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GeoVax Issues Open Letter to HHS Secretary Alex Azar

Comments on HHS Initiative “Ending the HIV Epidemic: A Plan for America”

ATLANTA, GA, February 14, 2019 – GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing human vaccines, today published an open letter to U.S. Department of Health and Human Services (HHS) Secretary Alex Azar in response to the HHS initiative “Ending the HIV Epidemic: A Plan for America.”


Dear Secretary Azar,

President Trump’s call for ending the HIV epidemic in the United States within 10 years establishes a long-overdue challenge for the public health sector. The initiative “Ending the HIV Epidemic: A Plan for America” proposed by HHS in response to the challenge, proposes pre-exposure prophylaxis (PrEP), a pill taken daily by people who do not have HIV but are at risk of such infections, as well as early diagnosis and immediate treatment with drug therapy for those who become infected. Given current medical paradigms, drugs will only be successful if used rigorously; and, for those who begin treatment post-infection, must be taken lifelong to prevent viral reemergence and spread.

We strongly urge that vaccines also be advanced in this eradication campaign. HIV has proven a difficult, but not impossible target for a vaccine; and a vaccine, in contrast to drugs, does not require a lifetime of continuous medication. The “Plan” as described by Dr. Anthony Fauci, Dr. Robert Redfield, and other HHS officials in a JAMA editorial on February 7, 2019, does not include any vaccine as part of the strategy. We believe that inclusion of a vaccine is a necessary “strategic pillar” for meeting the challenge of “Ending the HIV Epidemic”.

One of the challenges of developing an HIV vaccine for the United States has been that the Vaccine Trial Units are primarily based in academic centers disassociated from areas of high HIV incidence. This means that efficacy trials are exceptionally costly, requiring large numbers of individuals to achieve the number of infections required for determining statistical significance between vaccine and placebo arms of a trial. A key component of the initiative outlined by HHS is the development of new clinics (many likely to be mobile units) needed for the testing, treatment and monitoring called for by the Plan. Since these clinics will be focused on the 48 US counties with the highest HIV incidence, this presents a remarkable opportunity for testing candidates for the much-needed vaccine. This approach could be quite efficient (high incidence areas in the US have HIV incidences that rival those in Africa) and cost effective (shared costs for clinics and virus testing).

HIV vaccine testing via the new clinics is a strategy that deserves serious consideration, offering opportunities for creatively efficient clinical trial design. For example, given what we know about poor patient compliance with taking medication, a treatment trial could include an arm for treatment alone and an arm for treatment plus a candidate vaccine. Monitoring for efficacy would then be for viral breakthrough (those receiving pre-exposure prophylaxis) or viral break out (those receiving post infection drug treatment).

We encourage HHS to focus more resources and attention to a vaccine approach, the most effective and least expensive solution to the HIV epidemic. To date, empirical clinical evidence for HIV vaccines in development have been highly encouraging. The Plan outlined by HHS offers a unique opportunity to advance candidate vaccines for eradicating HIV in the United States to definitive real-world testing. To quote, Dr. Anthony Fauci from his statements in recognizing HIV Vaccine Awareness Day, 2016, “While we are making encouraging progress in preventing new HIV infections, the development of a safe and effective HIV vaccine would be the ultimate game-changer.” The proposed initiative, “Ending the HIV Epidemic”, provides a unique opportunity to deliver that critically important game-changer. Thank you.

GeoVax Labs, Inc.

David A. Dodd             Farshad Guirakhoo, Ph.D.            Harriet L. Robinson, Ph.D.
Chairman, CEO            Chief Scientific Officer                 Chief Scientific Officer, Emeritus

About GeoVax

GeoVax Labs, Inc., is a clinical-stage biotechnology company developing human vaccines against infectious diseases using its patented MVA-VLP vaccine platform. GeoVax’s vaccine platform supports in vivo production of non-infectious virus-like particles (VLPs) from the cells of the very person receiving the vaccine. The production of VLPs in the person being vaccinated mimics virus production in a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection.

The Company has the leading preventative HIV vaccine candidate designed to fight against the subtype of HIV prevalent in the United States and is also involved in collaborative efforts to develop an immunotherapy as a functional cure for HIV. GeoVax’s HIV vaccine has undergone many years of development, encompassing basic discovery research, preclinical animal testing, and safety testing in humans, and continues to move forward in human clinical trials managed by the HIV Vaccine Trials Network (HVTN) with the support of the National Institutes of Health (NIH). In addition to HIV, the Company’s development programs include vaccines against Zika, hemorrhagic fever viruses (Ebola, Sudan, Marburg and Lassa) and malaria. GeoVax also is evaluating the use of its MVA-VLP platform in cancer immunotherapy, and for therapeutic use in chronic Hepatitis B infections and in treating Human Papillomavirus (HPV) infections.

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GeoVax Labs, Inc.
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