FDA [to 12 May 2018]
May 11, 2018, 16:10 ET
Statement from FDA Commissioner Scott Gottlieb, M.D., on the Trump Administration’s plan to lower drug prices
Gavi [to 12 May 2018]
09 May 2018
IFPW and Gavi expand leadership training for a stronger supply chain
The partnership draws on private sector support to implement an innovative training and mentorship programme for supply chain managers in Gavi-supported countries.
07 May 2018

New management training for immunisation leaders kicks-off in Kigali
24 managers from five Gavi-supported countries will attend the first round of the nine-month programme.
07 May 2018

Largest cholera vaccine drive in history to target spike in outbreaks
Two million people in five African countries to be protected against cholera.
07 May 2018

Global Fund [to 12 May 2018];&country=
Global Fund Board Strengthens Sustainability and Domestic Financing
10 May 2018
SKOPJE – The Board of the Global Fund to Fight AIDS, Tuberculosis and Malaria, at its 39th Board meeting, highlighted the importance of strengthening sustainability and supporting successful transition to domestic financing to build long-term solutions and achieve greater health security.
The Global Fund is committed to being a good partner in working toward sustainability, acting as a catalyst to additional investment, filling short-term gaps, and addressing bottlenecks to successful transition to more domestic funding. While shifting financing often includes challenges, including how to effectively fund civil society, transition increases country ownership and is necessary to end epidemics.
Prime Minister Zoran Zaev spoke to the Board about the importance of allocating sufficient resources and engaging civil society in developing long-term sustainability of health programs. He expressed strong confidence that a collective approach can lead to success…

IVAC  [to 12 May 2018]

Now Available: HERMES (Highly Extensible Resource for Modeling Event-Driven Supply Chains)
Systems modeling is a tool for policymakers and program managers to capture all the direct and indirect effects of changes to a system, identify sustainable solutions to the root causes of issues and save time, effort, and resources in costly trial and error. Without systems modeling, evaluating systems, identifying gaps, and implementing solutions can be insufficient, unsustainable, and costly.

Vaccine supply chains are complex systems, comprising all the equipment, personnel, policies and processes needed to deliver a vaccine from its point of origin to the population. Understanding how the various components of a vaccine supply chain interact with each other is critical to evaluating supply chain function, identifying the root causes of issues, and formulating sustainable solutions…

Funded by the Bill & Melinda Gates Foundation, HERMES is a software program that allows users to generate a detailed computer simulation model of a supply chain. Researchers from the Global Obesity Prevention Center (GOPC) and International Vaccine Access Center (IVAC) at Johns Hopkins University, as well as the Pittsburgh Supercomputing Center (PSC) at Carnegie Mellon University, are releasing the new HERMES software to help decision makers around the world improve the delivery of vaccines. The model can serve as a “virtual laboratory” for users to evaluate a supply chain and test the effects of implementing different potential policies, interventions, practices, and technology changes…
IVI   [to 12 May 2018]
IVI acquires $6.46 million grant to measure single dose impact of HPV vaccine
The International Vaccine Institute (IVI) has acquired a 6.46 million-dollar grant from the Bill & Melinda Gates Foundation to conduct a Human papillomavirus (HPV) vaccine single-dose impact study in Thailand.  The study will be conducted in partnership with the Thailand Ministry of Public Health and proposes to measure the effectiveness of a single-dose of HPV vaccine administered to young women in Thailand, while also generating data of single dose effectiveness to inform global public health policy. IVI will receive a total of $6,465,516 from the foundation for this study through October 2023.

HPV is the most common viral infection of the reproductive tract. Some HPV strains are harmless but others cause cervical cancer, with HPV infection responsible for nearly all cases of cervical cancer. According to the World Health Organization, globally, cervical cancer is the fourth most common cancer in women with an estimated 530,000 new cases in 2012 alone, and accounts for 7.5 percent of all female cancer deaths. It is estimated that more than 270,000 die from cervical cancer yearly, with over 85 percent of these deaths occurring in less developed regions.

There are currently two internationally licensed HPV vaccines: Gardasil and Cervarix. Both vaccines are shown to be safe and very effective in preventing infection with HPV 16 and 18, which are known to cause at least 70 percent of all cervical cancers. By mid-2016, 65 countries had introduced HPV vaccines, including a growing number of middle- and low-income countries. Both vaccines are administered in a two- or three-dose regimen, which can be costly.

“Data of single dose effectiveness can be highly useful in informing the most cost-effective approach to HPV vaccination and global public health policy,” said Dr. Julia Lynch, Deputy Director General for Development and Delivery at IVI, who will lead the study. “If one dose is confirmed to offer sufficient protection, it could significantly reduce vaccine and administration costs while increasing uptake to save more lives.”
JEE Alliance  [to 12 May 2018]
11.5.2018   Events
“Investing for a Rainy Day: How to Finance Outbreak Preparedness?”
MSF/Médecins Sans Frontières  [to 12 May 2018]
Press release
MSF Responds to President Trump’s Speech on Drug Pricing
May 11, 2018
The international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) made the following statement today in response to President Trump’s speech on drug pricing.

Press release
DRC: Emergency Team Supports Rapid Response to Ebola Cases
May 09, 2018
[See Milestones above for more detail]

Press release
Yemen: Scores of civilians treated after airstrikes target Sana’a city center
May 08, 2018
A series of airstrikes by the Saudi and Emirati-led coalition aimed at the Presidential office in the heart of Sana’a, Yemen, killed at least six people and injured 72 others on Monday morning, according to staff at two hospitals supported by Doctors Without Borders/Médecins Sans Frontières (MSF) who received the dead and wounded. The airstrikes took place in a bustling area near a hotel, bank, pharmacies, and shops.

NIH  [to 12 May 2018]
May 8, 2018
Despite mutations in Makona Ebola virus, disease consistent in mice, monkeys
— Scientists previously speculated that genetic diversity of the Makona strain would result in more severe disease.
PATH  [to 12 May 2018]
Press release | May 07, 2018
New management training for immunisation leaders kicks-off in Kigali
24 managers from five Gavi-supported countries will attend the first round of the nine-month programme
KIGALI, May 7 2018—Yale’s Global Health Leadership Initiative (GHLI), the Rwanda-based University of Global Health Equity (UGHE), PATH, and Gavi, the Vaccine Alliance have joined forces to strengthen national leadership and management of immunisation programmes in Gavi-supported countries. The Expanded Program on Immunisation Leadership and Management Programme (EPI LAMP) is an innovative management training course for immunisation leaders in developing countries. The programme will improve the managerial capacity of governments to support Gavi’s mission to ensure every child is protected with lifesaving vaccines…

Sabin Vaccine Institute  [to 12 May 2018]
May 7, 2018
Georgian Leaders Gather to Discuss Immunization Regulations
TBILISI, GEORGIA —— Today, the Sabin Vaccine Institute and the Ministry of Labour, Health and Social Affairs of Georgia, together with the Parliament of Georgia, assembled senior officials and stakeholders to evaluate and prioritize policies to improve routine immunization coverage in Georgia.
UNAIDS [to 12 May 2018]
11 May 2018  Feature story
UNAIDS Executive Director puts the spotlight on the HIV response in Lesotho, South Africa and Zambia during five-day visit
UNAIDS Executive Director, Michel Sidibé, completed a five-day visit to three countries in southern Africa. The mission included high-level political discussions, the launch of the Lesotho HIV Health and Situation Room and frank and an open dialogue with women activists about how to address sexual harassment and abuse.

07 May 2018  Feature story
Measuring progress against the 10 commitments through Global AIDS Monitoring
At the United Nations High-Level Meeting on Ending AIDS in 2016, countries pledged to achieve a set of 10 Fast-Track commitments by 2020—an acceleration agenda that aims to end the AIDS epidemic by 2030 as part of the Sustainable Development Goals. To help ensure that the deadlines are met, the United Nations General Assembly requested an annual report on progress achieved in meeting those 10 commitments.
UNAIDS supports countries to collect information on their national HIV responses through the Global AIDS Monitoring (GAM) framework—an annual collection of 72 indicators on the response to HIV in a country. These data form part of the data set used to report back to the General Assembly.

07 May 2018  Feature story
Heads of H6 agencies embrace new results framework
…To accelerate change, the executive heads of the H6 partnership met on the sidelines of the United Nations System Chief Executives Board in London, United Kingdom, on 2 May and agreed a new results framework, H6 Results 2020. H6 Results 2020 aims to shape the H6 partnership into a trusted, valued source for technical support, strategic policy advice and best practices for the health and well-being of women, children and adolescents.
Developed under the chairpersonship of UNAIDS Executive Director Michel Sidibé, H6 Results 2020 is closely aligned with the Every Woman Every Child Every Adolescent Global Strategy and the 2020 Every Woman Every Child Partners’ Framework. H6 Results 2020 sets ambitious goals while committing to deliver on a number of concrete results for 2020.
“I am excited about our revitalized H6 partnership. As the technical arm of the Every Woman Every Child movement, we plan to further streamline and simplify the health architecture, coordinating with key partners to leverage political capital, technical expertise and advocacy for results for women, children and adolescents everywhere,” said Mr Sidibé…

UNICEF  [to 12 May 2018]
Selected Press Releases/Reports
770,000 children under five suffering from acute malnutrition in Kasai region of Democratic Republic of the Congo
NEW YORK/DAKAR/GENEVA/JOHANNESBURG/KINSHASA, 11 May 2018 – At least 770,000 children in the Kasai region in the Democratic Republic of Congo are suffering from acute malnutrition, including 400,000 children who are severely malnourished and at risk of death – UNICEF said in a report released today. The children’s agency went on to warn that unless urgent action was taken to strengthen the humanitarian response, the number of child deaths could skyrocket.

UNICEF welcomes Education Under Attack report
NEW YORK, 10 May 2018 – Speaking today at the launch of Education under Attack 2018, a new report by the Global Coalition to Protect Education from Attack (GCPEA), Shahida Afzar, UNICEF Deputy Executive Director, said: “Today’s report is helping us shine a light on an issue that is too often overlooked. Children are under attack around the globe.

On Mother’s Day, UNICEF calls for the narrowing of “breastfeeding gaps” between rich and poor worldwide
NEW YORK, 10 May 2018 – The number of babies missing out on breastfeeding remains high, particularly among the world’s richest countries, UNICEF said in a new analysis released today. Worldwide, approximately 7.6 million babies each year are not breastfed.

Immunization Financing in MENA Middle-Income Countries
May 2018
Most MENA countries have high immunization coverage rates. But immunization coverage has dropped considerably in some (including Iraq, the Syrian Arab Republic and Yemen), due to the conflicts, instability and the prevailing geopolitical situation in the region. Approximately 1.3 million surviving infants in MENA missed their third dose of DTP vaccine in 2016. In many of the region’s countries, problems of equity persist, particularly concerning displaced populations, nomads, ethnic groups and marginalized urban populations.
Key Points:
:: The Ministry of Health budget remains the mainstay of immunization financing in most of the countries.
:: New vaccine introductions pose challenges for the region.
:: The Sudan will be the first of the Gavi countries in MENA to move into the ‘accelerated transition process’
:: Local and external factors have made procuring and purchasing vaccines and related products a considerable challenge for most MENA countries.

Wellcome Trust  [to 12 May 2018]
News  Published: 10 May 2018
Wellcome pledges £2m after new Ebola outbreak confirmed
Wellcome is making an initial fund of up to £2 million available to support a rapid response to the new Ebola outbreak in the Democratic Republic of Congo (DRC).
The pledge comes after the DRC government announced the latest outbreak this week, following tests that confirmed two cases of Ebola in the Bikoro area, near the north-west border. It’s the ninth Ebola outbreak in DRC.
The funding will be available to the government of the DRC and the World Health Organization (WHO) for the critical research needed to support the operational response now underway in the country.
Wellcome’s £2m emergency funding will also be supported by £1m funding from the UK Department for International Development (DFID) through the Joint Initiative on Epidemic Preparedness.
Jeremy Farrar, Director of Wellcome, said: “It’s vital the global response to this outbreak is swift. We know from previous outbreaks that the DRC are ready to act, but they need global support to ensure this outbreak is contained effectively. We must ensure the very best protection for the communities at risk and for the health workers working to protect lives – now and for future outbreaks…

Distinguished scientists elected as Fellows and Foreign Members of the Royal Society
09 May 2018 – Fifty eminent scientists have been elected as Fellows of the Royal Society and ten as new Foreign Members for their exceptional contributions to science…
[10 Wellcome researchers have today been elected Fellows of @royalsociety. They are named in a list that celebrates over 50 eminent scientists and researchers for their exceptional contributions to science.]

BIO    [to 12 May 2018]
May 11 2018
BIO Statement on Trump Administration’s Plan to Lower Drug Costs
“We have concerns that some of the ideas proposed today could, if adopted, hurt patient access to the medicines they need …”

DCVMN – Developing Country Vaccine Manufacturers Network  [to 12 May 2018]
19 April 2018
Biovac awarded manufacturing licence
Cape Town, 18 April 2018 – The Biovac Institute (Biovac) has been awarded a manufacturing licence by a South African regulator, taking it one step closer to realising the government’s ambition of producing its own vaccines.
Biovac is a public-private partnership that was formed in 2003 to try and revitalise the state’s human vaccine manufacturing capacity, after the demise of the state vaccine institute…
PhRMA    [to 12 May 2018]
May 11, 2018
PhRMA Statement on President Trump’s Drug Pricing Blueprint
PhRMA president and CEO Stephen J. Ubl issued a statement on President Donald Trump’s drug pricing blueprint.
“These far-reaching proposals could fundamentally change how patients access medicines and realign incentives across the entire prescription drug supply chain. While some of these proposals could help make medicines more affordable for patients, others would disrupt coverage and limit patients’ access to innovative treatments…

Industry Watch    [to 12 May 2018]
:: Proposed Acquisition of Shire plc by Takeda  May 8, 2018 Osaka, Japan
Transaction Highlights
:: Brings together complementary positions in gastroenterology (GI) and neuroscience; provides leading positions in rare diseases and plasma-derived therapies to complement strength in oncology and focused efforts in vaccines
:: Creates a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, with an attractive geographic footprint and provides the scale to drive future development
:: Creates a highly complementary, robust, modality-diverse pipeline and a strengthened R&D engine focused on breakthrough innovation
:: Enhances Takeda’s cash flow profile, with management confident of delivering substantial annual cost synergies and generating attractive returns for shareholders
:: Takeda’s transformation positions the combined group to successfully integrate Shire and maximize value from the combination