Vaccines and Global Health: The Week in Review 30 August 2014

Vaccines and Global Health: The Week in Review

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 versionA pdf of the current issues is available here: Vaccines and Global Health_The Week in Review_30 August 2014

- 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

EBOLA [to 30 August 2014]

EBOLA [to 30 August 2014]

WHO issues roadmap to scale up international response to the Ebola outbreak in West Africa
Statement
28 August 2014
[Full text]
WHO is issuing today a roadmap to guide and coordinate the international response to the outbreak of Ebola virus disease in west Africa.

The aim is to stop ongoing Ebola transmission worldwide within 6–9 months, while rapidly managing the consequences of any further international spread. It also recognizes the need to address, in parallel, the outbreak’s broader socioeconomic impact.

It responds to the urgent need to dramatically scale up the international response. Nearly 40% of the total number of reported cases have occurred within the past three weeks.

The roadmap was informed by comments received from a large number of partners, including health officials in the affected countries, the African Union, development banks, other UN agencies, Médecins Sans Frontières (MSF), and countries providing direct financial support.

It will serve as a framework for updating detailed operational plans. Priority is being given to needs for treatment and management centres, social mobilization, and safe burials. These plans will be based on site-specific data that are being set out in regular situation reports, which will begin this week.

The situation reports map the hotspots and hot zones, present epidemiological data showing how the outbreak is evolving over time, and communicate what is known about the location of treatment facilities and laboratories, together with data needed to support other elements of the roadmap.
The roadmap covers the health dimensions of the international response. These dimensions include key potential bottlenecks requiring international coordination, such as the supply of personal protective equipment, disinfectants, and body bags.
The WHO roadmap will be complemented by the development of a separate UN-wide operational platform that brings in the skills and capacities of other agencies, including assets in the areas of logistics and transportation. The UN-wide platform aims to facilitate the delivery of essential services, such as food and other provisions, water supply and sanitation, and primary health care.

Resource flows to implement the roadmap will be tracked separately, with support from the World Bank.

Ebola response roadmap
WHO
28 August 2014 :: 27 pages pdf: http://apps.who.int/iris/bitstream/10665/131596/1/EbolaResponseRoadmap.pdf?ua=1
[Excerpt from introduction]
GOAL
To stop Ebola transmission in affected countries within 6-9 months and prevent international spread.

CONTEXT
… National authorities in the affected countries have been working with WHO and partners to scale-up control measures. However, the EVD outbreak remains grave and transmission is still increasing in a substantial number of localities, aggravating fragile social, political and economic conditions in the sub-region and posing increasingly serious global health security challenges and risks.

The Ebola response activities to date have generated significant knowledge on the effectiveness and limitations of current approaches, highlighting key areas for course corrections. Clearly, a massively scaled and coordinated international response is needed to support affected and at-risk countries in intensifying response activities and strengthening national capacities. Response activities must be adapted in areas of very intense transmission and particular attention must be given to stopping transmission in capital cities and major ports, thereby facilitating the larger response and relief effort.

This updated and more comprehensive roadmap builds on current, country-specific realities to guide response efforts and align implementation activities across different sectors of government and international partners.

PURPOSE OF DOCUMENT
To assist governments and partners in the revision and resourcing of country-specific operational plans for Ebola response, and the coordination of international support for their full implementation.

OBJECTIVES
1. To achieve full geographic coverage with complementary Ebola response activities in countries with widespread and intense transmission
2. To ensure emergency and immediate application of comprehensive Ebola response interventions in countries with an initial case(s) or with localized transmission
3. To strengthen preparedness of all countries to rapidly detect and respond to an Ebola exposure, especially those sharing land borders with an intense transmission area and those with international transportation hubs

WHO: Global Alert and Response (GAR) – Disease Outbreak News [to 30 August 2014]
http://www.who.int/csr/don/en/
:: Ebola virus disease update – west Africa 28 August 2014
Excerpt
Epidemiology and surveillance
:: The total number of probable and confirmed cases in the current outbreak of Ebola virus disease (EVD) in the four affected countries as reported by the respective Ministries of Health of Guinea, Liberia, Nigeria, and Sierra Leone is 3069, with 1552 deaths.
:: The outbreak continues to accelerate. More than 40% of the total number of cases have occurred within the past 21 days. However, most cases are concentrated in only a few localities.
:: The overall case fatality rate is 52%. It ranges from 42% in Sierra Leone to 66% in Guinea.
:: A separate outbreak of Ebola virus disease, which is not related to the outbreak in West Africa, was laboratory-confirmed on 26 August by the Democratic Republic of Congo (DRC) and is detailed in a separate edition of the Disease Outbreak News.
Health sector response
…WHO does not recommend any travel or trade restrictions be applied except in cases where individuals have been confirmed or are suspected of being infected with EVD or where individuals have had contact with cases of EVD. (Contacts do not include properly-protected health-care workers and laboratory staff.) Temporary recommendations from the Emergency Committee with regard to actions to be taken by countries can be found at:
HR Emergency Committee on Ebola outbreak in west Africa
:: Ebola virus disease – Democratic Republic of Congo 27 August 2014

NIH: Ebola
:: Single animal to human transmission event responsible for 2014 Ebola outbreak
August 29, 2014 — Scientists used advanced genomic sequencing technology to identify a single point of infection from an animal reservoir to a human in the current Ebola outbreak in West Africa. This research has also revealed the dynamics of how the Ebola virus has been transmitted from human to human, and traces how the genetic code of the virus is changing over time to adapt to human hosts. Pardis Sabeti, M.D., Ph.D, a 2009 National Institutes of Health Director’s New Innovator awardee and her team carried out the research…
…Joined by an international team of scientists, Dr. Sabeti used advanced technology to analyze the genetics of the Ebola samples extremely rapidly and with high levels of accuracy. Using this technology, the researchers pinpointed a single late 2013 introduction from an unspecified animal reservoir into humans. Their study showed that the strain responsible for the West African outbreak separated from a closely related strain found in Central Africa as early as 2004, indicating movement from Central to West Africa over the span of a decade. Studying RNA changes occurring over the span of the outbreak suggests that the first human infection of the outbreak was followed by exclusive human to human transmissions….
…While analyzing the genetic makeup of the Ebola samples, Dr. Sabeti and colleagues discovered a number of mutations that arose as the outbreak spread. Some of these mutations, termed nonsynonymous mutations, alter the biological state of the virus and may allow it to continually and rapidly adapt to human immune defenses as the outbreak continues. This feature points to the need for improved methods that will allow for close monitoring of changes in the viral genome and the impact on vaccine targets. Such monitoring, called genomic surveillance, can provide important insights into the biology of how the Ebola virus spreads and evolves. It may also allow scientists to develop improved methods to detect infection, and point the way to new and improved drug and vaccines….
:: NIH to Launch Human Safety Study of Ebola Vaccine Candidate
Trial is First in Series of Accelerated Safety Studies of Ebola Vaccines
August 28, 2014
Initial human testing of an investigational vaccine to prevent Ebola virus disease will begin next week by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

The early-stage trial will begin initial human testing of a vaccine co-developed by NIAID and GlaxoSmithKline (GSK) and will evaluate the experimental vaccine’s safety and ability to generate an immune system response in healthy adults. Testing will take place at the NIH Clinical Center in Bethesda, Maryland.

The study is the first of several Phase 1 clinical trials that will examine the investigational NIAID/GSK Ebola vaccine and an experimental Ebola vaccine developed by the Public Health Agency of Canada and licensed to NewLink Genetics Corp. The others are to launch in the fall. These trials are conducted in healthy adults who are not infected with Ebola virus to determine if the vaccine is safe and induces an adequate immune response.

In parallel, NIH has partnered with a British-based international consortium that includes the Wellcome Trust and Britain’s Medical Research Council and Department for International Development to test the NIAID/GSK vaccine candidate among healthy volunteers in the United Kingdom and in the West African countries of Gambia (after approval from the relevant authorities) and Mali.

Additionally, the U.S. Centers for Disease Control and Prevention has initiated discussions with Ministry of Health officials in Nigeria about the prospects for conducting a Phase 1 safety study of the vaccine among healthy adults in that country….

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Ebola vaccine trials fast-tracked by international consortium
Unprecedented international consortium assembled to accelerate collaborative multi-site trials of candidate Ebola vaccine
GSK Media Release
28 August 2014
Excerpt
A candidate Ebola vaccine could be given to healthy volunteers in the UK, The Gambia and Mali as early as September, as part of a series of safety trials of potential vaccines aimed at preventing the disease that has killed more than 1,400 people in the current outbreak in west Africa.

Human trials of this candidate vaccine, being co-developed by the US National Institutes of Health (NIH) and GlaxoSmithKline, are to be accelerated with funding from an international consortium in response to the Ebola epidemic…

A £2.8 million grant from the Wellcome Trust, the Medical Research Council (MRC) and the UK Department for International Development (DFID) will allow a team led by Professor Adrian Hill, of the Jenner Institute at the University of Oxford, to start safety tests of the vaccine alongside similar trials in the USA run by the National Institute of Allergy and Infectious Diseases (NIAID, a part of the NIH).

The phase 1 trials will begin as soon as they receive ethical and regulatory approvals, which will be considered on an expedited basis. If approvals are granted, the UK research teams could start vaccinating volunteers from mid-September.

The consortium’s funding will also enable GSK to begin manufacturing up to around 10,000 additional doses of the vaccine at the same time as the initial clinical trials, so that if the trials are successful stocks could then be made available immediately by GSK to the WHO to create an emergency immunisation programme for high-risk communities.
The candidate vaccine is against the Zaire species of Ebola, which is the one circulating in west Africa, and uses a single Ebola virus protein to generate an immune response. As it does not contain infectious virus material, it cannot cause a person who is vaccinated to become infected with Ebola. Pre-clinical research by the NIH and Okairos, a biotechnology company acquired last year by GSK, has indicated that it provides promising protection in non-human primates exposed to Ebola without significant adverse effects….

Full media release: http://www.gsk.com/en-gb/media/press-releases/2014/ebola-vaccine-trials-fast-tracked-by-international-consortium/

POLIO [to 30 August 2014]

POLIO [to 30 August 2014]
GPEI Update: Polio this week – As of 27 August 2014
Global Polio Eradication Initiative
Editor’s Excerpt and text bolding
Full report: http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx
:: Continued transmission in Kano: wild poliovirus 1 transmission continues in a geographically limited area of southern Kano state, Nigeria, indicating pockets where vaccination campaigns and social mobilization are still too weak to assure sufficient coverage during campaigns. Kano is the only state in Nigeria reporting cases of wild poliovirus since April.
:: Protecting west Africa: Even as polio programme staff across west Africa support efforts to control the Ebola outbreak affecting the region, preparations are going ahead for large scale multi-country vaccination campaigns in those countries not affected by Ebola, in mid-September.
Afghanistan
:: Vaccination activities have resumed in parts of Helmand Province, Southern Region, where no vaccination had taken place for 5 months.
Nigeria
:: One new case of WPV1 was reported in the past week. This most recent case, which had onset of paralysis in Sumaila Local Government Area (LGA), southern Kano, on 24 July, is the second to be reported in the LGA this year. Nigeria’s total case count for 2014 is now six. Kano is the only state with cases of WPV since April.
:: One new case of type 2 circulating vaccine-derived poliovirus (cVDPV2) was reported in the past week. The total number of cVDPV2 cases for 2014 is 19. The most recent cVDPV2 case had onset of paralysis on 22 June, also in Kano.
Pakistan
:: Two new WPV1 cases were reported in the past week, one from Khyber Agency in the Federally Administered Tribal Areas (FATA) and one from Karachi in Sindh, bringing the total number of WPV1 cases for 2014 to 117. The FATA case is the most recent WPV1 case in the country, with onset of paralysis on 30 July.

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The Weekly Epidemiological Record (WER) 29 August 2014, vol. 89, 35 (pp. 377–388)
Includes:
:: Assessing and mitigating the risks of outbreaks due to wild poliovirus in polio-free African countries, 2013–2014
:: Monthly report on dracunculiasis cases, January– July 2014
http://www.who.int/entity/wer/2014/wer8935.pdf?ua=1

EuBiologics and IVI announce OCV Milestones

Media Release: Major Milestones for Development of Korea’s First Cholera Vaccine for the World’s Poor
-Global Access Agreement between EuBiologics Co., Ltd. and International Vaccine Institute
– Investments by Global Health Investment Fund I, LLC (GHIF) and domestic investors to EuBiologics
– Milestones pave the way to make an oral cholera vaccine available for developing countries
Excerpt
SEOUL, KOREA – EuBiologics Co., Ltd. (EuBiologics) and the International Vaccine Institute (IVI) announced today that major milestones have been met in their collaborative efforts to develop an oral cholera vaccine (OCV) for use in developing countries. EuBiologics has entered into a Global Access Agreement with IVI to ensure that the cholera vaccine will be made available and accessible at an affordable price for the public sector. Furthermore, Global Health Investment Fund I, LLC (GHIF), a new $108 million USD fund developed by the Bill & Melinda Gates Foundation, Lion’s Head Global Partners and JPMorgan Chase & Co., has committed 2.5 million USD of equity capital and made a 2.5 million USD loan to support EuBiologics in the development and production of the OCV. In addition, Korea-Seoul Life Science Fund (KSLSF) and Korea Investment Global Frontier Fund (KIGFF) have each invested 1.25 million USD of equity capital alongside the GHIF in this financing.

“We are thankful to receive the OCV technology from IVI and are very much delighted to have an opportunity to work with GHIF,” said Mr. Yeong-Ok Baik, CEO of EuBiologics, “We are confident that our vaccine, Euvichol will achieve WHO prequalification with IVI’s support and assistance. We are pleased to supply Euvichol worldwide as per the Global Access Agreement made with IVI, and we are committed to contribute to global efforts to prevent and control cholera in poor communities around the world.”

The OCV was specifically developed for use in developing countries through a public-private partnership led by IVI with support from the Republic of Korea, Sweden, and the Bill & Melinda Gates Foundation. The partnership initially involved Shantha Biotechnics (part of the Sanofi group) in Hyderabad, India; Vabiotech, a state-owned vaccine manufacturer in Hanoi, Vietnam; and the University of Gothenburg in Sweden. IVI transferred the OCV production technology to Shantha, and the vaccine, licensed as Shancholin India, was prequalified by the World Health Organization (WHO) in September 2011.

“Through a phase III clinical trial in Kolkata, India, IVI has shown that the vaccine provides sustained protection against cholera at an efficacy of 65% for at least five years, the longest duration of protection conferred by an oral cholera vaccine to date,” said Dr. Thomas F. Wierzba, Deputy Director General for IVI’s Development and Delivery, “The vaccine is safe and it clearly works. IVI is gratified to be working with a partner like EuBiologics who share IVI’s mission of discovering, developing and delivering safe, effective and affordable vaccines for developing nations.”…

Aeras announces Phase IIb trial for novel vaccine candidate

Aeras announced the initiation of a large, multi-country Phase IIb clinical trial to evaluate the ability of a novel vaccine candidate to prevent tuberculosis in adults. Aeras and GSK will jointly conduct the double-blind, randomised, placebo-controlled study (ClinicalTrials.gov Identifier: NCT01755598) to evaluate the efficacy, safety and immunogenicity of GSK’s proprietary vaccine candidate M72/AS01E*. The trial will enroll more than 3500 healthy adults, with latent (asymptomatic) TB infection (LTBI), ages 18-50, in TB-endemic sub-Saharan African countries, starting in South Africa. Subjects will be enrolled in 2014 and 2015, with a 36-month follow-up, yielding study results in 2018.
August 28, 2014 – full press release.

CDC/MMWR Watch [to 30 August 2014]

CDC/MMWR Watch [to 30 August 2014]
http://www.cdc.gov/mmwr/mmwr_wk.html

MMWR Weekly – :: August 29, 2014 / Vol. 63 / No. 34
:: National, State, and Selected Local Area Vaccination Coverage Among Children Aged 19–35 Months — United States, 2013
Excerpt
…This report describes national, regional, state, and selected local area vaccination coverage estimates for children born January 2010–May 2012, based on results from the 2013 NIS. In 2013, vaccination coverage achieved the 90% national Healthy People 2020 target* for ≥1 dose of measles, mumps, and rubella vaccine (MMR) (91.9%); ≥3 doses of hepatitis B vaccine (HepB) (90.8%); ≥3 doses of poliovirus vaccine (92.7%); and ≥1 dose of varicella vaccine (91.2%).

Coverage was below the Healthy People 2020 targets for ≥4 doses of diphtheria, tetanus, and pertussis vaccine (DTaP) (83.1%; target 90%); ≥4 doses of pneumococcal conjugate vaccine (PCV) (82.0%; target 90%); the full series of Haemophilus influenzae type b vaccine (Hib) (82.0%; target 90%); ≥2 doses of hepatitis A vaccine (HepA) (54.7%; target 85%); rotavirus vaccine (72.6%; target 80%); and the HepB birth dose (74.2%; target 85%).

Coverage remained stable relative to 2012 for all of the vaccinations with Healthy People 2020 objectives except for increases in the HepB birth dose (by 2.6 percentage points) and rotavirus vaccination (by 4.0 percentage points).

The percentage of children who received no vaccinations remained below 1.0% (0.7%). Children living below the federal poverty level had lower vaccination coverage compared with children living at or above the poverty level for many vaccines, with the largest disparities for ≥4 doses of DTaP (by 8.2 percentage points), full series of Hib (by 9.5 percentage points), ≥4 doses of PCV (by 11.6 percentage points), and rotavirus (by 12.6 percentage points). MMR coverage was below 90% for 17 states. Reaching and maintaining high coverage across states and socioeconomic groups is needed to prevent resurgence of vaccine-preventable diseases….