector efforts on HIV vaccine research and development in the past year, with a focus on the US government agencies and pharmaceutical companies that are most likely to make a difference. It finds that, despite an impressive array of dedicated researchers and increasing funding for HIV vaccines, the world will fall short of President Clinton’s deadline. US government research efforts are not focused on results, leaders err on the side of caution rather than on moving forward, responsibility is diffuse, and the nation has stood silent as pharmaceutical companies, including the world’s largest vaccine producer, make little or no investment in one of the greatest public health challenges of our century. AVAC addresses these obstacles and recommends an agenda for action in this report.