Health & Fitness

WHO today accepted the recommendation from the Solidarity Trial’s International Steering Committee to discontinue the trial’s hydroxychloroquine and lopinavir/ritonavir arms. The Solidarity Trial was established by WHO to find an effective COVID-19 treatment for hospitalized patients.

The International Steering Committee formulated the recommendation in light of the evidence for hydroxychloroquine vs standard-of-care and for lopinavir/ritonavir vs standard-of-care from the Solidarity trial interim results, and from a review of the evidence from all trials presented at the 1-2 July WHO Summit on COVID-19 research and innovation. 

These interim trial results show that hydroxychloroquine and lopinavir/ritonavir produce little or no reduction in the mortality of hospitalized COVID-19 patients when compared to standard of care. Solidarity trial investigators will interrupt the trials with immediate effect. 

For each of the drugs, the interim results do not provide solid evidence of increased mortality. There were, however, some associated safety signals in the clinical laboratory findings of the add-on Discovery trial, a participant in the Solidarity trial. These will also be reported in the peer-reviewed publication. 

This decision applies only to the conduct of the Solidarity trial in hospitalized patients and does not affect the possible evaluation in other studies of hydroxychloroquine or lopinavir/ritonavir in non-hospitalized patients or as pre- or post-exposure prophylaxis for COVID-19. The interim Solidarity results are now being readied for peer-reviewed publication.

Wild poliovirus

Vaccine derived poliovirus (VDPV)

Impact of COVID-19

Conclusion

• Rising risk of WPV1 international spread: The progress made in recent years appears to have reversed, with the Committee’s assessment that the risk of international spread is at the highest point since 2014 when the PHEIC was declared. This risk assessment is based on the following:

• the ongoing WPV1 exportation from Pakistan to Afghanistan, and from Afghanistan to Pakistan;
• ongoing rise in the number of WPV1 cases and positive environmental samples in both Pakistan and
  Afghanistan with formerly polio free areas within the countries reporting cases in 2020;
• the quickly increasing cohort of inaccessible unvaccinated children in Afghanistan, with the risk of a major
  outbreak imminent if nothing is done to access them;
• the urgent need to overhaul the leadership and strategy of the program in Pakistan, which although already commenced, is likely take some time to lead to more effective control of transmission and ultimately eradication;
• increasing community and individual resistance to the polio program.

• Rising risk of cVDPV international spread: The clearly documented increased spread in recent months of cVDPV2 demonstrate the unusual nature of the current situation, as international spread of cVDPV in the past has been very infrequent.  The number of new emergences of cVDPV2 in Africa raises further concern.  The risk of new outbreaks in new countries is considered very high.  
• COVID-19:  This unprecedented pandemic is likely to continue to substantially negatively impact the polio eradication program and outbreak control efforts.  The need to take extra precautions to prevent COVID-19 transmission will probably have an impact on vaccination coverage, and also hamper polio surveillance activities leading to increased risk of missed transmission.  
• Falling PV2 immunity:  Global population mucosal immunity to type 2 polioviruses (PV2) continues to fall, as the cohort of children born after OPV2 withdrawal grows, exacerbated by poor coverage with IPV particularly in some of the cVDPV infected countries.
• Multiple outbreaks: The evolving and unusual epidemiology resulting in rapid emergence and evolution of cVDPV2 strains is extraordinary and not yet fully understood and represents an additional risk that is yet to be quantified.
• Weak routine immunization: Many countries have weak immunization systems that can be further impacted by various humanitarian emergencies including COVID19, and the number of countries in which immunization systems have been weakened or disrupted by conflict and complex emergencies poses a growing risk, leaving populations in these fragile states vulnerable to outbreaks of polio. 
• Lack of access: Inaccessibility continues to be a major risk, particularly in several countries currently infected with WPV or cVDPV, i.e. Afghanistan, Nigeria, Niger, Somalia and Myanmar, which all have sizable populations that have been unreached with polio vaccine for prolonged periods.
• Population movement: While border closures may have mitigated the short term risk, conversely the risk once borders begin to be re-opened is likely to be higher.  

Risk categories

• States infected with WPV1, cVDPV1 or cVDPV3, with potential risk of international spread.
• States infected with cVDPV2, with potential risk of international spread.
• States no longer infected by WPV1 or cVDPV, but which remain vulnerable to re-infection by WPV or cVDPV.

• Poliovirus Case: 12 months after the onset date of the most recent case PLUS one month to account for case detection, investigation, laboratory testing and reporting period OR when all reported AFP cases with onset within 12 months of last case have been tested for polio and excluded for WPV1 or cVDPV, and environmental or other samples collected within 12 months of the last case have also tested negative, whichever is the longer.
• Environmental or other isolation of WPV1 or cVDPV (no poliovirus case): 12 months after collection of the most recent positive environmental or other sample (such as from a healthy child) PLUS one month to account for the laboratory testing and reporting period
• These criteria may be varied for the endemic countries, where more rigorous assessment is needed in reference to surveillance gaps (e.g. Borno State, Nigeria)

TEMPORARY RECOMMENDATIONS

States infected with WPV1, cVDPV1 or cVDPV3 with potential risk of international spread 

These countries should:

• Officially declare, if not already done, at the level of head of state or government, that the interruption of poliovirus transmission is a national public health emergency and implement all required measures to support polio eradication; where such declaration has already been made, this emergency status should be maintained as long as the response is required.
  
• Ensure that all residents and long­term visitors (i.e. > four weeks) of all ages, receive a dose of bivalent oral poliovirus vaccine (bOPV) or inactivated poliovirus vaccine (IPV) between four weeks and 12 months prior to international travel.
• Ensure that those undertaking urgent travel (i.e. within four weeks), who have not received a dose of bOPV or IPV in the previous four weeks to 12 months, receive a dose of polio vaccine at least by the time of departure as this will still provide benefit, particularly for frequent travelers.
• Ensure that such travelers are provided with an International Certificate of Vaccination or Prophylaxis in the form specified in Annex 6 of the IHR to record their polio vaccination and serve as proof of vaccination.
• Restrict at the point of departure the international travel of any resident lacking documentation of appropriate polio vaccination. These recommendations apply to international travelers from all points of departure, irrespective of the means of conveyance (e.g. road, air, sea).
• Further intensify cross­ border efforts by significantly improving coordination at the national, regional and local levels to substantially increase vaccination coverage of travelers crossing the border and of high risk cross ­border populations. Improved coordination of cross ­border efforts should include closer supervision and monitoring of the quality of vaccination at border transit points, as well as tracking of the proportion of travelers that are identified as unvaccinated after they have crossed the border.
• Further intensify efforts to increase routine immunization coverage, including sharing coverage data, as high routine immunization coverage is an essential element of the polio eradication strategy, particularly as the world moves closer to eradication.
• Maintain these measures until the following criteria have been met: (i) at least six months have passed without new infections and (ii) there is documentation of full application of high quality eradication activities in all infected and high risk areas; in the absence of such documentation these measures should be maintained until the state meets the above assessment criteria for being no longer infected.
• Provide to the Director-General a regular report on the implementation of the Temporary Recommendations on international travel.

States infected with cVDPV2s, with potential or demonstrated risk of international spread 

• Mozambique cVDPV2 (most recent detection 17 December 2018)
• PNG cVDPV1 (most recent detection 6 November 2018)
• Indonesia cVDPV1 (most recent detection 13 February 2019)
• China (most recent detection 25 April 2019)

• Urgently strengthen routine immunization to boost population immunity.
• Enhance surveillance quality, including considering introducing supplementary methods such as environmental surveillance, to reduce the risk of undetected WPV1 and cVDPV transmission, particularly among high risk mobile and vulnerable populations.
• Intensify efforts to ensure vaccination of mobile and cross ­border populations, Internally Displaced Persons, refugees and other vulnerable groups.
• Enhance regional cooperation and cross border coordination to ensure prompt detection of WPV1 and cVDPV, and vaccination of high risk population groups.
• Maintain these measures with documentation of full application of high quality surveillance and vaccination activities.
• At the end of 12 months without evidence of reintroduction of WPV1 or new emergence and circulation of cVDPV, provide a report to the Director-General on measures taken to implement the Temporary Recommendations.

Additional considerations 

• The committee urges all countries, but particularly those at high risk of polio, to maintain a high level of polio surveillance throughout the ongoing pandemic, noting that the postponement of polio immunization campaigns whether preventive or in response to outbreaks may lead to an increase in polio transmission including international spread.  There may be opportunities to strengthen polio and COVID-19 surveillance synergistically.
• Secondly, outbreak affected countries should resume immunization response campaigns as soon as feasibly possible.  The planning and implementation of the response should employ a flexible approach whereby some activities are put on hold as the transmission of COVID-19 intensifies and then resumed as the COVID-19 transmission reverses back from community transmission to the interruption of COVID-19 transmission.  Critically, campaigns should be planned and implemented in such a way that they protect front line polio workers and also the communities they serve so that COVID-19 transmission is not increased.  This includes ensuring teams have access to appropriate personal protective equipment, teams are selected so that high risk workers are not put on the front-line, and that the risks related to the pandemic are factored into the selection and planning of areas targeted by polio campaigns.
• Given the risk of international spread, countries need to ensure that they are ready to use appropriate polio vaccines, as recommended by the Strategic Advisory Group of Experts on Immunization, in response to new outbreaks.
• The committee urged countries to maximize the use of polio assets to synergistically address the COVID19 pandemic, noting that polio affected countries may be vulnerable to poorer outcomes in the pandemic due to health care system fragility and poorer health status of the population generally.  
• Lastly the pandemic should serve as a reminder to high risk countries with poor immunization coverage that infectious disease outbreaks can lead to social and economic disruption as well as straining the health care system, and countries can increase their population resilience and recovery through prioiritising  robust immunization programmes. This is relevant not only to polio, but to all other vaccine preventable diseases particularly measles.  In particular, countries whether eligible for Gavi support or not should plan to implement a second dose of IPV now being introduced to protect children from paralytic polio.
  
  
  
  
  Based on the current situation regarding WPV1 and cVDPV, and the reports provided by affected countries, the Director-General accepted the Committee’s assessment and on 3 July 2020 determined that the situation relating to poliovirus continues to constitute a PHEIC, with respect to WPV1 and cVDPV.  The Director-General endorsed the Committee’s recommendations for countries meeting the definition for ‘States infected with WPV1, cVDPV1 or cVDPV3 with potential risk for international spread’, ‘States infected with cVDPV2 with potential risk for international spread’ and for ‘States no longer infected by WPV1 or cVDPV, but which remain vulnerable to re-infection by WPV or cVDPV’ and extended the Temporary Recommendations under the IHR to reduce the risk of the international spread of poliovirus, effective 3 July 2020. 
  
  

As reopening plans either stall or move forward slowly, the vast majority of states have not been able to drive down their infection rates, according to an internal HHS map obtained by Yahoo News.

However haltingly and incompletely, the president’s favorite news outlet has started to acknowledge that the coronavirus is a far graver threat than even Trump will acknowledge.

As the United States crossed 50,000 new daily cases, the president repeated a line he’s used for months: The virus will just disappear — eventually.

Arizona Gov. Doug Ducey told Vice President Mike Pence on Wednesday that the state needed an additional 500 health care workers as the number of cases of COVID-19 continues to set records there.

California locked down aggressively and never dismissed the threat. Yet now it’s being mentioned in the same breath as Florida, Arizona and Texas, states suffering new outbreaks. What went wrong?

In his keynote address, WHO Director General Dr Tedros emphasized the important strategic role of STAG-TB in efforts to end TB especially in light of the current COVID-19 pandemic. He said, “Even at this difficult time, with COVID-19 threatening the world, WHO remains committed to meet the TB targets and driving high-level action and investment. Commitments must be kept to address all communicable disease threats, and reach the triple billion targets, despite the COVID-19 crisis. Doing so offers hope to end avoidable death and suffering for millions of people worldwide at risk from preventable and treatable diseases like TB.”

The meeting was opened by Dr Ren Minghui, WHO Assistant Director-General, Universal Health Coverage, Communicable and Noncommunicable Diseases Division. The first day focused on briefings from the WHO Global TB Programme secretariat on ongoing WHO efforts towards ending TB, preparations underway for the development of the 2020 progress report of the UN Secretary General on TB, and the impact of the COVID-19 pandemic on the TB response. The second day included a special session of STAG-TB members with WHO Director-General Dr Tedros Adhanom Ghebreyesus. Key partners – Stop TB Partnership, Global Fund and UNITAID also participated in this session.

Dr Ariel Pablos-Méndez, STAG-TB Chair highlighted the group’s commitment to guide WHO’s TB response. He emphasized, “We need to leverage existing synergies between TB and universal health coverage to save lives. This is especially critical in this time of crisis. STAG-TB is dedicated to providing strategic direction that will guide WHO in supporting countries to accelerate progress and investment to reach targets set by the UN High-level Meeting on TB.”

Dr Tereza Kasaeva, Director of WHO’s Global TB Programme appreciated the role of STAG-TB, she said, “The STAG-TB provides a critical contribution to WHO, and the world, in combatting TB. We look forward to receiving strategic advice from STAG-TB during this, and coming, years on how the world can meet commitments to end the TB epidemic especially in the face of new threats”.

The next meeting of the STAG-TB will be held in November 2020.

The  Generation Equality Forum—a global gathering for gender equality, convened by UN Women and co-hosted by the governments of Mexico and France in partnership with civil society—today announced the leaders of the Generation Equality Action Coalitions, to achieve gender equality and all women’s and girls’ human rights. WHO, together with The United Nations Entity for Gender Equality and the Empowerment of Women (UN Women) have been invited to co-lead the Action Coalition focusing on ending gender-based violence. 

The Action Coalitions will deliver concrete and transformative change for women and girls around the world in the coming five years. They will focus on six themes  that are critical for achieving gender equality. In addition to the coalition on gender-based violence there are five other coalitions on economic justice and rights, bodily autonomy and sexual and reproductive health and rights, feminist action for climate justice, technology and innovation for gender equality, and feminist movements and leadership. Adolescent girls and young women will be at the heart of each Action Coalition’s work.    

The 65 initial leaders of the Action Coalitions represent Member States, diverse feminist and women’s rights organizations, youth-led organizations, philanthropic entities, UN agencies and other international organizations ( full list here).  The Action Coalitions’ leaders bring deep commitment to and experience in advancing gender equality and women’s human rights and reflect the different experiences and identities of women and girls from around the world.    

Further appointments of the Action Coalitions’ leaders will be made in the next few months, including private sector companies and youth-led organizations, to ensure intersectional and intergenerational leadership.  

The Action Coalitions’ leaders were selected by the Generation Equality Forum Core Group, which includes France, Mexico, Civil Society and UN Women.  Five criteria  were followed to select the leaders, including evidence of leaders’ commitment and past record of achievement in the respective Action Coalitions’ themes.  

The Action Coalitions are one of the key outcomes of the Generation Equality Forum that will kick off in Mexico City, Mexico, and culminate in Paris, France, in the first half of 2021. The Generation Equality Forum, accelerated by the Action Coalitions, will mobilize urgent action to make irreversible progress towards gender equality and women’s and girls’ human rights globally.  

This announcement comes as the world responds to the impacts of COVID-19, which is exacerbating gender and other inequalities and disproportionally affecting women and girls in all countries. In this context of the pandemic, the Generation Equality Forum and Action Coalitions are important and urgently needed to get through this pandemic, to recover faster, and build a more just, inclusive, and equitable future for everyone. 

Next steps

The Action Coalitions’ leaders will come together in the coming months to co-design concrete, game-changing Blueprints for action to be implemented over the next five years.  

Beginning in September 2020, a set of virtual public conversations will mobilize and capture women’s and young people’s voices to inform the Action Coalitions.  

The Action Coalition Blueprints will then be refined at the Generation Equality Forum in Mexico City, during the first part of 2021, and officially launched at the Generation Equality Forum in Paris, later in 2021.  

The Action Coalitions aim to mobilize a broad support in addition to the leadership structure. A broad set of stakeholders will be involved in the design of the Action Coalitions during the next months and will be provided with opportunities to commit to transformative actions to advance gender equality and women’s rights. 

Violence against women is a major threat to global public health and human rights, cutting across boundaries of age, race, religion, ethnicity, disability, geography, culture and wealth. WHO is committed to working towards a world in which all women live their lives free of violence and discrimination. Dr Tedros Adhanom Ghebreyesus, Director-General, World Health Organization

An initiative to provide Americans with free face coverings has run out of supplies, according to the U.S. Department of Health and Human Services.

As the coronavirus pandemic continues to ravage large swaths of the U.S., leading Republicans and even some right-wing TV personalities have come out in favor of wearing masks to prevent the spread of the virus.

For the first few months of the pandemic, the worst impacts were concentrated in rich countries. Recently, the number of cases in developing countries that may be vulnerable to severe outbreaks has increased.

Presumptive Democratic presidential nominee Joe Biden said Tuesday that President Trump has “surrendered” in the fight against the coronavirus as new cases skyrocket in the U.S.

An internal map from the CDC shows that as many as 32 states are not seeing any decreases in coronavirus cases, and positive lab test results have jumped to nearly 8 percent nationwide.

Using their expertise in military or intelligence services to compensate for what they see as President Trump’s deficient handling of the crisis, national security Democrats have enjoined their Republican counterparts to refocus on the pandemic. 

Local leaders are rolling back reopenings, issuing mandates for wearing masks and closing down some beaches in advance of the Fourth of July holiday.

Today marks the end of the 10th outbreak of Ebola virus disease in the Democratic Republic of the Congo (DRC). This long, complex and difficult outbreak has been overcome due to the leadership and commitment of the Government of the DRC, supported by the World Health Organization (WHO), a multitude of partners, donors, and above all, the efforts of the communities affected by the virus. 

WHO congratulates all those involved in the arduous and often dangerous work required to end the outbreak, but stresses the need for vigilance. Continuing to support survivors and maintaining strong surveillance and response systems in order to contain potential flare-ups is critical in the months to come.

"The outbreak took so much from all of us, especially from the people of DRC, but we came out of it with valuable lessons, and valuable tools. The world is now better-equipped to respond to Ebola. A vaccine has been licensed, and effective treatments identified,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus.

“We should celebrate this moment, but we must resist complacency. Viruses do not take breaks. Ultimately, the best defence against any outbreak is investing in a stronger health system as the foundation for universal health coverage.”

The outbreak, declared in North Kivu on 1 August 2018, was the second largest in the world, and was particularly challenging as it took place an active conflict zone. There were 3470 cases, 2287 deaths and 1171 survivors. 

Led by the DRC Government and the Ministry of Health and supported by WHO and partners, the more than 22-month-long response involved training thousands of health workers, registering 250 000 contacts, testing 220 000 samples, providing patients with equitable access to advanced therapeutics, vaccinating over 303 000 people with the highly effective rVSV-ZEBOV-GP vaccine, and offering care for all survivors after their recovery.

The response was bolstered by the engagement and leadership of the affected communities. Thanks to their efforts, this outbreak did not spread globally. More than 16 000 local frontline responders worked alongside the more than 1500 people deployed by WHO. Support from donors was essential, as was the work of UN partner agencies, national and international NGOs, research networks, and partners deployed through the Global Outbreak Alert and Response Network. Hard work to build up preparedness capacities in neighbouring countries also limited the risk of the outbreak expanding.

Work will continue to build on the gains made in this response to address other health challenges, including measles and COVID-19.

“During the almost two years we fought the Ebola virus, WHO and partners helped strengthen the capacity of local health authorities to manage outbreaks,” said Dr Matshidiso Moeti, WHO Regional Director for Africa.

“The DRC is now better, smarter and faster at responding to Ebola and this is an enduring legacy which is supporting the response to COVID-19 and other outbreaks.” 

As countries around the world face the COVID-19 pandemic, the DRC Ebola response provides valuable lessons. Many of the public health measures that have been successful in stopping Ebola are the same measures that are now essential for stopping COVID-19: finding, isolating, testing, and caring for every case and relentless contact tracing. 

In DRC, community workers were provided with training and a smartphone data collection app that enabled them to track contacts and report in real time rather than fill in laborious paper reports. Even when violence locked down cities, the community workers, many of them local women, continued to track and trace contacts using the application, something that was crucial for ending this outbreak.

While this 10th outbreak in DRC has ended, the fight against Ebola continues. On 1 June 2020, seven cases of Ebola were reported in Mbandaka city and neighbouring Bikoro Health Zone in Equateur Province and an 11th outbreak was declared. WHO is supporting the government-led response with more than 50 staff already deployed and more than 5000 vaccinations already administered.

WHO salutes the thousands of heroic responders who fought one of the world’s most dangerous viruses in one of the world’s most unstable regions. Some health workers, including WHO experts, paid the ultimate price and sacrificed their lives to the Ebola response. 

WHO thanks the many partners who supported the Government-led response

Note to Editors

WHO thanks the donors who provided funding to WHO for the Ebola response under the Strategic Response Plans: 

African Development Bank, Bill & Melinda Gates Foundation, Canada, China, Denmark, ECHO, European Commission/DEVCO, Gavi, the Vaccine Alliance, Germany, Ireland, Italy, Luxembourg, Norway, Paul Allen Foundation, Republic of Korea, Sweden, Switzerland, Susan T Buffett Foundation, UK DFID, UN CERF, USAID/OFDA, US CDC, Wellcome Trust, World Bank, World Bank Pandemic Emergency Financing Facility. 

Several donors also provided funding to the WHO Contingency Fund for Emergencies in recognition of the critical role the fund has played in responding to the Ebola outbreak.

The World Health Organization (WHO) is urging countries to expand access to rapid molecular tests for the detection of TB and drug-resistant TB in updated consolidated guidelines, released today. The guidelines are accompanied by an operational handbook to facilitate rapid implementation and roll out of rapid molecular tests by national TB programmes, ministries of health and technical partners.

“The use of rapid molecular assays as the initial test to diagnose TB is recommended instead of sputum smear microscopy as they have high diagnostic accuracy and will lead to major improvements in the early detection of TB and drug-resistant TB,” said Dr Tereza Kasaeva, Director of WHO’s Global TB Programme.  “We now need to urgently ensure universal access to these rapid molecular tests. This will impact positively on reducing transmission and enabling faster access to accurate life-saving treatment that will lead to better outcomes for those affected.”

The consolidated guidelines and the associated operational handbook recommend key updates of the approaches to diagnose TB including:

• The use of Xpert MTB/RIF assay, Xpert Ultra assay and Truenat assay as the initial test to diagnose pulmonary TB and to detect rifampicin resistance.  This replaces smear microscopy and culture.
• The use of Xpert MTB/RIF assay and Xpert Ultra assay for improved diagnosis of TB and rifampicin resistance in children, in specific specimens such as sputum, stool, nasopharyngeal and gastric specimens
• The use of Xpert MTB/RIF assay and Xpert Ultra assay for improved diagnosis of TB and rifampicin resistance in patients with broad range of extrapulmonary TB.

The Xpert MTB Rif assay has been used worldwide since 2010, while the Xpert Ultra assay and Truenat assay are new technologies.

The above updates were signaled in January 2020 through a Rapid Communication from WHO in advance of the publication of the updated guidelines. The purpose was to help national TB programmes and other stakeholders plan and prepare in advance for the rapid transition to new diagnostic tools at country level.

Globally, diagnosis of TB and drug-resistant TB remains a challenge with a third of people with TB and two-thirds of people with drug-resistant TB not being detected. Accelerated efforts to diagnose TB and drug-resistance are essential to end the global TB epidemic and achieve the targets of the political declaration of the UN high-level meeting, the WHO End TB Strategy, the UN Sustainable Development Goals, universal health coverage and the triple billion targets of WHO’s General Programme of Work.

Nucleic acid amplification tests (NAAT) are promising technologies for the rapid and accurate detection of TB and resistance to selected anti-TB agents. In December 2020, the World Health Organization (WHO) will convene a Guidelines Development Group (GDG) meeting to update its diagnostic guidelines on the use of NAATs to detect TB and resistance to selected anti-TB agents. Ahead of this meeting, WHO will commission reviews of relevant evidence on diagnostic accuracy for several NAAT assays.

The following NAAT assays or classes of NAAT assays will be discussed by the GDG:

Centralized assays that present end-to-end solutions for detection of TB and resistance to rifampicin and isoniazid (cDST: Index test 1);

Cartridge-based technology for isoniazid and second-line drug resistance detection (XDR cartridge: Index test 2);

Hybridization-based technology for pyrazinamide resistance detection (PZA LPA: Index test 3).

To enable this process, WHO is issuing a public call for data, appealing to industry, researchers, national TB programmes and other agencies to provide suitable evidence for the performance of these technologies. The obtained data will be essential to facilitate the process of WHO policy updates.

Please send relevant data by 1st August 2020, to ldr.policies@who.int. For more information on the parameters of the datasets, variables, and the process see below:

Annex 1: Data requirements

Index test 1: Centralized assays that present end-to-end solutions for detection of TB and resistance to rifampicin and isoniazid (cDST platforms).

Desirable characteristics of the test: (a) Sample preparation workflow included; (b) Automated DNA extraction; (c) Automated PCR preparation; (d) Automated result interpretation; (c) Capacity per run: ≥24 tests; (d) Time from sample to full MDR-TB diagnosis: <12 hours; (e) Minimal desirable drug resistance detection: at least to INH and RIF.

Study type: Clinical evaluation studies to confirm diagnostic performance on clinical samples.

Study population: Random sample of unselected patients with signs and symptoms of TB, requiring evaluation for TB and/or resistance to isoniazid and rifampicin in sites of intended use.

Reference standard: At a minimum, result of a single sputum culture and phenotypic DST, wherever applicable (liquid or solid, with speciation) should be included for each result of Index test 1. The use of a genotypic sequencing results where available will have an added value to confirm the presence of mutations in addition to phenotypic DST results.

Index test 2: Cartridge-based technology for isoniazid and second-line drug resistance detection (XDR cartridge);

Desirable characteristics of the test: (a) Automated real-time PCR; (b) Automated result interpretation; (b) Capacity per run: ≥ 4 tests; (c) Time test results: <4 hours; (d) Minimal desirable drug resistance detection: at least to INH and FQ.

Study type: (a) Analytical validation studies measuring accuracy, precision, and reproducibility of the test in contrived specimens or panels, covering all key mutations to isoniazid and second-line drugs. (b) Clinical evaluation studies to confirm diagnostic performance on clinical samples.

Study population: Patients with detected TB, requiring evaluation for resistance to isoniazid and second-line anti-TB agents in sites of intended use.

Reference standard: At a minimum, result of a single sputum phenotypic DST (liquid or solid, with speciation) should be included for each result of Index test 2. The use of a genotypic sequencing results where available will have an added value to confirm the presence of mutations in addition to phenotypic DST results.

Index test 3: Hybridization-based technology for pyrazinamide resistance detection (PZA LPA).

Desirable characteristics of the test: (a) Automated or manual hybridization methodology; (b) Automated or manual result interpretation (c) Time from sample to test results: <24 hours; (d) Minimal desirable drug resistance detection: at least to PZA.

Study type: (a) Analytical validation studies measuring accuracy, precision, and reproducibility of the test in contrived specimens or panels, covering all key mutations to pyrazinamide; (b) Clinical evaluation studies to confirm diagnostic performance on clinical samples;

Study population: Patients with detected TB and resistance to rifampicin, requiring evaluation for resistance to pyrazinamide in sites of intended use;

Reference standard: At a minimum, result of a single sputum phenotypic DST (liquid or solid, with speciation) should be included for each result of Index test 3. The use of a genotypic sequencing results where available will have an added value to confirm the presence of mutations in addition to phenotypic DST results.

On June 25, WHO Director General Dr Tedros  Adhanom Ghebreyesus and Dr Hand Kluge, Regional Director of WHO Europe, spoke at the European Parliament Committee for Environment, Public Health and Food Safety (ENVI) on the fight against COVID-19 and the global response and highlighted the leadership of the European Union during this unprecedented time. 

“The EU is in a unique position to provide global leadership in defining the “new normal” as part of the global recovery”, Dr Tedros said. 

He reminded parlamentarians, that “although the situation in Europe has improved, globally it is still getting worse” and he added that “In the first month of this outbreak, less than 10,000 cases were reported to WHO. In the last month, almost 4 million cases have been reported.”.

The pandemic is showing how essential it is for governments at all levels, including local governments, to strengthen their capacity for prevention, preparedness and response. 

But plans for the post-COVID-19 recovery, and to reduce the risk of future epidemics, must go further upstream than early detection and control of disease outbreaks – “they must also lessen our impact on the environment, to reduce risk at the source”, Dr Tedros stressed. 

In this regard, Dr Tedros welcomed the Team Europe approach and the European Union plans for a greener recovery, bringing nature back in our lives. He also praised the Global Coronavirus Response pledging campaign launched by the EU, which has so far raised €9.8 billion, and said more is needed.

Dr Kluge emphasized the complementarities and synergies between the European Programme of Work, entitled United Action for Better Health” entitled, in supporting WHO’s Thirteenth General Programme of Work (GPW13) and the EU4Health Programme of the European Commission. 

Dr Kluge warned parliamentarians about a second wave in Europe and that countries should be prepared. In this regard, he announced that the WHO European Region has started an ACTION REVIEW, gathering lessons learned in order to develop policy options to help countries to prepare for the Autumn. 

The Regional Director underlined that “health systems based on strong primary health care are the foundation for health security and universal health coverage” and that national routine immunization programmes needs to be maintained during the pandemic, he said.

Germany and France have reconfirmed their political, financial and technical support to WHO. His Excellency Olivier Véran, Minister for Solidarity and Health of the Republic of France, and His Excellency Jens Spahn Minister of Health of the Federal Republic of Germany, met with WHO Director General Dr Tedros Adhanom Ghebreyesus in Geneva on 25 June to discuss the status of the global COVID-19 pandemic and measures to help countries where it continues to spread.

“WHO is honoured to welcome you both here today,” said Dr Tedros during the press conference that followed the tripartite meeting, “we offer our sincere thanks for your expression of solidarity and support. We’re getting today all the support we need, political and financial.  I would like to express my gratitude.”

Germany will lead the EU Presidency for the next six months. “Global health and managing the pandemic will be key themes,” said Minister Spahn. “This is why I came to discuss the Presidency plans and ways to support WHO during this critical time. Germany remains a strong supporter and a friend; this is why I am here today.”  Germany will contribute an additional EUR 41.4 million to WHO‘s core work, and an additional EUR 200 million towards the implementation of the COVID-19 Strategic Preparedness and Response Plan. This follows Germany’s pledge in May of EUR 110 million to WHO in support of the Access to COVID-19 Tools (ACT) Accelerator, a Global Collaboration to Accelerate the Development, Production and Equitable Access to New COVID-19 diagnostics, therapeutics and vaccines.

“The world needs interconnected crisis management, we need a strong, efficient, transparent WHO, more than ever, that is able to lead and coordinate the response in a global crisis,” added  Minister Spahn. “Germany will do its part to give WHO the political, financial and technical support that is needed.”

Minister Véran reaffirmed France’s confidence in the Organization as the leading global public health agency and its crucial role in the response to epidemic diseases and in this case the COVID-19 pandemic. “I am also here to announce increased support to the work WHO, firstly with contribution in the amount of EUR 90 million towards the establishment of the WHO Academy, a centre of excellence that brings together international cooperation in the area of training and innovation”. He also highlighted the importance of the Germany-France partnership – both Member States of WHO and of the European Union -- saying that international cooperation is needed today more than ever. On this occasion Minister Véran also confirmed President Macron’s commitment during the ACT Accelerator Marathon on 4 May to support WHO’s coordination role and to provide and additional contribution of EUR 50 million for 2020-2021.

Germany and France both have longstanding partnerships with WHO and are strong supporters of global public health. Chancellor Angela Merkel was the first world leader to invite WHO to the G20 in 2017 under Germany’s leadership, thus highlighting importance of health for all people all around the world. Germany was at the center of the development of the Global Action Plan for Healthy Lives and Well-Being for All, to drive progress towards the Sustainable Development Goals. Germany and WHO have engaged together on a multi-year Collaborative Programme providing decisive support in particular to implementation of Sustainable Development Goal 3 to ensure healthy lives and well-being for all people of all ages, health systems strengthening,  health emergencies preparedness, anti-microbial resistance and access to medicine.

For more than 50 years, France has hosted the International Agency for Research on Cancer in Lyon. France has also hosted the WHO Lyon Office for Country readiness strengthening since 2001. More recently, France and WHO signed an agreement to establish the WHO Academy, also in Lyon, which will be a state-of-the-art training centre, bringing the latest lifelong learning innovations to the global health sector.

In addition to their political, financial and technical support, Germany and France have also donated masks, respirators and other medical supplies and equipment to vulnerable populations still suffering from the COVID-19 pandemic.

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The 2020 “Triad Statement” was issued at the close of the 8^th biennial meeting of the WHO, the International Confederation of Midwives, and the International Council of Nurses.  In 2020 the Triad Meeting took place under the dual spotlight of the International Year of the Nurse and the Midwife and the COVID-19 pandemic.  The resulting Triad Statement focuses on actions that participants in their respective roles agree to take to support WHO Member States in strengthening nursing and midwifery towards priority health targets, including responding to COVID-19 and achieving universal health coverage. 

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Emergency Committee for Ebola virus disease in the Democratic Republic of the Congo (provinces of Ituri, North Kivu, and South Kivu) on 26 June 2020

The 8^th 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.

Neighbouring countries:

• Continue to strengthen their surveillance for EVD to prevent the risk of potential spread.

For WHO:

• 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.  

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• 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[1]. 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.

For media enquiries: ACTacceleratormedia@who.int