Vaccines and Global Health: The Week in Review 28 March 2015

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

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

- pdf version A pdf of the current issue is available here:   Vaccines and Global Health_The Week in Review_28 March 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 28 March 2015]

POLIO [to 28 March 2015]
Public Health Emergency of International Concern (PHEIC)

GPEI Update: Polio this week – As of 25 March 2015
Global Polio Eradication Initiative
[Editor’s Excerpt and text bolding]
Full report: http://www.polioeradication.org/Dataandmonitoring/Poliothisweek.aspx

:: Inactivated polio vaccine (IPV) was launched this week in Bangladesh, as part of global efforts to introduce the vaccine globally by end-2015, ahead of the planned switch from trivalent OPV to bivalent OPV in early 2016. “Together with GPEI, Gavi is supporting an unprecedented push to introduce IPV into most countries by the end of 2015. Strong routine immunization is an essential factor to interrupt and maintain zero polio transmission,” commented Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance. More.
:: The GPEI is currently accepting applications from students and recent graduates interested in summer 2015 internships at the World Health Organization. More information is available here.

[Selected country-level report content]
Pakistan
:: One new WPV1 case was reported in the past week, from Quetta, Balochistan, with onset of paralysis on 20 February. This brings the total number of WPV1 cases for 2015 to 20 (and 2014 remains 306). The most recent case had onset of paralysis on 24 February (from Khyber, Federally Administered Tribal Areas – FATA).

EBOLA/EVD [to 28 March 2015]

EBOLA/EVD [to 28 March 2015]
Public Health Emergency of International Concern (PHEIC); “Threat to international peace and security” (UN Security Council)

Ebola Situation Report – 25 March 2015
Incorporating the WHO Activity Report
[Excerpts]
SUMMARY
:: A total of 79 new confirmed cases of Ebola virus disease (EVD) were reported in the week to 22 March: the lowest weekly total in 2015. There were 45 new confirmed cases reported from Guinea. Having reported no cases for 3 consecutive weeks, a new confirmed case was reported from Liberia on 20 March. Sierra Leone reported 33 new confirmed cases in the week to 22 March…
:: In the context of falling case incidence and a receding zone of transmission, treatment capacity now far exceeds demand in both Liberia and Sierra Leone. Accordingly, and with technical guidance from WHO, national authorities in both countries have begun to implement plans for the phased safe decommissioning of surplus facilities. Each country will retain a core capacity of high-quality Ebola treatment centres, strategically located to ensure complete geographic coverage, with additional rapid-response capacity held in reserve…
:: There have been almost 25 000 reported confirmed, probable, and suspected cases of EVD in Guinea, Liberia and Sierra Leone (table 1), with over 10 000 reported deaths (outcomes for many cases are unknown). A total of 45 new confirmed cases were reported in Guinea, 1 in Liberia, and 33 in Sierra Leone in the 7 days to 22 March…

WHO: Ebola diaries
27 March 2015 — Starting from the initial detection of the Ebola outbreak, to the arrival of the first responders, to the overwhelming spread of cases in West Africa — The Ebola Diaries is a series of first-person accounts describing what it has been like working on the front lines of a global health crisis of unprecedented proportion…

WHO Guinea: First Ebola vaccine to be tested in affected communities one year into outbreak

First Ebola vaccine to be tested in affected communities one year into outbreak
Guinea WHO Country Office
Ring vaccination starts in Coyah, Guinea
Conakry, 25 March, 2015 – The Guinean Government with the World Health Organization (WHO) initiated the very first efficacy trial of an Ebola vaccine this week in an affected community of the Basse-Guinée, one of the areas where most Ebola cases are found in the country. Ring vaccination tests of VSV-EBOV, a lead Ebola vaccine developed by the Public Health Agency of Canada, received an excellent response from the community in a small village in the Coyah prefecture, where the trial team arrived on 23 March.

“This landmark operation gives hope to all of us, in Guinea and in the world, that we might soon have an effective public health tool against Ebola, should the vaccine prove to be safe and effective,” stated the WHO Representative in Guinea, Dr. Jean-Marie Dangou. “The start of ring vaccination clinical testing today in Guinea is therefore one of the most important milestones we have achieved in seeking a modern line of defense against Ebola.”

Trained medical staff, vaccines and other essential equipment were dispatched from Conakry to Coyah to vaccinate contacts of recently infected people who have given consent in a village of the Coyah prefecture. Vaccinations for now will include only adults, who are most at risk of infection, with the exception of pregnant women.

“We are committed to ending this epidemic,” said Dr. Sakoba Keita, National Coordinator of the Fight against Ebola in Guinea. “Combined with control measures that we are putting in place with our partners, a safe and effective vaccine will allow us to close this trying chapter and start rebuilding our country.”

The ring vaccination strategy consists in identifying recently infected patients and vaccinating all their contacts, thereby creating a ‘ring of immunity’ around them to stop the virus from spreading.

“This very same strategy was a key contribution to eradicating smallpox in the 1970’s, and allows us to vaccinate all those at greatest risk,” explained WHO Coordinator for the Guinea Vaccine Trial, Dr. Ana Maria Henao Restrepo.

Dr. Bertrand Draguez, Medical Director for the Non-governmental Organization Médecins sans Frontières (MSF) stressed that: “The trial is organized on a voluntary basis, and participation is confidential, free and non-remunerated.”

The Guinean Government is fully committed to the success of the vaccine clinical trial. In a 20 March official letter addressed to all the Mayors, Prefects and local Health Officials in Guinea, the Head of the National Coordination Against Ebola in Guinea, Dr Sakoba Keita, asked all local public actors for their full cooperation and support.

A total of around 10,000 people are planned to be vaccinated in 190 rings within a six-eight week period. Volunteers will be followed for three months. Results could be available as early as July 2015.

Note to editors
About the vaccine and the vaccination strategy:
VSV-EBOV Vaccine was developed by the Public Health Agency of Canada. The vaccine was licensed to NewLink Genetics, and on November 24, 2014, NewLink Genetics and Merck announced their collaboration on the vaccine.
The concept of ring vaccination applied to the Guinea Ebola vaccine clinical trial is based on vaccinating the “rings” (group of contacts of a newly diagnosed Ebola “index case”) either immediately after confirmation of the Ebola diagnosis of the “index case”, or three weeks later (delayed vaccination). This strategy allows all the known contacts to be vaccinated within a short period of time, and it constitutes an excellent alternative to the use of a placebo. The ring vaccination trial design was developed by an international group of experts from Canada, France, Guinea, Norway, Switzerland, United Kingdom, United States, and WHO. This group included Professor Donald A. Henderson, who led the WHO smallpox eradication effort.

About the partners:
The Guinea Ebola vaccine trial is a coordinated effort among numerous international partners. The trial is implemented under the responsibility of the Guinean government. The World Health Organization (WHO) is the sponsor of the study. The Government of Guinea, Doctors without Borders / Medecins sans Frontières (MSF), Epicentre, the Norwegian Institute of Public Health and WHO are coordinating its implementation. The trial is funded by MSF; the Research Council of Norway through the Norwegian Institute of Public Health; the Canadian government through the Public Health Agency of Canada, Canadian Institutes of Health Research, International Development Research Centre and Department of Foreign Affairs, Trade and Development; and WHO, with support from the Wellcome Trust, United Kingdom.

NIH Watch [to 28 March 2015] – Ebola

NIH Watch [to 28 March 2015]
http://www.nih.gov/news/index.html

:: Ebola test vaccines appear safe in Phase 2 Liberian clinical trial
Liberia-U.S. partnership planning Phase 3 trial and study of Ebola survivors.
March 26, 2015 —
Two experimental Ebola vaccines appear to be safe based on evaluation in more than 600 people in Liberia who participated in the first stage of the Partnership for Research on Ebola Vaccines in Liberia (PREVAIL) Phase 2/3 clinical trial, according to interim findings from an independent Data and Safety Monitoring Board review. Based on these findings, the study, which is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, may now advance to Phase 3 testing.

“We are grateful to the Liberian people who volunteered for this important clinical trial and encouraged by the study results seen with the two investigational Ebola vaccine candidates,” said NIAID Director Anthony S. Fauci, M.D. “Now we must move forward to adapt and expand the study so that ultimately we can determine whether these experimental vaccines can protect against Ebola virus disease and therefore be used in future Ebola outbreaks.”

The PREVAIL trial, which began on Feb. 2, 2015 in Monrovia, Liberia, is testing the safety and efficacy of the cAd3-EBOZ candidate vaccine co-developed by NIAID scientists and GlaxoSmithKline, and the VSV-ZEBOV candidate vaccine developed by the Public Health Agency of Canada and licensed to NewLink Genetics Corporation and Merck. Volunteers are assigned at random to receive a single injection of the NIAID/GSK (cAd3-EBOZ) vaccine, the VSV-ZEBOV vaccine, or a placebo (saline) injection. The trial is also double-blinded, meaning that neither study subjects nor staff know whether a vaccine or placebo was administered. A randomized, double-blind, placebo-controlled trial is considered the “gold standard” in clinical research.
While the initial enrollment goal in the Phase 2 study has been met and the vaccines proven safe, the researchers are continuing Phase 2 study enrollment at Redemption Hospital in Monrovia, Liberia, through late April 2015. This would boost enrollment in the Phase 2 portion of the trial to approximately 1,500 people and would be done, in part, to increase the percentage of women (currently, about 16 percent) in the study for a more robust data set overall. The study follow-up period would be at least one year, and two additional blood samples would be obtained from all volunteers at six and 12 months post-vaccination to determine the durability of the immune responses. These proposed changes will be discussed with the U.S. Food and Drug Administration and are under review by the institutional review boards in Liberia and the United States.

Investigators planned to enroll 27,000 people in Liberia at risk of Ebola infection in the Phase 3 portion of the trial. However, there has been only one new confirmed case of Ebola infection in the country since Feb. 19, 2015. Given this decline in Ebola infection incidence, the trial leaders — H. Clif ford Lane, M.D., NIAID deputy director for clinical research, and Liberian co-principal investigators Stephen Kennedy, M.D., and Fatorma Bolay, Ph.D. — have determined that it is scientifically appropriate to expand the trial to additional sites in other West African countries. Discussions are underway to explore that possibility.

The Liberia–U.S. research team also plans to launch a separate natural history study of Ebola survivors to better understand the after-effects of Ebola virus disease. Four sites in Monrovia, Liberia and locations in the United States may begin enrollment into this study in the coming months, pending regulatory review and approval. More information on this study will be provided when the trial launches.

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:: NIH study finds no evidence of accelerated Ebola virus evolution in West Africa
March 26, 2015 — The study compares virus sequencing data from patient samples.
The Ebola virus circulating in humans in West Africa is undergoing relatively few mutations, none of which suggest that it is becoming more severe or transmissible, according to a National Institutes of Health study in Science. The study compares virus sequencing data from samples taken from patients in Guinea (March 2014), Sierra Leone (June 2014) and Mali (November 2014).

“The Ebola virus in the ongoing West African outbreak appears to be stable—that is, it does not appear to be mutating more rapidly than viruses in previous Ebola outbreaks, and that is reassuring,” said Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH. “We look forward to additional information to validate this finding, because understanding and tracking Ebola virus evolution are critical to ensuring that our scientific and public health response keeps pace.”

Obtaining virus samples for analysis was challenging for researchers during the outbreak. The NIAID study published today relies on data from the Guinea and Sierra Leone cases as well as samples from two case clusters in Mali obtained from the International Center for Excellence in Research (ICER) located in Bamako. NIAID and the Malian government have been partners in the ICER since 2002. The Mali case clusters originated from people who became infected in Guinea and traveled to Mali, where they were diagnosed.

Today’s study, from NIAID’s Rocky Mountain Laboratories, finds that there appear to be no genetic changes that would increase the virulence or change the transmissibility of the circulating Ebola virus, and that despite extensive human-to-human transmission during the outbreak, the virus is not mutating at a rate beyond what is expected. Further, they say, based on their data it is unlikely that the types of genetic changes thus far observed would impair diagnostic measures, or affect the efficacy of candidate vaccines or potential virus-specific treatments.

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:: Update on clinical status of patient with Ebola virus disease at the NIH Clinical Center
March 26, 2015 — Status changes from critical to serious condition.

Ebola Response: One Year Analyses – MSF, PLoS Medicine

Report: Pushed to the Limit and Beyond — A year into the largest ever Ebola outbreak
MSF, March 2015 :: 22 pages
Pdf: http://www.msf.org.uk/sites/uk/files/ebola_-_pushed_to_the_limit_and_beyond.pdf

Press Release
Pushed to the Limit and Beyond: MSF on the global Ebola response one year into the deadliest outbreak in history
March 23, 2015
One year ago today, an outbreak of Ebola in the West African country of Guinea was announced. Since then, nearly 10,000 people have died of the disease, and it has not yet been defeated. Médecins Sans Frontières/Doctors Without Borders (MSF) today released a critical analysis of the Ebola epidemic over the past year, revealing the shortcomings of the global response to the crisis and warning that the outbreak, despite an overall decline in cases, is not yet over.

The report, Pushed to the Limit and Beyond, is based on interviews with dozens of MSF staff involved in the organization’s Ebola intervention. It describes MSF’s early warnings one year ago about cases of Ebola spreading in Guinea, the initial denial by governments of the affected countries, and the unprecedented steps that MSF was forced to take in the face of global inaction as the outbreak engulfed neighbouring states.

Exposing inefficiencies in aid and health systems
“Today we share our initial reflections and take a critical look at both MSF’s response and the wider global response to the deadliest Ebola outbreak in history,” says Dr. Joanne Liu, MSF international president. “The Ebola epidemic proved to be an exceptional event that exposed the reality of how inefficient and slow health and aid systems are to respond to emergencies.”

The report details the effects of the several months-long “global coalition of inaction,” during which the virus spread wildly, leading MSF to issue a rare call for the mobilization of international civilian and military medical assets with biohazard capacity. By the end of August, MSF’s ELWA3 centre in Monrovia was overwhelmed with patients. Staff were forced to turn away visibly ill people from the front gate, in the full knowledge that they would likely return to their communities and infect others.

“The Ebola outbreak has often been described as a perfect storm: a cross-border epidemic in countries with weak public health systems that had never seen Ebola before,” says Christopher Stokes, MSF’s general director. “Yet this is too convenient an explanation. For the Ebola outbreak to spiral this far out of control required many institutions to fail. And they did, with tragic and avoidable consequences.”…

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PLoS Medicine
(Accessed 28 March 2015)
http://www.plosmedicine.org/

Policy Forum
Strengthening the Detection of and Early Response to Public Health Emergencies: Lessons from the West African Ebola Epidemic
Mark J. Siedner, Lawrence O. Gostin, Hilarie H. Cranmer, John D. Kraemer
Published: March 24, 2015
DOI: 10.1371/journal.pmed.1001804
Summary Points
:: The international response to the West African Ebola virus disease epidemic has exemplified the great potential of the global public health community. However, the protracted early response also revealed critical gaps, which likely resulted in exacerbation of the epidemic.
:: It is incumbent on international health partners to learn from missteps that occurred in the early stages of the epidemic and strengthen our public health capacity to better respond to future public health emergencies.
:: Strategies to consider include development of a more precise system to risk stratify geographic settings susceptible to disease outbreaks, reconsideration of the 2005 International Health Regulations Criteria to allow for earlier responses to localized epidemics before they reach epidemic proportions, increasing the flexibility of the World Health Organization director general to characterize epidemics with more granularity, development of guidelines for best practices to promote partnership with local stakeholders and identify locally acceptable response strategies, and, most importantly, making good on international commitments to establish a fund for public health emergency preparedness and response.
:: The recent success of the global action to stem the Ebola virus disease epidemic is laudable but should not encourage complacency in our efforts to improve the global public health infrastructure.

IVI Watch [to 28 March 2015]

IVI Watch [to 28 March 2015]
http://www.ivi.org/web/www/home

:: 160 000 people targeted with oral cholera vaccine in Nsanje [Malawi]
Written by Martin Chiwanda

Nsanje, Malawi March 25: The Ministry of Health is expected to embark on an Oral Cholera Vaccine campaign targeting 160,000 people in the flood hit Nsanje district.
Ministry of Health Epidemiologist Settie Kanyanda disclosed the development in an interview Tuesday on the sidelines of a District Executive Committee meeting in Nsanje.
He said the ministry had targeted Nsanje because it was prone to the cholera outbreak.

“Nsanje district is experiencing more cases of cholera as compared to other districts. We feel that the Oral vaccine is a preventive measure to the attacks,” he stated.
Kanyada assured communities in Nsanje that the vaccine would make a difference in the fight against cholera as it works for five years.

“The Shanchol vaccine which will be given in two doses with interval between 2 to 6 weeks is one of the oral cholera vaccine prequalified by World Health Organisation (WHO) in September 2011 for use by member countries. It is a bivalent whole cell killed oral cholera vaccine with an efficacy of 65percent for five years,” he explained.

With the limited resources available to the ministry, Kanyanda said the exercise will only be administered in Nsanje targeting 160,000 people which is half the district’s population projected at 280,000.

“The vaccine will be administered to all 100,000 to 160,000 people in the district with ages from one year and above living in camps and surrounding communities. We cannot afford to provide the vaccine to the whole population because of limited resources.”

“This exercise has been supported by the World Health Organization and the International Vaccine Institute of Korea. However, we are appealing to other partners to come in and assist in the course,” added Kanyanda.

He also challenged people in the lower shire district to continue exercising good hygiene practices if they were to be safe from typhoid and other diarrhea diseases.
“World Health Organization recommends that vaccination should be used as a tool to control cholera however provision of clean water and adequate sanitation remain the mainstays of cholera control,” clarified Kanyanda.

As of Monday, 23rd March, 2015, Nsanje district had recorded 137 cases of cholera with two deaths, according to District Medical Officer, Dr. Yamikani Mastala.
The Oral vaccine exercise first dose will commence on March 31 and ends on April 4, 2014.