Vaccines and Global Health: The Week in Review :: 27 July 2019

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

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David R. Curry, MS
Executive Director
Center for Vaccine Ethics and Policy

100 millionth person receives lifesaving meningitis vaccine

Milestones :: Perspectives :: Research

 

100 millionth person receives lifesaving meningitis vaccine
Affordable, safe, effective vaccine protecting young people from devastating disease
3 December 2019 [date as published]
News releases GENEVA
A revolutionary meningitis vaccine will reach the 100 millionth person this week in a region of Africa that has been plagued by deadly epidemics for more than a century. The milestone will take place in northern Nigeria, part of Africa’s ‘meningitis belt’, where the country is conducting its second seasonal immunization campaign against the disease.

The historic achievement comes two years after the MenAfriVac® vaccine was first launched in Burkina Faso. Since then, nine other countries have held vaccination campaigns to protect people from ages 1 to 29 against meningitis A.

Nigeria will vaccinate 16 million people over the next two weeks and Cameroon and Chad are also conducting immunization campaigns this week targeting 5.5 million and 2.3 million people respectively. By the end of this year, the vaccine will have reached more than 112 million people, providing widespread and long-awaited protection…

USAID Announces $300 Million Commitment in the Fight Against Tuberculosis

Milestones :: Perspectives :: Research

 

USAID Announces $300 Million Commitment in the Fight Against Tuberculosis
July 24, 2019
The U.S. Agency for International Development (USAID) is pleased to announce a five-year, $300 million award, the TB Implementation Framework Agreement (TIFA), to improve the prevention, detection, and treatment of tuberculosis (TB). The lead partner in the cooperative agreement for the TIFA effort is John Snow, Inc., Research and Training Institute.

A key component of the TB Accelerator initiative USAID Administrator Mark Green announced at the United Nations General Assembly (UNGA) High-Level Meeting (HLM) on TB in September of 2018, the TIFA will work to increase local ownership, financing, and accountability by creating partnerships with host-government entities in 24 USAID TB priority countries to empower them to implement locally generated, context-specific solutions.

The TIFA will contribute to the Journey to Self-Reliance by strengthening the ability of governments and civil society to reach the TB targets set by the UNGA HLM on TB. Financial support to government entities will depend on quantifiable milestones and targets designed to incentivize and strengthen the accountability of national TB programs, while simultaneously increasing domestic investment in the fight to eliminate the disease.

To accelerate the pathway toward the day when foreign assistance for TB is no longer necessary, the TIFA has three primary objectives:
:: Making catalytic financial and technical investments in national TB programs and local government entities to implement effective National TB Strategic Plans, including by embedding TB experts in these institutions;
:: Empowering local government entities to become more self-reliant; and
:: Leveraging and advocating for additional domestic resources for TB from both the public and private sectors.

Statement on governance and oversight of human genome editing

Milestones :: Perspectives :: Research

 

Statement on governance and oversight of human genome editing
26 July 2019 Geneva
WHO Statement
The WHO expert advisory committee on governance and oversight of human genome editing convened on 18-19 March 2019.  At this meeting the Committee in an interim recommendation to the WHO Director-general stated that “it would be irresponsible at this time for anyone to proceed with clinical applications of human germline genome editing.”

WHO supports this interim recommendation and advises regulatory or ethics authorities to refrain from issuing approvals concerning requests for clinical applications for work that involves human germline genome editing.

“Human germline genome editing poses unique and unprecedented ethical and technical challenges,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus. “I have accepted the interim recommendations of WHO’s Expert Advisory Committee that regulatory authorities in all countries should not allow any further work in this area until its implications have been properly considered.”

WHO’s Expert Advisory Committee continues its consideration of this matter, and will, at its forthcoming meeting in Geneva on 26-28 August 2019. evaluate, inter alia, effective governance instruments to deter and prevent irresponsible and unacceptable uses of genome edited embryos to initiate human pregnancies.

Continue reading

Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research

Milestones :: Perspectives :: Research

 

Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research
Notice Number: NOT-OD-19-128
Release Date: July 26, 2019
Issued by NATIONAL INSTITUTES OF HEALTH (NIH)
Purpose
The purpose of this notice is to inform the extramural research community of upcoming HHS requirements and review considerations regarding research that is supported by the NIH and involves the proposed use of human fetal tissue obtained from elective abortions (HFT) in extramural applications for grants, cooperative agreements and R&D contracts. These requirements are in addition to the existing requirements as detailed in the NIH Grants Policy Statement (4.1.14). In addition, NIH reminds the community of expectations to obtain informed consent from the donor for any NIH-funded research using HFT (NOT-OD-16-033).
Background
Currently, when an application/proposal for research involving HFT is submitted to NIH, the Authorized Organizational Representative’s (AOR) signature certifies that researchers using these tissues are in compliance with sections 498A and 498B of the Public Health Service (PHS) Act and the NIH Grants Policy Statement.

NIH is implementing requirements regarding the documentation of the use of HFT in research, as NIH does with other research materials and models, to ensure that it is utilized for research only when scientifically justifiable, and in the least amount possible to achieve the scientific outcomes. NIH will require applicants and contract offerors to provide detailed information addressing the use of HFT in applications/proposals and reports. These requirements are designed to enable NIH to assess whether extramural research applicants/contract offerors and recipients/awardees/contractors are adequately assuring compliance with all applicable laws and HHS/NIH policies concerning the acquisition and use of HFT obtained from elective abortion.

More at: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-128.html

Emergencies

Emergencies

POLIO
Public Health Emergency of International Concern (PHEIC)
Polio this week as of 24 July 2019
Summary of new viruses this week:
:: Pakistan — three WPV1-positive environmental samples;
:: Nigeria —two circulating vaccine-derived poliovirus type 2 (cVDPV2)-positive environmental samples;
:: Democratic Republic of the Congo (DRC) — four cVDPV2 cases.

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DRC – Ebola
Public Health Emergency of International Concern (PHEIC)

Disease Outbreak News (DONs}
Ebola virus disease – Democratic Republic of the Congo
25 July 2019
The Ebola virus disease (EVD) outbreak in North Kivu and Ituri provinces in Democratic Republic of the Congo is ongoing amidst a complex crisis, and we continue to observe sustained local transmission and a high number of cases. Most notably, Beni Health Zone accounted for over half of all new cases reported in the last three weeks, as well as a number of cases and contacts that travelled to other health zones. This is the second wave of the outbreak in Beni Health Zone, and it is larger in case numbers and longer in duration than the first. New healthcare worker and nosocomial infections continue to be reported in Beni and other affected health zones, despite substantial infection prevention and control by multiple agencies during the last wave of the outbreak; a total of 141 (5% of total cases) have been reported to date.
The intensive follow-up of contacts of the confirmed case who arrived in Goma on 14 July (see the 18 July Disease Outbreak News) will continue until the end of the 21-day period. In response to this case, 19 health workers were deployed from other posts to Goma to provide support. Rumours of his contacts travelling to Bukavu, South Kivu, were investigated and ruled out by response teams. No new cases have been reported in Goma to date. There are currently no confirmed cases of EVD outside of the Democratic Republic of the Congo…

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World Bank Mobilizes US$300 Million to Finance the Ebola Response in Democratic Republic of Congo
WASHINGTON, July 24, 2019—The World Bank Group today announced that it is mobilizing up to US$300 million to scale up support for the global response to the Ebola epidemic in the Democratic Republic of Congo (DRC). The announcement follows the declaration by the World Health Organization (WHO) that the current outbreak constitutes a Public Health Emergency of International Concern.
The US$300 million in grants and credits will be largely financed through the World Bank’s International Development Association (IDA) and its Crisis Response Window, which is designed to help countries respond to severe crises and return to their long-term development paths. The financing package will cover the Ebola-affected health zones in DRC and enable the government, WHO, UNICEF, WFP, IOM and other responders to step up the frontline health response, deliver cash-for-work programs to support the local economy, strengthen resilience in the affected communities, and contain the spread of this deadly virus…

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The United States Announces More Than $38 Million in Additional Assistance to Contain the Ebola Outbreak in the Democratic Republic of Congo
July 24, 2019
The United States, through the U.S. Agency for International Development (USAID) is providing more than $38 million in additional assistance to help end the ongoing Ebola outbreak in the Eastern Democratic Republic of Congo (DRC), including $15 million in new funding to the World Health Organization. This brings the total USAID funding for the response to Ebola to more than $136 million since the beginning of the outbreak in August 2018.

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Summary of new polio viruses this week:
Democratic Republic of the Congo
Four cases of circulating vaccine-derived poliovirus type 2 (cVDPV2) have been reported this week in the Democratic Republic of the Congo (DR Congo): two from Kalonda-Ouest and one from  Nyanga, Kasai province, with onset of paralysis on 3, 7, and 5 June 2019; one from Tshumbe, Sankuru province, with onset of paralysis on 14 June 2019.  There are 15 reported cases of cVDPV2 in 2019. The total number of cVDPV2 cases reported in 2018 is 20.  DRC is currently affected by eight separate cVDPV2 outbreaks; one each originated in Haut Katanga, Mongala, Sankuru, two in Haut Lomami and three in Kasai provinces.

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Editor’s Note:
WHO has posted a refreshed emergencies page which presents an updated listing of Grade 3,2,1 emergencies as below.
WHO Grade 3 Emergencies [to 27 Jul 2019]

Democratic Republic of the Congo
[See DRC Ebola+ above for detail]

Cyclone Idai – No new digest announcements identified
Mozambique floods – No new digest announcements identified
Nigeria – No new digest announcements identified
Somalia – No new digest announcements identified
South Sudan – No new digest announcements identified
Syrian Arab Republic – No new digest announcements identified
Yemen – No new digest announcements identified

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WHO Grade 2 Emergencies [to 27 Jul 2019]

Iraq
:: WHO Regional Director in Iraq to reinforce WHO support as country enters transition to development phase 15 July 2019

Myanmar
:: Bi‐weekly Situation Report 14 – 18 July 2019 pdf, 737kb

Afghanistan – No new digest announcements identified
Cameroon – No new digest announcements identified
Central African Republic – No new digest announcements identified
Ethiopia – No new digest announcements identified
HIV in Pakistan – No new digest announcements identified
Iran floods 2019 – No new digest announcements identified
Libya – No new digest announcements identified
Malawi floods – No new digest announcements identified
Measles in Europe – No new digest announcements identified
MERS-CoV – No new digest announcements identified
Niger – No new digest announcements identified
occupied Palestinian territory – No new digest announcements identified
Sao Tome and Principe Necrotizing Cellulitis (2017)
Sudan – No new digest announcements identified
Ukraine – No new digest announcements identified
Zimbabwe – No new digest announcements identified

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WHO Grade 1 Emergencies [to 27 Jul 2019]

Chad
:: Partner meeting for the eradication of poliomyelitis in the Lake Chad Basin under the coordination and leadership of the WHO African region [in French] 30 June 2018

Angola – No new digest announcements identified
Djibouti – No new digest announcements identified
Indonesia – Sulawesi earthquake 2018 – No new digest announcements identified
Kenya – No new digest announcements identified
Mali – No new digest announcements identified
Namibia – viral hepatitis – No new digest announcements identified
Tanzania – No new digest announcements identified

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UN OCHA – L3 Emergencies
The UN and its humanitarian partners are currently responding to three ‘L3’ emergencies. This is the global humanitarian system’s classification for the response to the most severe, large-scale humanitarian crises. 
Syrian Arab Republic
:: Humanitarian Update Syrian Arab Republic – Issue 04 | 25 July 2019
Upsurge in violence endangers 3 million people in northwest
The United Nations remains gravely concerned by the dramatic escalation of violence in northwest Syria which has resulted in over 400 civilians confirmed dead and hundreds of thousands of women, children and men displaced since the upsurge in violence began almost three months ago…

Yemen – No new digest announcements identified

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UN OCHA – Corporate Emergencies
When the USG/ERC declares a Corporate Emergency Response, all OCHA offices, branches and sections provide their full support to response activities both at HQ and in the field.
Editor’s Note:
Ebola in the DRC has bene added as a OCHA “Corporate Emergency” this week:
CYCLONE IDAI and Kenneth – No new digest announcements identified
EBOLA OUTBREAK IN THE DRC – No new digest announcements identified

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WHO & Regional Offices [to 27 Jul 2019]

WHO & Regional Offices [to 27 Jul 2019]
26 July 2019 News release
WHO urges countries to invest in eliminating hepatitis
Ahead of World Hepatitis Day (28 July), WHO calls on countries to take advantage of recent reductions in the costs of diagnosing and treating viral hepatitis and scale up investments in disease elimination.
A new study by WHO, published today in Lancet Global Health, has found that investing US$6bn per year in eliminating hepatitis in 67 low- and middle-income countries  would avert 4.5 million premature deaths by 2030, and more than 26 million deaths beyond that target date.
A total of US$58.7 billion is needed to eliminate viral hepatitis as a public health threat in these 67 countries by 2030. This means reducing new hepatitis infections by 90% and deaths by 65%…

24 July 2019 News release
WHO applauds Rwanda’s Ebola preparedness efforts

22 July 2019 News release
WHO recommends dolutegravir as preferred HIV treatment option in all populations
Based on new evidence assessing benefits and risks, the WHO recommends the use of the HIV drug dolutegravir (DTG) as the preferred first-line and second-line treatment for all populations, including pregnant women and those of childbearing potential.

Initial studies had highlighted a possible link between DTG and neural tube defects (birth defects of the brain and spinal cord that cause conditions such as spina bifida) in infants born to women using the drug at the time of conception. This potential safety concern was reported in May 2018 from a study in Botswana that found 4 cases of neural tube defects out of 426 women who became pregnant while taking DTG. Based on these preliminary findings, many countries advised pregnant women and women of childbearing potential to take efavirenz (EFV) instead.

New data from two large clinical trials comparing the efficacy and safety of DTG and EFV in Africa have now expanded the evidence base. The risks of neural tube defects are significantly lower than what the initial studies may have suggested.

The guidelines group also considered mathematical models of the benefits and harms associated with the two drugs; the values and preferences of people living with HIV, as well as factors related to implementation of HIV programmes in different countries, and cost.

DTG is a drug that is more effective, easier to take and has fewer side effects than alternative drugs that are currently used. DTG also has a high genetic barrier to developing drug resistance, which is important given the rising trend of resistance to EFV and nevirapine-based regimens. In 2019, 12 out of 18 countries surveyed by WHO reported pre-treatment drug resistance levels exceeding the recommended threshold of 10%.

All of above findings informed the decision to update the 2019 guidelines…

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Calls for consultants / proposals
22 July 2019
Consultant on Total Systems Effectiveness (TSE) tool development
pdf, 264kb

Deadline for applications: 11 August 2019

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Weekly Epidemiological Record, 26 July 2019, vol. 94, 30/31 (pp. 329–344)
:: Progress towards poliomyelitis eradication in Nigeria, January 2018 – May 2019
:: Performance of acute flaccid paralysis (AFP) surveillance and incidence of poliomyelitis, 2019

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WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: WHO’s Data Tool improves Ebola Surveillance, Contact Tracing and Decision Making in Uganda 26 July 2019
:: Countries strategize their plan on Integrated Community Case Management (iCCM) to end preventable child death 26 July 2019
:: Ethiopia, Somaliland and Puntland jointly plan for the synchronized HoA cross-border polio response 25 July 2019
:: SIDS Pooled Procurement Initiative to Improve Access To Quality Medicines
22 July 2019

WHO Region of the Americas PAHO
:: WHO urges countries to invest in eliminating hepatitis (07/26/2019)
:: IAS 2019: PAHO Director calls for new approach to HIV response in order to end the epidemic by 2030 (07/22/2019)

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

WHO European Region EURO
No new digest content identified.

WHO Eastern Mediterranean Region EMRO
:: Statement on Iraq by Dr Ahmed Al-Mandhari, WHO Regional Director for the Eastern Mediterranean

Cairo, Egypt, 24 July 2019 – I recently concluded a 4-day visit to Iraq where I saw firsthand a health system transitioning from emergency response to reconstruction, rehabilitation and resilience, while at the same time addressing the health needs of millions of vulnerable Iraqis and refugees. The country’s new national health priorities, including health financing, environmental health and sanitation, and universal health…

WHO Western Pacific Region
:: Risk of Ebola in the Western Pacific remains low 18 July 2019 News releases