Standardized procedure for broad-based testing for SARS-CoV-2 in congregate settings: Considerations for health departments and healthcare providers
The 8th meeting of the Emergency Committee, convened by the WHO Director-General under the International Health Regulations (IHR) (2005) to review the Ebola virus disease (EVD) outbreak in the Ituri, North Kivu, and South Kivu provinces of the Democratic Republic of the Congo (DRC), took place on Friday, 26 June 2020, from 13:00 to 15:50 Geneva time (CEST). The Committee’s role is to give advice to the Director-General, who makes the final decision on the determination of a Public Health Emergency of International Concern (PHEIC) and issues Temporary Recommendations as appropriate.Proceedings of the meeting
Members and advisors of the Emergency Committee were convened by teleconference.
The Secretariat welcomed the Committee and thanked them for their support. The Director-General welcomed the Committee and expressed gratitude for all who have responded to this outbreak.
Representatives of WHO’s legal department and the department of compliance, risk management, and ethics briefed the Committee members on their roles and responsibilities. Committee members were reminded of their duty of confidentiality and their responsibility to disclose personal, financial, or professional connections that might be seen to constitute a conflict of interest. Each member who was present was surveyed and no conflicts of interest were judged to be relevant to the meeting.
The meeting was turned over to the Chair, Dr Preben Aavitsland. Dr Aavitsland also welcomed the Committee, outlined the objectives of the meeting, and introduced the presenters.
Presentations were made by a representative of the Ministry of Health of the DRC and the WHO Secretariat to update the Committee on the situation.
The DRC Ministry of Health provided an update of the epidemiological situation. As of 23 June 2020, a total of 3 470 EVD cases were reported from 29 health zones, including 3 317 confirmed and 153 probable cases, of which 2 287 cases died (CFR 66%). Since the last reported case on 27 April 2020, no new confirmed or probable cases of EVD have been reported. On 25 June 2020, the DRC Ministry of Health declared that human-to-human transmission of Ebola virus had ended in Ituri, North Kivu, and South Kivu provinces. The Ministry of Health of DRC notes that a separate EVD outbreak is occurring in the Equateur Province, not epidemiologically related to the outbreak in the Ituri, North Kivu, and South Kivu provinces.
The DRC Ministry of Health is implementing their national response plan to strengthen surveillance, laboratory diagnostic capacities, infection prevention and control (IPC), risk communication and community engagement (RCCE), the EVD survivor care programme, and provincial health departments’ operational capacities.
The WHO Secretariat presented the WHO risk assessment and context. Based on the evolution of the outbreak, current epidemiology, and response in Ituri, North Kivu, and South Kivu provinces, the overall national and regional risk levels remain moderate. The global risk level remains low.
WHO noted that regional preparedness capacities built for EVD response, such as coordination mechanisms; response plans; laboratory diagnostic capacity; rapid response teams; and community-based surveillance systems, are also being used to facilitate a robust COVID-19 response.
Remaining challenges include the need for continued human and financial resources to maintain prevention, preparedness, response and control activities, such as the EVD survivor care programme; the volatile security situation; the new EVD outbreak in Equateur Province; and the concurrent burden of COVID-19, cholera, and measles.
Although the outbreak in Ituri, North Kivu, and South Kivu provinces has been officially declared over, the detection of a new EVD outbreak in Equateur Province highlights the potential for re-introduction from animal reservoirs. The DRC and at-risk countries need to maintain vigilance to mitigate the risk of EVD re-emergence as well as to rapidly detect and respond to any new cluster.Context and Discussion
The Committee congratulated the Ministry of Health on the conclusion of the EVD outbreak in Ituri, North Kivu, and South Kivu provinces. The Committee conveyed their strong appreciation to the World Health Organization for their support in ending this challenging outbreak. The Committee also thanked the health workers, donors, and all partners who have supported the successful response and recognized the international collaboration and strong solidarity among DRC, neighbouring countries, WHO, and partners.
The Committee noted that the genetic sequencing has confirmed that the EVD outbreaks in the Ituri, North Kivu, and South Kivu provinces and the Equateur province are epidemiologically distinct events.
The Committee highlighted the importance of the 90-day national response plan which includes maintaining intensive surveillance, response capacity, and follow-up with EVD survivors. DRC and partners are engaging in all measures to reduce the potential for a resurgence in Ituri, North Kivu, and South Kivu provinces. The Committee noted the importance of the EVD survivor care programme and continued RCCE activities, which will continue to be conducted by locally trained staff in each province with support from national staff as needed.
The Committee expressed concern over the lack of prioritized resources to operationalize the 90-day national response plan and maintain long-term local capacity for prevention and response. Financial and human resources of DRC, WHO, and partners are challenged by the concurrent COVID-19, cholera, and measles outbreaks. The Committee encouraged DRC, WHO, and partners to harmonize EVD, cholera, measles, and COVID-19 prevention and control activities.Conclusions and Advice
The Committee agreed that the current situation in the Ituri, North Kivu, and South Kivu provinces no longer constitutes a public health emergency of international concern.
The Committee emphasized the importance of continued donors’ funding and human resources to operationalize the 90-day day national response plan.
The Committee provided the following advice to the Director-General for his issuance as revised Temporary Recommendations, in accordance with Article 15(1) of the IHR (2005) “…Temporary Recommendations may be modified or extended as appropriate, including after it has been determined that a public health emergency of international concern has ended, at which time other temporary recommendations may be issued as necessary for the purpose of preventing or promptly detecting its recurrence […] These Temporary Recommendations shall automatically expire three months after their issuance.”
The Committee provided the following advice to the Director-General for his issuance as revised Temporary Recommendations under the IHR (2005).For DRC:
- Operationalize their 90-day national response plan and ensure the appropriate human and financial resources are available for implementation throughout the full duration.
- Continue their EVD survivor care programme which provides clinical, biological, and social support to survivors.
- Continue the use of the Community Action Cells, or comparable community-level resources, for locally based RCCE to address potential EVD flare-ups and spillover events. Leverage resources, as needed by integrating EVD RCCE activities with concurrent response efforts related to outbreaks of measles, cholera, and COVID-19.
- Take note of the upcoming Strategic Advisory Group of Experts on Immunization (SAGE) recommendations on the use of EVD vaccines.
- Develop an EVD prevention and control plan to sustain preparedness and response capacity beyond the initial 90-day national response plan.
- Continue to strengthen their surveillance for EVD to prevent the risk of potential spread.
- Continue to encourage research on animal reservoirs and the potential for spillover events.
- Continue engagement with countries and partners, including industry, to establish and maintain a strategic global stockpile for EVD vaccines.
- Collect and publish lessons learned with DRC and partners on this EVD outbreak, including on the effectiveness of vaccination and other interventions, and challenges related to emergency response in the context of civil unrest and insecurity.
Based on this advice, the report made by the affected State Party and the currently available information, the Director-General accepted the Committee’s assessment and on 26 June 2020 declared the end of the Public Health Emergency of International Concern (PHEIC) for this event.
The Director-General accepted the Committee’s advice and issued them as Temporary Recommendations under IHR (2005), effective 26 June 2020. The Director-General thanked the Committee Members and Advisors for their advice throughout the outbreak.
- The tools developed will benefit the whole world, and by saving lives and reducing severe COVID-19 disease, contribute to the goal of protecting health systems and restoring full societal and economic activity globally in the near term, and facilitating high-level control of COVID-19 disease in the medium term.
- The consolidated investment case calls for US$31.3 billion over the next 12 months. US$3.4 billion has been contributed to date, resulting in a funding gap of US$27.9 billion, of which $13.7 billion is urgently needed.
- Pillar plans published today show a path to the accelerated development, equitable allocation, and scaled up delivery of 500 million tests to LMIC’s by mid-2021, 245 million courses of treatments to LMICs by mid-2021, and 2 billion vaccine doses, of which 1 billion will be purchased for LMICs, by the end of 2021.
Today, the Access to COVID-19 Tools Accelerator (ACT-Accelerator) published its consolidated investment case, alongside the costed plans of the member organizations.
Launched at the end of April 2020, at an event co-hosted by the Director-General of the World Health Organization, the President of France, the President of the European Commission, and The Bill & Melinda Gates Foundation, the ACT-Accelerator brings together governments, health organizations, scientists, businesses, civil society, and philanthropists who have joined forces to speed up an end to the pandemic.
Since the ACT-Accelerator was launched, the partner organizations have moved fast to develop costed and implementable plans designed to contribute to the end of the pandemic through the accelerated development, equitable allocation, and scaled up delivery of new tools to reduce rapidly mortality and severe disease, protecting health systems and restoring full societal and economic activity globally in the near term, and facilitating high-level control of COVID-19 disease in the medium term.
The ACT-Accelerator’s investment case and the plans published by the organizations leading each of the ‘pillars’ show a path to the accelerated development, equitable allocation, and scaled up delivery of 500 million diagnostic tests to LMIC’s by mid-2021, 245 million courses of treatments to LMICs by mid-2021, and 2 billion vaccine doses, of which 50% will go to LMICs by the end of 2021.
To achieve this, the costed plans presented today call for US $31.3 billion in funding for diagnostics, therapeutics and vaccines, of which US$3.4 billion has so far been pledged. An additional US$27.9 billion is therefore needed, including US$13.7 billion to cover immediate needs (i.e. US$17.1 billion is immediately required, of which US$3.4 billion has been pledged).
The investment required is significant, but it pales in significance when compared to the cost of COVID-19: the total cost of the ACT-Accelerator's work is less than a tenth of what the IMF estimates the global economy is losing every month due to the pandemic. 468,000 thousand people have already lost their lives.
The tools developed will benefit the whole world; the ACT-Accelerator pillars will also buy and deliver tools to ensure that LMIC’s have access.
The ACT-Accelerator’s investment case is available here.ACT-Accelerator pillars
The ACT-Accelerator is led by the work of partner organizations collaborating under four pillars.
The diagnostics pillar is co-led by FIND and the Global Fund to Fight AIDS, Tuberculosis and Malaria, and aims to save 9 million lives and avoid 1.6 billion further infections through the power of equitable access to simple, accurate and affordable tests. With sufficient funding, it can bring to market 2–3 high-quality rapid tests, train 10,000 healthcare professionals across 50 countries, and establish testing for 500 million people in low- and middle-income countries. Its success will be determined by how quickly test, trace and isolate strategies can be put in place, to minimize disruption of health services and prepare countries for the effective roll-out of therapeutics and vaccines once available. The investment case is available here.
The therapeutics pillar is led by Unitaid and the Wellcome Trust (on behalf of the COVID-19 Therapeutics Accelerator) and seeks to accelerate the development and equitable delivery of treatments at all stages of disease, ensuring they are accessible to all, regardless of geography and level of economic resource. It targets development, manufacture, procurement and equitable distribution of 245 million courses of treatment for populations in Low and Middle Income Countries within 12 months. The investment case is available here.
The vaccine pillar, combines CEPI’s leadership in vaccine development and investment in manufacturing with GAVI’s track record in revolutionizing access and delivery, and WHO’s oversight of regulation, policy and allocation. Its role is to ensure that vaccines are developed as rapidly as possible, manufactured at the right volumes without compromising on safety and delivered to those that need them most. The current estimate to deliver 2 billion doses by the end of 2021, assuming a safe and effective vaccine is developed in the near future, is up to US$18.1 billion. In addition, 950 million doses will need to be procured by self-financing high-income countries and upper middle-income countries through the COVAX Facility. These numbers will become clearer once we get a better idea of, among other factors, the technology that the successful vaccine candidates will be based on and the number of doses required to protect people from COVID-19. The investment case is available here.
The health systems connector is the fourth pillar of the ACT-Accelerator and supports the other three by ensuring that health systems and local community networks can fully utilize these and other essential tools in their battle against COVID-19. This pillar is led by the World Bank and the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM) and supported by the WHO. It aims to build capacity – such as laboratory capacity, training for laboratory and health staff and management of protective equipment for health workers – needed to deploy the new tools effectively when they are ready. It also works on system innovations to complement the rollout of products, such as contact tracing, social distancing and isolation approaches as well as community engagement needed to sustain them. Global health security and the fight against COVID-19 depends on shoring up health systems around the world, now.
Since its launch, many governments and companies have signaled commitment to the ACT-Accelerator and made financial pledges. To date, contributing countries have committed a total US$3.4. The funding gap is US$ 27.9 billion.
On 27 June the Global Goal: Unite for Our Future, campaign, concert & summit will be calling on citizens to tackle global injustices by using our collective voice to drive change for everyone, everywhere. World leaders, corporations and philanthropists will announce new commitments to help develop equitable distribution of COVID-19 tests, treatments and vaccines, as well as rebuild communities devastated by the pandemic. Unite with Global Citizen, the European Commission, top artists and global leaders to end COVID-19, build equity for all and fight for the world we want. Link: https://www.globalcitizen.org/en/connect/globalgoalunite/
The Access to COVID-19 Tools ACT-Accelerator, is a new, groundbreaking global collaboration to accelerate the development, production, and equitable access to COVID-19 diagnostics, therapeutics, and vaccines. It was set up in response to a call from G20 leaders in March and launched by the WHO, EC, France and The Bill & Melinda Gates Foundation in April 2020.
The ACT-Accelerator is not a decision-making body or a new organization, but works to speed up collaborative efforts among existing organizations to end the pandemic. It is a framework for collaboration that has been designed to bring key players around the table with the goal of ending the pandemic as quickly as possible by reducing COVID-19 mortality and severe disease through the accelerated development, equitable allocation, and scaled up delivery of vaccines, therapeutics and diagnostics, thereby protecting health systems and restoring societies and economies in the near term. It draws on the experience of leading global health organizations which are tackling the world’s toughest health challenges, and who, by working together, are able to unlock new and more ambitious results against COVID-19. Its members share a commitment to ensure all people have access to all the tools needed to defeat COVID-19 and to work with unprecedented levels of partnership to achieve it.
The ACT-Accelerator has four areas of work: diagnostics, therapeutics, vaccines and the health system connector. Cross-cutting all of these is the workstream on Access & Allocation.
 An additional $1.7 billion has been pledged for health systems.
 The timeframe is 18 months for the vaccines pillar.
For more information please see ACT-Accelerator.
For media enquiries: ACTacceleratormedia@who.int