European Medicines Agency [to 19 May 2018]
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 May 2018
PRAC concludes two referrals, maintains recommendation on HES solutions for infusion and issues precautionary advice on HIV medicine
European Vaccine Initiative [to 19 May 2018]
16 May 2018
European-African partnership to advance the development of a Leishmania vaccine
Phase II clinical trials in Sudan of a therapeutic vaccine to prevent post kala azar dermal leishmaniasis to be supported by European & Developing Countries Clinical Trials Partnership
Gavi [to 19 May 2018]
19 May 2018
Gavi welcomes call for coordinated global action against cervical cancer
Alliance pledges to continue support for vaccines
– Gavi, the Vaccine Alliance today welcomed the call for coordinated global action against cervical cancer made by the World Health Organization Director-General, Dr Tedros Adhanom Ghebreyesus. Sustainable disease control through significant investments and holistic health system approaches are the first steps on the path to elimination of cervical cancer. Gavi pledged to continue its work to help countries access and introduce vaccines against human papillomavirus (HPV), the primary cause of cervical cancer…
Global Fund [to 19 May 2018]
France to Host Global Fund Replenishment Conference
16 May 2018
… The conference aims to raise new funds and mobilize partners toward ending AIDS, TB and malaria by 2030 in alignment with the Sustainable Development Goals. Held once every three years, the conference convenes leaders from governments, civil society, the private sector and communities affected by the three most devastating infectious diseases.
“As one of the founding partners of the Global Fund, France is demonstrating great leadership and sustained commitment in global health,” said Peter Sands, Executive Director of the Global Fund. “We are extremely grateful to President Macron for leading efforts to renew and expand our impact, to the benefit of millions of people.”
France is Global Fund’s second-largest donor, committing more than €4.2 billion to the Global Fund since 2002…
IAVI [to 19 May 2018]
May 18, 2018
IAVI Announces Renewed Support from the Danish Government
The International AIDS Vaccine Initiative (IAVI) is pleased to announce renewed funding from the Danish Government, a longtime partner in the mission to develop a safe, effective, and accessible HIV vaccine. IAVI will receive a total of DKK 20 million (USD $3.18 million) from 2018-2021, administered by the Danish Ministry of Foreign Affairs (Danida).
“IAVI is grateful to the Danish government for its renewed investment in the development of an HIV vaccine, and for its continuing attention to the needs of communities disproportionally affected by the disease,” said Dr. Mark Feinberg, MD, PhD, IAVI President and CEO. “We applaud the Ministry’s sustained commitment to combatting HIV/AIDS, and we are proud to count the people of Denmark among our partners toward expediting the development of an effective HIV vaccine, and ultimately, achieving the goal of a world without AIDS.”…
MSF/Médecins Sans Frontières [to 19 May 2018]
Syria: Children with Chronic Conditions Continue to Suffer from Consequences of War
May 18, 2018
The international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) has begun providing treatment for children in northeast Syria suffering from thalassemia, a life-threatening, chronic blood disorder requiring regular blood transfusions and chelation treatment, for which there is limited care across the country.
“Unacceptable and inhuman” violence by Israeli army against Palestinian protesters in Gaza
MAY 14, 2018—As teams from Doctors Without Borders/Médecins Sans Frontières (MSF) treat people wounded today in Gaza, Marie-Elisabeth Ingres, MSF representative in the Occupied Palestinian Territories, provided the following statement:
NIH [to 19 May 2018]
May 18, 2018
Experimental MERS treatments enter clinical trial
NIH-sponsored trial to test two human monoclonal antibodies.
Enrollment has begun in an early-stage clinical trial testing the safety of two human monoclonal antibodies (mAbs) designed to treat people infected with Middle East respiratory syndrome coronavirus (MERS-CoV). The trial is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and is funded in part by the Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response, Department Health and Human Services.
May 18, 2018
NIH statement on HIV Vaccine Awareness Day – May 18, 2018
HIV remains a burden to individuals and communities in the United States and abroad.
NIAID-supported scientists in clinics and laboratories around the world are following two complementary paths to expedite the development of an HIV vaccine. The empirical approach relies on building upon prior partial success with additional observation and experimentation to advance vaccine candidates into human clinical trials. Scientists also are pursuing a second, theoretical approach that designs vaccine candidates based on the reasonable assumption that a certain type of immune response would protect against HIV infection.
The empirical approach was reinvigorated in 2009 when results from the large RV144 clinical trial in Thailand showed for the first time that an investigational vaccine regimen could confer a degree of protection, albeit modest, against HIV. Today, NIH and our global partners are continuing to build upon the findings from RV144 and other HIV vaccine studies.
Two large HIV vaccine efficacy clinical trials are now ongoing in southern Africa. HVTN 702 launched in late 2016 and is designed to determine whether an experimental vaccine regimen based on the one used in RV144 can safely prevent HIV infection among adults in South Africa. The study team is enrolling 5,400 HIV-negative, sexually active men and women aged 18 to 35 years at 15 sites, and results are expected in late 2020.
In late 2017, NIAID and partners launched HVTN 705/HPX2008, also known as Imbokodo, a large proof-of-concept clinical trial in southern Africa to assess whether an experimental vaccine regimen is safe and able to prevent HIV infection. This regimen includes a “mosaic” vaccine designed to induce immune responses against a wide variety of global HIV strains. The investigators aim to enroll 2,600 HIV-negative women, and results are expected in 2021.
The theoretical approach to developing an HIV vaccine involves studying the immune response to HIV infection and finding ways to generate and enhance that response through vaccination. Some of these strategies aim to prevent HIV infection by developing broadly neutralizing antibodies, better understanding the structure of the virus, and generating a protective cellular response.
Researchers are studying the passive transfer of broadly neutralizing antibodies that could provide people with long-acting protection against HIV infection. This concept is being tested in two large clinical trials in the Americas and Africa to determine whether giving people an intravenous infusion of the antibody VRC01 every eight weeks is safe, tolerable, and effective at preventing HIV infection.
Other powerful antibodies also may provide protection against HIV. In September 2017, NIAID scientists and partners from the Paris-based pharmaceutical company Sanofi reported that a three-pronged antibody made in the laboratory protected monkeys from infection better than did the individual antibodies from which the engineered antibody is derived. This new antibody binds to three different sites on the virus, in contrast to natural, single-site antibodies, which could make it more difficult for HIV to escape. Plans are underway to conduct early phase clinical trials of this “trispecific” antibody in the expectation that it could eventually be used for long-acting HIV prevention and treatment.
These advances and ongoing investigations provide cautious optimism that the development of an HIV vaccine is making headway. With each new finding, and with gratitude to those who volunteer for HIV vaccine clinical trials, we move further along the pathway toward a vaccine. On this HIV Vaccine Awareness Day, we are encouraged by the progress that has been made, and pledge to continue our pursuit of the goal of developing a safe and effective HIV vaccine that could help end the HIV pandemic…
UNAIDS [to 19 May 2018]
Ending double jeopardy for women with HIV
18 May 2018
…To address the disproportionate risk of cervical cancer among women living with HIV and the need for increased rates of screening and treatment in sub-Saharan Africa, PEPFAR the George W. Bush Institute and UNAIDS recently announced a new partnership—the Partnership to End AIDS and Cervical Cancer—designed to effectively eliminate cervical cancer deaths among women living with HIV in sub-Saharan Africa within a generation. The partnership will build on successful efforts over the past seven years of the Pink Ribbon Red Ribbon initiative and, pending Congressional approval, will be supported by an initial investment of US$ 30 million from PEPFAR.
“When we confront suffering—when we save lives—we breath hope into devastated populations, strengthen and stabilize society, and make our country and the world safer,” said President George W. Bush. “This week, we are announcing the next phase of our partnership with the United States President’s Emergency Plan for AIDS Relief and UNAIDS: a plan to effectively eliminate cervical cancer amongst HIV-positive women within a generation.”
Women living with HIV in Rajasthan push for social protection and economic opportunities
17 May 2018
Women living with HIV in Rajasthan, India, have come together to lobby the State Government of Rajasthan for improved provision of social protection services. The Global Alliance for Human Rights and the Rajasthan Network of People Living with HIV organized an advocacy session in Jaipur on 15 May with more than 100 women living with HIV during which they presented their needs, including dairy booths for income generation and schooling for adolescents living with HIV…
UNICEF [to 19 May 2018]
Selected Press Releases/Reports
UNICEF calls for the urgent protection of children in the Central African Republic
BANGUI, Central African Republic, 12 May 2018 – A dramatic increase in violence in the Central African Republic in the first part of 2018 has forced at least 55,000 people, including 28,600 children to flee because of brutality and violence in their communities.
Wellcome Trust [to 19 May 2018]
Explainer / Published: 17 May 2018
Sharing Clinical Trial Data: what it means for you
Wellcome has joined ClinicalStudyDataRequest.com (opens in a new tab) (CSDR), a data-sharing initiative involving academic research funders and pharmaceutical companies. Jen O’Callaghan, from our Open Research team, explains why and what it means for researchers.
As a global research foundation, we’re dedicated to ensuring that the outputs of the research we fund – including clinical trial data – can be accessed and used in ways that will advance medical science by building on previous findings and exploring new questions.
CSDR (opens in a new tab) is a website portal for listing and sharing clinical trial datasets. Originally established to provide a way for researchers to access trial data from a consortium of 15 pharmaceutical companies, CSDR has expanded to include data from academic-led trials.
Data continues to be held by the study team and is only shared with data requestors following a successful data access request.
Update to Wellcome’s policy on clinical trials
Today, we’ve launched an updated policy on clinical trials.
The policy now:
:: makes it clearer what you need to do before, during and after you complete a trial funded by Wellcome
:: brings our requirements into line with the WHO joint statement on public disclosure of results from clinical trials (opens in a new tab), which Wellcome signed up to in May 2017
:: requires you to post summary results in the same registry as the one in which the trial was registered
:: requires you to publish a trial protocol and statistical analysis plan before you start a trial.
Through the policy, we strongly encourage Wellcome-funded researchers to use CSDR for sharing trial data.
If you’re already funded by Wellcome, you’re encouraged to adopt our new policy, but it’s not a requirement. You must abide by the policy in place at the time you received your funding. The same grant terms and conditions will still apply…
BIO [to 19 May 2018]
access to the medicines they need …”
DCVMN – Developing Country Vaccine Manufacturers Network [to 19 May 2018]
access to the medicines they need …”
PhRMA [to 19 May 2018]
access to the medicines they need …”