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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David R. Curry, MS
Executive Director
Center for Vaccine Ethics and Policy
a program of the
– Division of Medical Ethics, NYU Medical School
– The Wistar Institute Vaccine Center
– Children’s Hospital of Philadelphia Vaccine Education Center
Associate Faculty, Division of Medical Ethics, NYU Medical School

136th WHO Executive Board starts with special session on Ebola – Live Webcast
23 January 2015 — The 136th session of the WHO Executive Board will run from Monday, 26 January 2015. On Sunday, 25 January, the Board will hold a special session on the Ebola emergency. The special session will review the current state of WHO’s Ebola response and make recommendations for future large-scale and sustained outbreaks and emergencies. It will also discuss preparedness in non-affected countries and regions.
Live webcast: Sunday 25 January 2015 from 10:00 to 13:00 and 15:00 to 18:00 CET
– Special session – English http://www.who.int/mediacentre/executive-board-live/en/

World Health Organization update on Ebola outbreak in West Africa
23 Jan 2015
Speaker: Dr Bruce Aylward, WHO Assistant Director-General in charge of the Ebola operational response
Video: http://webtv.un.org/watch/world-health-organization-press-conference-geneva-15-january-2015/4006783074001

Major milestone for GSK/NIH candidate Ebola vaccine as first doses shipped to Liberia for use in phase III clinical trial
23 January 2015, Issued: London, UK
Healthcare workers among those to be vaccinated in large-scale trial involving up to 30,000 people due to start in the coming weeks
GSK has announced that the first batch of its candidate Ebola vaccine is being shipped to west Africa and is expected to arrive in Liberia later today Friday 23 January. The shipment, containing an initial 300 vials of the candidate vaccine, is the first to arrive in one of the main Ebola affected countries and will be used to start the first large-scale efficacy trial of experimental Ebola vaccines in the coming weeks.

The candidate vaccine is currently being tested in five small phase I clinical trials in the UK, USA, Switzerland and Mali, involving around 200 healthy volunteers in total. Initial data from these trials show that the candidate vaccine has an acceptable safety profile, including in a west African population, and across the different doses evaluated. Based on the safety and immunological data available from these trials, GSK has selected the most appropriate dosage level to advance to the next phases of clinical testing. Results from the first of the phase I studies were published in November 2014 and results from the remaining phase I studies will be published in the coming months.

The selected dose will now be tested in a large phase III clinical trial led by the US National Institutes of Health (NIH) which is expected to involve up to 30,000 people, one third of whom will receive GSK’s candidate Ebola vaccine. It will compare the candidate vaccine to a control vaccine to assess whether the immune response seen in phase I trials actually translates into meaningful protection against Ebola. This trial will begin in Liberia in the coming weeks, subject to regulatory approval, with further shipments of vaccines to follow.

Dr Moncef Slaoui, Chairman of Global Vaccines at GSK, said: “Shipping the vaccine today is a major achievement and shows that we remain on track with the accelerated development of our candidate Ebola vaccine. The initial phase I data we have seen are encouraging and give us confidence to progress to the next phases of clinical testing which will involve the vaccination of thousands of volunteers, including frontline healthcare workers. If the candidate vaccine is able to protect these people, as we hope it will, it could significantly contribute to efforts to bring this epidemic under control and prevent future outbreaks.
“It is important to remember that this vaccine is still in development and any potential future use in mass vaccination campaigns will depend on whether WHO, regulators and other stakeholders are satisfied that the vaccine candidate provides protection against Ebola without causing significant side effects and how quickly large quantities of vaccine can be made.”

GSK is working closely with the World Health Organization (WHO) and Centers for Disease Control and Prevention (CDC) in the USA to assist with the design and to potentially support trials in other affected countries – Sierra Leone and Guinea – in the coming months. In parallel, GSK plans to begin large phase II safety trials in non-affected west African countries.

The candidate Ebola vaccine shipped today was co-developed by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) and Okairos, a biotechnology company acquired by GSK in 2013. It uses a type of chimpanzee cold virus, known as chimpanzee adenovirus type 3 (ChAd3), as a carrier to deliver benign genetic material from the Zaire strain of the Ebola virus, which is responsible for the current Ebola outbreak in west Africa. GSK has been working with the NIH to accelerate development in response to the current Ebola epidemic.

Davos: UN launches $1 billion appeal for global Ebola response
21 January 2015
The United Nations today appealed for $1 billion needed for the first six months of 2015 to sustain the momentum to stamp out Ebola in West Africa, where ‘the epidemic has started to turn’ in all three of the worst-hit countries – Guinea, Liberia and Sierra Leone.

“We’re beginning to see an overall decline in number of new cases each week,” Dr. David Nabarro, the UN Special Envoy on Ebola, told a news conference in Davos, Switzerland, at the 2015 World Economic Forum, where global leaders from across business, Government, international organizations, academia and civil society are gathered for strategic dialogues on events and trends shaping the world.

Valerie Amos, UN Emergency Relief Coordinator, also welcomed the “early signs of reduction of Ebola in all three countries” but noted the need to remain vigilant.

And as the Secretary-General of the United Nations [Ban Ki-moon] said yesterday, complacency would be our worst enemy,” Ms. Amos, who is also the UN Under-Secretary-General for Humanitarian Affairs told reporters.

The appeal was launched by Ms. Amos and Dr. Nabarro, who are in Davos where there are some 20 scheduled events at the World Economic Forum devoted to the global fight against the Ebola epidemic…

Press Conference Needs and Requirements for a Global Ebola Response
Valerie Amos, UN Under-Secretary-General for Humanitarian Affairs and Emergency Relief Coordinator, and David Nabarro, the UN Secretary-General’s Special Envoy on Ebola, present the latest Overview of the UN system and partners’ Requirements for the Ebola Response. This is an appeal for funds to support the efforts of the national governments of Guinea, Liberia and Sierra Leone as they identify and treat people affected by Ebola, ensure a rapid end to the outbreak, re-establish essential social services and improve people’s food and nutrition security. The appeal includes funds needed for enabling nearby countries to reduce their people’s risk of Ebola infection.

Download audio: http://webcasts.weforum.org/widget/1/davos2015?p=1&pi=1&a=66503

WHO: Ebola response roadmap – Situation report 21 January 2015
[Excerpt]
SUMMARY
:: Case incidence continues to fall in Guinea, Liberia, and Sierra Leone, with a halving time of 1.4 weeks in Guinea, 2.0 weeks Liberia, and 2.7 weeks in Sierra Leone. A combined total of 145 confirmed cases were reported from the 3 countries in the week to 18 January: 20 in Guinea, 8 in Liberia, and 117 in Sierra Leone.
:: Mali has been declared free of Ebola virus disease (EVD) after completing 42 days since the last case tested negative for EVD.
:: Surveillance and information sharing will be increased in the border districts of Guinea-Bissau, Côte d’Ivoire, Mali and Senegal adjacent to the 3 intense-transmission countries.
:: Each of the intense-transmission countries has sufficient capacity to isolate and treat patients, with more than 2 treatment beds per reported confirmed, probable and suspected case. The planned numbers of beds in each country has now been reduced in accordance with falling case incidence.
:: Similarly, each country has sufficient capacity to bury all people known to have died from EVD.
:: Guinea, Liberia and Sierra Leone report that between 89% and 99% of registered contacts are monitored each day, though the number of contacts traced per EVD case remains lower than expected in many districts. In the week to 11 January, 53% of new confirmed cases in Guinea arose from known contacts; in the period between 1 January and 15 January, 53% of new confirmed cases in Liberia arose from known contacts. Equivalent data are not yet available for Sierra Leone.
:: There are currently 27 laboratories providing case-confirmation services in the 3 intense-transmission countries. Five more laboratories are planned in order to meet demand. The mean time between sample collection to sample testing in the 21 days to 18 January was 1.37 days in Guinea, 2.03 days in Liberia, and 2.32 days in Sierra Leone, although several districts in Guinea have yet to report data.
:: Case fatality among hospitalized patients (calculated from all hospitalized patients with a reported definitive outcome) is between 57% and 59% in the 3 intense-transmission countries, with no detectable improvement since the onset of the epidemic.
:: A total of 828 health worker infections have been reported in the 3 intense-transmission countries; there have been 499 reported deaths. The incidence of health worker infections has fallen in Liberia and Sierra Leone, but rose in Guinea throughout December.
:: As an indication of community engagement, 71% of districts in Guinea and 100% of districts in Sierra Leone have a list of key religious leaders who promote safe and dignified burials. No data are available for Liberia. Incidents of community resistance to safe burials and contact tracing continue to be reported in all 3 countries, although they are most common in Guinea.

COUNTRIES WITH WIDESPREAD AND INTENSE TRANSMISSION
:: There have been in excess of 21,000 reported confirmed, probable, and suspected cases (Annex 1) of EVD in Guinea, Liberia and Sierra Leone (table 1), with more than 8600 deaths (outcomes for many cases are unknown). A total of 20 new confirmed cases were reported in Guinea, 8 in Liberia, and 117 in Sierra Leone in the 7 days to 18 January.
:: A stratified analysis of cumulative confirmed and probable cases indicates that the number of cases in males and females is similar (table 2). Compared with children (people aged 14 years and under), people aged 15 to 44 are approximately three times more likely to be affected. :: People aged 45 and over are almost four times more likely to be affected than are children.
:: A total of 828 health worker infections have been reported in the 3 intense-transmission countries; there have been 499 reported deaths (table 3)…

Statement on the 4th meeting of the IHR Emergency Committee regarding the 2014 Ebola outbreak in West Africa
WHO statement
21 January 2015
The fourth meeting of the Emergency Committee convened by the WHO Director-General under the International Health Regulations (IHR) 2005 regarding the Ebola virus disease (EVD, or “Ebola”) outbreak in West Africa was conducted with members and advisors of the Emergency Committee on Tuesday, 20 January 2015.

This meeting was convened to review, in accordance with IHR provisions, whether the event continued to constitute a Public Health Emergency of International Concern and, if so, whether this warranted an extension or revision of the three -month date of the expiration of the temporary recommendations, which were first issued on 8 August 2014 and extended on 22 September 2014 and 23 October 2014.

Developments since the Committee’s last meeting were reviewed, including the most recent epidemiological situation. The Committee noted that the number of Ebola cases is decreasing in all three of the most affected countries.

Since the previous meeting, three countries have declared the end of Ebola transmission: Spain, the United States of America, and Mali. One case was imported into the United Kingdom of Great Britain and Northern Ireland (UK), in a health care worker who returned from Sierra Leone and was asymptomatic on exit screening and during travel; she became ill after arrival in the UK.

The Committee expressed concern that additional measures affecting travel, transport and trade that go beyond the temporary recommendations have been put in place in more than 40 countries.

Current response and preparedness activities were reviewed, as well as recent scaling up of the response. Priorities and strategies for moving towards zero cases were presented.

Guinea, Liberia, Sierra Leone, Mali and UK provided an update on and assessment of the Ebola situation in their countries, including progress towards implementation of the temporary recommendations.

Even though a few cases have occurred outside the three most affected countries, the measures recommended appear to have been helpful in limiting further international spread, including the exportation of disease from the three most affected countries.

It was the unanimous view of the Committee that the event continues to constitute a Public Health Emergency of International Concern. The Committee reviewed the temporary recommendations previously issued and stated that all previous temporary recommendations should remain in effect.

The committee provided the following additional advice to the Director-General for her consideration in addressing the Ebola outbreak in accordance with the IHR.

Recommendations for the most affected countries (Guinea, Liberia, Sierra Leone)
The Committee strongly reiterated the previous temporary recommendation on exit screening and highlighted the value of exit screening in these three countries. Exit screening remains critical for minimizing the risk of exportation of Ebola cases. The three most affected countries should maintain robust exit screening until Ebola transmission is confirmed to have stopped in these countries. The Committee again urged affected countries to provide WHO regularly with the number of people screened at international airports and the outcomes of exit screening. The international community should support a sustainable approach to this exit screening.

Recommendations for countries sharing borders with Guinea, Liberia and Sierra Leone
These countries should be conducting active surveillance, including in border areas, and engaging in cross-border cooperation, information and asset sharing, and continued vigilance for new cases. National governments should empower local communities that have land crossings at shared national borders to be part of these activities.

Recommendations for all countries
The Committee reaffirmed the need to avoid unnecessary interference with international travel and trade, as specified in Article 2 of the IHR 2005. The Committee noted that more than 40 countries have implemented additional measures, such as quarantine of returning travellers and refusal of entry. Such measures are impeding the recruitment and return of international responders. They also have harmful effects on local populations by increasing stigma and isolation, and by disrupting livelihoods and economies.

The Committee concluded that the primary emphasis must continue to be on ‘getting to zero’ Ebola cases, by stopping the transmission of Ebola within the three most affected countries. This action is the most important step for preventing international spread. Complacency is the biggest risk to not getting to zero cases. Continued vigilance is essential.

The Director-General thanked the Committee members and advisors for their advice and requested their reassessment of this situation within three months or earlier should circumstances require.

Briefing on the Ebola virus outbreak – General Assembly, Informal meeting of the plenary, 69th session
20 Jan 2015
Informal meeting of the plenary, to hear a briefing by Mr. Ismail Ould Cheikh Ahmed, Special Representative and Head of the United Nations Mission for Ebola Emergency Response (UNMEER), concerning the public health crisis emanating from the Ebola virus outbreak.

A letter from the Secretary-General addressed to the President of the General Assembly, containing a report on progress made in the Ebola response, was issued in document A/69/720.

Video: http://webtv.un.org/watch/briefing-on-the-ebola-virus-outbreak-general-assembly-informal-meeting-of-the-plenary-69th-session/4000843020001

Text: Statement by Ismail Ould Cheikh Ahmed, Special Representative and Head of UNMEER, to the UN General Assembly

Letter dated 12 January 2015 from the Secretary-General addressed to the President of the General Assembly  A/69/720 :: 21 pages, General Assembly, Sixty-ninth session; Agenda item 124; Global health and foreign policy

WHO: Protecting fans from Ebola at the Africa Cup of Nations
23 January 2015 — Thanks to preparedness activities by Equatorial Guinea’s Ministry of Health, FIFA and WHO, the one million people gathered in Equatorial Guinea for the 2015 Africa Cup of Nations are able to focus more on footie than on fears of Ebola. So what does it take to ensure that capacities are in place to prevent, identify and respond to potential Ebola virus transmission at such a large mass gathering?
Read the story from Equatorial Guinea

UNICEF [to 24 January 2015]
http://www.unicef.org/media/media_71508.html

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Media Releases [selected]
As schools reopen in Guinea, UNICEF helps efforts to reduce Ebola transmission risk
DAKAR/NEW YORK/GENEVA, 20 January 2015 – As schools reopen in Guinea, UNICEF and partners are helping reduce as much as possible the risk of Ebola transmission, training teachers to implement safety measures such as daily temperature screening, and supplying thermometers and handwashing kits for schools.

World Bank [to 24 January 2015]
http://www.worldbank.org/en/news/all

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Ebola: Most African Countries Avoid Major Economic Loss but Impact on Guinea, Liberia, Sierra Leone Remains Crippling
Africa-wide impact in 2015The Bank Group expects sub-Saharan Africa to grow at 4.6 percent in 2015, down from a 5.0 percent forecast in June 2014. Projections have been lowered because of global events, including the West African Ebola epidemic as well as the net effect of winners and losers from a steep fall in the global prices of oil and other commodities. Key risks to this projected growth include a renewed spread of Ebola, violent insurgencies, further reductions in commodity prices, and volatile global financial conditions.Much of the economic impact of Ebola beyond the epicenter of directly affected West African countries is based on fear, as was the case during the SARS outbreak in East Asia a decade ago…
January 20, 2015

POLIO [to 24 January 2015]
Public Health Emergency of International Concern (PHEIC)

GPEI Update: Polio this week – As of 21 January 2014
Global Polio Eradication Initiative
[Editor’s Excerpt and text bolding]
Full report: http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx
:: Ministers of Health from around the world will convene next week at WHO’s Executive Board meeting, to set global public health policies. Among other topics, representatives are expected to review the current polio epidemiology and global preparedness plans for the phased removal of oral polio vaccines. A report has been prepared, to facilitate discussions, available here and below.
:: In Nigeria, the Expert Review Committee on Polio Eradication and Routine Immunization (ERC) is meeting this week to discuss aggressive strategies to urgently eradicate both wild- and vaccine-derived polioviruses in the country as rapidly as possible.
:: The first wild poliovirus type 1 (WPV1) case of 2015 is reported this week, from Pakistan. The case had onset of paralysis on 3 January, from Khyber Pakhtunkhwa. See ‘Pakistan’ section for more.
:: Bill and Melinda Gates, co-chairs of the Bill & Melinda Gates Foundation, this week published their annual letter, outlining how they believe the world will look like in 15 years. In the letter, they highlight the urgent need to eradicate polio. “Destroying a disease utterly is a very difficult thing to do – so difficult in fact, that it’s happened only once in history, when smallpox was eradicated in 1980. But if we keep working hard… we can get polio out of Africa this year and out of every country in the world in the next several years.”

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Selected country report content:
Pakistan
:: Seven new wild poliovirus type 1 (WPV1) cases were reported in the past week, including the first case with onset of paralysis in 2015. The total number of WPV1 cases in 2014 is 303, and one for 2015 (onset of paralysis on 3 January, from Khyber Pakhtunkhwa – KP).
:: Pakistan accounts for more than 85% of all WPV1 cases worldwide in 2014.
:: To urgently address the intense transmission affecting the country, the government has put in place emergency measures to take advantage of the upcoming ‘low season’ for poliovirus transmission (in the early part of 2015). A ‘low season plan’ has been established, based on lessons learned on accessing populations in insecure areas, engaging communities and fixing remaining operational challenges. Implementation is overseen by Emergency Operations Centres at federal and provincial levels to ensure accountability for the quality of polio eradication operations. More
West Africa
:: Even as polio programme staff across West Africa support efforts to control the Ebola outbreak affecting the region, efforts are being made in those countries not affected by Ebola to vaccinate children against polio to create a buffer zone surrounding the Ebola-affected countries. The Ebola crisis in western Africa continues to have an impact on the implementation of polio eradication activities in Liberia, Guinea and Sierra Leone. Supplementary immunization activities (SIAs) in these countries have been postponed and the quality of acute flaccid paralysis surveillance has markedly decreased throughout 2014.
:: NIDs are planned using bivalent oral polio vaccine (OPV) in Niger and Benin on 27 February to 2 March, and Subnational Immunization Days (SNIDs) tentatively in Mali in February with dates to be confirmed. From 27 to 31 March, NIDs will take place in Benin, Burkina Faso, Côte d’Ivoire, Mali, Niger and Senegal using trivalent OPV. NIDs are also scheduled on those dates for the three Ebola-affected countries Guinea, Liberia and Sierra Leone.

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Poliomyelitis: Report by the secretariat
WHO 136th Executive Board (January 2015)
EB136/21 – 16 January 2015 – Provisional agenda item 8.2

WHO  [to 24 January 2015]
:: 136th WHO Executive Board session
26 January–3 February 2015 –
– Main Documents: http://apps.who.int/gb/e/e_eb136.html

:: Noncommunicable diseases take 16 million lives prematurely annually
19 January 2015 — Urgent government action is needed to meet global targets to reduce the burden of noncommunicable diseases (NCDs), and prevent the annual toll of 16 million people dying prematurely – before the age of 70 – from heart and lung diseases, stroke, cancer and diabetes, according to a new WHO report. The report states that most premature NCD deaths are preventable.
– Read the news release on the new NCDs status report
– Read the NCDs status report

:: Global Alert and Response (GAR): Disease Outbreak News (DONs)
– Middle East respiratory syndrome coronavirus (MERS-CoV) – Oman 23 January 2015
– Middle East respiratory syndrome coronavirus (MERS-CoV) – Saudi Arabia 20 January 2015
– Human infection with avian influenza A(H7N9) virus – China 19 January 2015

:: The Weekly Epidemiological Record (WER) for 23 January 2015, vol. 90,4 (pp. 17–24) includes –
Global Advisory Committee on Vaccine Safety, 3–4 December 2014

WHO Regional Offices

WHO African Region AFRO
Press Releases
:: More than 2.5 million people reached in emergency response campaign with anti-malarial medicines in Sierra Leone – 22 January 2015
:: Meningitis A vaccine now recommended in routine immunization schedules
Brazzaville, 20 January 2015 – The World Health Organization (WHO) now recommends the conjugate meningitis A vaccine MenAfriVac® to be introduced in routine immunization schedules in sub-Saharan Africa. This recommendation ensures that infants are protected against meningitis and population-wide immunity is maintained.The use of the MenAfriVac® vaccine to prevent meningitis A epidemics is one of the greatest vaccination success stories in public health history and highlights what partners can accomplish when unified by a compelling cause. In 2014, the MenAfriVac® campaigns reached more than 63 million people with remarkable success.

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WHO Region of the Americas PAHO
No new digest content identified.

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WHO South-East Asia Region SEARO
:: India: first to adapt the Global Monitoring Framework on noncommunicable diseases (NCDs)
January 2015
Every year, roughly 5.8 million Indians die from heart and lung diseases, stroke, cancer and diabetes. In other words, 1 in 4 Indians risks dying from an NCD before they reach the age of 70. Full story – India: first to adapt the Global Monitoring Framework on NCDs

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WHO European Region EURO
:: Ukraine health system buckling under weight of humanitarian crisis 19-01-2015

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WHO Eastern Mediterranean Region EMRO
:: WHO provides support for hearing impaired children in Iraq
22 January 2015 – WHO and the Ministry of Health of the Kurdistan region have provided cochlear implants to 20 internally displaced and refugee children in Iraq as part of a larger WHO disability prevention and reduction project targeting internally displaced persons, refugees and affected host communities in Dohuk. WHO is also providing support to strengthen health services. To continue to improve its humanitarian response in Iraq, WHO requires more financial resources. Of the US$ 187 million needed, the Organization has so far raised only US$ 55 million (29%).

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WHO Western Pacific Region
No new digest content identified.

California measles outbreak expands to 78 cases; more likely
By Rosanna Xia and Rong-Gong Lin II
Los Angeles Times, January 23,2 015

The measles outbreak centered in California continues to expand, with officials now confirming 78 cases of the illness in seven states and Mexico.

The California Department of Public Health said there are now 68 cases in the state – 48 that have been directly linked to being at Disneyland or Disney California Adventure last month. Some people also visited one or both of the parks while infectious in January.

The measles outbreak has also spread beyond those who visited Disneyland in December and January and is infecting people in the broader community…
…The California patients range in age from 7 months to 70 years. The vaccination status is known for 39 of the patients. Of those, 32 were unvaccinated, one had received partial vaccination and seven were fully vaccinated.

Of the cases in California, about one in four have had to be hospitalized, officials said.

Disneyland officials confirmed to The Times that five Disneyland employees have been diagnosed with measles. All Disneyland employees who could have been in contact with those five have been asked to provide vaccination records or do a blood test that shows they have built immunity to the disease.
Any employees who had not been vaccinated or could not confirm their immunity status have been asked to go on paid leave until their status could be confirmed, company officials said.

Healthcare officials said it is safe to go Disneyland and other venues with large crowds if you are immunized for measles…

European Medicines Agency Watch [to 24 January 2015]
21/01/2015

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:: New international standard to improve safety of medicines
New EMA guide will help industry and regulatory authorities to implement changes
The European Medicines Agency (EMA) has published a guide to support the implementation of a new international standard for the safety monitoring of medicines in the European Union (EU). The so-called ISO ICSR standard improves the reporting of suspected side effects of medicines in Individual Case Safety Reports (ICSRs). The use of the new international standard will take effect on 1 July 2016.

ISO ICSR aims to establish the same format for the reports on individual cases of suspected side effects in patients due to a medicine across the world. It also is expected to include better information on medicines that might be associated with an adverse drug reaction and on the therapeutic uses of those medicines.

In addition, the standard also strengthens personal data protection in the records of ICSRs collected by pharmaceutical companies and regulatory authorities.

FDA Watch [to 24 January 2015]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm

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:: FDA approves a second vaccine to prevent serogroup B meningococcal disease
January 23, 2015
The U.S. Food and Drug Administration today approved Bexsero, a vaccine to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.

Bexsero is the second vaccine approved by the FDA in the past three months to prevent this disease. The agency approved the first meningococcal serogroup B vaccine in October 2014. Before these approvals, existing approved meningococcal vaccines in the U.S. covered only four of the five main serogroups of N. meningitidis bacteria that cause meningococcal disease: A, C, Y and W…

… “With today’s approval of Bexsero, the U.S. now has two vaccines for the prevention of serogroup B meningococcal disease,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “The approval of these vaccines represents a major public health accomplishment toward preventing this life-threatening disease.”…

Industry Watch [to 24 January 2015]
:: Novartis Bexsero vaccine approved by FDA for the prevention of meningitis B, the leading cause of bacterial meningitis in the US
Jan 23, 2015, 18:35 ET
Novartis announced today that the US Food and Drug Administration (FDA) has granted accelerated approval of Bexsero® (Meningococcal Group B Vaccine [recombinant, adsorbed]) for active immunization to prevent invasive meningococcal disease caused by serogroup B (also known as meningitis…

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:: Major milestone for GSK/NIH candidate Ebola vaccine as first doses shipped to Liberia for use in phase III clinical trial
23 January 2015, Issued: London, UK
Healthcare workers among those to be vaccinated in large-scale trial involving up to 30,000 people due to start in the coming weeks [see full press release above in Ebola/EVD section]

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:: Prevenar 13 Receives CHMP Positive Opinion For Prevention Of Vaccine-Type Pneumococcal Pneumonia in Adults
January 22, 2015 11:21 AM Eastern Standard Time
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending that the indication for Prevenar 13* (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) be expanded to include the prevention of pneumonia caused by the 13 pneumococcal serotypes in the vaccine in adults 18 years and older. Prevenar 13 is currently approved in Europe for the prevention of invasive pneumococcal disease (IPD) in the same population. The CHMP’s positive opinion will now be reviewed by the European Commission (EC). The decision on whether to approve Prevenar 13 for this indication will be made by the EC and will be applicable to all European Union member states plus Iceland, Lichtenstein and Norway…

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:: Specialty Vaccine Company PaxVax Appoints Nima Farzan as President
January 21, 2015
REDWOOD CITY, Calif.–(BUSINESS WIRE)–PaxVax, Inc., a specialty vaccine company focused on travel and biodefense, today announced the appointment of Nima Farzan as President and Chief Operating Officer (COO). Mr. Farzan, who has served as PaxVax COO for the past three years, will be responsible for the company’s global operations including the finance, production and commercial functions. The company also announced today that Mr. Farzan has joined the PaxVax Board of Directors. Kenneth Kelley will continue to serve as the company’s Chief Executive Officer and as a Director….

BMGF – Gates Foundation Watch [to 24 January 2015]
http://www.gatesfoundation.org/Media-Center/Press-Releases

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:: Bill and Melinda Gates Release 2015 Annual Letter: “Our Big Bet for the Future”
SEATTLE (January 21, 2015)— Today, Bill and Melinda Gates share their 2015 Annual Letter.
“Our Big Bet for the Future” addresses the breakthroughs they see coming over the next fifteen years that will improve the lives of people in poor countries faster than at any other time in history.
Annual Letter segment – One: Health Child deaths will go down, and more diseases will be wiped out

Meeting Twenty: The Presidential Commission for the Study of Bioethical Issues – Focus on the current Ebola virus disease (EVD) epidemic
February 5-6, 2015, Washington, D.C.
Federal Register Notice
Agenda
Watch the live webcast Feb. 5-6
Location: The Hamilton Crowne Plaza Hotel, 1001 14th St. NW, Washington, DC 20005

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The Commission is considering three areas of ethical concern raised by public health emergency response with a focus on the current Ebola virus disease (EVD) epidemic. The first area concerns U.S. public policies that restrict association or movement (such as quarantine), which have recently been proposed and/or employed for health care workers and military personnel returning from countries affected by EVD in western Africa.

The second area concerns the ethics of placebo-controlled trials in the context of public health emergencies, and the EVD epidemic specifically, where the drug undergoing testing might be effective against the disease causing the emergency.
The third area of concern is the ethical considerations relevant to collecting and storing biospecimens during a public health emergency, such as the EVD epidemic, and sharing these
specimens and associated data internationally for future research…

The Bioethics Commission Requests Comment on Ethical Considerations in the EVD Response
…The Commission is particularly interested in receiving public commentary regarding the following issues in the context of public health emergency response generally and the EVD epidemic specifically:
:: Ethical and scientific standards for public health emergency response;
:: Ethical and scientific standards that guide the use of quarantine or other movement restrictions during public health emergencies;
:: The impact of quarantine or other movement restrictions on the availability or willingness of health workers to volunteer to contain the epidemic in disease-affected areas;
:: The impact of quarantine or other movement restrictions on public fear and anxiety about potential threats to public health;
:: How U.S. public policy and public health response to the current EVD epidemic might or should affect public attitudes to, and further U.S. policy and public health response to, other current and future public health issues and emergencies;
:: Ethical and scientific standards for placebo-controlled trials during public health emergencies;
:: Ethical and scientific standards for collection, storage, and international sharing of biospecimens and associated data during public health emergencies.

Annals of Internal Medicine
20 January 2015, Vol. 162. No. 2
http://annals.org/issue.aspx

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Ideas and Opinions | 20 January 2015
Drug and Vaccine Access in the Ebola Epidemic: Advising Caution in Compassionate Use
Andrew Hantel, MD; and Christopher Olusola Olopade, MD, MPH
Article and Author Information
Ann Intern Med. 2015;162(2):141-142. doi:10.7326/M14-2002
This article was published online first at http://www.annals.org on 14 October 2014.

BMC Health Services Research
http://www.biomedcentral.com/bmchealthservres/content
(Accessed 24 January 2015)

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Research article
Cost to households in treating maternal complications in northern Ghana: a cross sectional study
Maxwell Ayindenaba Dalaba12*, Patricia Akweongo3, Raymond Akawire Aborigo24, Happiness Pius Saronga15, John Williams2, Gifty Apiung Aninanya2, Rainer Sauerborn1 and Svetla Loukanova1
Author Affiliations
BMC Health Services Research 2015, 15:34 doi:10.1186/s12913-014-0659-1
Published: 22 January 2015
Abstract (provisional)
Background
The cost of treating maternal complications has serious economic consequences to households and can hinder the utilization of maternal health care services at the health facilities. This study estimated the cost of maternal complications to women and their households in the Kassena-Nankana district of northern Ghana.
Methods
We carried out a cross-sectional study between February and April 2014 in the Kassena-Nankana district. Out of a total of 296 women who were referred to the hospital for maternal complications from the health centre level, sixty of them were involved in the study. Socio-demographic data of respondents as well as direct and indirect costs involved in the management of the complications at the hospital were collected from the patient’s perspective. Analysis was performed using STATA 11.ResultsOut of the 60 respondents, 60% (36) of them suffered complications due to prolonged labour, 17% (10) due to severe abdominal pain, 10%(6) due to anaemia/malaria and 7%(4) due to pre-eclampsia . Most of the women who had complications were primiparous and were between 21?25 years old. Transportation cost accounted for the largest cost, representing 32% of total cost of treatment. The median direct medical cost was US$8.68 per treatment, representing 44% of the total cost of treatment. Indirect costs accounted for the largest proportion of total cost (79%). Overall, the median expenditure by households on both direct and indirect costs per complication was US$32.03. Disaggregating costs by type of complication, costs ranged from a median of US$58.33 for pre-eclampsia to US$6.84 for haemorrrhage. The median number of days spent in the hospital was 2?days – five days for pre-eclampsia. About 33%( 6) of households spent more than 5% of annual household expenditure and therefore faced catastrophic payments.
Conclusion
Although maternal health services are free in Ghana, women still incur substantial costs when complications occur and face the risk of incurring catastrophic health expenditure.

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Research article
Mobile phone text messaging interventions for HIV and other chronic diseases: an overview of systematic reviews and framework for evidence transfer
Lawrence Mbuagbaw123*, Sara Mursleen1, Lyubov Lytvyn1, Marek Smieja14, Lisa Dolovich5 and Lehana Thabane12678
Author Affiliations
BMC Health Services Research 2015, 15:33 doi:10.1186/s12913-014-0654-6
Published: 22 January 2015
Abstract (provisional)
Background
Strong international commitment and the widespread use of antiretroviral therapy have led to higher longevity for people living with human immune deficiency virus (HIV). Text messaging interventions have been shown to improve health outcomes in people living with HIV. The objectives of this overview were to: map the state of the evidence of text messaging interventions, identify knowledge gaps, and develop a framework for the transfer of evidence to other chronic diseases.
Methods
We conducted a systematic review of systematic reviews on text messaging interventions to improve health or health related outcomes. We conducted a comprehensive search of PubMed, EMBASE (Exerpta Medica Database), CINAHL (Cumulative Index to Nursing and Allied Health Literature), PsycINFO, Web of Science (WoS) and the Cochrane Library on the 17th April 2014. Screening, data extraction and assessment of methodological quality were done in duplicate. Our findings were used to develop a conceptual framework for transfer.
Results
Our search identified 135 potential systematic reviews of which nine were included, reporting on 37 source studies, conducted in 19 different countries. Seven of nine (77.7%) of these reviews were high quality. There was some evidence for text messaging as a tool to improve adherence to antiretroviral therapy. Text messages also improved attendance at appointments and behaviour change outcomes. The findings were inconclusive for self-management of illness, treatment of tuberculosis and communicating results of medical investigations. The geographical distribution of text messaging research was limited to specific regions of the world. Prominent knowledge gaps included the absence of data on long term outcomes, patient satisfaction, and economic evaluations. The included reviews also identified methodological limitations in many of the primary studies.
Conclusions
Global evidence supports the use of text messaging as a tool to improve adherence to medication and attendance at scheduled appointments. Given the similarities between HIV and other chronic diseases (long-term medications, life-long care, strong link to behaviour and the need for home-based support) evidence from HIV may be transferred to these diseases using our proposed framework by integration of HIV and chronic disease services or direct transfer.

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Research article
How rural and urban parents describe convenience in the context of school-based influenza vaccination: a qualitative study
Candace Lind1*, Margaret L Russell2, Ramona Collins1, Judy MacDonald3, Christine J Frank1 and Amy E Davis4
Author Affiliations
BMC Health Services Research 2015, 15:24 doi:10.1186/s12913-014-0663-5
Published: 22 January 2015
Abstract (provisional)
Background
Seasonal influenza vaccine uptake among school-age children has been low, particularly among rural children, even in jurisdictions in Canada where this immunization is publicly funded. Providing this vaccination at school may be convenient for parents and might contribute to increased vaccine uptake, particularly among rural children. We explore the construct of convenience as an advantage of school based influenza vaccination. We also explore for rural urban differences in this construct.
Methods
Participants were parents of school-aged children from Alberta, Canada. We qualitatively analyzed focus group data from rural parents using a thematic template that emerged from prior work with urban parents. Both groups of parents had participated in focus groups to explore their perspectives on the acceptability of adding an annual influenza immunization to the immunization program that is currently delivered in Alberta schools. Data from within the theme of `convenience? from both rural and urban parents were then further explored for sub-themes within convenience.
Results
Data were obtained from nine rural and nine urban focus groups. The template of themes that had arisen from prior analysis of the urban data applied to the rural data. Convenience was a third level theme under Advantages. Five fourth level themes emerged from within convenience. Four of the five sub-themes were common to both rural and urban participants: reduction of parental burden to schedule, reduction in parental lost time, decrease in parental stress and increase in physical access points for influenza immunization. The fifth subtheme, increases temporal access to influenza immunization, emerged uniquely from the rural data.
Conclusions
Both rural and urban parents perceived that convenience would be an advantage of adding an annual influenza immunization to the vaccinations currently given to Alberta children at school. Improving temporal access to such immunization may be a more relevant aspect of convenience to rural than to urban parents.

Emerging Infectious Diseases
Volume 21, Number 2—February 2015
http://wwwnc.cdc.gov/eid/

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Perspective
Evaluation of Border Entry Screening for Infectious Diseases in Humans
Linda A. Selvey , Catarina Antão, and Robert Hall
Author affiliations: Curtin University, Perth, Western Australia, Australia (L.A. Selvey, C. Antão); Monash University, Melbourne, Victoria, Australia (R. Hall)
Abstract
In response to the severe acute respiratory syndrome (SARS) pandemic of 2003 and the influenza pandemic of 2009, many countries instituted border measures as a means of stopping or slowing the spread of disease. The measures, usually consisting of a combination of border entry/exit screening, quarantine, isolation, and communications, were resource intensive, and modeling and observational studies indicate that border screening is not effective at detecting infectious persons. Moreover, border screening has high opportunity costs, financially and in terms of the use of scarce public health staff resources during a time of high need. We discuss the border-screening experiences with SARS and influenza and propose an approach to decision-making for future pandemics. We conclude that outbreak-associated communications for travelers at border entry points, together with effective communication with clinicians and more effective disease control measures in the community, may be a more effective approach to the international control of communicable diseases.

The European Journal of Public Health
Volume 25, Issue 1, 01 February 2015
http://eurpub.oxfordjournals.org/content/24/6

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Migration and health
Suicide among immigrants in Europe—a systematic literature review
Jacob Spallek, Anna Reeske, Marie Norredam, Signe Smith Nielsen, Jessica Lehnhardt, Oliver Razum
Eur J Public Health (2015) 25 (1): 63-71
DOI: http://dx.doi.org/10.1093/eurpub/cku121
First published online: 5 August 2014 (9 pages)
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How do immigrants use primary health care services? A register-based study in Norway
Esperanza Diaz, Amaia Calderón-Larrañaga, Alexandra Prado-Torres, Beatriz Poblador-Plou, Luis-Andrés Gimeno-Feliu
Eur J Public Health (2015) 25 (1): 72-78
DOI: http://dx.doi.org/10.1093/eurpub/cku123
First published online: 1 August 2014 (7 pages)
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Caesarean section by immigrants’ length of residence in Norway: a population-based study
Ingvil K. Sørbye, Anne K. Daltveit, Johanne Sundby, Camilla Stoltenberg, Siri Vangen
Eur J Public Health (2015) 25 (1): 78-84
DOI: http://dx.doi.org/10.1093/eurpub/cku135
First published online: 5 September 2014 (7 pages)
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Remigration of migrants with severe disease: myth or reality?—a register-based cohort study
Marie Norredam, Oluf Hoejbjerg Hansen, Jørgen Holm Petersen, Anton E Kunst, Maria Kristiansen, Allan Krasnik, Charles Agyemang
Eur J Public Health (2015) 25 (1): 84-89
DOI: http://dx.doi.org/10.1093/eurpub/cku138
First published online: 8 September 2014 (6 pages)
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Sexual and gender-based violence in the European asylum and reception sector: a perpetuum mobile?
Ines Keygnaert, Sonia F. Dias, Olivier Degomme, Walter Devillé, Patricia Kennedy, András Kováts, Sara De Meyer, Nicole Vettenburg, Kristien Roelens, Marleen Temmerman
Eur J Public Health (2015) 25 (1): 90-96
DOI: http://dx.doi.org/10.1093/eurpub/cku066
First published online: 29 May 2014 (7 pages)

Journal of Pediatrics
February 2015 Volume 166, Issue 2, p215-506
http://www.jpeds.com/current

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Frequent Vaccination Missed Opportunities at Primary Care Encounters Contribute to Underimmunization
Linda Y. Fu, MD, MS, Kathleen Zook, RN, MPH, Janet Gingold, MD, MPH, Catherine W. Gillespie, PH, PhD, Christine Briccetti, MD, MPH, Denice Cora-Bramble, MD, MBA, Jill G. Joseph, MD, PhD, Rachel Y. Moon, MD
Received: June 17, 2014; Received in revised form: September 10, 2014; Accepted: October 24, 2014; Published Online: November 21, 2014
DOI: http://dx.doi.org/10.1016/j.jpeds.2014.10.066
Abstract
Objective
To examine missed opportunities to administer an eligible vaccination (MOs) and their contribution to underimmunization in contemporary pediatric practices.
Study design
This study was a retrospective analysis from 42 diverse pediatric practices located throughout the US. Medical records of 50 randomly selected children 3-18 months of age per practice were reviewed in Spring 2013. Immunization status for age and MOs were assessed as of each encounter and as of March 1, 2013.
Results
Of 2076 eligible patients, 72.7% (95% CI 67.6-77.9) were up-to-date with receipt of standard vaccines. Most children (82.4%; 95% CI 78.3-85.9) had at least 1 MO, and 37.8% (95% CI 30.0-46.2) had at least one MO to administer an overdue vaccination. After adjustment, risk of underimmunization was 3.5 times greater for patients who had ever experienced an MO for an overdue vaccination compared with those who had not (adjusted relative risk = 3.5; 95% CI 2.8-4.3). If all age-appropriate vaccinations had been administered at the last recorded encounter, 45.5% (95% CI 36.8-54.5) of the underimmunized patients would have been up to date at the time of assessment.
Conclusion
MOs were common and contributed substantially to underimmunization in this contemporary sample of diverse primary care practice settings.

Nature
Volume 517 Number 7535 pp411-522 22 January 2015
http://www.nature.com/nature/current_issue.html

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Nature | Article
A new antibiotic kills pathogens without detectable resistance
Losee L. Ling, Tanja Schneider, Aaron J. Peoples, Amy L. Spoering, Ina Engels, Brian P. Conlon, Anna Mueller, Till F. Schäberle, Dallas E. Hughes, Slava Epstein, Michael Jones, Linos Lazarides,
Victoria A. Steadman, Douglas R. Cohen, Cintia R. Felix, K. Ashley Fetterman, William P. Millett,
Anthony G. Nitti, Ashley M. Zullo, Chao Chen & Kim Lewis
Affiliations
Nature 517, 455–459 (22 January 2015)
doi:10.1038/nature14098
Abstract
Antibiotic resistance is spreading faster than the introduction of new compounds into clinical practice, causing a public health crisis. Most antibiotics were produced by screening soil microorganisms, but this limited resource of cultivable bacteria was overmined by the 1960s. Synthetic approaches to produce antibiotics have been unable to replace this platform. Uncultured bacteria make up approximately 99% of all species in external environments, and are an untapped source of new antibiotics. We developed several methods to grow uncultured organisms by cultivation in situ or by using specific growth factors. Here we report a new antibiotic that we term teixobactin, discovered in a screen of uncultured bacteria. Teixobactin inhibits cell wall synthesis by binding to a highly conserved motif of lipid II (precursor of peptidoglycan) and lipid III (precursor of cell wall teichoic acid). We did not obtain any mutants of Staphylococcus aureus or Mycobacterium tuberculosis resistant to teixobactin. The properties of this compound suggest a path towards developing antibiotics that are likely to avoid development of resistance.

New England Journal of Medicine
January 22, 2015 Vol. 372 No. 4
http://www.nejm.org/toc/nejm/medical-journal

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Perspective
Foreseeable Risks? Informed Consent for Studies within the Standard of Care
Chana A. Sacks, M.D., and Celestine E. Warren, A.B.
N Engl J Med 2015; 372:306-307 January 22, 2015 DOI: 10.1056/NEJMp1415113
The Office for Human Research Protections has drafted guidelines on disclosing reasonably foreseeable risks in trials involving interventions that are within the standard of care. But what risks, aside from those already seen in clinical care, are reasonably foreseeable?

Pediatrics
January 2015, VOLUME 135 / ISSUE 1
http://pediatrics.aappublications.org/current.shtml
[Reviewed earlier]
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Published online January 19, 2015
Article
Geographic Clusters in Underimmunization and Vaccine Refusal
Tracy A. Lieu, MD, MPHa, G. Thomas Ray, MBAa, Nicola P. Klein, MD, PhDa,b, Cindy Chung, MDc, and Martin Kulldorff, PhDd
Author Affiliations
aDivision of Research, Kaiser Permanente Northern California, Oakland, California;
bVaccine Study Center, Kaiser Permanente, Oakland, California;
cDepartment of Pediatrics, San Rafael Medical Center, Kaiser Permanente Northern California, San Rafael, California; and
dDepartment of Population Medicine, Harvard Pilgrim Health Care and Harvard Medical School, Boston, Massachusetts
(doi: 10.1542/peds.2014-2715)
Abstract
BACKGROUND AND OBJECTIVE: Parental refusal and delay of childhood vaccines has increased in recent years and is believed to cluster in some communities. Such clusters could pose public health risks and barriers to achieving immunization quality benchmarks. Our aims were to (1) describe geographic clusters of underimmunization and vaccine refusal, (2) compare clusters of underimmunization with different vaccines, and (3) evaluate whether vaccine refusal clusters may pose barriers to achieving high immunization rates.
METHODS: We analyzed electronic health records among children born between 2000 and 2011 with membership in Kaiser Permanente Northern California. The study population included 154 424 children in 13 counties with continuous membership from birth to 36 months of age. We used spatial scan statistics to identify clusters of underimmunization (having missed 1 or more vaccines by 36 months of age) and vaccine refusal (based on International Classification of Diseases, Ninth Revision, Clinical Modification codes).
RESULTS: We identified 5 statistically significant clusters of underimmunization among children who turned 36 months old during 2010–2012. The underimmunization rate within clusters ranged from 18% to 23%, and the rate outside them was 11%. Children in the most statistically significant cluster had 1.58 (P < .001) times the rate of underimmunization as others. Underimmunization with measles, mumps, rubella vaccine and varicella vaccines clustered in similar geographic areas. Vaccine refusal also clustered, with rates of 5.5% to 13.5% within clusters, compared with 2.6% outside them.
CONCLUSIONS: Underimmunization and vaccine refusal cluster geographically. Spatial scan statistics may be a useful tool to identify locations with challenges to achieving high immunization rates, which deserve focused intervention.

PLoS Currents: Outbreaks
http://currents.plos.org/outbreaks/
(Accessed 24 January 2015)

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The Western Africa Ebola Virus Disease Epidemic Exhibits Both Global Exponential and Local Polynomial Growth Rates
January 21, 2015 • Research
Abstract
Background:
While many infectious disease epidemics are initially characterized by an exponential growth in time, we show that district-level Ebola virus disease (EVD) outbreaks in West Africa follow slower polynomial-based growth kinetics over several generations of the disease.
Methods:
We analyzed epidemic growth patterns at three different spatial scales (regional, national, and subnational) of the Ebola virus disease epidemic in Guinea, Sierra Leone and Liberia by compiling publicly available weekly time series of reported EVD case numbers from the patient database available from the World Health Organization website for the period 05-Jan to 17-Dec 2014.
Results:
We found significant differences in the growth patterns of EVD cases at the scale of the country, district, and other subnational administrative divisions. The national cumulative curves of EVD cases in Guinea, Sierra Leone, and Liberia show periods of approximate exponential growth. In contrast, local epidemics are asynchronous and exhibit slow growth patterns during 3 or more EVD generations, which can be better approximated by a polynomial than an exponential function.
Conclusions:
The slower than expected growth pattern of local EVD outbreaks could result from a variety of factors, including behavior changes, success of control interventions, or intrinsic features of the disease such as a high level of clustering. Quantifying the contribution of each of these factors could help refine estimates of final epidemic size and the relative impact of different mitigation efforts in current and future EVD outbreaks.

Vaccine
Volume 33, Issue 6, Pages 749-832 (4 February 2015)
http://www.sciencedirect.com/science/journal/0264410X/33/6

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Use of placebos in Phase 1 preventive HIV vaccine clinical trials
Pages 749-752
Yunda Huang, Shelly T. Karuna, Holly Janes, Nicole Frahm, Martha Nason, Paul T. Edlefsen, James G. Kublin, Lawrence Corey, M. Juliana McElrath, Peter B. Gilbert
Abstract
Phase 1 preventive HIV vaccine trials are often designed as randomized, double-blind studies with the inclusion of placebo recipients. Careful consideration is needed to determine when the inclusion of placebo recipients is highly advantageous and when it is optional for achieving the study objectives of assessing vaccine safety, tolerability and immunogenicity. The inclusion of placebo recipients is generally important to form a reference group that ensures fair evaluation and interpretation of subjective study endpoints, or endpoints whose levels may change due to exposures besides vaccination. In some settings, however, placebo recipients are less important because other data sources and tools are available to achieve the study objectives.
Highlights
:: Study objectives and the research context drive the design of Phase 1 preventive HIV vaccine trials.
:: The inclusion of placebo recipients enables blinding and fair assessment of study endpoints.
:: The inclusion of placebo recipients provides valuable in-study reference data.
:: Placebo recipients are less important for vaccines with extensive safety data.
:: Placebo recipients are less important when baseline data are proper as reference information.

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How and why researchers use the number needed to vaccinate to inform decision making—A systematic review
Review Article
Pages 753-758
Ahmed Hashim, Vica Dang, Shelly Bolotin, Natasha S. Crowcroft
Abstract
Background
The number needed to vaccinate (NNV) is a measure that has been widely used in the scientific literature to draw conclusions about the usefulness and cost-effectiveness of various immunization programmes. The main objective of this review is to examine how and why the NNV has been used and reported in the published literature.
Methods
Electronic databases were searched and records were screened against the eligibility criteria by two independent authors. We included papers that reported and interpreted NNV.
Results
We identified 27 studies, the designs including observational studies, economic analyses, systematic reviews, and commentaries. The NNV has been used in the literature to describe three main themes: potential benefits of vaccination programmes, cost-effectiveness, and economic analyses, and modelling studies to compare different vaccination strategies.
Conclusions
NNV has been used in a wide variety of ways in the literature, yet there are no defined thresholds for what is a favourable NNV. Furthermore, the generalizability of the NNV is usually limited. Further work is required to determine the most appropriate use of this measure.

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Interventions to increase influenza vaccination rates in children with high-risk conditions—A systematic review
Review Article
Pages 759-770
N.W. Aigbogun, J.I. Hawker, A. Stewart
Highlights
:: Influenza is a common cause of morbidity and mortality, and children with high-risk conditions (HRCs) are more likely to be hospitalized with influenza than previously healthy children.
:: Despite recommendations by the World Health Organization (WHO), annual influenza vaccination rates in children with HRCs have remained low, especially when compared to rates in other risk groups such as the elderly and pregnant women.
:: This systematic review identifies, describes and compares studies of interventions to improve influenza vaccination rates in children with HRCs – we found good evidence that reminder letters are effective, but weak evidence of effectiveness of other strategies or combination of strategies.
:: There is a need for further research of these interventions, possibly outside the United States, as almost all of the studies included in this review originated from there.

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Asking about human papillomavirus vaccination and the usefulness of registry validation: A study of young women recruited using Facebook
Original Research Article
Pages 826-831
Bharathy Gunasekaran, Yasmin Jayasinghe, Julia M.L. Brotherton, Yeshe Fenner, Elya E. Moore, John D. Wark, Ashley Fletcher, Sepehr N. Tabrizi, Suzanne M. Garland
Abstract
Background
Australia was the first country to implement a government-funded National Human Papillomavirus (HPV) Vaccination Programme. We assessed HPV vaccine uptake comparing self-reported and Register validated estimates, and the knowledge and attitudes of young women with regards to HPV vaccination post-implementation of the programme.
Methods
Females, aged 16–25 years living in Victoria, Australia, were recruited using targeted advertising on Facebook from May to September 2010, to complete a web-based questionnaire.
Results
Geographic distribution, Indigenous and socio-economic status of the 278 participants were representative of the target population. Overall, 210/278 (76%) had heard of HPV vaccines, with 162/278 (58%) reporting receipt of at least one dose of vaccine, and 54 (19%) unsure. Verification of HPV vaccination status of 142 consenting participants (51%) showed 71% had received at least one dose. Main reasons for vaccination were for protection against HPV infection and cervical cancer (96%) and because it was free (87%), whereas unvaccinated women were uncertain of their eligibility (50%), concerned about adverse reactions (32%), or perceived that vaccination was not needed if they were monogamous (32%).
Conclusion
The potential utility of a vaccination register in the context of a national programme is apparent from the large proportion of young women who were unsure of their vaccine status. HPV vaccine knowledge among participants was relatively high suggesting the national programme has successfully communicated to the majority of eligible women, the purpose and limitations of the vaccine. Vigilance is needed to ensure that young women follow through with Pap testing in vaccine eligible cohorts. The ongoing vaccination programme for pre-adolescent girls and boys should communicate to parents that those with one sexual partner can still acquire HPV and that the safety of the vaccine is now well demonstrated.

Vaccine
Volume 33, Issue 5, Pages 585-748 (29 January 2015)
http://www.sciencedirect.com/science/journal/0264410X/33/5

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Age at HPV vaccine initiation and completion among US adolescent girls: Trend from 2008 to 2012
Pages 585-587
Mahbubur Rahman, Christine J. McGrath, Jacqueline M. Hirth, Abbey B. Berenson
Highlights
:: We analyzed National Immunization Survey of Teens 2008–2012 data to examine what proportion of adolescent girls receives HPV vaccine at <13 years of age.
:: The weighted proportion of girls who initiated the vaccine at <13 years of age increased from 14.1% in 2008 to 55.9% in 2012.
:: Additional efforts are needed to increase HPV vaccine uptake among adolescent girls as only half of them receive this vaccine at ACIP recommended age.

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Supporting countries in establishing and strengthening NITAGs: Lessons learned from 5 years of the SIVAC initiative
Review Article
Pages 588-595
Alex Adjagba, Kamel Senouci, Robin Biellik, Nyambat Batmunkh, Pape Coumba Faye, Antoine Durupt, Bradford D. Gessner, Alfred da Silva
Abstract
To empower governments to formulate rational policies without pressure from any group, and to increase the use of evidence-based decision-making to adapt global recommendations on immunization to their local context, the WHO has recommended on multiple occasions that countries should establish National Immunization Technical Advisory Groups (NITAGs). The World Health Assembly (WHA) reinforced those recommendations in 2012 when Member States endorsed the Decade of Vaccines Global Vaccine Action Plan (GVAP). NITAGs are multidisciplinary groups of national experts responsible for providing independent, evidence-informed advice to health authorities on all policy-related issues for all vaccines across all populations. In 2012, according to the WHO–UNICEF Joint Reporting Form, among 57 countries eligible for immunization program financial support from the GAVI Alliance, only 9 reported having a functional NITAG. Since 2008, the Supporting Independent Immunization and Vaccine Advisory Committees (SIVAC) Initiative (at the Agence de Médecine Préventive or AMP) in close collaboration with the WHO and other partners has been working to accelerate and systematize the establishment of NITAGs in low- and middle-income countries. In addition to providing direct support to countries to establish advisory groups, the initiative also supports existing NITAGs to strengthen their capacity in the use of evidence-based processes for decision-making aligned with international standards. After 5 years of implementation and based on lessons learned, we recommend that future efforts should target both expanding new NITAGs and strengthening existing NITAGs in individual countries, along three strategic lines: (i) reinforce NITAG institutional integration to promote sustainability and credibility, (ii) build technical capacity within NITAG secretariats and evaluate NITAG performance, and (iii) increase networking and regional collaborations. These should be done through the development and dissemination of tools and guidelines, and information through a variety of adapted mechanisms.

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The role of parental attitudes and provider discussions in uptake of adolescent vaccines
Original Research Article
Pages 642-647
Vaughn I. Rickert, Susan J. Rehm, Matthew C. Aalsma, Gregory D. Zimet
Abstract
The purpose of this study was to examine the relationship between parental vaccine attitudes, the number of specific vaccines discussed with a provider, and immunization outcomes including discussing immunization with their teen, knowledge of adolescent vaccine schedule, and their son or daughter being up-to-date on recommended vaccines using a nationally weight sample. Parents completed an internet-based survey between December 2012 and January 2013 and we computed a vaccine attitude scale (higher scores indicating stronger and more positive attitudes toward vaccination of teen) for each parent and categorized them into one of three groups: low (n = 76), medium (n = 207) or high (n = 215). We also constructed a vaccine discussion scale representing the number of vaccines discussed with their adolescent’s physician. Parents who were identified as having high vaccine attitudes were significantly more likely to report their physician talked with them about a particular vaccine. Using logistic regression and controlling for respondent’s gender and age, income, and teen’s gender, we found medium as compared to low-attitude parents had a 6.21 (95%CI = 3.08, 12.51) greater odds of reporting that their teen had all recommended vaccines. Similarly, high as compared to low-attitude parents reported a 23.02 (95% CI = 11.27, 46.99) greater odds of having a teen who was up-to-date on recommended vaccines. We detected that for each additional vaccine discussed, there was a 1.24 (95%CI = 1.11, 1.39) increase in odds of the teen having all recommended vaccines. Parental immunization attitudes and provider discussion about vaccines are key ingredients to improving immunization rates among adolescents. While some parents may be reluctant to immunize their son or daughter with a recommended vaccine, vaccine-specific discussions between physicians and parents represent an important first step to continued discussions with providers regarding vaccination. Moreover, vaccine discussions must occur within the context of ongoing conversations about health and disease prevention.

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Using a school-based approach to deliver immunization—Global update
Original Research Article
Pages 719-725
Jos Vandelaer, Marianne Olaniran
Highlights
:: In 2012, school-based immunization was used in 95 out of 174 countries.
:: Tetanus and diphtheria toxoids are the most frequently administered antigens.
:: All school grades are targeted, but most countries give doses in first and sixth grade.
:: The approach can be a platform to reach school-aged children with immunization and other interventions but special approaches are needed to reach out-of-school and absent children.

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Expected cost effectiveness of high-dose trivalent influenza vaccine in US seniors
Pages 734-741
Ayman Chit, Julie Roiz, Benjamin Briquet, David P. Greenberg
Abstract
Objectives
Seniors are particularly vulnerable to complications resulting from influenza infection. Numerous influenza vaccines are available to immunize US seniors, and practitioners must decide which product to use. Options include trivalent and quadrivalent standard-dose inactivated influenza vaccines (IIV3 and IIV4 respectively), as well as a high-dose IIV3 (HD). Our research examines the public health impact, budget impact, and cost-utility of HD versus IIV3 and IIV4 for immunization of US seniors 65 years of age and older.
Methods
Our model was based on US influenza-related health outcome data. Health care costs and vaccine prices were obtained from the Centers for Medicare and Medicaid Services. Efficacies of IIV3 and IIV4 were estimated from various meta-analyses of IIV3 efficacy. The results of a head-to-head randomized controlled trial of HD vs. IIV3 were used to estimate relative efficacy of HD. Conservatively, herd protection was not considered.
Results
Compared to IIV3, HD would avert 195,958 cases of influenza, 22,567 influenza-related hospitalizations, and 5423 influenza-related deaths among US seniors. HD generates 29,023 more Quality Adjusted Life Years (QALYs) and a net societal budget impact of $154 million. The Incremental Cost Effectiveness Ratio (ICER) for this comparison is $5299/QALY. 71% of the probabilistic sensitivity analysis (PSA) simulations were <$100,000/QALY.
Compared to IIV4, HD would avert 169,257 cases of influenza, 21,222 hospitalizations and 5212 deaths. HD generates 27,718 more QALYs and a net societal budget impact of −$17 million and as such dominates IIV4. For this comparison, 81% of PSA simulations were <$100,000/QALY.
Conclusions
HD is expected to achieve significant reductions in influenza-related morbidity and mortality. Further, HD is a cost effective alternative to both IIV3 and IIV4 in seniors. Our conclusions were robust in the face of sensitivity analyses.

From Google Scholar & other sources: Selected Journal Articles, Newsletters, Dissertations, Theses, Commentary

Influenza and Other Respiratory Viruses
January 2015 Volume 9, Issue 1 Pages i–i, 1–57
http://onlinelibrary.wiley.com/doi/10.1111/irv.2014.9.issue-1/issuetoc
Short Article
Introducing seasonal influenza vaccine in low‐income countries: an adverse events following immunization survey in the Lao People’s Democratic Republic
Manilay Phengxay1,*, Sara A. Mirza2, Rita Reyburn1, Anonh Xeuatvongsa3, Christian Winter1, Hannah Lewis1, Sonja J. Olsen2, Reiko Tsuyuoka1, Viengphone Khanthamaly4, Francisco S. Palomeque2, Joseph S. Bresee2, Ann C. Moen2, Andrew L. Corwin4 and for the Lao PDR Field Epidemiology Training Cohort Team†
Article first published online: 17 JAN 2015
DOI: 10.1111/irv.12299
Abstract
Objective
In 2012, Lao PDR introduced seasonal influenza vaccine in pregnant women, persons aged ≥50 years, persons with chronic diseases, and healthcare personnel. We assessed adverse events following immunization (AEFI).
Methods
We used a multistage randomized cluster sample design to interview vaccine recipients.
Findings
Between April and May 2012, 355 902 were vaccinated. Of 2089 persons interviewed, 261 (12•5%) reported one or more AEFI. The most commonly reported AEFIs were local reactions. No hospitalizations or deaths were reported; 16% sought medical care. Acceptance and awareness of vaccination were high.
Conclusions
Following the introduction of seasonal influenza vaccine in Lao PDR, self-reported adverse events were mild.

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American Journal of Men’s Health (AJMH)
January 2015; 9 (1)
http://jmh.sagepub.com/content/current
Published online before print January 15, 2015, doi: 10.1177/1557988314567324
Has Their Son Been Vaccinated? Beliefs About Other Parents Matter for Human Papillomavirus Vaccine
Christine L. Schuler, MD, MPH1, Tamera Coyne-Beasley, MD, MPH2
1Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, USA
2University of North Carolina, Chapel Hill, NC, USA
Abstract
The goal of this study was to determine if parents’ beliefs about social norms of human papillomavirus (HPV) vaccination for sons were associated with knowledge of HPV, intention to vaccinate sons, or beliefs about side effects. A cross-sectional, survey-based study of parents with sons was performed in 2010. Fisher’s exact tests were used to examine associations between demographics and responses about social norms. Multivariate logistic regression models examined beliefs about social norms of male HPV vaccination and primary outcomes.

Few parents agreed that others were vaccinating sons (n = 31/267, 12%), including 1% responding strongly agree and 11% responding agree. Most parents, 52%, disagreed that others were vaccinating (40% disagree, 11% strongly disagree), and 37% chose prefer not to answer regarding others’ vaccination practices. Hispanic parents and those with a high school education or less were significantly more likely to choose prefer not to answer than their respective counterparts regarding vaccination norms. In multivariate models, parents agreeing others were vaccinating sons had greater odds of having high knowledge of HPV (adjusted odds ratio [aOR] high vs low knowledge 3.15, 95% confidence interval [CI] 1.13, 8.77) and increased intention to vaccinate sons (n = 243, aOR = 4.41, 95% CI = 1.51, 12.89).

Beliefs about side effects were not significantly associated with beliefs about social norms. Parents’ beliefs about others’ vaccination practices are important with regard to knowledge of HPV and intention to vaccinate sons. Studying how various public messages about HPV vaccine may influence normative beliefs could be relevant to improving vaccination coverage.

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Journal of Paediatrics and Child Health
January 2015 Volume 51, Issue 1 Pages 1–128
http://onlinelibrary.wiley.com/doi/10.1111/jpc.2015.51.issue-1/issuetoc
Article first published online: 14 JAN 2015
Review Article
Conquering rotavirus: From discovery to global vaccine implementation
Julie E Bines1,2,3,* and Carl D Kirkwood1,2
DOI: 10.1111/jpc.12815
Abstract
Rotavirus, the commonest cause of severe dehydrating gastroenteritis world-wide, was discovered less than 50 years ago. It causes about 450 000 deaths per year in children <5 years of age and hospitalises millions more. Rotavirus vaccines have been shown to have a major impact on hospital admissions due to rotavirus gastroenteritis and all-cause gastroenteritis and reduce mortality in developing countries. In Australia, there has been a 71% decrease in rotavirus hospitalisations in children 0–5 years of age. From the discovery of rotavirus as the major causative agent for severe gastroenteritis, through vaccine development and vaccine post-marketing surveillance activities, Australian scientists and clinicians have played a significant role in the global effort to reduce the burden of rotavirus infection.

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Nature Genetics
January 2015, Volume 47 No 1 pp1-97
http://www.nature.com/ng/journal/v47/n1/index.html
Published online 19 January 2015
Evolutionary history and global spread of the Mycobacterium tuberculosis Beijing lineage
Matthias Merker, Camille Blin, Stefano Mona, Nicolas Duforet-Frebourg, Sophie Lecher, Eve Willery, Michael Blum, Sabine Rüsch-Gerdes, Igor Mokrousov, Eman Aleksic, Caroline Allix-Béguec, Annick Antierens, Ewa Augustynowicz-Kopeć, Marie Ballif, Francesca Barletta, Hans Peter Beck, Clifton E Barry III, Maryline Bonnet, Emanuele Borroni, Isolina Campos-Herrero,
Daniela Cirillo, Helen Cox, Suzanne Crowe, Valeriu Crudu, Roland Diel et al.
Affiliations
doi:10.1038/ng.3195
Abstract
Mycobacterium tuberculosis strains of the Beijing lineage are globally distributed and are associated with the massive spread of multidrug-resistant (MDR) tuberculosis in Eurasia. Here we reconstructed the biogeographical structure and evolutionary history of this lineage by genetic analysis of 4,987 isolates from 99 countries and whole-genome sequencing of 110 representative isolates. We show that this lineage initially originated in the Far East, from where it radiated worldwide in several waves. We detected successive increases in population size for this pathogen over the last 200 years, practically coinciding with the Industrial Revolution, the First World War and HIV epidemics. Two MDR clones of this lineage started to spread throughout central Asia and Russia concomitantly with the collapse of the public health system in the former Soviet Union. Mutations identified in genes putatively under positive selection and associated with virulence might have favored the expansion of the most successful branches of the lineage.

Media/Policy Watch
This section is intended to alert readers to substantive news, analysis and opinion from the general media on vaccines, immunization, global; public health and related themes. Media Watch is not intended to be exhaustive, but indicative of themes and issues CVEP is actively tracking. This section will grow from an initial base of newspapers, magazines and blog sources, and is segregated from Journal Watch above which scans the peer-reviewed journal ecology.

We acknowledge the Western/Northern bias in this initial selection of titles and invite suggestions for expanded coverage. We are conservative in our outlook in adding news sources which largely report on primary content we are already covering above. Many electronic media sources have tiered, fee-based subscription models for access. We will provide full-text where content is published without restriction, but most publications require registration and some subscription level.

The Atlantic
http://www.theatlantic.com/magazine/
Accessed 24 January 2015
The Financial Consequences of a Bad Flu Shot
Bourree Lam Jan 21 2015, 7:30 AM ET
While the CDC doesn’t have an official estimate for the economic costs of ineffective seasonal vaccines, various studies have suggested that resistant viral strains can weigh on the economy.

Forbes
http://www.forbes.com/
Accessed 24 January 2015
Gates Foundation CEO: “History Is Going To Judge Us”
1/16/2015
Sue Desmond-Hellmann, the CEO of The Bill & Melinda Gates Foundation, came to San Francisco this week to meet with some of the life science and healthcare executives in town for the annual JP Morgan Healthcare Conference, which draws thousands of people from around the country and the world. Desmond-Hellmann and I got a chance to talk during her visit about what’s new and what’s in store at the foundation funded by the world’s two richest men — Bill Gates and Warren Buffett.

Desmond-Hellmann became the CEO of what is arguably the world’s largest private foundation (it has a $42.3 billion trust endowment) last May, after serving as chancellor of the University of California, San Francisco and working as the head of development at Genentech, where she led the development of cancer drugs Herceptin and Avastin.

Now, she’s on the other side of the table, trying to coax pharmaceutical company executives to produce vaccines for people in poor countries. “Capitalism and private companies are good at solving problems,” but not necessarily the problems of poor people, said Desmond-Hellmann. “What the foundation has started to do, which is exciting, [is looking at how] can we help create the market conditions that allow private companies to care about and start to work with us to solve the problems.” These are problems including malaria, HIV and neglected infectious diseases, including Ebola…

Fortune
http://fortune.com/
Accessed 24 January 2015
One shot to cure them all: The quest for the universal flu shot
by Erika Fry
January 21, 2015, 8:30 AM EST
The latest flu vaccine is no match for the year’s most common strains—but there’s a better way to fight the virus.

The Huffington Post
http://www.huffingtonpost.com/
Accessed 24 January 2015
A Birthday Gift to Last a Lifetime: Seth Berkley
22 January 2015
For most people a birthday is a cause for celebration, and today, 15 years after Gavi was first born — right here at the World Economic Forum in Davos — is certainly no exception. But for millions of children living in the poorest parts of the world a birthday means so much more, and is a truly life-changing milestone. That’s because growing up for example in sub-Saharan Africa, you are 15 times less likely to live long enough to see your fifth birthday, compared to children in wealthier parts of the world…

New York Times
http://www.nytimes.com/
Accessed 24 January 2015
Liberia Ebola Vaccine Trial ‘Challenging’ as Cases Tumble
January 24, 2015
West Africa, aims to enroll at-risk people such as healthcare staff, family members and burial workers. It will test a GSK vaccine, a rival one from Merck and NewLink, and a placebo. “It may, at this point, be hard to find 27,000…

Doctors Group Urges Measles Shots as Disneyland Outbreak Spreads
spread to more than 80 people in seven states and Mexico. The American Academy of Pediatrics said all children should get the vaccine for measles, mumps and rubella between 12 and 15 months of age and again between 4 and 6 years
January 24, 2015

Wall Street Journal
http://online.wsj.com/home-page?_wsjregion=na,us&_homepage=/home/us
Accessed 24 January 2015
Study of Ebola Drug ZMapp Set for West Africa
24 January 20215
A clinical trial of the experimental Ebola drug ZMapp may be ready to get under way in infected patients in West Africa in February, the latest effort to combat the current epidemic and any future outbreaks.

Washington Post
http://www.washingtonpost.com/
Accessed 24 January 2015
Africa
U.S.-built Ebola treatment centers in Liberia are nearly empty as outbreak fades
Kevin Sieff January 18
…It now appears that the alarming epidemiological predictions that in large part prompted the U.S. aid effort here were far too bleak. Although future flare-ups of the disease are possible, the near-empty Ebola centers tell the story of an aggressive American military and civilian response that occurred too late to help the bulk of the more than 8,300 Liberians who became infected. Last week, even as international aid organizations built yet more Ebola centers, there was an average of less than one new case reported in Liberia per day.
“If they had been built when we needed them, it wouldn’t have been too much,” said Moses Massaquoi, the Liberian government’s chairman for Ebola case management. “But they were too late.”…

Ebola/EVD: Additional Coverage [to 24 January 2015]

UNMEER [UN Mission for Ebola Emergency Response] @UNMEER #EbolaResponse

Editor’s Note: UNMEER’s website is aggregating and presenting content from various sources including its own External Situation Reports, press releases, statements and other formats.
We present a composite below from the week ending 24 January 2015. We also note that 1) a regular information category in these reports – human rights – has apparently eliminated as it no longer appears in any of the continuing updates, and 2) the content level of these reports continues, in our view, to trend less informative and less coherent. We will review continuing coverage of this material over the next few weeks.

UNMEER External Situation Reports
UNMEER External Situation Reports are issued daily (excepting Saturday) with content organized under these headings:
– Highlights
– Key Political and Economic Developments
– Human Rights
– Response Efforts and Health
– Logistics
– Outreach and Education
– Resource Mobilisation
– Essential Services
– Upcoming Events
The “Week in Review” will present highly-selected elements of interest from these reports. The full daily report is available as a pdf using the link provided by the report date.

:: 23 Jan 2015 UNMEER External Situation Report
Key Political and Economic Developments
1. In Davos, Switzerland, a panel discussion on ‘Confronting the Challenge of Catastrophic Outbreaks: What critical lessons can be learned from the 2014 Ebola outbreak to prepare us for the future?’ was held on 22 January. Moderating the talks, Peter Piot, the Director of the London School of Hygiene & Tropical Medicine, characterized the EVD outbreak in West Africa as a black swan event. The panel which included President Alpha Condé of Guinea and WHO Director-General Margaret Chan underscored the need to guard against complacency and donor fatigue, until we get to zero transmission as well as build resilient public health care systems and infrastructure to better cope with future outbreaks and endemic diseases.
Outreach and Education
10. Community resistance towards safe burials and general suspicion of burial teams continues in many parts of the Liberia. UNMEER and partners are engaging more with local communities to enhance awareness in the Phase II national response efforts. In this regard, UNMEER along with county authorities plan to follow up on some recent burials that took place in Flowin, Garbusi and Boapea towns in Nimba County.
Resource Mobilisation
7. The OCHA Ebola Virus Outbreak Overview of Needs and Requirements, now totaling USD 1.5 billion, has been funded for USD 1.18 billion, which is around 79% of the total ask.
8. The Ebola Response Multi-Partner Trust Fund currently has USD 135.8 million in commitments. In total USD 140 million has been pledged.
Essential Services
14. WFP, in coordination with the Government of Liberia, UNMEER and UNICEF, will be supporting re-opening of schools starting in February: WFP will facilitate the transport of WASH supplies to ensure that schools, as they open, have all supplies necessary to prevent the transmission of EVD.
15. In Sierra Leone, two successive emergency campaigns to distribute anti-malarial drugs successfully reached more than 2.5 million people in door-to-door distribution in 8 districts (Bombali, Kambia, Koinadugu, Moyamba, Port Loko and Tonkolili and Western Area – Urban and Rural). The campaign was implemented by the National Malaria Control Programme of the Ministry of Health and Sanitation with technical support and guidance by WHO in collaboration with MSF, UNICEF and other Roll Back Malaria partners. This effort will significantly reduce the number of people with fever that might be mistaken for EVD.

:: 22 Jan 2015 UNMEER External Situation Report
Key Political and Economic Developments
1. In a World Bank Report prepared for the 2015 World Economic Forum in Davos, the Bank acknowledged progress made in slowing the EVD transmission rate, but cautioned that recent efforts have likely reduced the impact of Ebola on the African economy perhaps from USD 30 billion to USD 6 billion. The report noted that most of these losses are forecasted to hit the affected countries.
2. In Davos, Switzerland, Special Envoy David Nabarro provided an updated Overview of Needs and Requirements in the global efforts to stop Ebola. The financial needs for the first six month of 2015 amount to 1.5 billion USD. Almost 500 million USD is already available and the appeal is now for the gap of 1 billion USD.
Response Efforts and Health
7. In Sierra Leone, 19,673 Ebola Response Workers (ERWs) were paid through mobile money between 7 and 19 January. Of these, 96% have cash-out their pay.
Essential Services
18. Following the reopening of schools in Guinea, attendance remain low in the first week. UNICEF and partners continue to monitor schools to ensure measures put in place for the safe return to school are being adhered to around the country. UNICEF and Enfance du Globe provided psychosocial support to 150 children affected by Ebola in Belya.

:: 21 Jan 2015 UNMEER External Situation Report
Key Political and Economic Developments
1. The UN General Assembly held an informal meeting on Ebola, yesterday and received briefings from the Secretary-General, SRSG Ould Cheikh Ahmed, SE David Nabarro and representatives of the affected countries among others. Participants assessed that the global response to address Ebola has significantly slowed transmission, highlighted that there is no room for complacency and reiterated the goal to reach zero transmission.
Logistics
7. WFP is enhancing operational capacity to undertake medical evacuation of humanitarian staff with EVD by deploying a WFP-charted Bell 412 helicopter to Freetown, Sierra Leone on 22 January. Plans are for the aircraft to be based in Freetown initially, and then to operate out of a field location, such as Bo or Port Loko, as required. This is the second dedicated Medevac helicopter that WFP has deployed to the region; the other is stationed in Conakry, serving Guinea.
Essential Services
18. Following the reopening of schools in Guinea, attendance remain low in the first week. UNICEF and partners continue to monitor schools to ensure measures put in place for the safe return to school are being adhered to around the country. UNICEF and Enfance du Globe provided psychosocial support to 150 children affected by Ebola in Belya.

:: 20 Jan 2015 UNMEER External Situation Report
Key Political and Economic Developments
1. In a press interview on his way to the World Economic Forum in Davos, Switzerland, President Alpha Condé of Guinea called on the IMF to cancel the debt of his country as well as of Liberia and Sierra Leone. He further indicated that the cancellation should be for bilateral and multilateral debt.
Outreach and Education
13. Similarly, UNICEF helped the Ministry of Youth broadcast Ebola sensitization messages to youth during the Africa Nations Cup. Messaging will continue 30 days after the end of the African Cup. UNICEF provided flat screen TVs, generators, retro-projectors, and screens to broadcast the Cup in 200 locations throughout the country.
Essential Services
16. Schools reopened across Guinea yesterday. In preparation, 80,657 teachers were trained on safe school opening protocol (100% teachers from preschool to higher education) with the assistance of UNICEF. UNICEF and partners also helped ensuring that thermoflash and hand washing stations were provided on locations. Early reporting suggests attendance is low, with for instance 63 students present at the Lycée 2 Octobre in Conakry out of 1,300 students. Current estimates are that students will receive 160 of the usual 180 days of instruction and local media are encouraging attendance to make best use of the reduced time.
18. In Liberia, schools began registering students on 12 January for the launch of the new academic year, and the Ministry of Education finalized a condensed 2015 academic calendar, including a minimum of 187 instructional days from 2 February to 2 November.

:: 19 Jan 2015 UNMEER External Situation Report
Key Political and Economic Developments
1. On 18 January, the Government of Mali, WHO and UNMEER declared Mali Ebola-free, after 42 days without any new EVD cases. They insisted on the need to remain vigilant as long as the outbreak is not contained in the three most affected countries.
4. The Red Cross indicated that security challenges in several areas in Guinea have prevented safe and dignified burials. The National Response Coordinator will work with both the gendarmerie and the Red Cross to look at the feasibility of escorts for safe burial teams.
9. In preparation for the potential reopening of the Liberia and Sierra Leone border, IOM Regional Office Dakar has signed a Memorandum of Understanding with the Mano River Union. IOM is urgently initiating a comprehensive border assessment in coordination with CDC.
Logistics
11. The WFP-led Emergency Telecoms (ET) Cluster is providing internet connectivity in 43 locations across the three Ebola-affected countries, ensuring reliable internet access for 741 humanitarian personnel. Last week in Guinea, the ET Cluster installed internet in the Ebola Treatment Unit (ETU) in Beyla to facilitate the critical efforts of health workers. It also installed radio equipment in the city of Kissidougou to enable humanitarian staff to communicate with one another and a radio base station for UNHAS/UNMEER in Conakry, in order to provide reliable communications between air and ground staff.
Essential Services
19. Schools and universities in Guinea are scheduled to reopen today.

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.
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– pdf version:  A pdf of the current issue is available here: Vaccines and Global Health_The Week in Review_17 January 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
– The Wistar Institute Vaccine Center
– Children’s Hospital of Philadelphia Vaccine Education Center
Associate Faculty, Division of Medical Ethics, NYU Medical School

POLIO [to 17 January 2015]
Public Health Emergency of International Concern (PHEIC)

GPEI Update: Polio this week – As of 14 January 2014
Global Polio Eradication Initiative
[Editor’s Excerpt and text bolding]
Full report: http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx
:: More than 6 months have passed since the most recent case of wild poliovirus in central Africa was detected in Cameroon on the 9 July 2014. This indicates that progress towards stopping the outbreak in this region is being made. However, outbreak response activities must continue and subnational surveillance systems strengthened to ensure the rapid detection of any residual transmission.
:: More than a year has passed since the last case of wild poliovirus in Ethiopia. With the most recent wild poliovirus case in the Horn of Africa detected in August 2014 in Somalia, outbreak response across the region is continuing.
:: No new cases of wild poliovirus have been reported anywhere in the world this week.

Selected country report content:
West Africa
:: The Ebola crisis in western Africa continues to have an impact on the implementation of polio eradication activities in Liberia, Guinea and Sierra Leone. Supplementary immunization activities (SIAs) in these countries have been postponed and the quality of acute flaccid paralysis surveillance has markedly decreased throughout 2014. National Immunization Days (NIDs) have been rescheduled for Guinea, Liberia and Sierra Leone from the 27 to 31 March. The programme continues to monitor the situation with concern.
:: Even as polio programme staff across West Africa support efforts to control the Ebola outbreak affecting the region, efforts are being made in those countries not affected by Ebola to vaccinate children against polio to create a buffer zone surrounding the Ebola-affected countries.
:: NIDs are planned using bivalent oral polio vaccine (OPV) in Niger and Benin on 27 February to 2 March, and Subnational Immunization Days (SNIDs) tentatively in Mali in February with dates to be confirmed. From the 27 to 31 March, NIDs will take place in Benin, Burkina Faso, Cote d’Ivoire, Mali, Niger and Senegal using trivalent OPV.

EBOLA/EVD [to 17 January 2015]
Public Health Emergency of International Concern (PHEIC); “Threat to international peace and security” (UN Security Council)

Editor’s Note:
Our extensive coverage of Ebola/EVD activity continues – including detailed coverage of UNMEER now available at the end of this digest and other INGO/agency activity reported in the relevant sections below. Please also note that many of the journals we cover continue to publish important EVD content which is threaded throughout this edition.
We note that the WHO will hold a “Special Session of the Executive Board on the Ebola Emergency” at its meeting later in January, with supporting documentation just below. This content includes an important call for a resolution to clarify and affirm the WHO’s role in large-scale health emergencies overall.

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:: 136th WHO Executive Board session
26 January–3 February 2015 –
– Main Documents: http://apps.who.int/gb/e/e_eb136.html
Selected documents of interest to Ebola:
EB136/49 – Ensuring WHO’s capacity to prepare for and respond to future large-scale and sustained outbreaks and emergencies
[Excerpt]
…4. As the number of emergencies with public health implications is rising, the need for effective, efficient and well-designed global response capacities has never been clearer. Though WHO has often been called on to support Member States as they respond to crises, the unprecedented complexity and scale of the current Ebola outbreak demonstrates that the Organization’s capacities, methods and approaches are not necessarily scalable or adaptable to novel or larger challenges. Further, WHO’s focus on technical support and normative guidance has left a gap in institutional capacity for and appreciation of the importance of operations.

5. The international community expects WHO to be able to mount a comprehensive and rapid response, whenever and wherever an emergency that impacts public health arises that outstrips national capacity. To meet this expectation, the Organization’s emergency management capacity must be ready to address the public health impact of emergencies of any category, irrespective of hazard, across the full emergency risk management spectrum. Today, WHO has the essential institutional experience and country presence needed, but is not designed or capacitated to fulfil this function. To rectify this, WHO must substantially strengthen and modernize its emergency management capacity.

In moving this forward, it is necessary that:
(a) there is a recognition and clear delineation of WHO’s mandate and role in emergency response;
(b) effective crisis management mechanisms – systems and structures – exist to enable WHO to fulfil that role;
(c) adequate capacities exists to predictably apply these crisis management mechanisms;
(d) appropriate and dedicated funding is in place; and
(e) a robust performance management and accountability framework is in place to provide timely, systematic and comprehensive evaluation of the Organization’s emergency response, and recalibration as required.

6. As such, a package of five proposals for adapting, modernizing and reforming WHO are presented here. If implemented, these changes could capacitate the Organization to successfully lead in protecting the most vulnerable populations from the devastating public health impacts of emergencies…

– EB136/26 –
[Ebola] Current context and challenges; stopping the epidemic; and preparedness in non-affected countries and regions
– EB136/INF./4 –
Fast-tracking the development and prospective roll-out of vaccines, therapies and diagnostics in response to Ebola virus disease
Special Session of the Executive Board on the Ebola Emergency
– EB136/INF./5
Building resilient health systems in Ebola-affected countries
Special Session of the Executive Board on the Ebola Emergency
– EB136/INF./6
Highlight of efforts made to date towards preparing non-affected countries and
regions to respond to potential importation of EVD
Special Session of the Executive Board on the Ebola Emergency
– EB136/INF./7
IHR and Ebola

WHO: Ebola response roadmap – Situation report 14 January 2015
[Excerpt]
Summary
:: Guinea reported its lowest weekly total of new confirmed Ebola virus disease (EVD) cases since the week ending 17 August 2014. Case numbers remain low in Liberia, with no confirmed cases nationally for the final 2 days of the week ending 11 January, and the lowest weekly total of confirmed cases since the first week of June 2014. Sierra Leone has now reported a decline in case incidence for the second week running, and recorded its lowest weekly total of new confirmed cases since the week ending 31 August 2014.

:: Each of the intense-transmission countries has sufficient capacity to isolate and treat patients, with more than 2 treatment beds per reported confirmed and probable case. However, the uneven geographical distribution of beds and cases, and the under-reporting of cases, means that not all EVD cases are isolated in several areas.

:: Similarly, each country has sufficient capacity to bury all people known to have died from EVD. However, the under-reporting of deaths means that not all burials are done safely.

:: Guinea, Liberia and Sierra Leone report that between 84% and 99% of registered contacts are monitored, though the number of contacts traced per EVD case remains lower than expected in many districts. In areas where transmission has been driven down to low levels, rigorous contact tracing will be essential to break chains of transmission. In the week to January 11, 15% of new confirmed cases in Guinea arose from known contacts (equivalent information is not yet available for Liberia and Sierra Leone).

:: There are currently 27 laboratories providing case-confirmation services in the 3 intense-transmission countries. Four more laboratories are planned in order to meet demand.

:: Case fatality among hospitalized patients (calculated from all hospitalized patients with a reported definitive outcome) is between 57% and 60% in the 3 intense-transmission countries.
A total of 825 health-care worker infections have been reported in the 3 intense-transmission countries; there have been 493 reported deaths.

:: Many elements of the response to the Ebola outbreak, from safe burials to contact tracing, rely on actively engaging affected communities to take ownership of the response. At present, 33 of 38 (87%) of districts in Guinea, 100% of districts in Liberia, and 57% (8 of 14) of districts in Sierra Leone have systems in place to monitor community engagement activities….

…There have been in excess of 21,000 reported confirmed, probable, and suspected cases of EVD in Guinea, Liberia and Sierra Leone (table 1), with more than 8,300 deaths (outcomes are under-reported)…
WHO: Video, audio and transcripts from the Ebola briefings
9 January 2015: Virtual press conference following the second high-level meeting on ebola vaccines access and financing. Discussion included the status of candidate vaccine clinical trials and scenarios about trial results and deployment recommendations.
– Audio of the press briefing
47 Mb, 50 minutes
– Transcript of the press briefing
pdf, 436kb
WHO: One year into the Ebola epidemic: a deadly, tenacious and unforgiving virus
15 January 2015 — Series of 14 papers that take an in-depth look at West Africa’s first epidemic of Ebola virus disease

One year after the first Ebola cases started to surface in Guinea, WHO is publishing this series of 14 papers that take an in-depth look at West Africa’s first epidemic of Ebola virus disease.

Introduction – This assessment looks at how West Africa’s epidemic of Ebola virus disease has evolved over the past year, giving special attention to the situation in Guinea, Liberia, and Sierra Leone. The success stories in Senegal, Nigeria, and likely Mali are also described to show what has worked best to limit onward transmission of Ebola following an imported case and bring the outbreak to a rapid end. The fact that a densely populated city like Lagos was successful in containing Ebola offers encouragement that other developing countries can do the same.
An overview of how the outbreak in the Democratic Republic of Congo evolved and was brought under control underscores the many differences between the outbreaks in West Africa and in equatorial Africa, where all previous outbreaks since the first two in 1976 have occurred.

Key events in the WHO response are outlined to show how initial control efforts were eventually overwhelmed by the wide geographical dispersion of transmission, the unprecedented operational complexity of the outbreaks, and the many factors that undermined the power of traditional containment measures to disrupt transmission chains. These factors are also described.

In efforts coordinated by WHO, scientists and the pharmaceutical industry have geared up to develop, test, license, and introduce the first Ebola vaccines, therapies, and point-of-care diagnostic tests. As a strong expression of solidarity with the people of West Africa, these groups are attempting to compress work that normally takes two to four years into a matter of months.

Finally, the assessment takes a look at the potential future evolution of the Ebola epidemic. Based on what has been learned during this first year, what critical strategies and interventions will give countries and their partners the best chance of bringing the outbreaks under control?

Contents
1. Introduction
2. Origins of the Ebola epidemic
3. Factors that contributed to undetected spread
4. Guinea: The virus shows its tenacity
5. Liberia: A country and its capital are overwhelmed
6. Sierra Leone: A slow start to an outbreak that eventually outpaced all others
7. Key events in the WHO response
8. WHO technical support – a lasting impact?
9. Modernizing the arsenal of control tools: Ebola vaccines
10. Classical Ebola virus disease in DRC
11. Successful Ebola responses in Nigeria, Senegal, Mali
12. The importance of preparedness – everywhere
13. The warnings the world did not heed
[Excerpt]
…What needs to change
On 25 January 2015, the WHO Executive Board will hold a special session to discuss the Ebola epidemic and what needs to be done to bring it under control. To guide these discussions, WHO staff prepared six background papers, including proposals for changing the systems and structures used by WHO when it responds to emergencies.
In connection with a reform process currently under way at WHO, Executive Board members will consider the extent to which WHO is expected to be operational in the field during extended emergencies, with its staff directly coordinating or supervising the response, or whether the WHO role should be confined to technical guidance and advice. Both functions – providing technical assistance and direct aid are constitutionally mandated. The Board will also consider administrative and managerial arrangements between WHO headquarters and its six regional offices.
14. What needs to happen in 2015

UNMEER Watch [to 17 January 2015]
:: UN envoy describes ‘sense of self-confidence’ among those battling Ebola outbreak
15 Jan 2015
The United Nations Special Envoy on Ebola today described a growing feeling of confidence among those responding to the outbreak in West Africa, but he warned that there is an absolute need to maintain focus, vigilance and discipline to ensure that the disease is wiped out.

:: Making a difference: Global Ebola Response Outlook Report 2015′
“A product of the Global Ebola Response Information Centre”
January 2015 :: 36 pages Posted on UNMEER website
Contents
– FOREWORD BY SECRETARY-GENERAL BAN KI-MOON

– INTRODUCTION BY THE SECRETARY-GENERAL’S SPECIAL ENVOY ON EBOLA DR. DAVID NABARRO
[Excerpt]
…Ebola has presented the world with an unprecedented challenge, and a unique opportunity. It has revealed flaws in our international and regional public health mechanisms, and the limited capacities within nations to deal with shocks. It has also drawn together an unprecedented coalition that, if it stays focused and committed, will help the Ebola-affected countries to tackle the outbreak and build back better health systems. It will contribute to systems that enable us to be safer and better off in the face of disease threats.

It is never easy to appreciate where we have come from and where we are headed when we are in the midst of a long and uncertain journey. This is especially the case when matters are as challenging and difficult as this Ebola outbreak. The following sections of this Outlook take us back to the beginning of the outbreak and provide perspectives from partners in the Global Ebola Response Coalition on their role, both now and going forward. I am grateful for their contributions and hope all readers will find the Outlook a useful resource as we work together on the 2015 phase of the response.

– PART ONE – FACING THE CRISIS

– PART TWO – BENDING THE CURVE

– PART THREE – THE ROAD TO ZERO

“The statements in this publication are the views of the authors and do not necessarily reflect the policies or the views of the United Nations or partners.”

European Union [to 17 January 2015]

The EU’s IMI (Innovative Medicines Initiative) announced a series of major grants totaling €200 million supporting its Ebola+ programme
15 January 2015
Summary
The IMI Ebola+ programme was launched in response to the Ebola virus disease (EVD) outbreak that started in western Africa in 2014. The comprehensive programme contributes to efforts to tackle a wide range of challenges in Ebola research, including vaccines development, clinical trials, storage and transport, as well as diagnostics and treatments. It is hoped that the programme, which complements work being carried out with the support of other funding bodies, will help to make a difference in the current and future outbreaks. In addition to Ebola, the programme will also address related diseases, such as Marburg.

Eight projects, with a total budget of over €200 million, have been selected for funding under the first Ebola+ Call for proposals:

:: VSV-EBOVAC
VSV-EBOVAC will build on existing work to advance the development of the Ebola vaccine candidate VSV-ZEBOV (‘vesicular stomatitis virus-vectored Zaire Ebola vaccine’). The World Health Organization (WHO) has identified VSV-ZEBOV as one of the most promising Ebola vaccine candidates, and clinical trials are already underway in Europe and Africa. The VSV-EBOVAC project will use cutting-edge technologies to carry out in-depth analyses of samples taken from clinical trial participants before and after vaccination. This will allow them to gather vital information on both the strength of the immune responses triggered by the vaccine and vaccine safety.

:: EBOVAC 1 and 2
Between them, the two EBOVAC projects will assess, through clinical trials in Europe and Africa, the safety and tolerability of the ‘prime-boost’ Ebola vaccine regimen (Ad26.ZEBOV and MVA-BN-Filo) in development at the Janssen Pharmaceutical Companies of Johnson & Johnson. In a prime-boost vaccine regimen, patients are first given a dose to prime the immune system, and then a boost dose which is intended to enhance the immune response over time.

Phase I trials will be carried out by the EBOVAC1 project. These trials will gather preliminary information on the safety and tolerability of the vaccine regimen. The immune response generated by the regimen will also be evaluated longer term.

Subject to review of the preliminary Phase I data, the Phase II and III trials, will be carried out in parallel by the EBOVAC2 and EBOVAC1 projects respectively to speed up the clinical development of the vaccine regimen. In these trials, larger groups of people will receive the vaccine regimen, allowing the projects to gather further information on the regimen’s safety and immunogenicity, including in specific groups such as children and the elderly, and to assess its efficacy against Ebola virus.

:: Vaccine manufacture capability
Ebola vaccines can only be manufactured in facilities with an appropriate biosafety rating. Relatively few manufacturers have the biosafety rating required for the manufacture of Ebola vaccines, and this is slowing down the production of vaccine candidates.

:: EBOMAN
The focus of the EBOMAN project is on accelerating the development and manufacturing of a ‘prime-boost’ Ebola vaccine regimen (Ad26.ZEBOV and MVA-BN-Filo) in development at the Janssen Pharmaceutical Companies of Johnson & Johnson. In the short term, this will ensure the delivery of sufficient quantities of the Ad26.ZEBOV and MVA-BN-Filo vaccine regimen to support the EBOVAC projects to perform the clinical trials. In parallel, this project will create additional vaccine production capacity to allow for the rapid preparation of large quantities of vaccines.

:: Deployment of and compliance with vaccination regimens
For a vaccine to have a real impact on an outbreak, high levels of vaccination coverage are essential. In addition, for lasting protection, two doses of the vaccine may be needed. However, the stigma surrounding Ebola, coupled with a suspicion of vaccines in general, could deter many people from getting vaccinated. Strong communication campaigns are therefore needed to address these challenges.

:: EBODAC
The EBODAC project will develop a communication strategy and tools to promote the acceptance and uptake of new Ebola vaccines. One of the project’s most important products will be a platform, based on mobile technology, dedicated to Ebola vaccines. As well as providing local communities with information on Ebola and vaccines, the platform will send reminders to people receiving the ‘prime boost’ vaccine to return to get their second ‘booster’ dose and facilitate the tracking of vaccination coverage. EBODAC will also set up local training programmes to make sure the communication strategy, and its tools, will be ready for deployment in the local setting.

:: Rapid diagnostic tests
There is an urgent need for fast, reliable tests to determine if someone is infected with Ebola or not. Three projects will pave the way for rapid diagnostic tests capable of delivering reliable results at the point of care in as little as 15 minutes.

:: Mofina
The Mofina project will develop a new diagnostic test that will deliver results in under 45 minutes on whether the patient has Ebola or a related disease such as Marburg virus. Crucially, the device is designed to work well in sites where high-end laboratory infrastructures are simply not available, while also protecting users from infection. The project will draw on two existing technologies: a conventional Ebola virus test, and a point-of-care molecular diagnostics platform. After testing a prototype of the system, the project partners will validate it in the field.

:: FILODIAG
The FILODIAG project aims to deliver an ultra-fast, accurate diagnostic instrument that will test for Ebola in under 15 minutes. Such a system could be used in both healthcare settings and at critical infrastructures like airports. Current tests for Ebola virus take a long time because samples must be heated and then cooled in each of the many processing cycles. This project will replace the heating/cooling steps with a technology based on laser-heated nanoparticles. Early tests of this technology have worked well. The project will add a step to concentrate the virus and refine and test the system before evaluating it in the field.

:: EbolaMoDRAD
The EbolaMoDRAD project aims to develop and validate in the field a rapid diagnostic tool that will be both simple and safe to use in low resource settings by people who may not have specialist training. At the same time, the project will implement a large-scale capacity building programme in West Africa with a strong focus on diagnostics, biosafety, and outbreak management. Finally, it will ensure its results are communicated widely, especially to public health bodies, charities, outbreak management teams, and local hospitals.
Note: The Grant Agreements for some projects are still being finalised. Final information on all selected projects, including full budget details, will be published here once the Grant Agreements have been signed.

:: Future plans
Further Calls for proposals under the Ebola+ programme are planned. These could address issues such as the development of a vaccine that offers broad protection against both Ebola and other, related viruses such as Marburg; the development of new treatments for Ebola; new vaccines that do not require extreme temperatures; and the generation of new diagnostic tests.

Johnson & Johnson Announces Formation of Ebola Vaccine Development Consortia, Gains Funding from Innovative Medicines Initiative
– Consortia funded through the IMI Ebola+ Programme Supported by the European Commission
– Brings together London School of Hygiene and Tropical Medicine, INSERM, University of Oxford University, La Centre Muraz, Bavarian Nordic A/S, Vibalogics, the Grameen Foundation and World Vision of Ireland with Janssen Pharmaceutical Companies to help accelerate Ad26 – MVA Ebola vaccine development and patient education

NEW BRUNSWICK, N.J., Jan. 16, 2015 /PRNewswire/ — Johnson & Johnson is pleased to announce the formation of consortia with leading global research institutions and non-government organizations to work in conjunction with Janssen Pharmaceutical Companies to accelerate the development of its Ebola vaccine regimen. The Innovative Medicines Initiative (IMI) plans to award these consortia grants totaling more than €100 million from the Ebola+ programme to support the development, manufacturing and patient education for the vaccine regimen.

The IMI is Europe’s largest public-private initiative aiming to speed up the development of better and safer medicines for patients. Funding for the IMI Ebola+ programme comes in part from Horizon 2020, the European Union’s research and innovation programme, and in part in the form of in-kind contributions from the European Federation of Pharmaceutical Industries and Associations (EFPIA) partners in the projects.

“In the face of the global challenge of Ebola, bringing together the expertise and capabilities of the pharmaceutical industry, academic centers and NGOs will be critical to help solve this crisis,” said Paul Stoffels, M.D., Chief Scientific Officer and Worldwide Chairman, Pharmaceuticals, Johnson & Johnson. “The European Commission’s support through IMI bolsters collaboration that should significantly accelerate efforts to help address this humanitarian crisis.”
“It is great to see the multiple partners come together to accelerate the development of an effective vaccine both for the current epidemic and future outbreaks,” said Professor Peter Piot, M.D., director of the London School of Hygiene & Tropical Medicine, one of the consortia partners. “This is an opportunity to make sure that this is the last Ebola epidemic in which our only tools to control it are isolation and quarantine.”

The funds were announced to support several consortia working together on a total of four projects. Three of the projects are designed to address the need to accelerate Phase I, II and III trials and scale up production of the prime-boost vaccine regimen. A Phase I trial led by Oxford Vaccines Group is currently underway with trials in Africa being planned. The Phase II and III trials in Europe and Africa, subject to review of the preliminary Phase I data, will be carried out in parallel. A fourth project will investigate innovative ways and technology to raise awareness and acceptance of vaccination campaigns. A total of eight projects are being funded under this round of the IMI’s Ebola+ programme.

“With people still contracting this disease, there is still a risk that Ebola will continue to spread and that we could have another major outbreak in the future,” said Johan Van Hoof, M.D., Global Head of Infectious Diseases and Vaccines, Janssen. “We highly appreciate the European Commission’s support and are pleased to be joined by them and our distinguished partners in further accelerating our goal of bringing this vaccine, if approved, to families and frontline health care professionals as fast as possible.”

Professor Andrew Pollard and Dr Matthew Snape, who are leading the Phase I and II Ebola vaccine trials at the University of Oxford for IMI, said “the initial testing of vaccines for Ebola is already underway at the University with an astonishing response from the public to volunteer for the trials, to provide the earliest possible information to guide further studies of a prime boost vaccine, that if approved, may help control the Ebola outbreak in West Africa.”
Organizations joining Janssen include the London School of Hygiene & Tropical Medicine, University of Oxford, Institut National de la Sante et de la Recherche Medicale (INSERM), La Centre Muraz, Bavarian Nordic A/S, Vibalogics, Grameen Foundation and World Vision of Ireland…

PLOS Biology
http://journals.plos.org/plosbiology/

Research Article
Ebola Cases and Health System Demand in Liberia
John M. Drake, RajReni B. Kaul, Laura W. Alexander, Suzanne M. O’Regan, Andrew M. Kramer, J. Tomlin Pulliam, Matthew J. Ferrari, Andrew W. Park
Affiliation: Odum School of Ecology, University of Georgia, Athens, Georgia, United States of America, College of Veterinary Medicine, University of Georgia, Athens, Georgia, United States of America
Published: January 13, 2015
DOI: 10.1371/journal.pbio.1002056
Abstract
In 2014, a major epidemic of human Ebola virus disease emerged in West Africa, where human-to-human transmission has now been sustained for greater than 12 months. In the summer of 2014, there was great uncertainty about the answers to several key policy questions concerning the path to containment. What is the relative importance of nosocomial transmission compared with community-acquired infection? How much must hospital capacity increase to provide care for the anticipated patient burden? To which interventions will Ebola transmission be most responsive? What must be done to achieve containment?

In recent years, epidemic models have been used to guide public health interventions. But, model-based policy relies on high quality causal understanding of transmission, including the availability of appropriate dynamic transmission models and reliable reporting about the sequence of case incidence for model fitting, which were lacking for this epidemic.

To investigate the range of potential transmission scenarios, we developed a multi-type branching process model that incorporates key heterogeneities and time-varying parameters to reflect changing human behavior and deliberate interventions in Liberia. Ensembles of this model were evaluated at a set of parameters that were both epidemiologically plausible and capable of reproducing the observed trajectory. Results of this model suggested that epidemic outcome would depend on both hospital capacity and individual behavior. Simulations suggested that if hospital capacity was not increased, then transmission might outpace the rate of isolation and the ability to provide care for the ill, infectious, and dying. Similarly, the model suggested that containment would require individuals to adopt behaviors that increase the rates of case identification and isolation and secure burial of the deceased.
As of mid-October, it was unclear that this epidemic would be contained even by 99% hospitalization at the planned hospital capacity. A new version of the model, updated to reflect information collected during October and November 2014, predicts a significantly more constrained set of possible futures. This model suggests that epidemic outcome still depends very heavily on individual behavior. Particularly, if future patient hospitalization rates return to background levels (estimated to be around 70%), then transmission is predicted to remain just below the critical point around Reff = 1. At the higher hospitalization rate of 85%, this model predicts near complete elimination in March to June, 2015.

Author Summary
There is considerable uncertainty regarding the steps needed to contain the ongoing Ebola crisis in West Africa, the timeline required to achieve control, and the projected burden of mortality. To address these issues, we develop a branching process model for Ebola transmission that focuses on offspring distributions (i.e., the numbers of new infections caused by each case). We use the model to assess the likely progression of Ebola in Liberia. The model assesses the feedback between new cases and hospital demand under a range of plausible intervention scenarios, particularly ramping-up of treatment facilities over time and increasing the number of individuals seeking hospital treatment through outreach and education. Transmission scenarios—to health care workers in hospitals, to caregivers in the community, to hospital visitors, and to individuals preparing bodies for funerals—are described by distinct offspring distributions based on available data. Results suggest that the outcome of the epidemic depends on both hospital capacity and individual behavior. Additionally, the model highlights the conditions under which transmission might have outpaced hospital capacity, and projects possible epidemic trajectories into 2015.

Draft road map for Ebola vaccine development [Team B]
12 January 2015
Wellcome Trust, Centre for Infectious Disease Research and Policy (CIDRAP)

A draft road map for the expedited development, testing, manufacture, delivery and financing of Ebola vaccines has today been published by a global group of experts supported by the Wellcome Trust.

The development and delivery of safe and effective vaccines would make a huge contribution to containing Ebola in Guinea, Liberia and Sierra Leone, as well as improving responses to future outbreaks and providing a model for vaccine development against other emerging infectious disease, the expert group has concluded.

The panel of 26 international experts, convened by the and the Centre for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, explains how the substantial scientific, financial, social and logistical challenges to rapid Ebola vaccine development and deployment can be overcome through collaboration between governments, industry and philanthropic bodies.

It highlights the potential need for multiple Ebola vaccines with different characteristics, which might enable different vaccination strategies such as ring-vaccination to prevent an outbreak from spreading, and prophylactic vaccination of high-risk individuals such as healthcare workers. It sets out the qualities that a successful vaccine should have and a set of principles for trial design.

The road map also emphasises the importance of community engagement so that vaccine trials and delivery programmes are positively received, and the need for such engagement campaigns to be adapted to national and local circumstances.

The recommendations are made in the interim report of Team B, which is co-chaired by Dr Jeremy Farrar, Director of the Wellcome Trust, and Professor Michael Osterholm, Director of CIDRAP. A full report will be published in the coming weeks, and the guidance will be a “living document” that evolves over time.

The group is called “Team B” in recognition of the principal role played by the World Health Organisation and national governments in leading the international Ebola response.

Dr Jeremy Farrar, Director of the Wellcome Trust and co-chair of Team B, said: “As Guinea, Liberia and Sierra Leone make encouraging progress in containing Ebola, we must not lose sight of the immense contribution that a safe and effective vaccine would make towards controlling both this and future epidemics. We need urgent global collaboration between governments, industry and philanthropy to ensure candidate vaccines progress through trials to manufacture and delivery as swiftly as possible.

“The draft road map we publish today, agreed by a global group of experts, offers solutions to the great scientific, social, logistical and financial challenges of delivering an Ebola vaccine on this urgent timescale. It is a living document that will evolve as we learn more about Ebola and the candidate vaccines that are available. As well as being of great value in the present crisis, it will enable vaccine strategies to begin without delay in future outbreaks, and provide a model for vaccine development in response to other emerging infectious diseases.”
The draft roadmap can be viewed here.