Vaccines and Global Health: The Week in Review 30 July 2016

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_30 July 2016

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

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

Publication will resume on 20 August 2016 following annual leave for the Editor.

Vaccines and Global Health: The Week in Review 23 July 2016

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_23 July 2016

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

Twitter:  Readers can also follow developments on twitter: @vaxethicspolicy.
.
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

Zika virus [to 23 July 2016]

Zika virus [to 23 July 2016]
Public Health Emergency of International Concern (PHEIC)
http://www.who.int/emergencies/zika-virus/en/

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5 reasons to support WHO’s global response to Zika virus
Zika virus and its complications represent a new type of public health threat that requires a unique and integrated strategy. WHO/PAHO and 14 partners need a combined amount of US$122.1 million for the global response plan….
[The “five reasons” presented without supporting text available at link above]
1. WHO is the only agency with universal legitimacy in matters of international health, to lead and coordinate the response to Zika.
2. WHO helps countries develop and strengthen health and social services for individuals, families and communities affected by Zika.
3. WHO fast-tracks the availability of effective diagnostic tests, vaccines and public health guidance.
4. WHO works to prevent adverse health outcomes through mosquito control, risk communication and community engagement.
5. WHO communicates vital information to decision-makers

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Zika situation report – 21 July 2016
Full report: http://apps.who.int/iris/bitstream/10665/246241/1/zikasitrep21Jul16-eng.pdf?ua=1
Summary [Excerpt]
:: WHO and partners established a definition of what constitutes an outbreak, endemic transmission, and the interruption of mosquito-borne transmission in order to better characterize the level of transmission of Zika virus infection (Table 1, Fig. 2). This classification system was put into use as of the situation report of 7 July 2016.

:: As of 20 July 2016, 65 countries and territories (Fig. 1, Table 1) have reported evidence of mosquito-borne Zika virus transmission since 2007 (62 of these countries and territories have reported evidence of mosquito-borne Zika virus transmission since 2015):
…48 countries and territories with a first reported outbreak from 2015 onwards (Table 1).
…Four countries are classified as having possible endemic transmission or have reported evidence of local mosquito-borne Zika infections in 2016.
…13 countries and territories have reported evidence of local mosquito-borne Zika infections in or before 2015, but without documentation of cases in 2016, or with the outbreak terminated.

:: No new country or territory has reported mosquito-borne Zika virus transmission in the week to 20 July 2016.

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Zika Open [to 23 July 2016]
[Bulletin of the World Health Organization]
:: All papers available here
RESEARCH IN EMERGENCIES
A rapid review of personal protective measures for preventing Zika virus infection among pregnant women
– Vicky Nogueira Pileggi, Giordana Campos Braga, Fernando Bellissimo-Rodrigues, João Paulo Dias de Souza
Posted: 21 July 2016
http://dx.doi.org/10.2471/BLT.16.182592

Designing serological diagnostics based on evolutionarily divergent immunogenic regions in the Zika virus genome
– Hsiao-Han Chang, Yonatan H. Grad, David Camerini, & Marc Lipsitch
Posted: 18 July 2016
http://dx.doi.org/10.2471/BLT.16.182105

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CDC/ACIP [to 23 July 2016]
http://www.cdc.gov/media/index.html
Press Release
THURSDAY, JULY 21, 2016
CDC awards $60 million to help states and territories battle Zika
The Centers for Disease Control and Prevention (CDC) will begin making awards totaling nearly $60 million to states, cities, and territories to support efforts to protect Americans from Zika virus…

Media Advisory
WEDNESDAY, JULY 20, 2016
Webcast: Clinical Evaluation & Management of Infants with Congenital Zika Infection
CDC will host a meeting in collaboration with the American Academy of Pediatrics.

Transcript
TUESDAY, JULY 19, 2016
Transcript for CDC Media Availability: Support for Utah investigation of Zika

Media Statement
MONDAY, JULY 18, 2016
CDC assisting Utah investigation of Zika virus infection apparently not linked to travel
CDC is assisting in the investigation of a case of Zika in a Utah resident who is a family contact of the elderly Utah resident who died in late June….

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UNICEF [to 23 July 2016]
http://www.unicef.org/media/media_89711.html
18 July 2016
Twelvefold increase in Zika cases since Ecuador earthquake
NEW YORK/PANAMA/QUITO,– Three months after the Ecuador earthquake, the number of Zika Virus cases increased from 92 to 1,106 country-wide, with the sharpest increase in the quake-hit areas.

POLIO [to 23 July 2016]

POLIO [to 23 July 2016]
Public Health Emergency of International Concern (PHEIC)

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Polio this week as of 19 July 2016
:: The Independent Monitoring Board is meeting in London on 20-21 July to assess progress towards polio eradication .
:: The Technical Advisory Group on polio eradication for Afghanistan met in Kabul on 11-13 July and commended progress towards interrupting the transmission of polio whilst stressing the challenges that remain. Progress in the context of surveillance was also commended in the Acute Flaccid Paralysis (AFP) Surveillance Review that took place in Afghanistan in June.
:: Selected Country Levels Updates [excerpted]
No new cases at country level reported.

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World Bank [to 23 July 2016]
http://www.worldbank.org/en/news/all
Date: July 19, 2016
Amidst Conflict, World Bank Reaches 1.5 Million Yemeni Children with Polio Vaccines
:: The crisis in Yemen has taken a heavy toll on the country’s children, with thousands killed and thousands more at risk of disease and malnutrition.
:: All World Bank Group operations in Yemen were suspended when the conflict worsened, but a partnership with the United Nations Children’s Emergency Fund (UNICEF) and the World Health Organization (WHO) has allowed for the continuation of key activities of two Bank-funded health projects.
:: The Health and Population Project has provided critical support for the national polio campaign that has managed to vaccinate 1.5 million Yemeni children despite the conflict.

Yellow Fever [to 23 July 2016]

Yellow Fever [to 23 July 2016]
http://www.who.int/emergencies/yellow-fever/en/

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Yellow Fever – Situation Report – 21 July 2016
Full Report:
http://apps.who.int/iris/bitstream/10665/246242/1/yellowfeversitrep-21Jul16-eng.pdf?ua=1
Summary:
Angola: 3682 suspected cases
In Angola, as of 15 July 2016 a total of 3682 suspected cases have been reported, of which 877 are confirmed. The total number of reported deaths is 361, of which 117 were reported among confirmed cases. Suspected cases have been reported in all 18 provinces and confirmed cases have been reported in 16 of 18 provinces and 79 of 125 reporting districts.

Mass reactive vaccination campaigns first began in Luanda and have now expanded to cover most of the other affected parts of Angola. Recently, the campaigns have focused on border areas.
Mass vaccination campaigns were completed in several districts in Benguela, Huambo, Huila, Kwanza Norte, Lunda Norte, Malange and Uige provinces. All districts continued with house to house immunization campaigns and routine vaccination.

Democratic Republic of the Congo: 1798 suspected cases
For the last four weeks the national laboratory in the Democratic Republic of The Congo (DRC) has been unable to confirm or discard any suspected cases of yellow fever due to technical issues and corrective actions are underway. According to the latest available information (as of 11 July), the total number of notified suspected cases is 1798, with 68 confirmed cases (as of 24 June) and 85 reported deaths. Cases have been reported in 22 health zones in five of 26 provinces. Of the 68 confirmed cases, 59 were imported from Angola, two are sylvatic (not related to the outbreak) and seven are autochthonous.

In DRC, surveillance efforts have increased and vaccination campaigns have centred on affected health zones in Kinshasa and Kongo Central. Reactive vaccination campaigns started on 20 July in Kisenso health zone in Kinshasa province and in Kahemba, Kajiji and Kisandji health zones in Kwango province.

The risk of spread
Two additional countries have reported confirmed yellow fever cases imported from Angola: Kenya (two cases) and People’s Republic of China (11 cases). These cases highlight the risk of international spread through non-immunised travellers…

Seven countries (Brazil, Chad, Colombia, Ghana, Guinea, Peru and Uganda) have reported yellow fever outbreaks or sporadic cases not linked to the Angolan outbreak…
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Fractional dose yellow fever vaccine as a dose-sparing option for outbreak response
WHO Secretariat information paper
WHO reference number: WHO/YF/SAGE/16.1
Published: July 2016 ::39 pages
[Excerpts]
1. Preamble
This document represents the World Health Organization (WHO) Secretariat position on the use of yellow fever (YF) vaccine in the context of supply shortages in response to the current outbreak in Africa in 2016. The development of this paper was led by the WHO Initiative for Vaccine Research with contributions to specific sections from the WHO Departments of Pandemic and Epidemic Diseases, Essential Medicines, and Immunization Vaccines and Biologicals. The evidence and the proposed recommendations, reflected in this document, has been discussed with YF experts and reviewed by the WHO Strategic Advisory Group of Experts (SAGE) on Immunization. SAGE and the YF experts provided input to this paper. The recommendations were vetted by SAGE, but they don’t represent a formal SAGE recommendation. The paper will be updated as additional data become available. A full review on the use of fractional dose YF vaccine will be conducted by SAGE in October 2016….

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12. Ethical considerations
In emergencies the international community has a collective duty of care to ensure that effective affordable measures are available to those most in need. The duty of care principle demands that effective vaccinations against disease threats should be available to those at risk. Emergencies often require rapid decision-making under uncertain and unconventional situations, but ethical principles need to be adhered to even in these situations.

In the face of shortages, a usual strategy is prioritization among different population groups. Another is to use a dose-sparing approach in order to cover as much of the population as possible. Both options could also be combined. The best of these options should be chosen based on a rigorous public health and ethical analysis.

A number of ethical issues arise when choosing a dose-sparing approach:
Risk-benefit considerations
First, the risk of harm to populations and individuals needs to be analysed (the ‘first do no harm’ principle). These risks and possible mitigating actions to minimize them should be explicitly discussed. Second, there should be robust evidence for benefit, i.e. for non-inferiority in comparison to the full dose. In addition, the dose-sparing strategy should be considered based on robust evidence for its benefit.

The obligation to produce and share data
In public health emergencies there is an ethical duty to produce and rapidly share all relevant data. The use of lower doses of vaccine as an emergency measure entails an ethical obligation to learn as much as possible as quickly as possible. Even if the dose-sparing approach is not designed as a research project, research components should be embedded to use this opportunity to gain new knowledge. Ideally, protocols should be submitted for pre-approval so that the final ethics review can be expedited.

Distributive justice and equity
Unless there is scientific necessity and evidence for doing so (e.g. based on safety or futility), the immunization programmes should not discriminate against any population groups. Special measures should be taken to facilitate the access of vulnerable groups, such as children and pregnant women.

Transparency, trust, public engagement
The vaccination strategy should be well communicated by national policy-makers to the public health officials, the public and the media. Special effort should be made to ensure that media understand well the rationale for the dose sparing strategy and become real partners in disseminating the messages of the vaccine programmes. Public engagement will facilitate uptake and trust in the programme.

Informed consent
During mass vaccination campaigns, consent is normally presumed (implicit consent), with a possibility to opt out. This means that information about the vaccine must be disseminated widely in an accessible format, and that it is ensured that members of the public know that they can opt out of vaccination, if they so wish. If mass vaccination campaigns are being planned with the lower-dose vaccine, it is an ethical requirement to provide minimum additional information, i.e. that a lower than usual dose will be used but that it is considered as safe and effective as the normal dose.

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13. Recommendations
1. Fractional dose YF vaccination, an off-label use of the product, should be considered in response to an emergency situation in which current vaccine supply is insufficient. Fractional dose vaccination should be used for vaccination campaigns in response to an outbreak or in settings where the extension of the outbreak is imminent and should not be used for routine immunization. As soon as the vaccine supply situation normalizes, fractional dose should be replaced by full dose vaccination. Fractional dose vaccination is an off-label use of the product.

2. Under no circumstances should YF vaccine be reconstituted in a different volume of diluent than that recommended by the manufacturer, and no other method of diluting the vaccine should be used.

3. When fractional dose YF vaccine is used, preference should be given to the administration of the vaccine according to standard route, i.e. SC or IM. The minimal dose administered should preferentially contain 3000 IU/dose, but no less than 1000 IU/dose and the minimum volume of the inoculum should be not less than 0.1 ml.

4. The dose fractioning (e.g. 1/2 or 1/5th) should be done considering the potency of the vaccine batch, the shortage of supply and availability of suitable injection devices.
5. In the absence of data on the use of fractional dose YF vaccination in young children, children aged less than 2 years should preferentially be offered a full dose of vaccine (i.e. at least 3000 IU) during emergency campaigns.

6. Different expansion scenarios for YF vaccine fractional dose administration should be considered in view of the potential risk of further spread of the disease, and shortage of vaccine supply. Actual potencies of available vaccines need to be considered to meet the necessary potency levels:
a. 1/2 dose of Bio-Manguinhos vaccine administered SC.
b. Should the shortage of vaccine limit the use of a 1/2 dose, use of a 1/5th dose of Bio-Manguinhos vaccine administered SC could be considered.
c. If the shortage limits fractional dose supplies, all WHO prequalified vaccines could be administered as 1/2 or 1/5th fractional dose SC, depending on potency of the batch. In this context, use of Stamaril ® (Sanofi) via ID administration (0.1.ml) is, while off-label, also acceptable, depending on the preferences of the country. As a general rule, fractional doses should not be less than the minimal dose range (see recommendation 3).

7. Reconstituted YF vaccine is heat labile and must be kept at 2–8 °C at all times and discarded after 6 hours in accordance with WHO’s open vial policy.

8. Multidose vials containing more than 10 full doses should not be used for fractional dose administration in order to avoid increased risk of contamination due to multiple punctures of the septum.

9. Every effort should be made to monitor safety and YF vaccine AEFIs.

10. Vaccination with fractional doses should be recorded using personalized registries for the purpose of safety and effectiveness monitoring. Such information may prove useful in assessing eventual re-vaccination needs with full doses, for which currently there is no recommendation.

11. All other precautions and recommendations for YF vaccination remain valid as detailed in the WHO yellow fever vaccine position paper (2013)…

WHO & Regional Offices [to 23 July 2016]

WHO & Regional Offices [to 23 July 2016]

WHO Secretariat paper on the use of a fractional dose yellow fever vaccine as a dose-sparing option for outbreak response to the ongoing yellow fever outbreak in Africa
21 July 2016
[See Yellow Fever section above for more detail]

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Disease Outbreak News (DONs)
:: Human infection with avian influenza A(H7N9) virus – China 22 July 2016
:: Enterohaemorrhagic Escherischia coli – United Kingdom 20 July 2016

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Countries act on noncommunicable diseases, but more effort needed
18 July 2016 – A new WHO report highlights the need to intensify national action to meet global targets on noncommunicable diseases such as heart disease, cancers, diabetes, and lung diseases, which collectively represent the largest cause of death in people aged under 70 years. A number of countries have put in place measures to prevent tobacco use, harmful use of alcohol, unhealthy diet, and physical inactivity, but progress is insufficient and uneven.

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Highlights
Tropical Data helps countries collect and leverage data
July 2016 − A new WHO initiative called Tropical Data provides an end-to-end epidemiological survey support service, covering planning and protocol development, training, data processing, and application of the survey outputs. The initiative will initially focus on supporting trachoma prevalence surveys.

Antibiotics needed for maternal and congenital syphilis
July 2016 – New evidence shows that shortages of benzathine penicillin are prevalent in countries with high numbers of pregnant women and infants who are infected with syphilis. Shortages of this antibiotic may lead to a lack of treatment for pregnant women, and ultimately to adverse birth and health outcomes.

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:: WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: WHO encourages countries to act now to reduce deaths from viral hepatitis
20 July 2016, Geneva – Ahead of World Hepatitis Day, 28 July 2016, WHO is urging countries to take rapid action to improve knowledge about the disease, and to increase access to testing and treatment services. Today, only 1 in 20 people with viral hepatitis know they have it. And just 1 in 100 with the disease is being treated

WHO Region of the Americas PAHO
:: PAHO urges health and agriculture sectors in the Americas to work together to ensure prudent use of antimicrobials (07/21/2016)
:: PAHO/WHO updates the characterization of Zika Congenital Syndrome (07/21/2016)

WHO South-East Asia Region SEARO
:: Sri Lanka celebrates elimination of lymphatic filariasis
World Health Organization presented a certificate to Sri Lanka for eliminating lymphatic filariasis at the event in Colombo on 21 July 2016.

WHO European Region EURO
:: Escherischia coli (E. coli) outbreak in United Kingdom 21-07-2016
:: Greece and Portugal exchange experience and good practices in health technology assessment (HTA) 20-07-2016

WHO Eastern Mediterranean Region
:: WHO condemns multiple attacks on Syrian hospitals
19 July 2016 WHO condemns the attacks on hospitals in Aleppo and Idleb governorates in the Syrian Arab Republic, and offers its condolences to the families and colleagues of the health staff and patients killed in these attacks. These latest events represent a serious setback for the affected community and an additional challenge to humanitarian work in Syria. It is unacceptable that such attacks on health care, which violate international humanitarian law, are increasing in both frequency and scale.

WHO Western Pacific Region
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