Vaccines and Global Health: The Week in Review 25 July 2015

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

.Request an Email Summary: Vaccines and Global Health : The Week in Review is published as a single email summary, scheduled for release each Saturday evening before midnight (EDT in the U.S.). If you would like to receive the email version, please send your request to david.r.curry@centerforvaccineethicsandpolicy.org.

pdf version A pdf of the current issue is available here:  Vaccines and Global Health_The Week in Review_25 July 2015

blog edition: comprised of the approx. 35+ entries posted below on this date.

Twitter:  Readers can also follow developments on twitter: @vaxethicspolicy.
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Links:  We endeavor to test each link as we incorporate it into any post, but recognize that some links may become “stale” as publications and websites reorganize content over time. We apologize in advance for any links that may not be operative. We believe the contextual information in a given post should allow retrieval, but please contact us as above for assistance if necessary.
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David R. Curry, MS
Executive Director
Center for Vaccine Ethics and Policy
a program of the
– Division of Medical Ethics, NYU Medical School
– Children’s Hospital of Philadelphia Vaccine Education Center
Associate Faculty, Division of Medical Ethics, NYU Medical School

WHO Grade 3 and Grade 2 emergencies [accessed 24 July 2015]

Editor’s Note:
We provide below the current list of WHO Grade 3 and Grade 2 emergencies. We note that the WHO web pages associated with country links often do not evidence any current information. In a number of cases, the most current information posted is from weeks or months ago.

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WHO Grade 3 and Grade 2 emergencies
[accessed 24 July 2015]

WHO Grade 3 emergencies
Guinea
Iraq
Liberia
Nepal
Philippines
Sierra Leone
South Sudan
The Syrian Arab Republic

WHO Grade 2 emergencies
Central African Republic
Democratic Republic of the Congo
Malawi
Mozambique
Niger
Nigeria
Philippines
Ukraine
Vanuatu
Yemen

Grade definitions
:: Grade 2: a single or multiple country event with moderate public health consequences that requires a moderate WCO response and/or moderate international WHO response. Organizational and/or external support required by the WCO is moderate. An Emergency Support Team, run out of the regional office (the Emergency Support Team is only run out of HQ if multiple regions are affected), coordinates the provision of support to the WCO.

:: Grade 3: a single or multiple country event with substantial public health consequences that requires a substantial WCO response and/or substantial international WHO response. Organizational and/or external support required by the WCO is substantial. An Emergency Support Team, run out of the regional office, coordinates the provision of support to the WCO.

EBOLA/EVD [to 25 July 2015]

EBOLA/EVD [to 25 July 2015]
Public Health Emergency of International Concern (PHEIC); “Threat to international peace and security” (UN Security Council)

Ebola Situation Report – 22 July 2015
[Excerpts]
SUMMARY
:: There were 26 confirmed cases of Ebola virus disease (EVD) reported in the week to 19 July: 22 in Guinea and 4 in Sierra Leone. Liberia reported no new cases. For the second consecutive week more than half of all cases were reported from the capitals of Guinea and Sierra Leone, Conakry and Freetown. By contrast, other recent hotspots of transmission such as Boke in Guinea and Kambia in Sierra Leone have now reported no cases for 18 and 9 days, respectively. There are also indications of a continuation of the improvements in contact tracing and case investigation seen in recent weeks, with all but 2 cases arising among registered contacts of previous cases, including all 13 of the cases reported from the Guinean capital Conakry. This is the highest proportion of cases to arise among contacts since the beginning of the outbreak. However, one of the 2 cases reported from Freetown arose from an unknown source of infection, and is considered to represent a high risk of further transmission. In addition, 2 cases, both from Guinea, were identified as EVD-positive only after post-mortem testing of community deaths….

COUNTRIES WITH WIDESPREAD AND INTENSE TRANSMISSION
:: There have been a total of 27 705 reported confirmed, probable, and suspected cases of EVD in Guinea, Liberia and Sierra Leone (figure 1, table 1) up to 19 July, with 11 269 reported deaths (this total includes reported deaths among probable and suspected cases, although outcomes for many cases are unknown). A total of 22 new confirmed cases were reported in Guinea and 4 in Sierra Leone in the week to 19 July…

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WHO Stories from Countries
:: Vaccinating and registering the children born during Ebola
23 July 2015
:: Ebola diaries: Helping people to stay safe
21 July 2015

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UNMEER
:: Acting UNMEER SRSG Peter Graaff’s remarks at press conference on Ebola preparedness mission to Guinea-Bissau
25 Jun 2015

POLIO [to 25 July 2015]

POLIO [to 25 July 2015]
Public Health Emergency of International Concern (PHEIC)

GPEI Update: Polio this week – As of 22 July 2015
Global Polio Eradication Initiative
[Editor’s Excerpt and text bolding]
Full report: http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx
:: Last week, Forbes.com featured a live discussion on the global polio eradication effort with Dr Hamid Jafari, Director for the Global Polio Eradication Initiative at WHO, and Dr John Sever, Vice Chair of Rotary International’s Polio Plus Program. A podcast of the discussion can be accessed here.
:: 24 July 2015 will mark 12 months since the last reported case due to wild poliovirus in Nigeria had onset of paralysis. See ‘Nigeria’ section for more. As Nigeria approaches a year with no child paralyzed with polio this week, influential figures are calling for continued vigilance and commitment both from the Nigerian government and internationally. Read Nigerian Academy of Science President Oyewale Tomori’s appeal to President Buhari and President Obama here.

Selected excerpts from Country-specific Reports
Nigeria
:: No new wild poliovirus type 1 (WPV1) cases were reported in the past week. No cases have been reported in 2015. Nigeria’s total WPV1 case count for 2014 remains 6. The most recent case had onset of paralysis on 24 July 2014 in Sumaila Local Government Area (LGA), southern Kano state.
:: No new cases of type 2 circulating vaccine-derived poliovirus (cVDPV2) cases were reported in the past week. The most recent case had onset of paralysis in Kwali Local Government Area (LGA), Federal Capital Territory (FCT) Abuja, with onset of paralysis on 16 May; this is the only cVDPV2 case reported in Nigeria in 2015.
:: 24 July 2015 will mark 12 months since the last reported case due to wild poliovirus in Nigeria had onset of paralysis (the full 12-month data is pending final laboratory classification from all environmental samples and acute flaccid paralysis (AFP) cases, collected up until 24 July 2015. Results are expected by September).
:: This progress is thanks to the hard work of the Nigerian government, partners, religious and community leaders, and health workers.
:: While Nigeria is closer than ever to ending polio, the job is not yet finished. At least two more years must pass without a case of wild poliovirus for Nigeria to be certified polio-free along with the rest of the WHO’s African region. To achieve this goal, Nigeria and all countries in the African region must maintain high-quality surveillance for poliovirus and vaccination campaigns, particularly in hard-to-reach and insecure areas, and improve routine immunization.
:: At the same time, efforts are ongoing to rapidly stop a cVDPV2 outbreak affecting the country, with aggressive outbreak response using trivalent OPV being implemented in the affected and high-risk areas.

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Buhari and Obama can end polio in Africa
By Oyewale Tomori, DVM, PhD –
Opinion | Op-Ed
The Hill
07/20/15 01:00 PM EDT
For every one of the almost 70 years I have lived in Nigeria, children – often by the hundreds – have become paralyzed from a virus that I’ve spent my professional life trying to stop. But this year may be different.

Since July 24, 2014, one year ago this week, Nigeria has not recorded a single case of wild poliovirus. This is the first time this has happened in history. If Nigeria is able to stay on track, it can be removed from the short list of countries that have never halted polio transmission.

Also this week, Nigeria’s new president, Muhammadu Buhari, is meeting with President Obama – his first official visit to the White House. I do not expect polio to be top of their agenda. Bringing peace and stability to the northeast and instituting economic and political reforms are clearly key priorities, but it would be a mistake to overlook what could be one of President Buhari’s greatest achievements: the eradication of polio in Nigeria.

Nigeria’s progress to date is encouraging, but the country must go an additional two years without a case to be certified polio-free along with the rest of the WHO African region. We will not make it that far without the steadfast commitment of both leaders. For Buhari, he must appoint a strong health minister and publicly commit to freeing Nigeria from polio by 2017. The U.S. has been a historically strong donor to the Global Polio Eradication Initiative and until Africa is certified polio free and cases have also been stopped in Afghanistan and Pakistan – the only two countries that have had cases of wild polio this year – it is critical that Obama continues to lead the global effort.

Nigeria has shown the world that polio eradication is possible. With the help of seven Emergency Operations Centres throughout the country, the government and partners have been able to respond in real-time to polio outbreaks and coordinate vaccination campaigns. At the local level, health workers, often drawn from the communities they serve, have partnered with polio survivors and religious leaders to help parents understand the importance of the vaccine for their children.

We have also learned from others. Nigeria built on India’s polio eradication success by improving immunization microplans, where local leaders and health workers walk through their communities and map each house so that vaccinators know where to go and no child is missed. In conflict zones, health workers have learned to be nimble and take advantage of short periods of calm to vaccinate children.

But I hope that the most important lesson we’ve learned is not to be complacent. Nigeria is the only country in Africa that has never stopped polio. We have been close before to ridding our country of the deadly virus, but we let our guard down and the disease came roaring back, re-infecting dozens of other African countries.

Yet, despite all the lessons we’ve learned, the end of polio will not come quietly. Insecurity in the northeast part of the country has left many settlements in the area inaccessible to health workers. A recent case of circulating vaccine-derived poliovirus (cVDPV) – a very rare form of the virus mutated from the oral polio vaccine that emerges in under-immunized populations – shows that polio vaccination rates in Nigeria are still not high enough.

Buhari has the historic opportunity to end polio forever on his watch, but only if he dedicates the necessary resources to improve campaign quality, intensify surveillance measures, and reach children in all parts of the country – particularly in insecure areas in the northeast. Until we reach every child, all children remain at risk.

Freeing my country of polio will have benefits beyond just taking Nigeria’s name off that short, inglorious list. The polio program has provided a framework for reaching children all over the country with life-saving vaccines and critical health services. It also taught us how to effectively respond to disease outbreaks, as we did when Ebola came calling.

While it’s critical that we don’t lose focus on eradication, we must also increase investment in our often fragile health system. One in eight Nigerian children still die before reaching their fifth birthday – the vast majority from preventable diseases – making Nigeria one of the most dangerous countries in the world to be a child. A strong and resilient Nigeria rests on building an effective health system that delivers for its citizens, and for its children.

I dream that I will live the last years of my life in Nigeria – in a country where no child becomes paralyzed by polio, or dies from vaccine preventable diseases. So, to Buhari and our friend to the West, let us commit, once again and finally, to rid Nigeria and Africa of polio. Our children, our country and our continent depend on it.
Tomori is president of the Nigerian Academy of Science.

MERS-CoV [to 25 July 2015]

MERS-CoV [to 25 July 2015]

Global Alert and Response (GAR) – Disease Outbreak News (DONs)
:: 24 July 2015 – Middle East Respiratory Syndrome coronavirus (MERS-CoV) – Saudi Arabia
Between 1 and 14 July 2015, the National IHR Focal Point for the Kingdom of Saudi Arabia notified WHO of 6 additional cases of Middle East respiratory syndrome coronavirus (MERS-CoV) infection…
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:: 21 July 2015 – Middle East respiratory syndrome coronavirus (MERS-CoV) – Republic of Korea
Situation in the Republic of Korea
Between 18 and 21 July 2015, the National IHR Focal Point of the Republic of Korea notified WHO of no additional cases of infection and no new deaths related to Middle East Respiratory Syndrome Coronavirus (MERS-CoV).
Additional information on the outbreak in the Republic of Korea
To date, a total of 186 MERS-CoV cases, including 36 deaths, have been reported. One of the 186 cases is the case that was confirmed in China and also notified by the National IHR Focal Point of China…

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MERS-CoV cases 21 July 2015 xlsx, 19kb

GSK’s malaria candidate vaccine, Mosquirix (RTS,S), receives positive opinion from European Medicines Agency

European Medicines Agency [to 25 July 2015]
http://www.ema.europa.eu/ema/
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:: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2015
24/07/2015
Ten new medicines recommended for authorisation in the EU, and first malaria vaccine receives positive scientific opinion for use outside the EU
At its July meeting, the Committee for Medicinal Products for Human Use (CHMP) gave a positive scientific opinion for Mosquirix (Plasmodium falciparum and hepatitis B vaccine), the first vaccine for malaria to be assessed by a regulatory agency for use outside the European Union (EU).

Mosquirix was submitted to the European Medicines Agency (EMA) under a regulatory procedure (Article 58) that allows EMA to assess the quality, safety and efficacy of a medicine or vaccine and its benefit-risk balance, although it will not be marketed in the EU…

:: First malaria vaccine receives positive scientific opinion from EMA
Mosquirix to be used for vaccination of young children, together with established antimalarial interventions
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive scientific opinion for Mosquirix (Plasmodium falciparum and hepatitis B vaccine), for use outside the European Union (EU).

The malaria vaccine Mosquirix, also known as RTS,S/AS01, was submitted to EMA under a regulatory procedure (Article 58) that allows EMA to assess the quality, safety and efficacy of a medicine or vaccine and its benefit-risk balance, although it will not be marketed in the EU. This means that EMA can help facilitate access to new medicines for people living outside the EU.

Mosquirix is intended for use in areas where malaria is regularly found, for the active immunisation of children aged 6 weeks to 17 months against malaria caused by the Plasmodium falciparum parasite, and against hepatitis B. After decades of research into malaria vaccinations, Mosquirix is the first vaccine for the disease to be assessed by a regulatory agency.

The CHMP highlighted in its opinion that Mosquirix is for use in line with official recommendations that take into account the risk of Plasmodium falciparum malaria in different geographical areas and available malaria control interventions. These recommendations will be defined by the World Health Organization (WHO) and regulatory authorities in the non-EU countries where the vaccine would be used.

As in all Article 58 procedures, the CHMP worked closely with other experts, including from WHO and regulatory authorities from the relevant countries. In its assessment, the CHMP applied the same rigorous standards as for medicines to be marketed within the EU…

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GSK’s malaria candidate vaccine, Mosquirix™ (RTS,S), receives positive opinion from European regulators for the prevention of malaria in young children in sub-Saharan Africa
WHO will now assess how the world’s first malaria candidate vaccine might be used alongside other tools to prevent malaria
GSK Press Release
24 July 2015 Issued: London, UK

GSK announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive scientific opinion for its malaria candidate vaccine MosquirixTM, also known as RTS,S, in children aged 6 weeks to 17 months. Following this decision, the World Health Organization (WHO) will now formulate a policy recommendation on use of the vaccine in national immunisation programmes once approved by national regulatory authorities.

RTS,S, which was developed in partnership with the PATH Malaria Vaccine Initiative (MVI), is the first candidate vaccine for the prevention of malaria to reach this milestone. While other vaccines tackle viruses or bacteria, RTS,S has been designed to prevent malaria caused by the Plasmodium falciparum parasite, which is most prevalent in sub-Saharan Africa (SSA). In 2013, there were an estimated 584,000 deaths from malaria with around 90% of these occurring in SSA, and 83% in children under the age of five in SSA.1

The CHMP scientific opinion is a key step in the regulatory process toward making RTS,S available alongside existing tools currently recommended for malaria prevention. The positive opinion for young children was based on the review of data assessing the candidate vaccine’s safety, efficacy and quality. Clinical data submitted for CHMP assessment were mainly from a phase III clinical trial programme involving more than 16,000 young children that was conducted by 13 African research centres in eight African countries (Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, Nigeria, and Tanzania).

Data from this trial programme demonstrate that over the first 18 months following three doses of RTS,S, malaria cases were reduced by almost half in children aged 5-17 months at the time of first vaccination and by 27% in infants aged 6-12 weeks. At study end, four doses of RTS,S reduced malaria cases by 39% over four years of follow-up in children, and by 27% over three years of follow-up in infants.2 In areas of the highest malaria burden, more than 6,000 clinical malaria cases were prevented over the study period for every 1,000 children vaccinated.2 The efficacy of RTS,S was evaluated in addition to existing malaria control measures, such as insecticide treated bed nets, which were used by approximately 80% of the children and infants in the trial.

Sir Andrew Witty, CEO of GSK said: “Today’s scientific opinion represents a further important step towards making available for young children the world’s first malaria vaccine. While RTS,S on its own is not the complete answer to malaria, its use alongside those interventions currently available such as bed nets and insecticides, would provide a very meaningful contribution to controlling the impact of malaria on children in those African communities that need it the most. The work doesn’t stop here and GSK remains committed to investing in R&D for malaria vaccines and treatments to find more ways to tackle this devastating disease.”

Dr David C. Kaslow, Vice President of Product Development at PATH said: “Today marks a significant scientific milestone for the long-standing partnership to develop a vaccine, yet several more steps remain before a malaria vaccine might reach the young children in Africa who most need protection against this deadly human parasite. PATH will continue to work with GSK and other partners to ensure that the evidence is available, as soon as possible, to support informed decision-making on those remaining steps.”

GSK has committed to a not-for-profit price for RTS,S so that, if approved, the price of RTS,S would cover the cost of manufacturing the vaccine together with a small return of around five per cent that will be reinvested in research and development for second-generation malaria vaccines, or vaccines against other neglected tropical diseases.

Next steps
Following the CHMP positive scientific opinion, two of the WHO’s independent advisory groups, the Strategic Advisory Group of Experts (SAGE) on Immunization and the Malaria Policy Advisory Committee (MPAC) will now jointly review the evidence base for RTS,S and make a joint policy recommendation for how it might be used alongside other tools to prevent malaria in the event the vaccine candidate is approved by national regulatory authorities in SSA. The WHO has indicated that such a policy recommendation may be possible by end of this year.

Following the WHO policy recommendation, GSK will also submit an application to the WHO for pre-qualification of RTS,S. WHO pre-qualification involves a scientific assessment of the quality, safety and efficacy of any new vaccine proposed for introduction in WHO Expanded Programme on Immunization. A pre-qualification decision is used by the United Nations agencies and other large scale public procurement agencies to help inform vaccine purchasing decisions.

Once a WHO pre-qualification is granted, GSK would then apply for marketing authorisation in countries in sub-Saharan Africa on a country-by-country basis. These regulatory and policy decisions would, if positive, enable countries to begin implementation of RTS,S through their universal immunisation programmes.

Both a WHO policy recommendation and WHO pre-qualification are requirements for Gavi, the Vaccine Alliance, to support eligible African countries introducing RTS,S into local immunisation programmes supported by UNICEF.

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PATH [to 25 July 2015]
http://www.path.org/news/index.php
Press release | July 13, 2015
:: PATH Malaria Vaccine Initiative welcomes positive opinion by European regulators on GSK’s Mosquirix™ (RTS,S)
Announcement | July 23, 2015
Decision paves the way for World Health Organization to assess how a malaria vaccine might be used in young children in sub-Saharan Africa

WHO & Regionals [to 25 July 2015]

WHO & Regionals [to 25 July 2015]
The Weekly Epidemiological Record (WER) 24 July 2015, vol. 90, 30 (pp. 373–380) includes:
:: Genetic diversity of wild-type measles viruses and the global measles nucleotide surveillance database (MeaNS)
http://www.who.int/entity/wer/2015/wer9030.pdf?ua=1

WHO calls for urgent action to curb hepatitis
News release
23 JULY 2015 ¦ GENEVA – On World Hepatitis Day (28 July) WHO highlights the urgent need for countries to enhance action to prevent viral hepatitis infection and to ensure that people who have been infected are diagnosed and offered treatment. This year, the Organization is focusing particularly on hepatitis B and C, which together cause approximately 80% of all liver cancer deaths and kill close to 1.4 million people every year…

The control of neglected zoonotic diseases
July 2015 — A newly published report finds that most neglected zoonotic diseases can be controlled through the use of existing knowledge and tools. WHO estimates that nearly two-thirds of all human pathogens originate from zoonoses.
:: WHO Regional Offices
WHO African Region AFRO
:: High level delegation from the Bill & Melinda Gates Foundation visits World Health Organization Regional Office for Africa
Brazzaville, 21 July 2015 – A high level delegation from the Bill & Melinda Gates Foundation (BMGF) has begun a four-day official visit to the World Health Organization Regional Office for Africa (AFRO) in Brazzaville, Congo from 21-24 July 2015. The aim of the visit is to review ongoing collaboration between the two organizations and explore new ways of working together to improve the health of people in the African Region. An initial team of senior leaders from BMGF including Dr Steve Landry Director, Multilateral Partnerships and Mr Tom Hurley, Deputy Director, Multilateral Partnerships, began discussions with the senior management…

WHO Region of the Americas PAHO
:: WHO validates Cuba’s elimination of mother-to-child transmission of HIV and syphilis (06/30/2015)
:: Women’s health needs still not adequately met, according to new articles in the Pan American Journal of Public Health (06/24/2015)
:: Health Coverage Reaches 46 Million More in Latin America and the Caribbean, says new PAHO/WHO–World Bank report (06/22/2015)

WHO South-East Asia Region SEARO
No new digest content identified.

WHO European Region EURO
:: WHO delivers emergency health kits to Suruc in Turkey 24-07-2015
:: Georgia sets sights on eliminating hepatitis C 23-07-2015
:: Viral hepatitis – 400 deaths a day in the WHO European Region could be prevented 23-07-2015
:: WHO receives Turkmenistan State award for collaboration in public health 21-07-2015

WHO Eastern Mediterranean Region EMRO
:: World Hepatitis Day in Egypt focuses on hepatitis B and C prevention
23 July, 2015 | Cairo – Preventing hepatitis B and C is the regional theme of this year’s World Hepatitis Day. Viral hepatitis is a global health problem affecting hundreds of millions of people worldwide. The Eastern Mediterranean Region has some of the highest rates of viral hepatitis in the world, with an estimated 4.3 million people becoming infected with hepatitis B and 800 000 with hepatitis C every year. This year, the WHO Regional Office will host an event to observe World Hepatitis Day on 28 July 2015 in Cairo, Egypt.

WHO Western Pacific Region
:: Do your part to prevent hepatitis
MANILA, 24 July 2015 – Nearly 40% of global deaths attributable to viral hepatitis occur in the Western Pacific, more than the combined death toll from HIV/AIDS, tuberculosis and malaria. To mark World Hepatitis Day on 28 July, the World Health Organization (WHO) in the Western Pacific Region urges policy-makers, health workers and the public to take action to stop infection and death from hepatitis B and C.
Read the news release