Vaccines

Ensuring universal health coverage for key populations

20 May 2015

Without addressing HIV among marginalized populations and human rights, it will not be possible to end the AIDS epidemic as a public health threat by 2030, according to experts at a World Health Assembly side event.

A high-level panel, which included UNAIDS Executive Director Michel Sidibé, called on health ministers to pledge to remove structural barriers to accessing HIV services and health care for all. The speakers also stressed the need for political commitment to leave no one behind. Ensuring that marginalized populations are not excluded from the universal health coverage target of the next sustainable development goals will be vital, they noted.

According to the participants, there is a risk that countries could seek to advance progress towards universal health coverage by focusing on easier to reach populations. In order to ensure that no one is left behind, measures will be needed to reduce the discrimination facing all marginalized groups and to ensure their meaningful participation in the development and implementation of health strategies.

The event set the stage for further dialogue among ministers of health to promote sharing of experiences on securing access to HIV services and health care for all.

Organized by the International HIV/AIDS Alliance, co-hosted by Luxembourg, Morocco and Ecuador and supported by UNAIDS, the event took place on 19 May at the International Red Cross and Red Crescent Museum in Geneva, Switzerland.

Quotes

“In the post-2015 era, global governance systems must be inclusive and people-centred. Fragile communities exist from Baltimore to Bamako and we need better systems for health to make sure we reach people on the margins.”

Michel Sidibé, UNAIDS Executive Director

“We need a system for health rather than a health system! Since 2008, Ecuador’s constitution has embraced universal coverage. It is important that universal coverage includes social protection and human rights, including for marginalized people.”

Fausto David Acurio Páez, Vice-Minister of Public Health, Ecuador

“We really have to fight to have equal access to universal health coverage and social protection. For this, we have to work together: civil society, governments and the different ministries at the global, national and local level.”

Lydia Mutsch, Minister of Health, Luxembourg

“Universal health coverage should not be a question of gender, sexual orientation or age.”

Brant Luswata, Clinic and Resource Manager from Icebreakers Uganda

“It is really a multisectoral approach from here to September. We need to fit our issues into the universal health system. We have two overarching goals: to remove the barriers and to have equity for all.”

Marielle Hart, Policy Manager, Stop AIDS Alliance

68th World Health Assembly

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UNAIDS calls for sustained commitment to develop an effective HIV vaccine

18 May 2015

GENEVA, 18 May 2015—On HIV Vaccine Awareness Day, UNAIDS is calling for a renewed global commitment to finding an effective HIV vaccine.

“A vaccine would be a major step towards ending the AIDS epidemic,” said UNAIDS Executive Director Michel Sidibé. “There have been encouraging recent scientific advances that give us hope for the future development of an HIV vaccine.”  

UNAIDS is committed to leaving nobody behind in the HIV response. A major advantage of vaccines is that they promote equity and can be used effectively in all communities and settings, including those where many other health services can be harder to deliver.

Studies show that an HIV vaccine is possible. The RV144 vaccine trial in 2009 lowered the rate of HIV infection by 31%. There is much hope that ongoing research will build on this trial and deliver results. Newer vaccine candidates, as well as neutralizing antibodies, are also being studied.

Vaccines have eradicated smallpox, and polio is close to eradication. Vaccines have also effectively controlled diphtheria, pertussis, tetanus, mumps, measles and rubella, among other infectious diseases.

However, in 2013, HIV vaccine research and development saw the largest decline in investment since 2008. In order to transform promising concepts into an effective and accessible vaccine increased and sustained funding will be critical.

UNAIDS

The Joint United Nations Programme on HIV/AIDS (UNAIDS) leads and inspires the world to achieve its shared vision of zero new HIV infections, zero discrimination and zero AIDS-related deaths. UNAIDS unites the efforts of 11 UN organizations—UNHCR, UNICEF, WFP, UNDP, UNFPA, UNODC, UN Women, ILO, UNESCO, WHO and the World Bank—and works closely with global and national partners towards ending the AIDS epidemic by 2030 as part of the Sustainable Development Goals. Learn more at unaids.org and connect with us on Facebook, Twitter, Instagram and YouTube.

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Landmark HIV diagnostic access program will save $150m and help achieve new global goals on HIV

25 September 2014

NEW YORK, 25 September 2014—Roche today announced a major Global Access Program to sharply lower the price of HIV viral load tests in low- and middle-income countries. This new initiative creates a ceiling price of US$ 9.40 per test, and will reduce Roche’s average price by more than 40% in low- and middle-income countries.  When fully implemented, the Global Access Program is projected to save more than US$ 150 million in costs over the next five years.

By increasing access to viral load testing, this new deal will dramatically improve the quality of HIV treatment services and strengthen capacity to achieve the global goal of ensuring that 90% of all people receiving antiretroviral therapy achieve viral suppression. The high price of viral load testing – is an important reason why less than one in four people on antiretroviral therapy currently have access to viral load testing. 

Increasing the affordability and availability of viral load testing is pivotal to hopes to end the AIDS epidemic. With the aim of laying the foundation to end the AIDS epidemic by 2030, the world has embraced a new treatment target for 2020: 90% of all people living with HIV know their HIV status; 90% of all people with diagnosed HIV infection receive antiretroviral therapy; and 90% of all people receiving HIV treatment are virally suppressed. More than 13 million people currently receive HIV treatment.

“We welcome this significant price breakthrough—the urgent call of people living with HIV is being answered. Now, with viral load testing, we can help ensure HIV treatment improves quality of life,” said UNAIDS Executive Director Michel Sidibé. “I congratulate all partners for this timely agreement. It is an excellent example of public-private partnership in action and the kind of innovation needed to accelerate ending the AIDS epidemic.”

With viral load testing, doctors and nurses in developing countries can help ensure that their patients are on the right drug regimens and keep the amount of the HIV virus in their patients at ‘undetectable’ levels. This helps ensure that patients stay healthy while also preventing HIV transmission. 
The UNAIDS sponsored Diagnostics Access Initiative, launched at the International AIDS Conference in Australia in July 2014, issued a call to the global community to achieve more affordable pricing for viral load testing. Through the leadership of South Africa and in partnership with CHAI, UNAIDS, The Global Fund and the US President’s Emergency Plan for AIDS Relief (PEPFAR), suppliers were challenged to lower viral load prices, and Roche is the first company to step forward and offer the HIV community an access policy that will accomplish these goals. Other partners in the DAI include the World Health Organization, US Centers for Disease Control and Prevention, African Society for Laboratory Medicine, UNITAID, the Global Fund, PEPFAR, Clinton Health Access Initiative and UNICEF.

“We applaud all the global partners who came together to ensure that over 31 million people living with HIV/AIDS in low and middle-income countries will be able to access viral load testing at this reduced price,” said President Bill Clinton, Chairman of the Clinton Health Access Initiative. “The Clinton Health Access Initiative has partnered with South Africa in its fight against HIV for more than a decade. We are honored to work with a government that is committed to HIV treatment not only in its own borders, but around the world.”

South Africa is the largest purchaser of viral load tests in the world, and the National Health Laboratory Service (NHLS) has the largest viral load program on the continent. The NHLS worked closely with Roche and other partners to create a framework that would benefit not only the 2.5 million people on treatment in South Africa, but millions more receiving antiretroviral therapy across sub-Saharan Africa and beyond.

“To end the AIDS epidemic in South Africa, we will need to build on this record of success to deliver the very highest quality of HIV treatment services, as measured by the proportion of people living with HIV who have viral suppression,” said President Jacob Zuma of South Africa. “Thanks to our ongoing partnership with the Clinton Health Access Initiative and UNAIDS, South Africa has been able to significantly reduce the per-patient price of this essential diagnostic test.”

The Global Access Program continues the longstanding leadership of Roche, which has played an important role in the AIDS response.

“As the leader in HIV viral load testing, Roche supports the UNAIDS 90-90-90 goal and the Diagnostics Access Initiative by expanding access to quality HIV testing through affordable pricing to those countries hardest hit by the disease,” stated Roland Diggelmann, Chief Operating Officer of Roche Diagnostics. “With 70% of all people living with HIV residing in Sub-Saharan Africa, we believe our commitment can truly make a difference to UNAIDS’ goal for achieving control of the HIV/AIDS epidemic.”

Leading AIDS donors welcomed the Program and pledged to effectively leverage it to scale-up viral load testing. “PEPFAR is committed to moving forward to increase use of viral load to monitor patient outcomes for PEPFAR-supported clients with the ultimate goal that all patients remain undetectable for their own health and for increasing control of the HIV pandemic,” said Ambassador Deborah L. Birx, M.D., the US Global AIDS Coordinator. “We are working on roll-out plans in partnership with countries to ensure that over the next four years all PEPFAR-supported patients and clinicians have access to accurate quality viral load data.” PEPFAR currently supports antiretroviral therapy for more than four million patients, excluding South Africa. 

“The Global Fund welcomes this new initiative,” said Global Fund Executive Director Mark Dybul. “Due in large part to the high price of available technologies, many treatment programs have yet to prioritize scale-up of viral load testing. The Roche Access Program offers an important incentive to rapidly expand access to viral load testing.”

The Clinton Health Access Initiative was founded in 2002 (then the Clinton HIV/AIDS Initiative) to support government partners and address the HIV/AIDS crisis in developing countries. CHAI began work in South Africa in 2003, where they supported the government in their first national HIV treatment scale-up plan. Since then, CHAI has helped South Africa save $900M on ARV costs over 4 years; supported a testing initiative that reached 15 million people over 15 months; and assisted in the scale-up of HIV treatment to more than 4,000 health facilities around the country.

The Clinton Health Access Initiative’s role in helping to structure the new viral load agreement was made possible by the UK Department for International Development (DFID), one of CHAI’s closest and most long-standing partners. DFID funds pioneering market shaping work for essential health commodities such as medicines, vaccines, diagnostics and contraceptives. This helps organizations and governments to allocate and spend their funding more efficiently and enhances access for those most in need. They also work closely with the government of South Africa and support their efforts to aggressively scale-up HIV treatment and achieve greater efficiency in HIV spending.

About the Clinton Global Initiative

Established in 2005 by President Bill Clinton, the Clinton Global Initiative (CGI), an initiative of the Clinton Foundation, convenes global leaders to create and implement innovative solutions to the world's most pressing challenges. CGI Annual Meetings have brought together more than 180 heads of state, 20 Nobel Prize laureates, and hundreds of leading CEOs, heads of foundations and NGOs, major philanthropists, and members of the media. To date, members of the CGI community have made more than 3,100 Commitments to Action, which have improved the lives of over 430 million people in more than 180 countries.

CGI also convenes CGI America, a meeting focused on collaborative solutions to economic recovery in the United States, and CGI University (CGI U), which brings together undergraduate and graduate students to address pressing challenges in their community or around the world. For more information, visit clintonglobalinitiative.org and follow us on Twitter @ClintonGlobal and Facebook at facebook.com/clintonglobalinitiative.

UNAIDS

The Joint United Nations Programme on HIV/AIDS (UNAIDS) leads and inspires the world to achieve its shared vision of zero new HIV infections, zero discrimination and zero AIDS-related deaths. UNAIDS unites the efforts of 11 UN organizations—UNHCR, UNICEF, WFP, UNDP, UNFPA, UNODC, UN Women, ILO, UNESCO, WHO and the World Bank—and works closely with global and national partners towards ending the AIDS epidemic by 2030 as part of the Sustainable Development Goals. Learn more at unaids.org and connect with us on Facebook, Twitter, Instagram and YouTube.

Contact

UNAIDS
Sophie Barton-Knott
tel. tel. +41 79 514 6894
bartonknotts@unaids.org

Declining investment could slow research and rollout of new HIV prevention options

18 July 2014

Report shows prevention R&D funding falls 4% due to public sector research budget reductions in US, Europe

Melbourne, Australia, 18 July 2014 – Investment in HIV prevention research fell US$50 million, or 4 percent, to US$1.26 billion in 2013, due to declining investments by the United States and European government donors, changes in the international development landscape and changes in the pipeline of HIV prevention products in various stages of development and implementation, according to a new report from the HIV Vaccines and Microbicides Resource Tracking Working Group.

HIV Prevention Research & Development Investment in 2013: In a changing global development, economic, and human rights landscape is the tenth annual report by the Working Group, a collaboration between AVAC, UNAIDS, and the International AIDS Vaccine Initiative (IAVI). The report summarizes investment in HIV prevention research across seven prevention options. The report was released today ahead of the 20th International AIDS Conference (AIDS 2014) in Melbourne, Australia. Breakdowns by prevention modality are available in the full report at www.hivresourcetracking.org.

Despite overall US budget cuts in 2013 and a decline in support for HIV prevention research, the US government remains the single largest funder of prevention research, accounting for more than 70 percent of total investment over the past five years. The US contribution decreased US$44 million to US$881 million in 2013, largely due to automatic, across the board cuts to all federally funded programs as a result of sequestration. Funding from European government donors, including 12 countries and the European Commission, was also reduced as priorities for international development in some countries have continued to shift.

“Research and development has produced a valuable range of medicines, diagnostics and devices to prevent and treat HIV which have to be made more widely available. However, funding is declining at a time when services need to be expanded and better treatments and additional HIV prevention options are needed,” said Luiz Loures, Deputy Executive Director, UNAIDS. “Now is not the time to pull back from science, but rather to push forward towards ending the AIDS epidemic.”

Investment declined in research & development related to voluntary medical adult male circumcision (VMMC) and female condoms, both options that have long been proven effective and are now being scaled-up as part of broader HIV prevention programs. Investment increased for R&D related to treatment as prevention (TasP) and pre-exposure prophylaxis (PrEP), which have more recently proven effective and now require additional research to support wide scale implementation.

Vaccine R&D in 2013 also saw the largest real decrease in investment since such research began, with the effects of U.S. sequestration, reduced bilateral funding from European governments, and the lack of large efficacy trials in the latter part of the year accounting for much of the decline. Substantial public sector funding cuts and dropped support from past philanthropic funders also played a role in the more pronounced decline for microbicides funding, which still drew heavily on the US government for support even as its contributions declined.

“There is a growing consensus that we can end the AIDS epidemic if we develop and deploy the right tools and reach those most at risk,” said Mitchell Warren, AVAC Executive Director. “But we won’t be able to make a sustained impact on the cycle of new infections without development and aggressive rollout of new prevention options – voluntary medical male circumcision, PrEP, treatment as prevention, microbicides and eventually vaccines. We need sustained and flexible funding to ensure that we efficiently develop new options, demonstrate how proven options can be rolled out and deliver what we know works.”

The decline in prevention funding comes within a changing and very challenging human rights environment. Harsh new anti-homosexuality laws and other legislation criminalize those most at risk from HIV/AIDS and make it increasingly difficult to answer critical questions supported by HIV prevention R&D, such as how to meet the needs of men who have sex with men, transgender people, sex workers, people who inject drugs and other populations most affected by HIV. This will continue to have an impact on how those trials are funded and where they can be conducted.

"A combination of long-term vision, scientific innovation and generous funding has eradicated smallpox, is close to eradicating polio, and has brought us to an era in which a positive HIV test is no longer an automatic death sentence," said Margie McGlynn, IAVI President & CEO. "A vaccine will be essential to the global, comprehensive response that can end AIDS once and for all, and sustained and broadened support will be crucial to its development."

The report is online at www.hivresourcetracking.org.

The HIV Vaccines and Microbicides Resource Tracking Working Group is composed of AVAC, the International AIDS Vaccine Initiative (IAVI) and the Joint United Nations Programme on HIV/AIDS (UNAIDS). The Working Group has been tracking investment in HIV prevention research since 2004.


Office of the UNAIDS Science Panel

On HIV Vaccine Awareness Day UNAIDS calls for scaled-up action to find a vaccine for HIV

16 May 2014

GENEVA, 18 May 2014—On HIV Vaccine Awareness Day UNAIDS is urging for global efforts to be stepped up to find an effective HIV vaccine and accelerate progress towards ending the AIDS epidemic.

“Although great strides have been made in preventing new HIV infections alongside expanding access to treatment, we still don’t have an effective HIV vaccine,” said UNAIDS Executive Director Michel Sidibé. “Finding a vaccine for HIV will be the push we need to achieve zero new HIV infections.”

There have been important breakthroughs in vaccine research in recent years. The RV144 trial, conducted in Thailand and reported in 2009, showed that a vaccine could lower the rate of HIV infection by 31% and provided important clues as to how a more effective vaccine might work. Follow-on studies are now aiming to increase the level and durability of protection.

Recent advances in understanding how the virus behaves, and how the immune system responds, have greatly increased the likelihood of finding an effective vaccine. For example, vaccine trials in monkeys have prevented and cleared HIV infection. Ensuring sustained funding for HIV vaccine research will help to transform promising concepts into effective and affordable HIV vaccines.

“Research is bringing us closer to a vaccine every day, thanks to the tenacity of scientists and support from many donors and communities,” said Margie McGlynn, President and Chief Executive Officer of the International AIDS Vaccine Initiative. “Only with sustained commitment can we all continue to build on these promising efforts to develop a rich pipeline of vaccine candidates.”

 

UNAIDS

The Joint United Nations Programme on HIV/AIDS (UNAIDS) leads and inspires the world to achieve its shared vision of zero new HIV infections, zero discrimination and zero AIDS-related deaths. UNAIDS unites the efforts of 11 UN organizations—UNHCR, UNICEF, WFP, UNDP, UNFPA, UNODC, UN Women, ILO, UNESCO, WHO and the World Bank—and works closely with global and national partners to maximize results for the AIDS response. Learn more at unaids.org and connect with us on Facebook and Twitter.

 

Contact

UNAIDS Geneva
Sophie Barton-Knott
tel. +41 22 791 1697
bartonknotts@unaids.org

Thai-US partnership confirms renewed push on HIV vaccine

02 September 2013

On 29 August at the AIDS Vaccine Efficacy Consortium (AVEC) Summit for an AIDS-Free Generation in Thailand, a Thailand-United States partnership working on the development of an HIV vaccine has announced its commitment to build on the success of previous trials, giving a renewed push to vaccine research.

In 2009, the landmark RV144 Thai vaccine study—jointly developed by the Thai health ministry and US military researchers—proved the first evidence in humans that a safe and effective preventive HIV vaccine is possible. Results of the RV144 found 31.2% efficacy at the end of the study among 16 000 Thai volunteers.

Building on this, researchers will work to improve the levels of protection found previously and conduct additional trials in Thailand over the coming years, focusing on key populations at higher risk of infection, including men who have sex with men. The aim of the on-going research is that a modified version of the vaccine would raise the protection rate to around 50%—the figure needed to obtain regulatory approval for public release.

The Thai Government will take a leadership role by supporting the future HIV vaccine efficacy study and assisting in the establishment of flexible manufacturing systems and infrastructure that could support the production of a registered HIV vaccine.

Quotes

The Government of Thailand has given high priority to the HIV epidemic and we strongly believe that the development of an effective vaccine is possible. We are fully committed to playing a constructive role.

Minister of Public Health of Thailand, H.E. Pradit Sintavanarong

Some of our most exciting partnership work with Thailand has been on HIV. Today we have the opportunity to step our efforts up a notch, towards our united goal of an HIV-free generation.

US Ambassador to Thailand, Kristie Kenney

The Government of Thailand is showing important leadership in taking HIV vaccine research to the next step. This can be a win-win situation: for example, development of a manufacturing facility will provide opportunities not only for HIV vaccine production but also more broadly for other disease concerns.

Col. Jerome Kim, Project manager on HIV vaccines and Principal Deputy of the US Military Research Programme within the US Army Medical Research and Material Command

A vaccine is an essential component to getting to zero on HIV and it is important that this is happening in Thailand, building Southern capacity for development and manufacturing, and focusing efforts where they are most needed. To get to the end of AIDS, we cannot leave anybody behind – this partnership is putting that consideration at the centre of its work.

UNAIDS Deputy Executive Director, Programme, Dr Luiz Loures

Finding an AIDS Vaccine in the Context of Combination Prevention

18 September 2012

William Snow, Executive Director of the Global AIDS Vaccine Enterprise, organizer of the conference, speaking during the opening ceremony. Credit: Rick Friedman

From 9-12 September, more than a thousand HIV researchers and advocates, meeting in Boston for the AIDS Vaccine 2012 Conference, discussed the contribution of vaccine science to achieving the goal of zero new HIV infections in an increasingly complex HIV prevention landscape.

Several HIV prevention approaches such as male and female condom use, voluntary medical male circumcision, prevention of new HIV infections in children, post-exposure prophylaxis (PEP), pre-exposure prophylaxis (PrEP) and treatment as prevention, are now established tools to enable people to avoid exposure to HIV or to reduce their infectiousness. Modelling studies predict that by scaling up access to strategic combinations of these approaches that are adapted to local needs, national HIV programmes can significantly reduce the number of new HIV infections.

Do we need a vaccine?

Despite recent evidence that HIV treatment prevents onward transmission of HIV as well as the fact that vaccine discovery and development is costly in time and funding (US$845 million in 2011 alone), leaders from across the spectrum of HIV research attending the conference unanimously agreed on the need to continue the quest for an HIV vaccine.

Our knowledge is more sophisticated and moving much faster toward approaches and products that have a high likelihood of success in clinical trials

Professor Glenda Gray, Executive Director of the Perinatal HIV Research Unit, University of Witwatersrand and Director of the HIV Vaccine Trials Network Africa programmes

Professor Myron Cohen of the University of North Carolina at Chapel Hill, who led the multi-country study by the HIV Prevention Trials Network that proved the efficacy of AIDS treatment for prevention (the HPTN 052 study), said that scale-up of treatment is both a human rights imperative and an effective public health measure. At the same time, he threw his full weight behind the quest for a more effective HIV vaccine. “We recognize that suppressive treatment of HIV infection drastically reduces the probability of onward HIV transmission, which should eventually slow the spread of HIV. But the urgent and widespread treatment of HIV is not a substitute for a preventive vaccine. We need an HIV vaccine,” said Dr Cohen.

Vaccine trials

The RV144 vaccine trial in Thailand, which tested a combination of two vaccines, reported a modest 31% efficacy in 2009. However, it sparked a wide array of new questions about how and when the human immune system may respond to HIV. “Our knowledge is more sophisticated and moving much faster toward approaches and products that have a high likelihood of success in clinical trials,” said Professor Glenda Gray, Executive Director of the Perinatal HIV Research Unit, University of Witwatersrand and Director of the HIV Vaccine Trials Network Africa programmes. Currently there is only one HIV vaccine trial under way, which is testing a combination of experimental vaccines in men who have sex with men and transgender women in the United States (HVTN 505). Additional studies are planned, including three studies to pursue an improvement on the RV144 results in South Africa and Thailand, but these are not likely to begin before 2014.

Synergies between vaccine and non-vaccine prevention strategies

According to scientists at the conference, to evaluate any new technologies in human trials, the new product first must be proved safe, and then must be tested against the standard of care or prevention. They noted that, as the standard evolves to include new tools such as medical male circumcision, PrEP and early AIDS treatment, more complex trial designs are needed to evaluate the efficacy of the new technology, and larger sample sizes will be required.

L to r: Dr Dan Barouch, Professor of Medicine at Harvard Medical School, Chief of the Division of Vaccine Research at Beth Israel Deaconess Medical Center, and Co-Chair of the AIDS Vaccine 2012 conference and Dr Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases. Credit: Rick Friedman

Dr Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases pointed out that given the availability of other partially effective prevention strategies, the world may not need a vaccine that provides 95% protection. According to him, a vaccine that reduces risk in combination with other prevention strategies may be sufficient. Researchers at the conference said that there are also indications that antiretroviral-based prevention approaches could increase the vaccine effects or offer protection during the post-vaccination period when the immune system has to ramp up production of a protective antibody response.

Building knowledge one trial at a time

Participants agreed that large scale production of a prophylactic HIV vaccine is well over a decade away under the best of assumptions. Vaccine discovery, development, obtaining official license and scaling up production and delivery take many years and large investments. Mathew Rose, Policy Chair for the Young Black Gay Men’s Leadership Initiative, used a boxing metaphor to explain the challenge ahead. To sustain enthusiasm and commitment until a more effective AIDS vaccine is discovered, “we need to stop waiting for a single, knock-out punch, and instead, we must perfect the art of the jab,” said Mr Rose. “Each clinical trial may produce the final answer, or it may open up more key questions,” he added. According to Mr Rose, each new question will require a strategic study—a new “jab” that will build general knowledge about how the human body recognizes and fights infection, and will build the scientific capacity to finally outwit HIV. 

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