Ebola – DRC+
Public Health Emergency of International Concern (PHEIC)
Ebola Outbreak in DRC 72: 17 December 2019
In the week of 9 to 15 December 2019, 24 new confirmed Ebola virus disease (EVD) cases were reported from three health zones in two affected provinces in the Democratic Republic of the Congo. The majority of these new confirmed cases are from Mabalako (22/24; 92%), and the other cases were reported from Biena (1/24; 4%) and Mandima (1/24; 4%) health zones.
The new cases from Mabalako and Biena, are linked to a single chain of transmission, in which one individual was a potential source of infection for 24 people. This was the second documentation of EVD illness in this individual within a 6-month period. Based on the preliminary sequencing of samples from the case, this is being classified as a relapse of EVD. Rare cases of relapse have been documented, in which a person who has recovered from EVD gets disease symptoms again, but this is the first documented relapse in this outbreak.
The volume of alerts reported has returned to levels seen before the security incidents in the past weeks. In general, the overall average proportion of contacts under surveillance in the last seven days has returned to previously observed levels. However, Mabalako, the health zone with the highest volume of contacts, has the lowest performance with 73% of contacts under surveillance…
First FDA-approved vaccine for the prevention of Ebola virus disease, marking a critical milestone in public health preparedness and response
December 19, 2019
The U.S. Food and Drug Administration announced today the approval of Ervebo, the first FDA-approved vaccine for the prevention of Ebola virus disease (EVD), caused by Zaire ebolavirus in individuals 18 years of age and older. Cases of EVD are very rare in the U.S., and those that have occurred have been the result of infections acquired by individuals in other countries who then traveled to the U.S., or health care workers who became ill after treating patients with EVD.
“While the risk of Ebola virus disease in the U.S. remains low, the U.S. government remains deeply committed to fighting devastating Ebola outbreaks in Africa, including the current outbreak in the Democratic Republic of the Congo,” said Anna Abram, FDA Deputy Commissioner for Policy, Legislation, and International Affairs. “Today’s approval is an important step in our continuing efforts to fight Ebola in close coordination with our partners across the U.S. Department of Health and Human Services, as well as our international partners, such as the World Health Organization. These efforts, including today’s landmark approval, reflect the FDA’s unwavering dedication to leveraging our expertise to facilitate the development and availability of safe and effective medical products to address urgent public health needs and fight infectious diseases, as part of our vital public health mission.”…
… “Ebola virus disease is a rare but severe and often deadly disease that knows no borders. Vaccination is essential to help prevent outbreaks and to stop the Ebola virus from spreading when outbreaks do occur,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “The FDA’s approval of Ervebo is a major advance in helping to protect against the Zaire ebolavirus as well as advancing U.S. government preparedness efforts. The research approach used to study the effectiveness and safety of this vaccine was precedent-setting during a public health emergency and may help create a model for future studies under similar circumstances. The FDA is committed to continuing our work across the U.S. government and with our international partners to prevent future Ebola outbreaks and mitigate the current outbreak in the DRC, reflecting our nation’s commitment to preparing for and responding to biological threats, like Ebola.”’’’
…The FDA granted this application Priority Review and a Tropical Disease Priority Review Voucher under a program intended to encourage development of new drugs and biologics for the prevention and treatment of certain tropical diseases. The FDA also granted Breakthrough Therapy designation for Ervebo to facilitate the development and scientific evaluation of the vaccine. Because of the public health importance of a vaccine to prevent EVD, the FDA worked closely with the company and completed its evaluation of the safety and effectiveness of Ervebo in less than six months. The approval was granted to Merck & Co., Inc.
Merck Announces FDA Approval for ERVEBO® (Ebola Zaire Vaccine, Live)
Action Represents Another Milestone for the Global Partnership Against Ebola
December 20, 2019 07:15 AM Eastern Standard Time
KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved ERVEBO® (Ebola Zaire Vaccine, Live) (pronounced er-VEE-boh) for the prevention of disease caused by Zaire ebolavirus in individuals 18 years of age and older. The duration of protection conferred by ERVEBO is unknown. ERVEBO does not protect against other species of Ebolavirus or Marburgvirus. Effectiveness of the vaccine when administered concurrently with antiviral medication, immune globulin (IG), and/or blood or plasma transfusions is unknown. Do not administer ERVEBO to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine, including rice protein.
“Approval of this vaccine by the FDA represents another important milestone in the global response to Ebola Virus Disease and stands as a tremendous accomplishment by a unique global partnership,” said Dr. Roger M. Perlmutter president, Merck Research Laboratories. “In acknowledging this event, I wish in particular to recognize the heroic efforts being made by frontline responders to the ongoing outbreak in the Democratic Republic of the Congo. We are proud and honored to play a role in supporting their vital activities, and we remain focused on the important work ahead.”
“Having an Ebola vaccine approved by the FDA is a significant milestone in Ebola preparedness and prevention efforts,” said Rick Bright, Ph.D., deputy assistant secretary for preparedness and response and director of the Biomedical Advanced Research and Development Authority (BARDA). “At BARDA, we are tremendously proud to have been a part of this unprecedented collaboration between private and public sectors in multiple countries that has led to this important moment in public health history.”…
Public Health Emergency of International Concern (PHEIC)
Summary of new viruses this week (AFP cases and ES positives):
:: Afghanistan – two WPV1 cases and two WPV1-positive environmental samples.
:: Pakistan – seven WPV1 cases, one cVDPV2 case and 12 WPV1-positive environmental samples.
:: DR Congo – Eight cVDPV2 cases.
:: Somalia – two cVDPV2-positive environmental sample.
:: Angola – 11 cVDPV2 cases and two cVDPV2-positive environmental samples.
:: Chad – one cVDPV2 case.
:: Ethiopia – one cVDPV2-positive environmental sample.
:: Ghana – three cVDPV2 cases.
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 21 Dec 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
WHO Grade 2 Emergencies [to 21 Dec 2019]
Measles in Europe
:: Nordic countries working together to sustain measles and rubella elimination 20-12-2019
:: 2019: the WHO European Region’s year in review 19-12-2019
:: Bi‐weekly Situation Report 24 – 5 December 2019
:: A total of 1,270,70 doses of oral cholera vaccine (OCV) was approved for the OCV campaign, targeting around 635,000 individuals, which will take place from 8 to 14 December in the Rohingya camps and 8 to 31 December in the host communities.
:: Since 5 September 2019, a total of 213 cases of Acute Watery Diarrhea (AWD) have tested positive by cholera Rapid Diagnostic Tests (RDTs), or culture.
:: An assessment undertaken for the operational risks associated with Fecal Sludge management (FSM) and water sources has concluded that, urgent actions are required to improve the water safety situation in these camps…
Oral Cholera Vaccine and Measles Outbreak Response Immunization campaigns
:: The Civil Surgeon, with support from WHO and UNICEF, established an immunization core group. The first meeting took place at the Ministry of Health and Family Welfare (MoHFW) Coordination Cell offices. Details of the upcoming Oral Cholera Vaccine (OCV) campaign were discussed.
:: A total of 1 270 170 doses of OCV was approved for the OCV campaign targeting around 635 000 individuals. The campaign will take place from 8 to 14 December in the Rohingya camps and 8 to 31 December in the host communities.
:: Several preparatory meetings have taken place. This includes District planning and Coordination meeting on 27 November, Upazila planning and microplanning meetings on 28 November and several advocacy meetings involving different target leaders including political leaders, Imams, Ministry of Education officials, among others.
:: Training has taken place for 34 OCV Camp Coordinators, 34 OCV Associate Camp Coordinators on 23 and 24 November 2019. These trainings were cascaded to over 2750 Community Health Workers and Communication for Development volunteers and 240 team supervisors between 28 and 30 November 2019, with support from partners.
:: For the host community, 300 vaccinators and mobilizers have been trained alongside 50 supervisors. Training for 1 050 and 900 volunteers commenced and will be completed by 4 December 2019, for Teknaf and Ukhia respectively.
:: The Rohingya Camp Wide Measles Rubella Outbreak Response Immunization (MR ORI) is planned in response to the measles outbreak that is currently confirmed in 16 of 34 camps in the Ukhia and Teknaf Upazila. Discussions on MR ORI took place 28 November 2019 during Scientific and Technical Sub- Committee (STSC) of the National Committee for Immunization Practices (NCIP) meeting held in Dhaka. There is need for timely ORI while ensuring quality, good coverage and proper capacity and management plan for any Adverse Events Following Immunization (AEFI).
:: MR ORI implementation planned for first week of January 2020 subject to Government approvals and favorable preparedness assessment. The target age group for this ORI is all children 6 months to less than 10 years of age in the Rohingya camps of Ukhia and Teknaf in Cox’s Bazar district.
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
MERS-CoV – 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
WHO Grade 1 Emergencies [to 21 Dec 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
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
:: Syrian Arab Republic: Recent Developments in Northwestern Syria Flash Update No. 1 – As of 20 December 2019
:: Following the intensification of airstrikes and shelling since 16 December in southern Idleb, tens of thousands of civilians are reportedly fleeing from Ma’arrat An-Nu’man area in southern Idleb governorate to north. Thousands of others are reportedly waiting for the bombardment to ease allowing them to move. The shortage of fuel in Idleb area is also limiting the movement of civilians fleeing from hostilities.
:: As of 20 December, ground fighting also resumed along the frontlines in southern Idleb governorate, amplifying displacement from southern Idleb as civilians are fleeing in anticipation of fighting directly affecting their communities.
:: Displacement happening in winter months is exacerbating the vulnerability of people in need. Many of those who fled are in urgent need of humanitarian support, particularly shelter, food, health, non-food and winterization assistance.
Yemen – No new digest announcements identified
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.
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