Vaccines and Global Health: The Week in Review :: 16 November 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

EMA – First vaccine to protect against Ebola (updated) :: WHO prequalifies Ebola vaccine, paving the way for its use in high-risk countries :: Merck’s ERVEBO® [Ebola Zaire Vaccine (rVSVΔG-ZEBOV-GP) live] Granted Conditional Approval in the European Union

Milestones :: Perspectives :: Research

 

EMA – First vaccine to protect against Ebola (updated)
CHMP, Last updated: 14/11/2019
EMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorisation in the European Union for Ervebo (rVSVΔG-ZEBOV-GP), the first vaccine for active immunisation of individuals aged 18 years and older at risk of infection with the Ebola virus.

“This is an important step towards relieving the burden of this deadly disease,” said Guido Rasi, EMA’s Executive Director. “The CHMP’s recommendation is the result of many years of collaborative global efforts to find and develop new medicines and vaccines against Ebola. Public health authorities in countries affected by Ebola need safe and efficacious medicines to be able to respond effectively to outbreaks and save lives.”…

Ervebo is a genetically engineered, replication-competent, attenuated live vaccine. Data from clinical trials and compassionate use programs have shown that Ervebo protects against Ebola virus disease in humans following a single dose administration.

The clinical development of Ervebo was initiated in response to the 2014-2016 Ebola outbreak in cooperation with public health stakeholders, including national institutes of health, ministries of health in countries such as Guinea and DRC, WHO, the US Centers for Disease Control and Prevention, the Public Health Agency of Canada, Médecins Sans Frontières and others. In the ongoing Ebola outbreak in DRC, the vaccine is being used under an Expanded Access Protocol or ‘compassionate use’ to protect people at highest risk of infection such as healthcare workers, or people who have come into contact with infected patients or contacts of contacts according to a ring vaccination strategy.

Ervebo has been tested in approximately 16,000 individuals involved in several clinical studies in Africa, Europe and the United States where it has been proven to be safe, immunogenic (i.e. able to make the immune system respond to the virus) and effective against the Zaire Ebola virus that circulated in West Africa in 2014-2016. Preliminary data suggest that it is effective in the current outbreak in DRC. Additional efficacy and safety data are being collected through the Expanded Access Protocol and should be included in post-marketing safety reports, which are continuously reviewed by EMA.

Ervebo was supported through EMA’s PRIority MEdicines (PRIME) scheme, which provides early and enhanced scientific and regulatory support to medicines that have a particular potential to address patients’ unmet medical needs. Ervebo was granted eligibility to PRIME in June 2016 for active immunisation against Ebola…

 

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WHO prequalifies Ebola vaccine, paving the way for its use in high-risk countries
12 November 2019 News release
The World Health Organization (WHO) today prequalified an Ebola vaccine for the first time, a critical step that will help speed up its licensing, access and roll-out in countries most at risk of Ebola outbreaks. This is the fastest vaccine prequalification process ever conducted by WHO.
Prequalification means that the vaccine meets WHO standards for quality, safety and efficacy. United Nations agencies and Gavi, the Vaccine Alliance, can procure the vaccine for at-risk countries based on this WHO recommendation.

“This is a historic step towards ensuring the people who most need it are able to access this life-saving vaccine,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “Five years ago, we had no vaccine and no therapeutics for Ebola. With a prequalified vaccine and experimental therapeutics, Ebola is now preventable and treatable.”

The injectable Ebola vaccine, Ervebo, is manufactured by Merck (known as MSD outside the US and Canada). It has been shown to be effective in protecting people from the Ebola Zaire virus and is recommended by the WHO Strategic Advisory Group of Experts (SAGE) for vaccines as part of a broader set of Ebola response tools. The decision is a step towards greater availability of the vaccine in the future, though licensed doses will only be available mid-2020.

This announcement comes less than 48 hours after the European Commission decision to grant a conditional marketing authorization for the vaccine, following the recommendation from the European Medicines Agency (EMA)...

 

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Merck’s ERVEBO® [Ebola Zaire Vaccine (rVSVΔG-ZEBOV-GP) live] Granted Conditional Approval in the European Union
:: Authorization Represents Significant Advancement in the Global Response to Ebola
:: Merck Remains Committed to Working with International Health Partners in Ebola Outbreak Response
November 11, 2019
KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the European Commission has granted a conditional marketing authorization to ERVEBO for active immunization of individuals 18 years of age or older to protect against Ebola Virus Disease (EVD) caused by Zaire Ebola virus. The use of ERVEBO should be in accordance with official recommendations. The approval is based on data submitted to the European Medicines Agency for accelerated assessment in March 2019. With this approval, the European Commission will grant a centralized marketing authorization with unified labeling that is valid in the 28 countries that are members of the European Union, as well as European Economic Area members, Iceland, Liechtenstein and Norway. ERVEBO is currently under Priority Review with the U.S. Food and Drug Administration (FDA) with a target action date of March 14, 2020.

“The European Commission’s marketing authorization of ERVEBO is the result of an unprecedented collaboration for which the entire world should be proud. It is a historic milestone and a testament to the power of science, innovation and public-private partnership,” said Kenneth C. Frazier, chairman and chief executive officer, Merck. “After recognizing the need and urgency for an Ebola Zaire vaccine, many came together across sectors to answer the global call for outbreak preparedness. We at Merck are honored to play a part in Ebola outbreak response efforts and we remain committed to our partners and the people we serve. We also look forward to continuing to work with the FDA and the African countries on their regulatory reviews over the coming months and with the World Health Organization on vaccine prequalification, which will help broaden access to this important vaccine for those who need it most.”

Given the unique manufacturing requirements for ERVEBO, this approval allows Merck to initiate manufacturing of licensed doses in Germany, which are expected to start becoming available in the third quarter of 2020. Merck is also working closely with the World Health Organization (WHO), the United States Government, and Gavi, the Vaccine Alliance, to ensure uninterrupted access of its investigational Ebola Zaire vaccine (V920) in support of ongoing international response efforts in the DRC. As previously announced, Merck has committed to manufacture additional doses of investigational V920 over the coming year.

As part of its clinical development, and in response to requests from the WHO, Merck has, to date, donated more than 250,000 1.0mL doses of V920 to the WHO for use in outbreak response efforts occurring in the DRC since May 2018.

Merck has made a submission to the WHO seeking prequalification status for the vaccine, as well as submissions to selected African country National Regulatory Authorities in collaboration with the African Vaccine Regulatory Forum (AVAREF), which, if approved, will allow the vaccine to be registered in several African countries….

More People in the United States Dying from Antibiotic-Resistant Infections than Previously Estimated

More People in the United States Dying from Antibiotic-Resistant Infections than Previously Estimated
Wednesday, November 13, 2019

The Centers for Disease Control and Prevention (CDC) today released its updated Antibiotic Resistance Threats in the United States (AR Threats Report) indicating that antibiotic-resistant bacteria and fungi cause more than 2.8 million infections and 35,000 deaths in the United States each year. That means, on average, someone in the United States gets an antibiotic-resistant infection every 11 seconds and every 15 minutes someone dies. When Clostridioides difficile, a bacterium which is not typically resistant but can cause deadly diarrhea and is associated with antibiotic use, is added to these, the U.S. toll of all the threats in the report exceeds 3 million infections and 48,000 deaths.

Using data sources not previously available, the new report shows that there were nearly twice as many annual deaths from antibiotic-resistant infections as CDC originally reported in 2013. Since then, the new report shows, prevention efforts have reduced deaths from antibiotic-resistant infections by 18 percent overall and by nearly 30 percent in hospitals. Without continued vigilance, however, this progress may be challenged by the increasing burden of some infections.

CDC’s 2019 report thus establishes a new national baseline of infections and deaths from antibiotic-resistant germs. Moreover, the new report categorizes the top antibiotic-resistant threats based on level of concern to human health: urgent, serious, or concerning…

Vaccine-related advertising in the Facebook Ad Archive

Featured Journal Content

 

Vaccine
Available online 13 November 2019
In Press, Corrected Proof
Vaccine-related advertising in the Facebook Ad Archive
Amelia M.Jamison, David A.Broniatowski, Mark Dredze, ZachWood-Doughty Dure AdenKhan, Sandra Crouse Quinna
https://doi.org/10.1016/j.vaccine.2019.10.066Get rights and content
Highlights
:: First assessment of vaccine-related advertisements on Facebook Ad Archive.
:: Top pro-vaccine ad themes: vaccine promotion, philanthropy, news.
:: Top anti-vaccine ad themes: vaccine harm, promoting choice, uncovering “fraud”.
:: Two buyers accounted for majority (54%) of anti-vaccine advertising content.
:: Facebook policies negatively impact first time ad buyers, largely pro-vaccine.
Abstract
Background
In 2018, Facebook introduced Ad Archive as a platform to improve transparency in advertisements related to politics and “issues of national importance.” Vaccine-related Facebook advertising is publicly available for the first time. After measles outbreaks in the US brought renewed attention to the possible role of Facebook advertising in the spread of vaccine-related misinformation, Facebook announced steps to limit vaccine-related misinformation. This study serves as a baseline of advertising before new policies went into effect.
Methods
Using the keyword ‘vaccine’, we searched Ad Archive on December 13, 2018 and again on February 22, 2019. We exported data for 505 advertisements. A team of annotators sorted advertisements by content: pro-vaccine, anti-vaccine, not relevant. We also conducted a thematic analysis of major advertising themes. We ran Mann-Whitney U tests to compare ad performance metrics.
Results
309 advertisements were included in analysis with 163 (53%) pro-vaccine advertisements and 145 (47%) anti-vaccine advertisements. Despite a similar number of advertisements, the median number of ads per buyer was significantly higher for anti-vaccine ads. First time buyers are less likely to complete disclosure information and risk ad removal. Thematically, anti-vaccine advertising messages are relatively uniform and emphasize vaccine harms (55%). In contrast, pro-vaccine advertisements come from a diverse set of buyers (83 unique) with varied goals including promoting vaccination (49%), vaccine related philanthropy (15%), and vaccine related policy (14%).
Conclusions
A small set of anti-vaccine advertisement buyers have leveraged Facebook advertisements to reach targeted audiences. By deeming all vaccine-related content an issue of “national importance,” Facebook has further the politicized vaccines. The implementation of a blanket disclosure policy also limits which ads can successfully run on Facebook. Improving transparency and limiting misinformation should not be separate goals. Public health communication efforts should consider the potential impact on Facebook users’ vaccine attitudes and behaviors.

Emergencies

Emergencies

 

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

Ebola Outbreak in DRC 67: 12 November 2019
1. Situation update
Over the last three months, there has been a steady decrease in confirmed cases of Ebola Virus Disease (EVD) in the Democratic Republic of the Congo. At the peak of the epidemic in the last week of April 2019, 120 cases were reported. In the week of 4 to 10 November 2019 only 12 cases were reported. Teams are building on this progress by enhancing efforts to thoroughly investigate all new cases and improving contact tracing in order to break the remaining transmission chains…

 

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POLIO
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 13 November 2019
:: Besides Acute Flaccid Paralysis surveillance and Environmental surveillance, how else do disease surveillance officers track the poliovirus in populated cities, hard-to-reach geographical areas and in conflict zones? Find out here.
:: With the current VDPV outbreaks in the Philippines, the Government with the support of GPEI and other partners is working hard to tackle the virus. The Government has pledged US$ 9 million in domestic resources and has to date disbursed US$ 6.7 million, complemented by contributions from the GPEI. Read the country’s latest situation report [below]

Summary of new viruses this week (AFP cases and ES positives):
:: Pakistan— two WPV1 cases, three WPV1-positive environmental samples, seven cVDPV2 cases and nine cVDPV2 positive environmental samples;
:: Nigeria – one cVDPV2 case;
:: Democratic Republic of the Congo (DR Congo)- eight cVDPV2 cases;
:: Angola— three cVDPV2 cases;
:: Chad— two cVDPV2 community contacts;
:: Côte d’Ivoire- one cVDPV2 positive environmental sample.

 

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Weekly Epidemiological Record, 15 November 2019, vol. 94, 46 (pp. 525–540)
:: Progress towards poliomyelitis eradication – Pakistan, January 2018–September 2019
:: Update on vaccine-derived polioviruses – worldwide, January 2018–June 2019

 

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Philippines
Situation Report 9 – Polio Outbreak
WHO-UNICEF 9 November 2019
Highlights
– 4th confirmed poliovirus type 2 case is a three-year old female from Maguindanao. Virus was found to be genetically linked to other 2 cases from Mindanao. Outbreak immunization for 18,268 children 0-59 months in the area was conducted on 4-8 November: 16,295 children (89.2%) vaccinated thus far.
– Synchronized polio vaccination campaigns on 14-27 October covered 1,628,717 children under 5: 95.5% of the target. Preparations ongoing for the next round on 25 November-7 December in National Capital Region (NCR) and all provinces of Mindanao targeting 4,388,281 children 0-59 months.
– Current polio outbreak resulting from persistently low routine immunization coverage, and poor sanitation and hygiene.
– Circulating vaccine-derived poliovirus (cVDPV) is considered a public health emergency of international concern (PHEIC).

… Risk assessment
The risk for further polio transmission in the country continues to be assessed as high at the national level, because of chronically suboptimal immunisation coverage, sub-optimal performance of AFP sur-veillance, and poor sanitation and hygiene conditions.
The regional risk of potential spread across international borders is assessed as moderate considering the large number of Overseas Filipino Workers (OFW). Although many OFW work globally, the risk of in-ternational spread is still considered low, but not negligible, further influenced by dynamic migratory patterns (particularly the USA).

… Immunization response
The first of three rounds of scheduled mass vaccination campaigns has been successfully implemented in polio affected areas. Between 14 and 27 October 2019, a total of 1,628,717 children under 5 were vac-cinated out of a targeted 1,703,639 in NCR, Davao del Sur, Davao City and Lanao del Sur. Both NCR and Davao City have reported reaching the target of 95% children vaccinated…

 

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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 16 Nov 2019]

Democratic Republic of the Congo
:: Ebola Outbreak in DRC 67: 12 November 2019

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 16 Nov 2019]

Afghanistan – No new digest announcements identified
Angola – No new digest announcements identified
Burkina Faso [in French] – No new digest announcements identified
Burundi – 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
Iraq – 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
Myanmar – No new digest announcements identified
Niger – No new digest announcements identified
occupied Palestinian territory – No new digest announcements identified
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 16 Nov 2019]

Chad – No new digest announcements identified
Djibouti – 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 06 |14 November 2019
Response Efforts Increase in North-east Syria
The UN and its partners are working to address the needs of hundreds of thousands of people recently impacted by last month’s military escalation in north-east Syria.
Since Turkey’s military offensive began on 9 October, more than 190,000 women, children and men have been displaced. As of 12 November, more than 74,000 people remain displaced, including from Al-Hasakeh (48,134), Ar-Raqqa (19,471) and Aleppo (6,776) governorates. More than 14,000 people have reportedly fled to Iraq.
The fighting has seen civilian casualties in both Syria and Turkey, damage to and closure of critical infrastructure, including health and water treatment facilities, as well as significant forced displacement. At least 92 civilians have been killed in north-west and north-east Syria during these latest hostilities, according to the United Nations High Commissioner for Human Rights (OHCHR).
Of particular concern are threats to civilians and critical infrastructure, forced displacement of civilians within or outside Syria, the potential negative impact on essential services and livelihoods, as well as the obstruction of access for humanitarian assistance and protection services…

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
:: 13 Nov 2019 Southern Africa: 12 million people are food insecure
:: 12 November 2019 Southern Africa Humanitarian Snapshot (November 2019)

EBOLA OUTBREAK IN THE DRC – No new digest announcements identified

 

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WHO & Regional Offices [to 16 Nov 2019]

WHO & Regional Offices [to 16 Nov 2019]
14 November 2019 News release
New report exposes horror of working conditions for millions of sanitation workers in the developing world

14 November 2019 News release
Mosquito sterilization offers new opportunity to control chikungunya, dengue, and Zika

13 November 2019 News release
WHO launches first-ever insulin prequalification programme to expand access to life-saving treatment for diabetes

12 November 2019 News release
WHO prequalifies Ebola vaccine, paving the way for its use in high-risk countries

 

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Weekly Epidemiological Record, 15 November 2019, vol. 94, 46 (pp. 525–540)
:: Progress towards poliomyelitis eradication – Pakistan, January 2018–September 2019
:: Update on vaccine-derived polioviruses – worldwide, January 2018–June 2019

 

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GIN October 2019 pdf, 2.29Mb 11 November 2019

 

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WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: Democratic Republic of the Congo accelerates training of emergency medical units for…
14 November 2019 To efficiently provide treatment to people needing urgent medical care during epidemic situations, the Ministry of Health in the Democratic Republic of the Congo (DRC) and the World Health Organization (WHO) are this week training inaugural members of the country’s first national emergency medical units for epidemics.

WHO Region of the Americas PAHO
:: Dengue in the Americas reaches highest number of cases recorded (11/13/2019)
:: United Nations calls for urgent action to curb the rise in hunger and obesity in Latin America and the Caribbean (11/11/2019)

WHO South-East Asia Region SEARO
:: 14 November 2019 Statement To tackle diabetes, strengthen primary health care and empower families

WHO European Region EURO
:: Floods across Europe affect thousands 15-11-2019
:: Rapid HIV testing saves lives – it’s time to make the switch 11-11-2019

WHO Eastern Mediterranean Region EMRO
:: WHO remains vigilant in the detection, prevention and control of communicable diseases in Yemen 13 November 2019
:: US Department of State’s contribution boosts primary and referral health services for Syrian refugees in Iraq 13 November 2019

WHO Western Pacific Region
No new digest content identified.

CDC/ACIP [to 16 Nov 2019]

CDC/ACIP [to 16 Nov 2019]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html
Thursday, November 14, 2019
Transcript of November 13, 2019, AR Threats Report – Tele-briefing

Wednesday, November 13, 2019
More People in the United States Dying from Antibiotic-Resistant Infections than Previously Estimated
[See Milestones above for detail]

MMWR News Synopsis for Friday, November 15, 2019
Update on Vaccine-Derived Poliovirus Outbreaks — Worldwide, January 2018–June 2019
Stopping current outbreaks and limiting the risk of vaccine-derived poliovirus (VDPV) emergence requires increasing assistance to type-2-circulating VDPV outbreak countries; using a novel, stabilized monovalent type 2 oral polio virus in the future; maintaining high population immunity in all countries; and ending all live, attenuated oral poliovirus vaccine use after certification of polio eradication.
In under-immunized populations, strains of poliovirus in oral poliovirus vaccine (OPV) can circulate and mutate to behave like wild poliovirus, leading to outbreaks of paralytic poliomyelitis. During January 2018–June 2019, the number of circulating vaccine-derived poliovirus (cVDPV) outbreaks increased from nine to 29 during January 2017–June 2018. Of these, 86% were caused by cVDPV type 2 that occurred both inside and outside monovalent type 2 OPV outbreak response areas. Global OPV immunization after April 2016 only contained types 1 and 3 strains.

Progress Toward Poliomyelitis Eradication — Pakistan, January 2018–September 2019
Despite earlier progress, interruption of wild polio virus type 1 (WPV1) circulation in Pakistan failed in 2018-2019. Pakistan’s polio program has identified key gaps to address, including multiple managerial and operational challenges and reversing negative community perceptions of polio vaccination. Stopping WPV1 transmission in Pakistan will require sustained, quality implementation of eradication activities with a renewed sense of urgency.
Pakistan and Afghanistan are the only countries that continue to confirm ongoing wild poliovirus type 1 (WPV1) transmission. Despite reporting 12 cases in 2018, an increase to 80 cases as of Nov. 2019 shows that polio eradication efforts in Pakistan failed to interrupt transmission. The Pakistan Polio Eradication program has identified key gaps that need to be addressed, and national leadership has committed to making transformative changes. Pakistan’s program management, supervision and oversight in core transmission areas must be strengthened to support vaccination efforts and allow access to chronically missed children. Fully engaging communities and addressing resistance to vaccination will help rebuild trust and restore progress toward WPV1 elimination in Pakistan. WPV1 transmission can be interrupted in Pakistan, but it will require full and rapid implementation of recommendations.