Vaccines and Global Health: The Week in Review 29 July 2017

Vaccines and Global Health: The Week in Review is a weekly digest  summarizing news, events, announcements, peer-reviewed articles and research in the global vaccine ethics and policy space. Content is aggregated from key governmental, NGO, international organization and industry sources, key peer-reviewed journals, and other media channels. This summary proceeds from the broad base of themes and issues monitored by the Center for Vaccine Ethics & Policy in its work: it is not intended to be exhaustive in its coverage. You are viewing the blog version of our weekly digest, typically comprised of between 30 and 40 posts below all dated with the current issue date

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 pdf version A pdf of the current issue is available here: Vaccines and Global Health_The Week in Review_29 July 2017

– blog edition: comprised of the approx. 35+ entries posted below.

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David R. Curry, MS
Executive Director
Center for Vaccine Ethics and Policy

Milestones :: Perspectives

Milestones :: Perspectives

Editor’s Note:
We urge readers to invest the time necessary to read and absorb the “Five Most Important Points” below excerpted from this first report of the Transition Independent Monitoring Board (TIMB). We are reflecting on their strategic impact to the poliovirus eradication effort, early planning for GVAP 2.0, and, indeed, the “immunization enterprise” overall.

THE END OF THE BEGINNING – First Report of the Transition Independent Monitoring Board of the Polio Programme
July 2017 :: 35 pages
This report
The Transition Independent Monitoring Board (TIMB) was created by the Global Polio Eradication Programme (GPEI) to monitor and guide the process of polio transition planning. This is our first report. It provides an initial analysis of the priorities, plans, risks and opportunities as the eradication of polio appears to be drawing closer. In this first report, we have concluded by identifying areas of further work. Our subsequent reports will make recommendations for action.

F I V E  M O S T  I M P O R TA N T  P O I N T S
:: On average, 25% to 50% of staff funded through the Global Polio Eradication Initiative (GPEI) spend time on non-polio activities such as routine immunisation, broader disease surveillance, laboratory support, and responding to public health emergencies; some countries’ health systems have been heavily dependent on polio funding for decades; 95% of the polio asset footprint is concentrated in 16 countries that are the most vulnerable to withdrawal of funding; many of the same countries face simultaneous withdrawal of funding from Gavi and some other sources.

:: If polio eradication succeeds but poorer countries’ public health services collapse in the initiative’s wake, it would be a major failure of global governance and stewardship. The risks to global health and to vulnerable populations are high if the polio transition process is mismanaged. They include: disruption of the path to eradication so that polio resurges; failure to secure and sustain staff, infrastructure and expertise necessary to detect, prevent and control other communicable diseases; direct threats to global biosecurity; rises in death rates from vaccine preventable diseases; humanitarian crises in fragile states; lost opportunities to develop health systems; a drop in resources to respond to public health crises.

:: The transition planning process initiated by the Global Polio Eradication Initiative (GPEI) is predicated on four assumptions: firstly, that to the degree possible, countries will absorb the costs of sustaining polio assets within their public health systems; secondly, that countries will prepare national plans that map out the role polio assets play in their health systems and the deficits that will be created when the GPEI closes; thirdly, that the national plans will align with the targets laid out in the Global Vaccine Action Plan (GVAP) approved and endorsed by all WHO member states; fourthly, that by-and-large donors will be prepared to fill the gap.

:: The GPEI is not a donor. It has been a vehicle for receipt of donations and targeting expenditure for 30 years. As polio eradication nears, the GPEI’s legitimacy to mobilise and oversee resources for the resulting gaps in public health provision is fading. It will not be in a position to receive, coordinate, or allocate donor funding for such purposes; soon it will not exist. Once at the end of polio eradication, funding gaps for routine immunisation and other services will be recurrent and permanent; there will be less donor tolerance towards those countries that they feel should be providing their own resources for non-polio public health services.

:: Beyond the world of polio leaders, academics, donors, and enthusiasts, there is little awareness or understanding of the enormity, complexity, and urgency of the action needed to deal effectively winding down of polio funding begun in 2017; nor is there enough appreciation that the poliovirus will not feel the need to comply with an orderly series of planned measures that will allow itself to be eradicated; polio eradication is progressing alongside polio transition planning and if the latter speeds too far ahead, there is a huge risk that resources will not be available to respond to polio and other disease outbreaks.
Experimental HIV vaccine regimen is well-tolerated, elicits immune responses
NIH   Monday, July 24, 2017
Results from early-stage NIH-funded trial support further development of candidate vaccines.
Results from an early-stage clinical trial called APPROACH show that an investigational HIV vaccine regimen was well-tolerated and generated immune responses against HIV in healthy adults. The APPROACH findings, as well as results expected in late 2017 from another early-stage clinical trial called TRAVERSE, will form the basis of the decision whether to move forward with a larger trial in southern Africa to evaluate vaccine safety and efficacy among women at risk of acquiring HIV.

The APPROACH results will be presented July 24 at the 9th International AIDS Society Conference on HIV Science in Paris.

The experimental vaccine regimens evaluated in APPROACH are based on “mosaic” vaccines designed to induce immunological responses against a wide variety of HIV subtypes responsible for HIV infections globally. Different HIV subtypes, or clades, predominate in various geographic regions around the world. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, funded pre-clinical development of these vaccines. Together with other partners, NIAID supported the APPROACH trial, which is sponsored by Janssen Vaccines & Prevention B.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson. The manufacture and clinical development of the mosaic vaccines are led by Janssen.

“A safe and effective HIV vaccine would be a powerful tool to reduce new HIV infections worldwide and help bring about a durable end to the HIV/AIDS pandemic,” said NIAID Director Anthony S. Fauci, M.D. “By exploring multiple promising avenues of vaccine development research, we expand our opportunities to achieve these goals.”…

Johnson & Johnson Announces Encouraging First-in-Human Clinical Data for Investigational HIV Preventive Vaccine
…In Phase 1/2a APPROACH study, HIV-1 antibody response observed in all healthy volunteers
…Mosaic-based vaccine regimen is designed to elicit an immune response against a wide variety of HIV subtypes prevalent worldwide
…Positive clinical and preclinical results inform selection of lead mosaic HIV vaccine regimen for further evaluation in Phase 2b proof-of-concept study
July 24, 2017
PARIS, France–(BUSINESS WIRE)–Johnson & Johnson today announced encouraging first-in-human clinical data for an investigational HIV-1 vaccine regimen in development at its Janssen Pharmaceutical Companies. In an oral presentation of the early stage Phase 1/2a APPROACH study at the 9th IAS Conference on HIV Science (IAS 2017), the “mosaic”-based vaccine regimen from Janssen Vaccines & Prevention B.V. (Janssen) appeared to be well-tolerated and elicited HIV-1 antibody responses in 100% of healthy volunteers (n=393).

“Finding a preventive vaccine has proven to be one of the biggest scientific challenges in the 35-year quest to end the HIV pandemic. A successful preventive vaccine for HIV will need to provide broad protection against a wide range of viral strains,” said Professor Dan Barouch, Harvard Medical School, Director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center and a key collaborator for APPROACH. “These promising, early-stage results suggest that these vaccines utilizing mosaic immunogens should be evaluated further for their potential ability to achieve this historic goal.”

Significant progress has been made in the global battle against HIV/AIDS, including the development of critical antiretroviral treatments and HIV prevention tools, yet the disease remains one of the greatest global health threats of our time. An estimated 37 million people are currently living with HIV-1 globally, and nearly 2 million people become newly infected each year. An effective HIV vaccine is elusive due to the unique properties of the virus – including its genetic diversity and ability to mutate rapidly.

Mosaic-based vaccines contain immunogens created using genes from different HIV subtypes responsible for HIV-1 infections worldwide. These immunogens are delivered through viral vectors, including Janssen’s AdVac® technology based on adenovirus serotype 26 (Ad26). The viral vectors are combined with other components such as soluble proteins to form mosaic-based prime-boost vaccine regimens that first prime and then boost the immune system, with the aim of producing stronger and longer-lasting immunity to HIV.

Paul Stoffels, M.D., Chief Scientific Officer, Johnson & Johnson said, “In recent years, a new optimism has emerged that we will find an effective HIV vaccine in our lifetime. The results from today’s study add to that belief and we look forward to advancing to the next stage of clinical development as quickly as possible.”

In pre-clinical studies, regimens incorporating mosaic vaccines demonstrated protection against infection with an HIV-like virus. The most effective prime-boost regimen in these studies reduced the per-exposure risk of infection by 94 percent and resulted in 66 percent complete protection after six exposures.

Based on immunologic responses observed in APPROACH, as well as protection observed in pre-clinical studies, a lead HIV-1 vaccine regimen comprising Janssen’s Ad26 mosaic candidate and the Clade C gp140 soluble protein has been selected as the basis for further evaluation in a potential Phase 2b proof-of-concept efficacy study. Should this study move forward, Janssen and its global partners anticipate initiating this investigation in southern African countries in late 2017 or early 2018…
Statement by UNICEF Executive Director, Anthony Lake, WFP Executive Director, David Beasley and WHO Director-General, Dr Tedros Adhanom Ghebreyesus, following their joint visit to Yemen
Joint WHO/UNICEF/WFP statement
26 JULY 2017 | ADEN/SANA’A – “As the heads of three United Nations agencies – UNICEF, the World Food Programme (WFP) and WHO – we have travelled together to Yemen to see for ourselves the scale of this humanitarian crisis and to step up our combined efforts to help the people of Yemen.

“This is the world’s worst cholera outbreak in the midst of the world’s largest humanitarian crisis. In the last 3 months alone, 400 000 cases of suspected cholera and nearly 1900 associated deaths have been recorded. Vital health, water and sanitation facilities have been crippled by more than 2 years of hostilities, and created the ideal conditions for diseases to spread.

“The country is on the brink of famine, with over 60 per cent of the population not knowing where their next meal will come from. Nearly 2 milllion Yemeni children are acutely malnourished. Malnutrition makes them more susceptible to cholera; diseases create more malnutrition. A vicious combination…

“Amid this chaos, some 16 000 community volunteers go house to house, providing families with information on how to protect themselves from diarrhea and cholera. Doctors, nurses and other essential health staff are working around the clock to save lives.

“More than 30 000 health workers haven’t been paid their salaries in more than 10 months, but many still report for duty. We have asked the Yemeni authorities to pay these health workers urgently because, without them, we fear that people who would otherwise have survived may die. As for our agencies, we will do our best to support these extremely dedicated health workers with incentives and stipends.

“We also saw the vital work being done by local authorities and NGOs, supported by international humanitarian agencies, including our own. We have set up more than 1000 diarrhoea treatment centres and oral rehydration corners. The delivery of food supplements, intravenous fluids and other medical supplies, including ambulances, is ongoing, as is the rebuilding of critical infrastructure – the rehabilitation of hospitals, district health centres and the water and sanitation network. We are working with the World Bank in an innovative partnership that responds to needs on the ground and helps maintain the local health institutions.

“But there is hope. More than 99 per cent of people who are sick with suspected cholera and who can access health services are now surviving. And the total number of children who will be afflicted with severe acute malnutrition this year is estimated at 385,000.

“However, the situation remains dire. Thousands are falling sick every day. Sustained efforts are required to stop the spread of disease. Nearly 80 percent of Yemen’s children need immediate humanitarian assistance.

“When we met with Yemeni leaders — in Aden and in Sana’a — we called on them to give humanitarian workers access to areas affected by fighting. And we urged them – more than anything – to find a peaceful political solution to the conflict.

“The Yemeni crisis requires an unprecedented response. Our 3 agencies have teamed up with the Yemeni authorities and other partners to coordinate our activities in new ways of working to save lives and to prepare for future emergencies.

“We now call on the international community to redouble its support for the people of Yemen. If we fail to do so, the catastrophe we have seen unfolding before our eyes will not only continue to claim lives but will scar future generations and the country for years to come.”
[See UN OCHA – L3 Emergencies below for Yemen cholera response plan and status of OCV as an intervention]



Public Health Emergency of International Concern (PHEIC)

Polio this week as of 19 July 2017 [GPEI]
:: The first report of the Transition Independent Monitoring Board (TIMB) has now been published, following the group’s first meeting last month.  The TIMB has been established at the request of the Polio Oversight Board (POB) to independently monitor and guide the polio transition process, especially in the 16 countries prioritized for transition planning.  The group’s next meeting will be held in London, United Kingdom, on 2-3 November.  More.

:: Five country-wide vaccination campaigns have been held in Pakistan since October 2016, preparing for the 2017 high season for poliovirus transmission, which runs from June until September. Read more about what the high season means for eradication.

:: Read the latest polio update from WHO Afghanistan to see information on cases, surveillance and vaccination campaigns for the month of June.

:: Summary of newly-reported viruses this week:  Pakistan – six new wild poliovirus type 1 (WPV1)-positive environmental samples


WHO-UNICEF: Syria cVDPV2 outbreak Situation Report # 6   25 July 2017
Key highlights
:: No new cVDPV2 cases reported this week. The total number of cVDPV2 cases remains 27 (26 cases are from Mayadeen district, Deir Ez-Zor governorate, and 1 case from Tell Abyad district, Raqqa governorate).

:: The first mOPV2 vaccination round in Deir Ez-Zor started on 22 July. A total of 59,051 children under the age of five were vaccinated on the first day of the campaign.

:: Given high temperatures, WHO has arranged for local ice-cream factories to assist in the daily freezing of ice packs.

:: Community mobilization activities continue throughout the campaign. Household visits have focused on addressing vaccine refusal through use of community influencers.

:: In addition to administering mOPV2, vaccination teams are searching for AFP cases during campaign days. An AFP case detected during vaccination visits in Mayadeen district is under investigation.

:: The total number of acute flaccid paralysis (AFP) cases detected in Deir Ez-Zor governorate since the beginning of 2017 is 89 (67 from Mayadeen, 10 from Deir Ez-Zor, and 12 from Boukamal districts). Raqqa governorate has reported 14 AFP cases (6 from Raqqa, 7 from Tell Abyad, and 1 from Thawra districts).


WHO Grade 3 Emergencies  [to 29 July 2017]
::  The life and death struggle against cholera in Yemen   25 July 2017
Cholera continues to spread in Yemen, causing more than 390 000 suspected cases of the disease and more than 1800 deaths since 27 April.
WHO and its partners are responding to the cholera outbreak in Yemen, working closely with UNICEF, local health authorities and others to treat the sick and stop the spread of the disease…

The Syrian Arab Republic
:: Read the latest WHO & UNICEF cVDPV2 outbreak situation report  25 July 2017
[See Polio above for more detail]

South Sudan – No new announcements identified.
Iraq  – No new announcements identified.
NigeriaNo new announcements identified.
WHO Grade 2 Emergencies  [to 29 July 2017]
Myanmar  No new announcements identified
Cameroon  No new announcements identified
Central African Republic  – No new announcements identified. 
Democratic Republic of the CongoNo new announcements identified
EthiopiaNo new announcements identified.
LibyaNo new announcements identified.
Niger  – No new announcements identified.
Ukraine  – No new announcements identified
UN OCHA – L3 Emergencies
The UN and its humanitarian partners are currently responding to three ‘L3’ emergencies. This is the global humanitarian system’s classification for the response to the most severe, large-scale humanitarian crises. 
:: Iraq: Mosul Humanitarian Response Situation Report No. 40 (12 to 26 July 2017)
:: Almost 1 million people fled from western Mosul and western Ninewa Governorate as of 26 July, surpassing humanitarians’ ‘worst-case’ estimates. Beyond Mosul, sustained efforts are now needed to support more than 700,000 people who lost everything.
:: Protection remains a top priority, especially for minority groups, women and children. The targeting of these groups is a particularly disturbing feature in Ninewa Governorate and in other areas of the country.
:: While the battle for Mosul is declared over, other areas remain under the Islamic State in Iraq and the Levant’s (ISIL) control. This means civilians continue to be in danger as induced displacement, mostly from Ba’aj and Telafar, continues.
:: Outside of camps and in Mosul city water issues remain critical. This is mainly due to the logistical challenges caused by the temporary closure of Qayyarah bridge and lack of funding.

Syrian Arab Republic
:: 28 Jul 2017  2017 Regional Refugee & Resilience Plan – 3RP (all agencies) – Funding snapshot as of 27-Jul-17
:: Under-Secretary-General for Humanitarian Affairs and Emergency Relief Coordinator, Stephen O’Brien Statement to the Security Council on the Humanitarian Situation in Syria
New York, 27 July 2017

:: Key messages on cholera (23 July 2017)
[No reference to vaccination, immunization, OCV]
:: Joint Cholera Response Plan – Yemen – July 2017
[Excerpts referencing vaccination/OCV]
4) Oral Cholera Vaccine [p.8, 9]
Conduct risk assessment to determine locations and population eligible for vaccination,
explore availability of the vaccine globally, discuss with MoPHP and other stakeholders
the feasibility of a cholera vaccination campaign in high risk areas eligible to receive
the vaccine…

ANNEX 6: Funding Requirements for Health and WASH Response – budget breakdown [p.29]
…Community awareness
Social mobilization and communication for OCV campaign $500,000

Editor’s Note:
We continue to monitor how OCV is being factored into response strategies in the Yemen context. We note that the Joint Cholera Response Plan document above does not include any reference to the “much larger preventive campaign” noted below from last week’s WHO situation report.
::  [WHO] Yemen cholera situation report no. 4   19 JULY 2017
Highlights [Excerpt]
:: A cholera vaccination campaign originally planned for July 2017 has been postponed at the request of the health authorities, in favour of a much larger preventive campaign next year targeting millions of Yemenis at risk of the disease.


UN OCHA – Corporate Emergencies
When the USG/ERC declares a Corporate Emergency Response, all OCHA offices, branches and sections provide their full support to response activities both at HQ and in the field.
:: Ethiopia Weekly Humanitarian Bulletin, 24 July 2017
Key Issues
:: The UN Humanitarian Coordinator allocated US$44.7 million through the OCHA managed Ethiopia Humanitarian Fund (EHF), to address the most life-saving and time critical needs. All eligible partners are encouraged to consult respective clusters and submit their project proposal online on the Grant Management System not later than 8 August 2017.
:: An estimated US$30 million required to assist the most vulnerable Ethiopian returnees from the Kingdom of Saudi Arabia.
:: Ethiopia continues to receive Somali and South Sudanese refugees fleeing conflict and food insecurity.

:: United Nations relief chief appeals for urgent funds for people in need in DR Congo
3.8 million people are now displaced within the Democratic Republic of the Congo
(Kinshasa/New York/Geneva, 21 July 2017): The United Nations Under-Secretary-General for Humanitarian Affairs and Emergency Relief Coordinator, Stephen O’Brien, today wrapped up a four-day mission to the Democratic Republic of the Congo (DRC) by calling on the world “not to forget the DRC, where millions of girls, boys, women and men are suffering from violence, diseases, and malnutrition.”…

:: Trapped in displacement: Lessons and voices from internally displaced   Published on 21 Jul 2017
:: Somalia: Drought Response – Situation Report No. 15  Published on 24 Jul 2017
:: While extensive humanitarian operations are ongoing, with over three million people being reached monthly with lifesaving assistance, livelihoods support and protection services, humanitarian needs are expected to persist at current levels through the end of the year. As a result of below average Gu rains, pest infestation and reduced area cultivated, overall cereal production is expected to be 50-60 percent of average, according to the Post Gu Preliminary Assessment Results by Food Security and Nutrition Analysis Unit (FSNAU).
:: Results of nutrition surveys conducted by FSNAU indicate a critical nutrition situation (Global Acute Malnutrition (WHZ) prevalence of 15 per cent or higher) in 9 out of 12 displaced people’s settlements.
::The first ever Somalia Country Humanitarian Forum was held on 19 July, in Mogadishu. The forum will now serve as an information sharing and coordination platform with international humanitarian actors.
:: On 15 July, AMISOM handed over the Somali National University to the Federal Government. The handover of the last civilian learning facility occupied by armed actors comes after over 30 years of occupation and is an important step in expanding opportunities for youth.
:: The Humanitarian Coordinator for Nigeria condemns recent attacks on civilians in camps for internally displaced persons
Abuja, 25 July 2017 – The Humanitarian Coordinator for Nigeria, Edward Kallon, condemns in the strongest terms the deadly suicide attacks that took place in the Dalori I and Dalori II IDP camps in the outskirts of Maiduguri, the capital of Borno State, on 24 July 2017, which resulted in the deaths of several civilians, including women and children, and injured many others.
These suicide attacks are the latest in the recent accelerating trend of attacks against civilians in north-east Nigeria over the past few months…

Dashboard: International Coordinating Group (ICG) on Vaccine Provision on cholera 
[accessed 29 July 2017]
[No new request activity identified]

Editor’s Note:
We will cluster these recent emergencies as below and continue to monitor the WHO webpages for updates and key developments.

MERS-CoV [to 29 July 2017]
21 July 2017   WHO/MERS/RA
WHO MERS-CoV Global Summary and Assessment of Risk
Global summary
Between 2012 and 21 July 2017, 2040 laboratory-confirmed cases of Middle East respiratory syndrome-coronavirus (MERS-CoV) infection were reported to WHO, 82% of whom were reported by the Kingdom of Saudi Arabia (Figure 1). In total, cases have been reported from 27 countries in the Middle East, North Africa, Europe, the United States of America, and Asia (Table 1). Males above the age of 60 with underlying conditions, such as diabetes, hypertension and renal failure, are at a higher risk of severe disease, including death. To date, at least 710 individuals have died (crude CFR 34.8%)…

Overall, the epidemiology, transmission patterns, clinical presentation of MERS patients and viral characteristics reported since the last update are consistent with past patterns described in previous WHO risk assessments: MERS-CoV is a zoonotic virus that has repeatedly entered the human population via direct or indirect contact with infected dromedary camels in the Arabian Peninsula. Limited, non-sustained human-to-human transmission in health-care settings continue to occur, primarily in the Kingdom of Saudi Arabia,…

The continued importance of MERS-CoV in health-care settings
Since the last global update of 5 December 2016, approximately 31% of cases reported to WHO were associated with transmission in a health-care facility. These cases included health-care workers (40 cases), patients sharing rooms/wards with MERS patients, or family visitors.

Though not unexpected, these transmission events continue to be deeply concerning, given that MERS-CoV is still a relatively rare disease about which medical personnel in health-care facilities have low awareness. Globally, awareness for MERS-CoV is low and, because symptoms of MERS-CoV infection are non-specific, initial cases are sometimes easily missed. With improved compliance in infection prevention and control, namely adherence to the standard precautions at all times, human-to-human transmission in health-care facilities can be reduced and possibly eliminated with additional use of transmission-based precautions…

WHO & Regional Offices [to 29 July 2017]

WHO & Regional Offices [to 29 July 2017]

Eliminate hepatitis: WHO
News release
27 July 2017 | GENEVA – New WHO data from 28 countries – representing approximately 70% of the global hepatitis burden – indicate that efforts to eliminate hepatitis are gaining momentum. Published to coincide with World Hepatitis Day, the data reveal that nearly all 28 countries have established high-level national hepatitis elimination committees (with plans and targets in place) and more than half have allocated dedicated funding for hepatitis responses.
On World Hepatitis Day, WHO is calling on countries to continue to translate their commitments into increased services to eliminate hepatitis. This week, WHO has also added a new generic treatment to its list of WHO-prequalified hepatitis C medicines to increase access to therapy, and is promoting prevention through injection safety: a key factor in reducing hepatitis B and C transmission.
From commitment to Action
“It is encouraging to see countries turning commitment into action to tackle hepatitis.” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “Identifying interventions that have a high impact is a key step towards eliminating this devastating disease. Many countries have succeeded in scaling-up the hepatitis B vaccination. Now we need to push harder to increase access to diagnosis and treatment.”…

WHO prequalifies first generic hepatitis C medicine and first HIV self-test
July 2017 – In the lead-up to Paris AIDS conference, WHO today prequalified the first generic version of sofosbuvir, a critical medicine for the treatment of hepatitis C, as well as the OraQuick ® HIV Self-Test.


Weekly Epidemiological Record, 21 July 2017, vol. 92, 29/30 (pp. 405–416)
:: Progress towards measles elimination in Bangladesh, 2000–2016
:: Performance of acute flaccid paralysis (AFP) surveillance and incidence of poliomyelitis, 2017

WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: WHO participates in a forum on effective interventions to reduce harmful use of alcohol 26 July 2017
:: WHO provides lifesaving treatment for severely malnourished children with medical complication in South Sudan  26 July 2017
:: WCO Tanzania takes the Transformation Agenda forwards  26 July 2017

:: Partners agree to harmonise actions to improve the effectiveness of humanitarian efforts
Dakar, 18 July 2017 – Organisations involved in managing health emergencies and disease outbreaks in the African Region have agreed on better ways of coordinating their activities in the event of a crisis so as to save more lives and resources.
With more than 100 public health emergencies occurring each year in the African Region, the need to maximize the efficiency and effectiveness of the preparedness and response to health emergencies to meet the needs of affected communities has become paramount.
At the end of a three – day meeting in Dakar, Senegal, the Organisations agreed to undertake a number of specific joint actions in the next two years aimed at improving the quality and impact of their interventions. Some of the activities include:
…Mapping of partner institutions capacities in African region,
…Mapping of laboratory capacity in the region including diagnostics and vet labs for One Health
…Engaging key partners in the Pandemic Supply Chain Network Lead organizations: WFP
…Harmonize emergency training programs in the African region
…Develop repository of tools and documents for response to public health emergencies.
…Lead organizations: WHO AFRO , GOARN and Africa CDC
The event attracted over 70 representatives and experts from national, regional and international organizations. Among these were UNICEF, FAO, OCHA, WFP, UNHCR, IOM, MSF International, US CDC, AFENET, ALIMA, Nigeria CDC, IFRC, ARC, NICD South Africa, Institut Pasteur de Dakar, Public Health England, UVRI, KEMRI, Africa CDC, GOARN and WHO.

:: The Regional Expert Meeting on Medicine Regulatory Harmonization Initiative is being convened by IGAD  24 July 2017

WHO Region of the Americas PAHO
:: Countries of the Americas take action to eliminate hepatitis (07/28/2017)
…According to a PAHO/WHO survey in May 2017, at least 21 of the 25 countries surveyed in the Region of the Americas have created frameworks within their Ministries of Health that are now addressing and implementing hepatitis response measures.

WHO South-East Asia Region SEARO
::  Enhance awareness, action to eliminate hepatitis in South-East Asia Region 27 July 2017
WHO European Region EURO
:: World Hepatitis Day: making hepatitis elimination a reality 27-07-2017

WHO Eastern Mediterranean Region EMRO
:: WHO commemorates World Hepatitis Day in Pakistan  27 July 2017
:: Statement by UNICEF Executive Director, Anthony Lake, WFP Executive Director, David Beasley and WHO Director-General, Dr Tedros Adhanom Ghebreyesus, following their joint visit to Yemen  26 July 2017  [See Milestones/Perspectives above for full text]
:: GoS, WHO, FAO, and OIE fight antimicrobial resistance with new national plan 25 July 2017

CDC/ACIP [to 29 July 2017]

CDC/ACIP [to 29 July 2017]

Press Release
July 24, 2017
Country with world’s highest HIV prevalence is now controlling its HIV epidemic
New findings from Swaziland, supported by the Swazi Ministry of Health and the U.S. Centers for Disease Control and Prevention (CDC) through the President’s Emergency Plan for AIDS Relief (PEPFAR), reveal remarkable progress in controlling the country’s HIV epidemic and are the latest to show that global HIV efforts are helping to curb the HIV epidemic and saving lives…
MMWR News Synopsis for July 27, 2017
:: Progress Toward Elimination of Hepatitis C Virus Infection — Georgia, 2015–2016


MSF/Médecins Sans Frontières  [to 29 July 2017]
Press release
DRC: Doctors Without Borders Vaccinates More than One Million Children Against Measles
July 28, 2017
As measles sweeps across Democratic Republic of Congo (DRC), more than one million children have been vaccinated against the deadly disease during a nine-month campaign by the international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF).

Press release
MSF Sounds Alarm Over High Numbers of People Dying from AIDS in Africa
July 25, 2017
Greater global attention is needed to prevent and treat AIDS, as too many patients are dying despite the availability of antiretroviral treatment.
CEPI – Coalition for Epidemic Preparedness Innovations  [to 29 July 2017]
08 July 2017
CEPI welcomes global leadership shown by government of Norway
Media release, Oslo– CEPI welcomes the vital contribution of additional funding from the government of Norway, which today announced it is increasing its original investment in CEPI by $70m. The government of Norway is a founding investor in CEPI, which will create new vaccines against epidemic threats through an innovative partnership between public, private, philanthropic and civil organizations.
Together with the governments of Germany and Japan, the Bill & Melinda Gates Foundation and Wellcome, the founding investors contributed a total of $540m to launch CEPI in January 2017. CEPI’s mission is to outsmart epidemics by developing safe and effective vaccines against known infectious diseases that can be deployed rapidly to contain outbreaks, before they become global health emergencies…


NIH  [to 29 July 2017]
July 20, 2017
Immune system may mount an attack in Parkinson’s disease
July 27, 2017 — NIH-funded study suggests role for specific immune cells in brain disease.

Discovery documentary First in Human gives an up-close look at how advances in medicine are made at the NIH Clinical Center
July 26, 2017 — Three-part series airing in August portrays the hopes and setbacks of patients, doctors, and nurses seeking cures.

In adolescents, oral Truvada and vaginal ring for HIV prevention are safe, acceptable
July 25, 2017 — NIH-funded clinical trials are first of their kind to include younger adolescent girls.

NCI-COG Pediatric MATCH trial to test targeted drugs in childhood cancers
July 24, 2017 — Nationwide trial to explore targeted therapies for children and adolescents with solid tumors.

Drug interaction concerns may negatively affect HIV treatment adherence among transgender women
July 24, 2017 — Participants in NIH-supported study apprehensive about combining HIV medications and hormones.

Experimental HIV vaccine regimen is well-tolerated, elicits immune responses
July 24, 2017 — Results from early-stage NIH-funded trial support further development of candidate vaccines.

Child living with HIV maintains remission without drugs since 2008
July 24, 2017 — Child treated in infancy as part of NIH-funded study.
PATH  [to 29 July 2017]
Announcement | July 26, 2017
Kenya County Governor Signs Landmark Maternal Child Health and Family Planning Act
The law is the first in the country to allocate county-level resources to support access to critical health services for the most vulnerable mothers, newborns, and children
Kakamega County Governor H.E. Wycliffe Oparanya of Western Kenya signed the Kakamega County Maternal Child Health and Family Planning Bill 2017 into law, guaranteeing pregnant women living on less than one US dollar a day additional support to access essential antenatal and postnatal care for themselves and their babies. PATH Kenya advocates, UNICEF, and other partners played a key role in guiding the overarching strategy for the bill, drafting core language, and securing critical buy-in from high-level leaders and civil society members…

UNAIDS [to 29 July 2017]
Press statement
UNAIDS welcomes the launch of the End AIDS Coalition at the 9th International AIDS Conference on HIV Science in Paris
PARIS/GENEVA, 25 July 2017—UNAIDS has welcomed the launch of the End AIDS Coalition (EAC) during the 9th International AIDS Conference on HIV Science taking place in Paris, France. The EAC brings together a strong collaboration of leading AIDS experts, scientists, clinicians, policy-makers, faith leaders, business leaders and activists determined to end the AIDS epidemic as a public health threat by 2030.
The EAC aims to amplify efforts to end the AIDS epidemic by strengthening linkages across research, resources and implementation, by encouraging the aggregation and analysis of data from the global AIDS response to identify barriers and encourage efficiencies and by inspiring a movement to mobilize and engage the next generation of young leaders in the response to HIV…
FDA [to 29 July 2017]
What’s New for Biologics
Influenza Virus Vaccine for the 2017-2018 Season
Updated: 7/27/2017
European Medicines Agency  [to 29 July 2017]
Concept paper on development and lifecycle of personalised medicines and companion diagnostics
Public consultation to end on 31 October 2017 …

EU report: more evidence on link between antibiotic use and antibiotic resistance
The European Food Safety Authority, the European Medicines Agency and the European Centre for Disease Prevention and Control are concerned about the impact of use of antibiotics on the increase in antibiotic-resistant bacteria. …

Reducing off-label use of antimicrobials in veterinary medicine to reduce risk of resistance
EMA invites comments on a draft reflection paper by 31 January 2018
GHIT Fund   [to 29 July 2017]
GHIT was set up in 2012 with the aim of developing new tools to tackle infectious diseases that devastate the world’s poorest people. Other funders include six Japanese pharmaceutical ·
2017.07.25      News
New investment opportunity for Hit-to-lead Platform

2017.07.25      News
New investment opportunity for Product Development Platform

2017.07.25      News
New investment opportunity for Target Research Platform in Partnership with Wellcome Trust

Wellcome Trust  [to 29 July 2017]
News / Published: 26 July 2017
Mike Ferguson is new Deputy Chair of Governors
Professor Mike Ferguson will become Deputy Chair of our Board of Governors in January 2018. He is taking over from Professor Dame Kay Davies.
Mike, who is Regius Professor of Life Sciences at the University of Dundee, has been on the Board of Governors since January 2012.

Opinion / Published: 26 July 2017
Let’s transform the way research is translated into health benefits
Stephen Caddick, Wellcome’s Director of Innovation, says building a UK environment where research findings are translated into treatments and products is a challenge – but one we must meet.
It’s good to see the launch of Transforming UK translation [PDF 99KB], a set of commitments from the leading science and engineering organisations, including Wellcome, to transform UK research translation.

PhRMA    [to 29 July 2017]
July 27, 2017
Biopharmaceutical industry policies aim to increase access to clinical trial data
The biopharmaceutical industry has been at the forefront of initiatives to improve access to clinical trial data.

July 25, 2017
Finding cures for incurable diseases
74 percent of the medicines in the pipeline have the potential to be first-in-class therapies.

DCVMN – Developing Country Vaccine Manufacturers Network  [to 29 July 2017]
25 September 2017 to 28 September 2017
DCVMN Annual General Meeting
Seoul / Korea

Featured Journal Content

Featured Journal Content

JAMA Pediatrics
New Online – July 24, 2017
Original Investigation
Public Health and Economic Consequences of Vaccine Hesitancy for Measles in the United States
Nathan C. Lo, BS1; Peter J. Hotez, MD, PhD2,3,4,5
Key Points
How does vaccine hesitancy affect annual measles cases and economic costs in the United States?
In this modeling study of children (age 2-11 years), a 5% reduction in measles, mumps, and rubella vaccination coverage resulted in a 3-fold increase in annual measles cases with an additional US$2.1 million in public sector costs.
Even small declines in vaccination coverage in children owing to vaccine hesitancy may have substantial public health and economic consequences that will be larger when considering unvaccinated infants, adolescents, and adults.
Routine childhood vaccination is declining in some regions of the United States due to vaccine hesitancy, which risks the resurgence of many infectious diseases with public health and economic consequences. There are ongoing policy debates on the state and national level, including legislation around nonmedical (personal-belief) exemptions for childhood vaccination and possibly a special government commission on vaccine safety, which may affect vaccine coverage.
To estimate the number of measles cases in US children and the associated economic costs under scenarios of different levels of vaccine hesitancy, using the case example of measles, mumps, and rubella (MMR) vaccination and measles.
Design, Setting, and Participants
Publicly available data from the US Centers for Disease Control and Prevention were used to simulate county-level MMR vaccination coverage in children (age 2-11 years) in the United States. A stochastic mathematical model was adapted for infectious disease transmission that estimated a distribution for outbreak size as it relates to vaccine coverage. Economic costs per measles case were obtained from the literature. The predicted effects of increasing the prevalence of vaccine hesitancy as well as the removal of nonmedical exemptions were estimated. The model was calibrated to annual measles cases in US children over recent years, and the model prediction was validated using an independent data set from England and Wales.
Main Outcomes and Measures
Annual measles cases in the United States and the associated public sector costs.
A 5% decline in MMR vaccine coverage in the United States would result in an estimated 3-fold increase in measles cases for children aged 2 to 11 years nationally every year, with an additional $2.1 million in public sector costs. The numbers would be substantially higher if unvaccinated infants, adolescents, and adult populations were also considered. There was variation around these estimates due to the stochastic elements of measles importation and sensitivity of some model inputs, although the trend was robust.
Conclusions and Relevance
This analysis predicts that even minor reductions in childhood vaccination, driven by vaccine hesitancy (nonmedical and personal belief exemptions), will have substantial public health and economic consequences. The results support an urgent need to address vaccine hesitancy in policy dialogues at the state and national level, with consideration of removing personal belief exemptions of childhood vaccination.

BMC Medicine
(Accessed 29 July 2017)
The public health value of vaccines beyond efficacy: methods, measures and outcomes
Wilder-Smith, I. Longini, P. L. Zuber, T. Bärnighausen, W. J. Edmunds, N. Dean, V. Masserey Spicher, M. R. Benissa and B. D. Gessner

BMC Medicine 2017 15:138
Published on: 26 July 2017
Assessments of vaccine efficacy and safety capture only the minimum information needed for regulatory approval, rather than the full public health value of vaccines. Vaccine efficacy provides a measure of proportionate disease reduction, is usually limited to etiologically confirmed disease, and focuses on the direct protection of the vaccinated individual. Herein, we propose a broader scope of methods, measures and outcomes to evaluate the effectiveness and public health impact to be considered for evidence-informed policymaking in both pre- and post-licensure stages.
Pre-licensure: Regulatory concerns dictate an individually randomised clinical trial. However, some circumstances (such as the West African Ebola epidemic) may require novel designs that could be considered valid for licensure by regulatory agencies. In addition, protocol-defined analytic plans for these studies should include clinical as well as etiologically confirmed endpoints (e.g. all cause hospitalisations, pneumonias, acute gastroenteritis and others as appropriate to the vaccine target), and should include vaccine-preventable disease incidence and ‘number needed to vaccinate’ as outcomes.
Post-licensure: There is a central role for phase IV cluster randomised clinical trials that allows for estimation of population-level vaccine impact, including indirect, total and overall effects. Dynamic models should be prioritised over static models as the constant force of infection assumed in static models will usually underestimate the effectiveness and cost-effectiveness of the immunisation programme by underestimating indirect effects. The economic impact of vaccinations should incorporate health and non-health benefits of vaccination in both the vaccinated and unvaccinated populations, thus allowing for estimation of the net social value of vaccination.
The full benefits of vaccination reach beyond direct prevention of etiologically confirmed disease and often extend across the life course of a vaccinated person, prevent outcomes in the wider community, stabilise health systems, promote health equity, and benefit local and national economies. The degree to which vaccinations provide broad public health benefits is stronger than for other preventive and curative interventions.