Vaccines and Global Health : The Week in Review 17 June 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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– 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 lead this week’s edition with developments around polio, including major commitments of new financial resources for eradication, and updates on type 2 (cVDPV2) outbreaks in Syria and DRC.

Global Leaders Unite to Bring Polio One Step Closer to Eradication
Countries and partners pledge US$ 1.2 billion to protect 450 million children from polio every year
ATLANTA (12 June 2017) – Today, global health leaders gathered at the Rotary Convention in Atlanta to reaffirm their commitment to eradicating polio and pledge US$ 1.2 billion to finance efforts to end the disease.

Thirty years ago, polio paralyzed more than 350,000 children each year in more than 125 countries around the world. Thanks to the extraordinary efforts of governments, health workers, donors and the partners of the Global Polio Eradication Initiative (GPEI), a public-private partnership dedicated to ending the disease, the highly contagious virus has now been eliminated in all but three countries: Afghanistan, Nigeria and Pakistan. There have been only five cases to date in 2017.

However, children remain at risk everywhere until polio is completely stopped. To end the disease for good, government representatives and partners came together to renew their commitment to supporting crucial activities such as vaccination and disease monitoring, which will protect more than 450 million children from polio each year.

“Thanks to the incredible efforts of Rotarians, governments, health workers, partners and donors – including those who have gathered at the Rotary Convention in Atlanta – we are closer than ever to making history,” said Chris Elias, Global Development President, Bill & Melinda Gates Foundation and Chair of the GPEI Polio Oversight Board. “These new commitments will help ensure that we will finish the job.”

In a time of many global challenges and priorities, governments and partners have stepped forward to demonstrate their collective resolve to seeing the second human disease ever eradicated. Major pledges include: US$ 75 million from Canada, US$ 61.4 million from the European Commission, US$ 55 million from Japan, US$ 30 million from Sheikh Mohamed bin Zayed Al Nahyan, Crown Prince of Abu Dhabi, United Arab Emirates, US$ 30 million from the Dalio Foundation, US$ 25 million from Bloomberg Philanthropies, US$ 15 million from an anonymous donor, US$ 13.4 million from Australia, US$ 11.2 million from Germany, US$ 5 million from easyJet, US$ 5 million from Italy and US$ 4 million from the Republic of Korea.

Bill Gates, co-chair of the Bill & Melinda Gates Foundation, and John Germ, president of Rotary International, also announced an extension of their partnership in front of more than 20,000 Rotarians. Up to US$ 150 million in funds raised by Rotary members over the next three years will be matched 2:1 by the Gates Foundation, resulting in up to US$ 450 million in the next three years for the GPEI. The Gates Foundation pledged a total of US$ 450 million, including this matching agreement.

“The global eradication of polio has been Rotary’s top priority since 1985. Rotary members have been the driving force behind the fight to end polio since its inception,” said John Germ, President of Rotary International. “Their continued commitment to raising funds for eradication – coupled with today’s match by the Bill & Melinda Gates Foundation – makes that impact even greater.”

Today’s funding helps address a US$1.5 billion funding need that will help ensure that the virus is eliminated from these remaining countries and prevented from regaining a foothold anywhere else in the world.

“Constant innovation has been key to improving vaccination coverage and reaching more children with the polio vaccine,” said Dr. Anne Schuchat, Acting Director of the U.S. Centers for Disease Control and Prevention. “The unrelenting commitment and support of these global leaders will help us do just that—and ultimately end this disease for everyone and forever. CDC remains deeply committed to polio eradication and has contributed US$ 2.28 billion since the beginning of the initiative.”

Today’s funding commitments will enable the program to continue to improve performance and overcome challenges to reach every child, including vaccinating children in conflict areas…


Gavi to help protect millions more children against polio
Gavi Board agrees to extend support for inactivated polio vaccine (IPV) to 2020; new policy on fragile settings, emergencies and refugees also approved

Geneva, 15 June 2017 – Support for the introduction of inactivated polio vaccine (IPV) will be extended to 2020 in up to 70 low- and middle-income countries, Gavi, the Vaccine Alliance announced today. The Gavi Board decision will enable routine immunisation programmes to reach millions more children with this critical vaccine and support the final drive towards eradication.

“We now have a unique opportunity to consign polio to the history books, but we cannot afford to be complacent,” said Dr Ngozi Okonjo-Iweala, Chair of the Gavi Board. “We cannot and will not rest as long as any child anywhere in the world is at risk of contracting this terrible disease. Gavi fully supports the Global Polio Eradication Initiative and partners, and this decision means we will continue to work together as we edge ever closer to a polio-free world.”

As transmission of wild poliovirus has not yet been stopped, the target date for global certification of eradication has had to be pushed back by at least two years – from 2018 to 2020 at the earliest. Polio remains endemic in three countries – Afghanistan, Nigeria and Pakistan. Five wild poliovirus cases have been recorded since the beginning of the year: three in Afghanistan and two in Pakistan.

Moreover vaccine supply constraints have delayed introductions or interrupted IPV use in some Gavi-supported countries. To date 53 countries have introduced IPV to their immunisation programme with Gavi support. Until all poliovirus cases are fully eradicated and contained all countries are at risk, especially those with weak vaccine coverage levels.

The cost of extending support to 2020 is projected to be up to US$ 250 million which will be financed by additional funding raised by the Global Polio Eradication Initiative (GPEI) and by existing funds from Norway, the Bill & Melinda Gates Foundation and the UK Department for International Development (DFID). The Gavi Board decision should provide reassurance to countries and manufacturers of Gavi’s continued support for IPV and polio eradication.

“We will need to evaluate Gavi support to IPV beyond 2020 to make sure that the disease doesn’t re-emerge after global certification,” said Dr Seth Berkley, CEO of Gavi the Vaccine Alliance. “The vaccine will have to be assessed differently from other vaccines based on its value to the global public good. Polio eradication will rank as one of the greatest achievements in the history of global health, reflecting the combined efforts of funders and of hundreds of thousands of scientists, health workers and ordinary vaccinators over three decades.”

Ensuring continued high immunisation coverage of children in the poorest countries is critical to protect children everywhere from the spread of infectious diseases.

New policy on Fragility, Emergencies and Refugees
Gavi operates in many of the most fragile settings where health needs are often the greatest. These circumstances require a different approach to ensure children get the vaccines they need. The Gavi Board approved a new policy on Fragility, Emergencies and Refugees to enable a rapid and tailored response in these settings.

“As climate change, conflict and economic crises continue to drive people from their homes and devastate health systems, we must make sure that the weakest and most vulnerable are not excluded from receiving life-saving vaccines,” added Dr Berkley. “Good health is a fundamental human right. It is unacceptable that hundreds of thousands of child refugees or children trapped in war-torn countries are excluded from receiving basic health services, including vaccines.”

Gavi-supported host countries will for instance be able to request additional support to immunise refugees. In the case of emergencies, countries can request flexibility in the vaccine application process or while implementing Health System Strengthening (HSS) support. Where needed, the new policy enables Gavi to work more directly with partners and non-state actors including civil society organisations (CSO) operating in affected areas.

Lastly, the Board decided that, due to the on-going conflict, Yemen will continue to receive Gavi support in spite of co-financing challenges that the country is facing.
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 14 June 2017 [GPEI]
:: Global health leaders are meeting this week at the Rotary International Convention in Atlanta, USA, and reaffirmed their commitment to eradicating polio by pledging US$1.2 billion to end the disease.  [See above]

:: Addressing Rotarians from around the world, Bill Gates, co-chair of the Bill & Melinda Gates Foundation, said:  “People often ask me how I know the world is getting better. I usually point to numbers like this one: Because of efforts to eradicate polio by groups like Rotary International, more than 16 million people are walking today who would otherwise have been paralyzed.  That’s more than 16 million people who can walk to school. More than 16 million people who are better able to start a business or carry their child to bed. More than 16 million people who are living better lives, because a group of health care workers, volunteers, government leaders, and funders devoted themselves to fighting polio. Polio eradication is a testament to the compassion, generosity, and kindness of more than a million Rotarians around the world. You are the people who are making it possible to get to zero. And that will be something worth celebrating. Thank you.”  More.

:: Newly-elected WHO Director-General Elect Dr Tedros Adhanom Ghebreyesus addressed the assembled Rotarians:  “Today I speak to you as the Director-General Elect of the World Health Organization and as a Paul Harris Fellow with Rotary International. In both roles, the eradication of polio is close to my heart.  Together we have achieved something phenomenal.  Thanks to all of you, generations of children have grown up without ever experiencing polio.   The end of polio is now in sight, but this is the most critical moment of covering the last mile. We must keep our eyes firmly on the final goal.  Thank you for your commitment.  Together, we will continue to make a difference”.

:: Summary of newly-reported viruses this week: Afghanistan – one new wild poliovirus type 1 (WPV1) was isolated from a healthy household contact of an acute flaccid paralysis (AFP) case.

WHO: Disease Outbreak News [DONs]
Circulating vaccine-derived poliovirus type 2 – Syrian Arab Republic
Disease outbreak news
13 June 2017
A circulating vaccine-derived poliovirus type 2 (cVDPV2) outbreak has been confirmed in the Deir Al Zour Governorate of the Syrian Arab Republic. There is evidence of genetic linkage among three isolates of type-2 vaccine-derived polioviruses (VDPV2) isolated in the stool specimens of two acute flaccid paralysis (AFP) cases with dates of onset of paralysis on 5 March and 6 May 2017, and the contact specimen of an AFP case collected on 17 April 2017. Al Mayadeen was also the epi-centre of the wild poliovirus type 1 (WPV1) outbreak in Syrian Arab Republic in 2013. Aggressive multi-country polio outbreak response effectively controlled the WPV1 outbreak and no WPV1 case has been reported in Syrian Arab Republic since 21 January 2014…

Circulating vaccine-derived poliovirus type 2 – Democratic Republic of the Congo
Disease outbreak news
13 June 2017
In the Democratic Republic of the Congo (DRC), two separate circulating vaccine-derived poliovirus type 2s (cVDPV2s) have been confirmed. The first cVDPV2 strain has been isolated from two acute flaccid paralysis (AFP) cases from two districts in Haut-Lomami province, with onset of paralysis on 20 February and 8 March 2017. The second cVDPV2 strain has been isolated from Maniema province, from two AFP cases (with onset of paralysis on 18 April and 8 May 2017) and a healthy contact in the community.
Public health response
The Ministry of Health, supported by WHO and partners of the Global Polio Eradication Initiative (GPEI), has completed a risk assessment, including evaluating population immunity and the risk of further spread.
Outbreak response plans are currently being finalized, consisting of strengthening surveillance, including active case searching for additional cases of AFP, and supplementary immunization activities (SIAs) with monovalent oral polio vaccine type 2 (mOPV2), in line with internationally-agreed outbreak response protocols.
Surveillance and immunization activities are being strengthened in neighbouring countries…



WHO Grade 3 Emergencies  [to 17 June 2017]
:: Iraq: WHO and health authorities immediately investigate suspected cases of foodborne illness in Hassan Sham U2 camp
Baghdad, 13 June 2017 – The World Health Organization, in coordination with Erbil and Ninewa Directorates of Health, rapidly responded to a suspected foodborne illness outbreak in Hassan Sham U2 camp by conducting an investigation with the aim of identifying the source and cause of the outbreak, treating those who are ill as well as containing and preventing any spread.
The Syrian Arab Republic 
:: WHO and health partners provide vital care to displaced people in northern Syria
13 June 2017– Responding to evacuations and a growing number of displaced people in northern Syria, WHO and its health partners are providing life-saving medical care to thousands of families. In spring 2017, following discussions between the Government of the Syrian Arab Republic and other groups, families from formerly besieged areas of the country were evacuated to areas further north.

:: Read the latest situation report on the cholera outbreak in Yemen, 27 April–12 June [pdf 1.27Mb]
:: Epidemiology bulletin 9, 27 April–14 June 2017

NigeriaNo new announcements identified.
South SudanNo new announcements identified.

WHO Grade 2 Emergencies  [to 17 June 2017]
Cameroon  No new announcements identified

Central African Republic  – No new announcements identified.  [see UNICEF reports below]
Democratic Republic of the CongoNo new announcements identified.
EthiopiaNo new announcements identified.
LibyaNo new announcements identified.
MyanmarNo 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. 37 (5 to 11 June 2017)
…Humanitarian and protection needs remain severe, both among displaced families and vulnerable residents of newly accessible areas. While humanitarian partners continue to respond to the outflow of people providing emergency assistance – including shading, ready-to-eat meals, water, sanitation facilities, and medical and protection services – capacities are being stretched, and funding concerns are being reported in some areas, such as water, sanitation and hygiene (WASH) and health…

Syrian Arab Republic
:: 16 Jun 2017 Mobile clinics reach far-flung regions of Syria

:: Key messages on cholera (12 June 2017)
Current situation
Yemen is in the grip of a fast spreading cholera outbreak of an unprecedented scale. As of 12 June, WHO reports a cumulative total of 124,002 suspected cases and 923 associated deaths. More than half of the suspected cholera cases have been reported from four governorates: Amanat Al Asimah, Hajjah, Amran and Al Hudeideh. [These figures likely underrepresent the magnitude of the epidemic since only 45% of health facilities in Yemen are effectively functioning and surveillance systems, data collection and verification continues to be a challenge throughout the country. Although rapid test are available, only 2 labs (Sanaa and Aden) are ‘authorised’ to confirm suspected cases. On 14 May, the MoPHP declared a state of emergency in Sana’a governorate stating that the health system is unable to contain this unprecedented health and environmental disaster.]…
…The risk of the epidemic spreading further and affecting thousands more is real as the health/wash systems are unable to cope. Congested urban centers where garbage remains uncollected and overcrowded IDP collective centers/ settlements with precarious sanitation are at high risk of contagion.
Malnourished children, malnourished pregnant women and people living with other chronic health conditions are now at greater risk of death as they face the “triple threat” of conflict, famine and cholera. Their vulnerability cannot be overstated…

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.
:: Humanitarian Common Feedback Project for Accountability to Affected People & Communication with Communities in Somalia for Prevention of Famine, June 2017
Published on 16 Jun 2017
The humanitarian situation in Somalia continues to deteriorate and an elevated risk of famine persists in some parts of the country, only six years after the devastating 2011 famine led to the death of over a quarter million people, half of them children. Over 6.7 million people are now estimated to need humanitarian assistance. This is more than half of the population of Somalia.
Led by OCHA, the Common Feedback Project (CFP) was rolled out in March through the Drought Operations Coordination Centres as part of a collective approach to strengthening two-way consultations between relief workers and affected communities. Working with humanitarian partners, the CFP is collecting, collating and analysing feedback from multiple platforms to identify key themes and issues being raised by communities, particularly related to ongoing drought…
:: Somalia: Drought Response – Situation Report No. 12 (as of 13 June 2017)

:: Ethiopia Weekly Humanitarian Bulletin, 12 June 2017

DRC (Kasai crisis)No new announcements identified.
NigeriaNo new announcements identified.

UNICEF  [to 17 June 2017]
Children account for half of all suspected cholera cases in Yemen
SANA’A, 13 June 2017- “The cholera outbreak in Yemen continues to spread at an alarming speed. Over 124,000 cases have been recorded – almost half of them are children.
“Children continue to bear the brunt of the war in Yemen. Many who have become ill or have died from cholera were suffering from malnutrition. At least 923 people have died from the disease since late April. Children account for one quarter of the deaths.
“The cholera outbreak is overwhelming what remains of Yemen’s conflict-battered health system. Hospitals and treatment centres are struggling to cope with the large number of patients coming in from across the country. Medicines and intravenous fluids are quickly running out.
“But despite these massive challenges, health workers have spared no effort in responding to the emergency – even when their salaries have not been paid for nearly nine months.
“Without an urgent solution to pay health workers, more children will die – no matter how much humanitarian aid is delivered to the country.
“With no end in sight to the conflict, the cholera outbreak – and potentially other disease will continue to stalk the lives of children.”


Unicef Steps In to Pay Yemen’s Doctors as War and Cholera Rage
New York Times – JUNE 15, 2017
Desperate to halt the cholera crisis afflicting Yemen, Unicef has taken the unusual step of paying the country’s doctors and nurses, who have not received salaries in months.
The regional director for Unicef, Geert Cappelaere, said on Thursday that Yemen’s health workers are crucial to the effort to combat cholera and that they should not be expected to work for free.
Their normal pay has been disrupted by the civil war that has raged since March 2015 between the Saudi-backed government and the country’s Houthi rebels and their allies.
Mr. Cappelaere said Unicef, the United Nations children’s agency, started paying the health workers about four weeks ago. The agency is borrowing the money from an emergency fund to provide medical workers with about 70 percent of what they ordinarily would be paid. The money, which he described as daily stipends, has already amounted to millions of dollars.
“It’s not a common practice at all,” Mr. Cappelaere said in an interview. “That’s also a practice I would not want to see sustained.”
Still, Mr. Cappelaere said it was necessary because, “We’re not going to let kids die.”
He described the cholera crisis ravaging Yemen as “really a massive, massive outbreak” the magnitude of which the country, the poorest in the Middle East, has never experienced…
Half of the country’s health facilities have been destroyed or closed because of the war, which has left roughly 10,000 people dead and millions displaced.
The cholera crisis, Mr. Cappelaere said, “just comes on top of what already was an incredibly daunting situation.”

EBOLA/EVD  [to 17 June 2017]
External Situation Report 24: 16 June 2017
WHO, UN Agencies, international organizations, non-governmental organizations (NGOs) and partners continue to support the Ministry of Health (MoH) in the Democratic Republic of the Congo to rapidly investigate and respond to the outbreak of Ebola virus disease (EVD) in Likati Health Zone, Bas Uele Province in the north-east of the country.
On 15 June 2017, no new confirmed or probable cases were reported. Since the last situation update on 13 June, 9 alerts have been reported and investigated of which two fulfilled the case definition as a suspected case. Both of these suspected cases were from Ngayi. Samples were collected and both tested negative by PCR for EVD. Therefore there are currently a total of five confirmed and three probable cases….
Data modelling suggests that the risk of further cases is currently low but not negligible, and decreases with each day without new confirmed/probable cases. As of the reporting date, 95% of simulated scenarios predict no further cases in the next 30 days.

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 17 June 2017]
DONs- Disease Outbreak News
Middle East respiratory syndrome coronavirus (MERS-CoV) – Saudi Arabia
13 June 2017
Between 1 and 10 June 2017, the national IHR focal point of Saudi Arabia reported 35 additional cases of Middle East Respiratory Syndrome Coronavirus (MERS-CoV) infection including three fatal cases and one death among previously reported cases (case number 5 in the Disease Outbreak News published on 6 June 2017)….
Zika virus  [to 17 June 2017]
[No new digest content identified]

Yellow Fever  [to 17 June 2017]
[No new digest content identified]

WHO & Regional Offices [to 17 June 2017]

WHO & Regional Offices [to 17 June 2017]

Bhutan, Maldives eliminate measles
13 June 2017 – Bhutan and Maldives have eliminated measles, a highly infectious disease that is a major childhood killer globally. The 2 countries are the first in the WHO South-East Asia Region to be verified for having interrupted endemic measles virus transmission, ahead of the 2020 regional target.

Abuse of older people on the rise – 1 in 6 affected
14 June 2017 – Around 1 in 6 older people experience some form of abuse, a figure higher than previously estimated and predicted to rise as populations age worldwide. Awareness about elder abuse, still largely a taboo topic, has started to increase across the world. It is defined as actions or lack of appropriate action which can cause harm or distress to an older person, occurring within any relationship where there is an expectation of trust.

WHO and health authorities investigate suspected cases of foodborne illness in Hassan Sham U2 camp
June 2017 – WHO, in coordination with Iraq’s Erbil and Ninewa Directorates of Health, rapidly responded to a suspected foodborne illness outbreak in Hassan Sham U2 camp by conducting an investigation with the aim of identifying the source and cause of the outbreak, treating those who are ill as well as containing and preventing any spread.

Weekly Epidemiological Record, 16 June 2017, vol. 92, 24 (pp. 333–344)
333 Validation of maternal and neonatal tetanus elimination in Equatorial Guinea, 2016

WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
No new digest content identified.

WHO Region of the Americas PAHO
:: Caribbean Regulatory System recommends its first generic drugs for sale in the region (06/12/2017)
:: Voluntary blood donors are increasing, but the numbers are not enough to ensure sufficient blood supplies (06/12/2017)

WHO South-East Asia Region SEARO
:: ·  Bhutan, Maldives eliminate measles  13 June 2017
WHO European Region EURO
:: Day 3 of Environment and Health Conference: Commitments to advance the agenda in Europe 16-06-2017
:: Day 2 of Environment and Health Conference: Addressing inequalities, good governance, rights and resilience 15-06-2017
: Day 1 of Environment and Health Conference: Taking stock of the past to transform the future 14-06-2017
:: United Nations agencies urge Europe’s action on 1.4 million annual deaths from polluted environments 13-06-2017
:: WHO and health partners provide vital care to displaced people in northern Syria 13-06-2017

WHO Eastern Mediterranean Region EMRO
:: King Salman Centre for Humanitarian Aid and Relief supports cholera response in Yemen
15 June 2017
:: WHO and health authorities immediately investigate suspected cases of foodborne illness in Hassan Sham U2 camp in Iraq
13 June 2017
:: WHO conducts EWARN evaluation protocol training workshop in Cairo  13 June 2017

WHO Western Pacific Region
:: Commonwealth of the Northern Mariana Islands achieves hepatitis B milestone
SAIPAN, 15 June 2017 — The Commonwealth of the Northern Mariana Islands – a stretch of 14 islands in the northwest Pacific – may be small, but it is scoring big goals in health. This island chain in political union with the United States of America has just been confirmed by the World Health Organization (WHO) as having reduced hepatitis B infection among children to less than 1%.


PATH  [to 17 June 2017]
Announcement | June 15, 2017
Administration’s budget devastating for the world’s most vulnerable
New analysis from leading humanitarian, development and global health organizations calculates the devastating human costs of cuts to foreign assistance
[See Reports section below for full text]
Press release | June 12, 2017
United States and Vietnam launch oral HIV pre-exposure option to reduce new infections
Oral HIV pre-exposure prophylaxis (PrEP) is a powerful tool for HIV prevention, especially for those most at risk

UNAIDS  [to 17 June 2017]
Selected Press Releases & Updates
Update – 8 June 2017
Partners come together for gender-responsive change management
Partners from across the United Nations system came together on 30 May in UNAIDS headquarters in Geneva, Switzerland, to discuss how behavioural, institutional and cultural change can accelerate progress for gender equality.
In her keynote speech, Jan Beagle, Deputy Executive Director of UNAIDS, emphasized that if change management is undertaken in a gender-responsive manner, barriers to gender equality in the workplace can be addressed and overcome. She shared the progress that UNAIDS has made in gender equality, including near gender parity among staff, 40% of UNAIDS country directors being female and 100% compliance with the performance indicators of the United Nations System-Wide Action Plan on Gender Equality and the Empowerment of Women. She also underlined the need to shift organizational cultures to empower staff everywhere. UNAIDS is taking gender out of isolation and mainstreaming equality and inclusion throughout the Secretariat…
European Medicines Agency  [to 17 June 2017]
EMA Management Board: highlights of June 2017 meeting
Focus on Brexit preparations and the development of the EU clinical trial portal and database …
Entry into application of EU Clinical Trial Regulation postponed to 2019
The Board discussed the progress made regarding the development of the EU clinical trial portal and database. Due to technical difficulties with the development of the IT systems, the portal’s go-live date has to be postponed. EMA is working closely with its IT service provider to ensure that corrective measures are implemented and will closely monitor progress. The Board was informed about the mitigation measures taken and the revised plan from the developer. The Agency will provide an update at the next meeting of the Management Board in October 2017 where a new delivery time frame will be discussed once progress with development has been confirmed. Due to these delays, the EU Clinical Trial Regulation will now come into application in 2019 instead of October 2018, as previously scheduled.
EMA’s priority is to ensure that a high quality and functional system is delivered to the EU regulatory network and its stakeholders.
The EU clinical trial portal and database supports the ambitious modernisation of the processes for authorisation and oversight of clinical trials in the EU laid down in the EU Clinical Trial Regulation. The system will provide a single portal for submission and maintenance of clinical trial applications and authorisations, and support coordinated assessment and supervision. The portal and database will also serve as the source of public information on the full lifecycle of all clinical trials conducted in the EU, from their initial review up to the publication of their results.
This is the most ambitious IT system required by the EU legislation in the last decade, involving a complete EU-wide system to be used for clinical trial applications, urgent safety measures and other notifications to regulators before, during and after the conduct of clinical trials.
Wellcome Trust  [to 17 June 2017]
News / Published: 17 June 2017
MBE for Beth Thompson in Queen’s Birthday Honours
Beth Thompson, Wellcome’s Head of Policy (UK and EU), has been awarded an MBE for her work on the EU Data Protection Regulation.
Jeremy Farrar, Wellcome’s Director, says: “I am thrilled that Beth Thompson’s outstanding leadership in policy has been recognised today in the Queen’s Birthday Honours. Beth’s determination to bring policy makers, researchers and patients together during negotiations about EU Data Protection Regulation resulted in a solution that allows vital cross-border research to take place while protecting individuals’ privacy.
Industry Watch
:: Nearly One in Four New and Expectant Parents Have Never Heard of Invasive Pneumococcal Disease According to a New Survey
Pfizer and Parents Magazine Team Up to Educate Parents About a Serious Disease That Can Put a Child’s Life at Risk
June 13, 2017
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE), in partnership with Parents magazine (NYSE:MDP), announced today the results of a national survey of more than 2,000 new and expectant parents assessing their knowledge of childhood infectious diseases, such as measles, whooping cough and invasive pneumococcal disease (IPD), and the measures parents can take to help prevent them…
Conducted online by Harris Poll, the survey found that parents were least knowledgeable about IPD, when compared among 11 childhood illnesses. In fact, only three of every 10 (30%) parents of children under two years of age and expectant parents report they are knowledgeable about IPD.1 Although IPD may be discussed in well-child visits, nearly one in four (23%) have never even heard of it, illustrating the need for more education.1,2 …

Reports/Research/Analysis/Commentary/Conferences/Meetings/Book Watch/Tenders

Reports/Research/Analysis/Commentary/Conferences/Meetings/Book Watch/Tenders

Vaccines and Global Health: The Week in Review has expanded its coverage of new reports, books, research and analysis published independent of the journal channel covered in Journal Watch below. Our interests span immunization and vaccines, as well as global public health, health governance, and associated themes. If you would like to suggest content to be included in this service, please contact David Curry at:

[U.S] Administration’s budget devastating for the world’s most vulnerable
New analysis from leading humanitarian, development and global health organizations calculates the devastating human costs of cuts to foreign assistance
15 June 2017,  Washington, DC—Leading American humanitarian, development and health organizations working around the globe have analyzed the Administration’s proposed International Affairs budget for Fiscal Year 2018 (FY 2018) and have estimated that the impact of the proposed cuts would be devastating for the poorest and most vulnerable women, children, and families around the world, as well as for American interests. The organizations, including Bread for the World, Catholic Relief Services, CARE USA, the International Rescue Committee, InterAction, Mercy Corps, ONE Campaign, Oxfam, PATH, Save the Children, and World Vision strongly urge Congress to reject the President’s foreign affairs budget request and maintain current funding of $60 billion.

Congress is considering the FY 2018 budget and the nomination of Ambassador Mark Green to lead the U.S. Agency for International Development in the context of a daunting set of simultaneous and significant global challenges—including famine conditions that threaten the lives of 30 million people, global displacement at an all-time high of 65 million, and more frequent infectious disease outbreaks.

Slashing foreign aid by nearly one-third would shirk America’s longstanding bipartisan commitment to help the world’s most vulnerable people, and would also put the health, security and prosperity of Americans at risk. The deep and disproportionate cuts proposed in the Administration’s FY 2018 International Affairs budget request will have life and death consequences today, and will also undercut America’s – and the world’s – ability to address tomorrow’s global threats.

Sterile statistics on paper are excruciating choices in practice for aid agencies and those we seek to serve in nearly every country around the world. If enacted, the Administration’s FY 2018 budget proposal could result in:
: A 50% cut to agricultural development and nutrition, which would in turn deprive 9 million children of life-saving nutrition interventions and treatments and abandon 5.25 million farmers working to feed their families;
:: The complete elimination of (Title II) food aid and of food security programming- during a hunger crisis and famine constituting the most serious humanitarian crisis since World War II- removing access to life-saving food assistance and long-term food security programming from 30 million people;
: A 45% cut to water and sanitation programs, resulting in over 2 million people losing access to drinkable water;
:: A 53% cut to basic education programming – critical to the futures of millions caught in crisis around the world – including the total elimination of basic education funding in Djibouti, Liberia, Malawi, Mozambique, Rwanda, South Africa, Zambia, Burma, Cambodia, Laos, Ukraine, Tajikistan, Dominican Republic, Nicaragua, Peru, Barbados and Eastern Caribbean;
:: A 44% cut to international disaster assistance, lessening the ability of USAID and partner agencies to reach tens of millions of vulnerable men, women and children with basic humanitarian aid, including over 3 million Yemenis and nearly 2 million Syrians;
: An 18% cut to migration and refugee assistance, cutting off 3.5 million refugees and internally-displaced persons from basic assistance, leading to increased displacement and instability;
:: A 17% cut to the Global Fund to Fight AIDS, TB and Malaria, resulting in the inability to prevent over 4 million new HIV, TB and malaria infections; an 11% cut to the President’s Emergency Plan for AIDS relief (PEPFAR), resulting in over 77,000 AIDS-related deaths; and a 10% cut to the President’s Malaria Initiative, putting an additional 40 million people at risk of contracting malaria;
: A nearly 8% cut to maternal, newborn, and child health funding, which would result in more than 30,000 deaths of mothers and children each year;
Zero funding for the USAID Emergency Reserve Fund and a 14% cut to core global health security programs at the Centers for Disease Control that would increase the likelihood of a global pandemic which is capable of claiming twice as many American lives as the total number of US battlefield fatalities since 1776;
: A 55% cut to gender programs, which would prevent nearly 2 million girls from receiving an education.

In addition to the moral defeat inherent in abandoning millions who rely on lifesaving US assistance around the world, this analysis shows that the impact of these cuts to global humanitarian and development assistance as laid out in the Administration’s budget request, if enacted, would be swift, devastating, and felt for years to come, imperiling millions of lives and the course of global development, stability, and partnership. The U.S. FY 2018 International Affairs budget should match the scale and nature of the global challenges facing America, and reflect the U.S. government’s longstanding bipartisan commitment to shared responsibility and the safeguarding of its own vital interests.

Editor’s Note: The NGOs were listed as involved in the analysis above: