Statement of the Twenty-Seventh Polio IHR Emergency Committee

19 Feb

The twenty-seventh meeting of the Emergency Committee under the International Health Regulations (2005) (IHR) on the international spread of poliovirus was convened by the WHO Director-General on 1 February 2021 with committee members and advisers attending via video conference, supported by the WHO Secretariat.  The Emergency Committee reviewed the data on wild poliovirus (WPV1) and circulating vaccine derived polioviruses (cVDPV).  The following IHR States Parties provided an update at the video conference on the current situation in their respective countries: Afghanistan, Burkina Faso, the Republic of the Congo, Côte d’Ivoire, Egypt, the Islamic Republic of Iran, Liberia, Madagascar, Mali, Sierra Leone and Pakistan and Tajikistan.

Wild poliovirus

The committee noted that the rising incidence of global WPV1 cases seen since 2019 may have peaked with 140 cases with onset of illness in 2020 as at 21 January 2021 compared to the 137 cases that had occurred in 2019 as reported at 21 January 2020.  While in Pakistan the number fell from 111 cases to 84, it is not clear that this is going to be sustained, while the number in Afghanistan had more than doubled from 26 to 56.  Transmission persists in the core reservoirs of Karachi and Quetta Block in Pakistan and in Southern Afghanistan and has expanded to previously polio-free areas such as North Sindh and South Punjab in Pakistan and the Western and Northern regions in Afghanistan. The increase in Afghanistan is likely due to the growing cohort of missed children throughout the country due to local vaccination bans and the effect of COVID-19. The number of positive environmental samples has increased from 463 in 2019 to 503 so far in 2020. 

The Committee noted that based on results from sequencing of WPV1 since the last committee meeting in October 2020, there were further instances of international spread of viruses from Pakistan to Afghanistan.  The ongoing frequency of WPV1 international spread between the two countries and the increased vulnerability in other countries where routine immunization and polio prevention activities have both been adversely affected by the COVID-19 pandemic are two major factors that suggest the risk of international spread may be at the highest level since 2014.  While border closures and lockdowns may mitigate the risk in the short term while in force, this would be outweighed in the longer term by falling population immunity through disruption of vaccination and the resumption of normal population movements.

Circulating vaccine derived poliovirus (cVDPV) 

The committee was very concerned that cVDPV2 continues to spread rapidly.  The number of cases in 2020 is 1009 (year to date), 254% higher than the total for 2019.  As in all the years following 2016 when OPV2 was withdrawn, the number of cVDPV2 cases globally has been greater than the number of WPV1 cases. The Global Polio Laboratory Network routinely analyzes and tracks vaccine derived polioviruses just as it does wild polioviruses, to assist the polio program identify the patterns of spread and thereby provide opportunities to limit or prevent the circulation.  In the most recent quarterly routine analysis (July to September 2020) there has been evidence of exportation of cVDPV2 from:


  • Pakistan to Afghanistan
  • Sudan to Egypt
  • Afghanistan to Iran
  • Côte D’Ivoire to Mali
  • Benin to Nigeria
  • Afghanistan to Pakistan
  • Chad to Sudan
  • Chad into Cameroon
    • Côte D’Ivoire and Togo to Burkina Faso
    • Somalia to Ethiopia
    • Burkina Faso to Mali
    • Angola to Republic of Congo
    • Chad and Sudan to Republic of South Sudan
    • Ethiopia to Somalia


More recently, in addition to the exportation of cVDPV2 to Egypt and the Republic of the Congo mentioned above, in West Africa, cVDPV2 that has been circulating in Côte d’Ivoire has now been found in sewage in Liberia, and similarly cVDPV2 previously found in Guinea has now caused an outbreak with at least three cases so far in Sierra Leone.  Following the earlier event in September 2020 where virus circulating in Darfur in Sudan was detected in sewage in Giza, Cairo, a second exportation has been detected in sewage in Alexandria in Egypt with links to the cVDPV2 found in the River Nile state in Sudan, and one detection in each of Anwan and Qena in southern Egypt linked to Alexandria.  The cVDPV2 virus causing the large outbreak in Afghanistan has now been detected in Sistan and Baluchistan province of the Islamic Republic of Iran, where it has been found in sewage in two districts on three separate occasions.  It has also been detected in two AFP cases in Tajikistan.

However, the number of lineages detected so far in 2020 is 35, compared to 44 for the whole of 2019, and the number of newly emerged viruses is only 13 so far in 2020, compared to 38 during 2019.  This reduction may reflect refinement and modification of cVDPV2 outbreak management to lessen the risk of seeding new emergences. 

The committee noted that novel OPV2 (nOPV2) has received an interim recommendation for use under WHO’s Emergency Use Listing procedure (EUL) to enable rapid field availability, and potential wider rollout of the vaccine.  The EUL involves careful and rigorous analysis of existing data to enable early, targeted use of unlicensed products for a Public Health Emergency of International Concern.  WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) endorsed accelerated clinical development of novel OPV2 and its assessment in October 2019.

COVID-19

The committee was concerned that COVID-19 continues to have an impact on polio eradication at many levels.  Many of the polio affected countries are currently experiencing a second wave of COVID-19, notably Malaysia, Pakistan and Nigeria. Although resumption of SIAs is now a major focus of the polio program the effect of the pause in 2020 and the current second wave will hamper this resumption. There are ongoing signs of the impact of COVID-19 on surveillance, particularly with slow shipment and handling and reporting of samples for polio testing.   All these factors serve to heighten the risk of polio transmission.

The committee noted that since the beginning of the pandemic, the value of polio-funded staff and assets contributed to the COVID-19 response in more than 50 countries is estimated at USD $104 million. In view of the overwhelming public health imperative to end the COVID-19 pandemic, the POB has committed to the polio program’s continued support for the next phase of COVID-19 response, COVID-19 vaccine introduction and delivery, through existing assets, infrastructure and expertise in key geographies.

Conclusion

The Committee unanimously agreed that the risk of international spread of poliovirus remains a Public Health Emergency of International Concern (PHEIC) and recommended the extension of Temporary Recommendations for a further three months.  The Committee recognizes the concerns regarding the lengthy duration of the polio PHEIC, but concludes that the current situation is extraordinary, with clear ongoing and increasing risk of international spread and ongoing need for coordinated international response. The Committee considered the following factors in reaching this conclusion: 

Rising risk of WPV1 international spread:  

Based on the following factors, the risk of international spread of WPV1 appears to be currently very high:

  • transmission in Pakistan and Afghanistan remains high noting that the small decrease in Pakistan is yet to be sustained, and in Afghanistan case numbers have doubled;
  • expansion of WPV1 transmission into previously polio free areas in both countries and rising positive environmental samples in both endemic countries;
  • the ongoing inaccessibility in many provinces of Afghanistan leading increasingly to highly susceptible populations which are and will continue to drive higher transmission; over 3 million children were missed in the October and November NIDs, and the cohort of missed children continues to grow quickly;
  • ongoing vaccine hesitancy in Pakistan leading to higher numbers of missed children particularly in high risk districts;
  • the fall in population immunity consequent on the four months pause in polio vaccination necessitated by the COVID-19 pandemic, leading to greater susceptibility to poliovirus importation and outbreaks in high risk countries; 
  • the complicated context of WPV eradication activities in Afghanistan and Pakistan created by the need to simultaneously respond to cVDPV2 and COVID-19;
  • the second wave of COVID-19 that appears to be currently under way in many polio affected countries making interventions more difficult;
  • the difficulties in supplying vaccines due to the pandemic (as is being seen in Yemen, for example). 

Rising risk of cVDPV2 international spread:

Based on the following factors, the risk of international spread of cVDPV2 appears to be currently very high:

  • The increasingly large number of cases, environmental detections and documented exportations across borders to both new countries and already infected countries;
  • The ever widening gap in population intestinal mucosal immunity in young children since the withdrawal of OPV2 in 2016;
  • The same factors regarding the COVID-19 pandemic as mentioned above;
  • The population of inaccessible children in Afghanistan that appears to be driving intense transmission there.

Other factors include

  • 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

The Committee provided the Director-General with the following advice aimed at reducing the risk of international spread of WPV1 and cVDPVs, based on the risk stratification as follows:

  1. States infected with WPV1, cVDPV1 or cVDPV3.
  2. States infected with cVDPV2, with or without evidence of local transmission:
  3. States no longer infected by WPV1 or cVDPV, but which remain vulnerable to re-infection by WPV or cVDPV.

Criteria to assess States as no longer infected by WPV1 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.

Once a country meets these criteria as no longer infected, the country will be considered vulnerable for a further 12 months.  After this period, the country will no longer be subject to Temporary Recommendations, unless the Committee has concerns based on the final report.

TEMPORARY RECOMMENDATIONS

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

WPV1                                                                                                       

Afghanistan                       (most recent detection 1 Jan 2021)              

Pakistan                            (most recent detection 13 Jan 2021)

 

cVDPV1

Malaysia                            (most recent detection 13 March 2020)

Philippines                         (most recent detection 28 November 2019)

Yemen                               (most recent detection 6 Aug 2020)

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 cross­border 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 cross­border populations. Improved coordination of cross­border 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 cVDPV2, with or without evidence of local transmission:

Afghanistan           (most recent detection 1 Jan 2020)

Angola                   (most recent detection 9 February 2020)

Benin                     (most recent detection 30 Nov 2020)

Burkina Faso          (most recent detection 14 Nov 2020)

Cameroon             (most recent detection 29 Septr 2020)

CAR                       (most recent detection 2 Oct 2020)

Chad                     (most recent detection25 Nov 2020)

Rep Congo             (most recent detection 8 Sept  2020)

DR Congo              (most recent detection 28 Oct 2020)

Côte d’Ivoire          (most recent detection 9 Oct 2020)

Egypt                     (most recent detection 23 January 2021)

Ethiopia              (most recent detection 30 Aug 2020)

Ghana                   (most recent detection 9 March 2020)

Guinea                  (most recent detection 26 Oct 2020)

Iran                       (most recent detection 25 December 2020)

(Islamic Republic of)

Liberia                   (most recent detection 3 Nov 2020)

Malaysia             (most recent detection 13 March 2020)

Mali                      (most recent detection 31 Oct June 2020)

Niger                     (most recent detection 25 August 2020)

Nigeria               (most recent detection 13 Nov 2020)

Pakistan                (most recent detection 28 Dec 2020)

Philippines             (most recent detection 16 January 2020)

Sierra Leone          (most recent detection 19 Nov 2020

Somalia                 (most recent detection 25Oct 2020)

South Sudan          (most recent detection 6 Nov 2020)

Sudan                    (most recent detection 3 Dec 2020)

Tajikistan               (most recent detection 15 Jan 2021)

Togo                      (most recent detection 3 May 2020)

States that have had an importation of cVDPV2 but without evidence of local transmission should:

  • Officially declare, if not already done, at the level of head of state or government, that the prevention or interruption of poliovirus transmission is a national public health emergency
  • Undertake urgent and intensive investigations to determine if there has been local transmission of the imported cVDPV2
  • Noting the existence of a separate mechanism for responding to type 2 poliovirus infections, consider requesting vaccines from the global mOPV2 stockpile based on the recommendations of the Advisory Group on mOPV2.
  • Further intensify efforts to increase IPV immunization coverage, including sharing coverage data.
  • Intensify national and international surveillance regional cooperation and cross­border coordination to enhance surveillance for prompt detection of poliovirus.

States with local transmission of cVDPV2, with risk of international spread should in addition to the above measures should:

  • Encourage residents and long­term visitors to receive a dose of IPV four weeks to 12 months prior to international travel.
  • Ensure that travelers who receive such vaccination have access to an appropriate document to record their polio vaccination status.
  • Intensify regional cooperation and cross­border coordination to enhance surveillance for prompt detection of poliovirus, and vaccinate refugees, travelers and cross­border populations, according to the advice of the Advisory Group.

For both sub-categories:

  • Maintain these measures until the following criteria have been met: (i) at least six months have passed without the detection of circulation of VDPV2 in the country from any source, 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 criteria of a ‘state no longer infected’.
  • At the end of 12 months without evidence of transmission, provide a report to the Director-General on measures taken to implement the Temporary Recommendations.

 States no longer infected by WPV1 or cVDPV, but which remain vulnerable to re-infection by WPV or cVDPV

WPV1

none                    

cVDPV

Mozambique         (most recent cVDPV2 detection 17 December 2018)

Indonesia              (most recent cVDPV1 detection 13 February 2019)

Myanmar              (most recent cVDPV1 detection 9 August 2019)

China                    (most recent cVDPV2 detection 18 August 2019)

Zambia                  (most recent cVDPV2 detection 25 November 2019)

These countries should:

  • 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 cross­border 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 welcomed the Emergency Use Listing of novel OPV2 but cautioned there was much to be done before the new vacccine could be expected to have a significant impact globally on the spread of cVDPV2. The phased replacement during 2021 of Sabin OPV2 with novel OPV2 is expected to substantially reduce the source of cVDPV2 emergence, transmission and subsequent risk of international spread.  Full licensure and pre-qualification of nOPV2 is not expected before 2022; therefore all countries at risk of cVDPV2 outbreak should consider preparing for novel OPV2 use under Emergency Use Listing procedure.

The committee welcomed the progress being made in individual countries that were facing huge challenges with both polio and COVID-19.  COVID-19 is also likely to continue to have a significant adverse impact on stopping polio transmission throughout 2021, with diversion of resources, barriers to successful polio campaign implementation and the consequential growing immunity gap.  However, the committee urged countries to look for where synergies can be built between polio and COVID -19 control, such as countering vaccine hesitancy, expanding and sharing testing resources, and vaccine management.  Countries also needed to make sure that local lockdowns and border restrictions were implemented in such a way as to avoid hampering specimen shipment and testing, particularly in West Africa where there are already constraints in lab capacity.  As testing for COVID-19 is strengthened, this should be done so as to strengthen lab capacity for other infectious diseases such as polio.  The committee urges affected countries to strengthen cross border cooperation as this appeared to be inconsistently carried out.

The committee also noted the risk of vaccine hesitancy could be exacerbated during the pandemic, so that adverse events during the development or future deployment of any COVID-19 vaccine could compound the existing issues around polio vaccines, particularly but not only in Pakistan.  Conversely, vaccine issues arising out of novel OPV2 or trivalent OPV use could adversely affect any future COVID-19 vaccine deployment.  The committee urged countries with particular issues around vaccine hesitancy to make preparations now to avert situations of greater vaccine refusals through education campaigns, activities to counter misinformation and rumors and wherever possible provide incentives to target populations such as multi-antigen campaigns and offering other health and wellbeing services (vitamins, anti-worming medication, soap etc).

The committee was also very concerned about the polio program funding gap which is developing in 2021 and beyond, noting several countries in Africa had been adversely affected by funding constraints.  The committee called on donors to maintain funding of polio eradication activities, as the potential for reversal of progress appears high, with many years of work undone easily and swiftly if WPV1 spreads outside the endemic countries. 

Noting the serious situation in Afghanistan, the committee welcomed the recent agreement regarding mosque to mosque vaccination campaign activities but urged using multiple vaccines to avoid outbreaks of other vaccine preventable diseases such as measles.

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 19 February 2021 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 19 February 2021.

From paper to digital pathway: WHO launches first ‘SMART Guidelines’

18 Feb

WHO has launched its first SMART Guideline, a landmark effort to accelerate the availability and impact of WHO health and data recommendations within digital systems at the country level, starting with antenatal care.

What are SMART guidelines?

As countries increasingly invest in digital technologies for health system strengthening, SMART Guidelines constitute a practical approach to making global guidance more effective across all areas of health and wellbeing.

They will support guideline developers, policy makers, technology teams, and health workers through the process of adapting and applying WHO global health and data recommendations to countries’ existing – and evolving – digital systems.

‘SMART’ stands for Standards-based, Machine-readable, Adaptive, Requirements-based, and Testable. The SMART Guideline approach includes documentation, procedures, and digital health tools, introduced in a new comment published in The Lancet Digital Health.

“In this day and age, the rigorous process of developing WHO guidance is only one part of improving health outcomes for people around the world,” said Dr Soumya Swaminathan, WHO Chief Scientist.

“Recommendations become meaningful when they are lifted off the page and effectively applied to local systems at the country level; when they are aligned with an evolving evidence base. SMART Guidelines are a pioneering approach to digital health systems transformation.”

Why are SMART Guidelines needed?

Digital tools have huge potential to improve the reach and accessibility of WHO guidelines in every country, strengthening quality of care and accelerating progress towards national and Sustainable Development Goals.

However, adapting recommendations in line with existing digital systems, as well as local policies, procedures, is a well-documented challenge.

“Every country’s digital health landscape is different, from the software that has been selected to the data that is available and the priorities that have been defined. To reduce error, ensure transparency and adhere to technical standards, a systematic approach to understanding and adapting WHO recommendations is essential,” said Dr Nancy Kidula, Medical Officer in the WHO Regional Office for Africa. 

The SMART Guidelines approach recognizes the complexity of this digital adaptation journey for health systems, facilities and providers. It is divided into five ‘knowledge layers’ which provide a systematic, transparent and testable structure for countries to work through. This ensures guidance is translated  into effective and interoperable digital systems – systems which are fully able to connect, communicate and share with any other device or digital platform, for maximum benefit.

All SMART Guidelines content is software-neutral, meaning it can be adapted into whichever software platform a country has elected to use. The approach is rooted in respect for the privacy and security of patient health information.

Applying SMART Guidelines to maternal health and rights

The new WHO SMART Antenatal Care Guidelines support a key WHO priority: improving maternal health and well-being.

WHO advocates for health planning where women’s values and preferences are at the centre of their care. Localized adaptation of global recommendations is essential to ensure quality antenatal care, leading to the best possible physical, emotional, and psychological outcomes for all.

Applying the SMART approach to the WHO recommendations on antenatal care for a positive pregnancy experience is a dynamic way of repackaging existing, evidence-based guidance, making it easier to implement with digital solutions.  

The WHO Antenatal Care SMART Guidelines build on groundwork laid by the Antenatal care recommendations adaptation toolkit for policymakers, and the WHO monitoring framework for antenatal care. They include a Digital Adaptation Kit, an implementation guide for machine-readable recommendations, and a WHO digital ANC module for health care providers.

Partnership and transparent process are key

SMART Guidelines are not a standalone solution. Good planning and governance on digital health by investors, governments, and technical bodies is needed when working to integrate digital approaches and investments into health systems.

“Digital health can transform health outcomes – but only if it is supported by sufficient resources for governance, people and processes,” said Dr Dan Rosen, Chief of Health Informatics Data Management and Statistics at the U.S. Centers for Disease Control and Prevention Division of Global HIV & TB.

“At this exciting moment in the history of digital development, we are committed to working with WHO and partners across all sectors to support equitable and universal access to quality health services for all.”

 SMART Guidelines for HIV, STIs, immunization, family planning, child health and humanitarian emergencies are in development and will be released later this year. SMART guidelines will be vital to digital health systems transformation, and attainment of universal health coverage and UN Sustainable Development Goals.

WHO calls for partners to help build and sustain effective digital health systems and support the SMART Guideline approach.

 

WHO announces updates on new molecular assays for the diagnosis of tuberculosis (TB) and drug resistance

17 Feb

Significant advances to the diagnosis of tuberculosis (TB) and drug resistance in adults, adolescents and children are expected, following key updates on new molecular assays, announced by the World Health Organization (WHO) in a Rapid Communication released today.

Diagnosis of TB and drug-resistant TB remains a challenge with a third of people with TB and more than a half of people with drug-resistant TB not receiving quality diagnosis and care globally. To address this challenge, WHO convened a meeting of a Guideline Development Group in December 2020, to update WHO policies on molecular assays used for the diagnosis of TB and drug resistance.

Highlights from the evidence reviewed and presented in the Rapid Communication show high diagnostic accuracy for 3 new classes of technologies:

  1. Moderate complexity automated Nucleic Acid Amplification Tests (NAATs), for detection of TB and resistance to rifampicin and isoniazid;
  2. Low complexity automated NAATs for detection of resistance to isoniazid and second-line anti-TB agents;
  3. High complexity hybridization-based NAATs for detection of resistance to pyrazinamide.
The Rapid Communication has been released in advance of updated WHO guidelines expected later in 2021, to inform national TB programmes and other stakeholders about these new developments for the diagnosis of TB and drug resistance in order to allow for rapid transition and planning at country level.

“The diagnostic options for people with TB and drug-resistant TB are increasing thanks to the engagement of manufacturers and to research that is generating new evidence. Ensuring that everyone can obtain a rapid and accurate diagnosis, followed by treatment according to the latest WHO guidelines, will save lives and reduce suffering” said Dr Tereza Kasaeva, Director of the WHO Global TB Programme. “We ask for renewed political commitment and stakeholder support in ensuring these updates are rapidly implemented.”

COVAX Statement on WHO Emergency Use Listing for AstraZeneca/Oxford COVID-19 Vaccine

16 Feb

The Coalition for Epidemic Preparedness Innovations (CEPI), Gavi, the Vaccine Alliance (Gavi) and the World Health Organization (WHO), as co-leads of the COVAX initiative for equitable global access to COVID-19 vaccines, alongside key delivery partner UNICEF, are pleased to welcome the news that two versions of the AstraZeneca/Oxford COVID-19 vaccine have been given WHO Emergency Use Listing (EUL). Yesterday’s announcement means that two versions of the AstraZeneca/Oxford vaccine, produced by AstraZeneca-SK Bioscience (AZ-SKBio) and the Serum Institute of India (AZ-SII), are now available for global rollout through the COVAX Facility.

Building on the early information provided in the interim distribution forecast published on 3 February 2021, COVAX will now complete the process of final Q1/Q2 allocations of the AstraZeneca/Oxford vaccine to Facility participants. Information on these final allocations will be communicated to all participants and published online the week of February 22nd.

In order for doses to be delivered via this first allocation round, several critical pieces must be in place:

  • All Facility participants must have given national regulatory authorisation for the vaccines in question, a process which can be expedited by issuing special authorisations for use based on granting of WHO EUL. 
  • All Facility participants must have signed indemnity agreements with the manufacturers in question in order to receive doses through COVAX. The COVAX Facility is helping to facilitate the process of getting these agreements in place. In particular, COVAX is supporting AMC-eligible participants by negotiating a template indemnity agreement on their behalf – saving time and resources – and establishing a no-fault compensation mechanism and fund.
  • AMC-eligible economies must have submitted National Deployment and Vaccination Plans (NDVPs) through the COVID-19 Partners Platform, that have then been reviewed and validated by COVAX.

In preparation for this unprecedented global rollout, COVAX partners have been working closely with all Facility participants for many months, providing support for regulatory and indemnity and liability issues as well as the submission of completed NDVPs. Throughout this process, Facility participants have been moving at speed to ensure all preparations are in place for the first deliveries.

As participants fulfil the above criteria and finalise readiness preparations, COVAX will issue purchase orders to the manufacturer and ship and deliver doses via an iterative process. This means deliveries for this first round of allocation will take place on a rolling basis and in tranches.

Due the high number of doses available as well as the high number of countries getting ready for delivery in Q1 2021, the capacity of supplier and freight forwarders will be under considerable pressure. Shipment timelines will be impacted by logistical preparedness and delivery lead times, which may vary depending on the location of the receiving participant.

Based on this, COVAX anticipates the bulk of the first round of deliveries taking place in March, with some early shipments to those that have already fulfilled the above criteria, occurring in late February. More information related to these first deliveries will be shared in the coming days.

 

Taeniasis: large-scale treatment shows interesting and far-reaching results

16 Feb

A three-year pilot project for the control of taeniasis in Madagascar has shown very interesting and far-reaching results. Eligible adults and children aged five and over in 52 villages in the District of Antanifotsy1 were treated with the medicine praziquantel2 (at a dose of 10 mg/kg). The medicine was well-tolerated, with no major side events reported throughout the duration of the project.

“This is the first such project for the control of taeniasis in Madagascar and we achieved a treatment coverage as high as 95%” said Dr Sylvia Ramiandrasoa, who managed the project. “The key factors that led to this achievement include a comprehensive social mobilization campaign comprising education and communication awareness and the proximity of community health workers with the communities which resulted in high treatment compliance.”

An average of over 73,000 people were treated, every year, for 3 years with a total of 221,308 treatments. Adults and children over 5 years of age were included. The outcome was a significant reduction in the prevalence of taeniasis, observed four months after the last mass treatment of communities in the villages.

“The lessons from this important project and its impact go beyond Madagascar” said Dr Bernadette Abela-Ridder, in charge of WHO’s Neglected Zoonotic Diseases programme. “They show that if we treat people with the right dose at regular intervals, few will get infected or develop neurocysticercosis.”

However, this reduction could not be maintained, and sixteen months after the last treatment, taeniasis returned to its original levels, but the outcome of the pilot project implies a ‘One Health’ approach3 is required to break the cycle of infection. This can effectively happen when regular treatment of people living in endemic areas is combined with pig vaccination and pig treatment.

People in one of the 52 villages in Madagascar’s Antanifotsy District waiting to be treated with praziquantel against taeniasis during a pilot project that ran from 2015-2017

Picture: WHO / People in one of the 52 villages in Madagascar’s Antanifotsy District waiting to be treated with praziquantel against taeniasis during a pilot project that ran from 2015-2017

 

The project, led by the Ministry of Health of Madagascar and supported by the World Health Organization (WHO), started in 2015.

Taeniasis is prevalent in rural areas of Madagascar where people practice backyard pig rearing. The parasite that causes taeniasis, T. solium, was first described in the early 1900s in Madagascar.

Taeniasis/cysticercosis

Taeniasis - an intestinal infection caused by T. solium tapeworm - occurs when humans eat raw or undercooked, infected pork.

People who have tapeworms in the intestine will shed tapeworm eggs.

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  1. A rural District in Madagascar and considered the 8th largest, located about 112 kilometres from the capital, Antananarivo.

  2. Praziquantel (PZQ) is a WHO-recommended medicine for the control and treatment of schistosomiasis (bilharzia). It forms part of a class of medications known as anthelminthics. Studies have shown its potential as a highly effective taeniacide.

  3. The health of animals, people, plants and the environment is interconnected. One Health is an integrated approach that recognizes this fundamental relationship and ensures that specialists in multiple sectors work together to tackle health threats to animals, humans, plants and the environment"- Food and Agriculture Organization of the UNited Nations.(FAO).

Consultation: Draft Global Strategy on WASH and NTDs 2021−2030

16 Feb

In 2015, WHO and partners mobilized the WASH community to help accelerate and sustain efforts to control and eliminate NTDs  through a Global Strategy for 2015-2020. This was later supplemented by the publication of a toolkit, developed jointly with the NTD NGO Network (NNN), to help health and WASH partners with the practicalities of working together.

The NTD road map 2021-2030 was launched on 28 January 2021. It aims to strengthen programmatic responses to NTDs, and specifically encourages cross-sector actions in NTD control, elimination and eradication. The road map includes a cross-cutting target on “achieving universal access to at least basic water supply, sanitation and hygiene in areas endemic for NTDs by 2030”, and calls for strengthened coordination and collaboration with WASH stakeholders to ensure that services are delivered and sustained in communities that are most affected by NTDs.

WHO is now updating the 2015 Global WASH-NTD strategy to support the new NTD road map and to incorporate lessons learnt on WASH-NTD collaboration over the past 5 years. The draft Strategy document can be accessed here.

Interested stakeholders are invited to provide feedback using this online form and to circulate among their networks to facilitate broader, comprehensive feedback.

Feedback would be greatly appreciated by 3 March 2021.

 

 

WHO lists two additional COVID-19 vaccines for emergency use and COVAX roll-out

15 Feb

Today WHO listed two versions of the AstraZeneca/Oxford COVID-19 vaccine for emergency use, giving the green light for these vaccines to be rolled out globally through COVAX. The vaccines are produced by AstraZeneca-SKBio (Republic of Korea) and the Serum Institute of India.

WHO’s Emergency Use Listing (EUL) assesses the quality, safety and efficacy of COVID-19 vaccines and is a prerequisite for COVAX Facility vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.

“Countries with no access to vaccines to date will finally be able to start vaccinating their health workers and populations at risk, contributing to the COVAX Facility’s goal of equitable vaccine distribution,” said Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products.

‘But we must keep up the pressure to meet the needs of priority populations everywhere and facilitate global access. To do that, we need two things – a scale-up of manufacturing capacity, and developers’ early submission of their vaccines for WHO review.”

The WHO EUL process can be carried out quickly when vaccine developers submit the full data required by WHO in a timely manner. Once those data are submitted, WHO can rapidly assemble its evaluation team and regulators from around the world to assess the information and, when necessary, carry out inspections of manufacturing sites.

In the case of the two AstraZeneca/Oxford vaccines, WHO assessed the quality, safety and efficacy data, risk management plans and programmatic suitability, such as cold chain requirements. The process took under four weeks.

The vaccine was reviewed on 8 February by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), which makes recommendations for vaccines’ use in populations (i.e. recommended age groups, intervals between shots, advice for specific groups such as pregnant and lactating women). The SAGE recommended the vaccine for all age groups 18 and above. 

The AstraZeneca/Oxford product is a viral vectored vaccine called ChAdOx1-S [recombinant]. It is being produced at several manufacturing sites, as well as in the Republic of Korea and India. ChAdOx1-S has been found to have 63.09% efficacy and is suitable for low- and middle-income countries due to easy storage requirements.

WHO emergency use listing

The emergency use listing (EUL) procedure assesses the suitability of novel health products during public health emergencies. The objective is to make medicines, vaccines and diagnostics available as rapidly as possible to address the emergency, while adhering to stringent criteria of safety, efficacy and quality. The assessment weighs the threat posed by the emergency as well as the benefit that would accrue from the use of the product against any potential risks.

The EUL pathway involves a rigorous assessment of late phase II and phase III clinical trial data as well as substantial additional data on safety, efficacy, quality and a risk management plan. These data are reviewed by independent experts and WHO teams who consider the current body of evidence on the vaccine under consideration, the plans for monitoring its use, and plans for further studies.

As part of the EUL process, the company producing the vaccine must commit to continue to generate data to enable full licensure and WHO prequalification of the vaccine. The WHO prequalification process will assess additional clinical data generated from vaccine trials and deployment on a rolling basis to ensure the vaccine meets the necessary standards of quality, safety and efficacy for broader availability.

WHO also listed the Pfizer/BioNTech vaccine for emergency use on 31 December 2020.

Listings

WHO recomendation AstraZeneca/SKBio - COVID-19 Vaccine (ChAdOx1-S [recombinant])

WHO recommendation Serum Institute of India Pvt Ltd - COVID-19 Vaccine (ChAdOx1-S [recombinant]) - COVISHIELD™

WHO launches new tools to help countries build effective childhood cancer programmes

15 Feb

A suite of tools to help countries improve diagnosis and treatment of cancer among children is being released today by the World Health Organization, on International Childhood Cancer Day. The package includes a “how-to” guide for policy-makers, cancer control programme managers and hospital managers; an assessment tool to inform implementation; and a multilingual online portal for information-sharing.

The new tools will support countries with implementation of the CureAll approach, adopted by WHO’s Global Initiative for Childhood Cancer.  The Initiative, launched in 2018, aims to achieve at least 60% survival for childhood cancer globally by 2030. Currently, children living in high-income countries have an 80% chance of cure, while less than 30% of children diagnosed with cancer in many low- and middle-income countries (LMICs) survive.

During the last two years, the Global Initiative, supported by St. Jude Children’s Research Hospital, a WHO Collaborating Centre in the United States of America, has become active in more than 30 countries and benefits from the participation of more than 120 global partners. These partners work together to support governments with the implementation of the CureAll approach, addressing common reasons for the low survival of children with cancer in LMICs. These reasons include late or incorrect diagnosis, insufficient diagnostic capacity, delays in or inaccessible treatment and treatment abandonment.

Solutions to all of these issues are provided in the new “how-to” guide, which is based on four pillars: centres of excellence with defined referral pathways and a trained workforce; inclusion of childhood cancer in national benefit packages for universal health coverage; treatment standards based on evidence and tailored to local capacity; and robust information systems for continuous monitoring of programme performance. Case studies from countries which have begun implementing the CureAll approach, such as Ghana, Peru and Uzbekistan, are also included.

New assessment tool to facilitate the design of tailored approaches for cancer control

An assessment tool to inform implementation of the Initiative and support real-time interpretation of data is also being launched today. The tool, developed under the leadership of WHO with the International Atomic Energy Agency, the International Agency for Research on Cancer and other partners, will enable national cancer programmes to develop tailored approaches for cancer control in their setting. This tool can generate data for decision-making and help address data gaps in LMICs.

Multilingual portal for information-sharing

The importance of  sharing of data, clinical experience and expertise is key to improving standards and performance in cancer programmes around the world. A new online community of practice, the WHO Knowledge Action Portal, will support implementation of the Global Initiative for Childhood Cancer. The Portal, with content in six languages, offers focal points for cancer in ministries of health a forum for establishing and managing partnerships, organizing training programmes and sharing resources.

The avoidable burden of childhood cancer: time to accelerate action

The onset of the COVID-19 pandemic in early 2020 created a need for another type of data, on the effect of COVID-19 on children with cancer. In response, St. Jude Children’s Research Hospital began collecting, in collaboration with partners, data on COVID-19 infection among children with cancer. As of early February, more than 1500 childhood cancer patients from 48 countries had tested posted for COVID-19.

Data available appears to indicate that the effect of COVID-19 on children with cancer is less severe than feared, although there remains a concern about the effect of the pandemic on willingness to seek care and complete therapy. This will have consequences for children with cancer in the longer term and may lead to worsened outcomes.

 “Providing childhood cancer care and implementing the Global Initiative remain priorities during the COVID-19 pandemic and will continue to be priorities when it ends,” said Dr Bente Mikkelsen, Director of WHO’s Department of Noncommunicable Diseases. “Each year, an estimated 400 000 children are diagnosed with cancer globally, and the vast majority of these children live in low- and middle-income countries where the likelihood of survival is much lower. We can – and must  – give these children a better chance at life.”

Small, strategic investments, to the order of approximately US$ 0.03-0.15 per capita, are sufficient, when delivered appropriately, to build and sustain comprehensive childhood cancer services. Such investments could save the lives of hundreds of thousands of children over the next decade.

 


Acute malnutrition threatens half of children under five in Yemen in 2021: UN

12 Feb

Nearly 2.3 million children under the age of five in Yemen are projected to suffer from acute malnutrition in 2021, four United Nations agencies warned today. Of these, 400,000 are expected to suffer from severe acute malnutrition and could die if they do not receive urgent treatment.

The new figures, from the latest Integrated Food Security Phase Classification (IPC) Acute Malnutrition report released today by the Food and Agriculture Organization of the United Nations (FAO), UNICEF (the United Nations Children’s Fund), the World Food Programme (WFP), the World Health Organization (WHO) and partners, mark an increase in acute malnutrition and severe acute malnutrition of 16 per cent and 22 per cent, respectively, among children under five years from 2020. 

The agencies also warned that these were among the highest levels of severe acute malnutrition recorded in Yemen since the escalation of conflict in 2015.

Malnutrition damages a child’s physical and cognitive development, especially during the first two years of a child’s life. It is largely irreversible, perpetuating illness, poverty and inequality.

Preventing malnutrition and addressing its devastating impact starts with good maternal health, yet around 1.2 million pregnant or breastfeeding women in Yemen are projected to be acutely malnourished in 2021.

Years of armed conflict and economic decline, the COVID-19 pandemic and a severe funding shortfall for the humanitarian response are pushing exhausted communities to the brink, with rising levels of food insecurity. Many families are having to resort to reducing the quantity or quality of the food they eat, and in some cases, families are forced to do both.

“The increasing number of children going hungry in Yemen should shock us all into action,” said UNICEF Executive Director Henrietta Fore. “More children will die with every day that passes without action. Humanitarian organizations need urgent predictable resources and unhindered access to communities on the ground to be able to save lives.”

“Families in Yemen have been in the grip of conflict for too long, and more recent threats such as COVID-19 have only been adding to their relentless plight,” said FAO Director-General QU Dongyu. “Without security and stability across the country, and improved access to farmers so that they are provided with the means to resume growing enough and nutritious food, Yemen’s children and their families will continue to slip deeper into hunger and malnutrition.”

“These numbers are yet another cry for help from Yemen where each malnourished child also means a family struggling to survive” said WFP Executive Director David Beasley. “The crisis in Yemen is a toxic mix of conflict, economic collapse and a severe shortage of funding to provide the life-saving help that’s desperately needed. But there is a solution to hunger, and that’s food and an end to the violence. If we act now, then there is still time to end the suffering of Yemen’s children.”

Diseases and a poor health environment are key drivers of childhood malnutrition,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus. “At the same time, malnourished children are more vulnerable to diseases including diarrhea, respiratory infections and malaria, which are of great concern in Yemen, among others. It is a vicious and often deadly cycle, but with relatively cheap and simple interventions, many lives can be saved.”

Acute malnutrition among young children and mothers in Yemen has increased with each year of conflict with a significant deterioration during 2020 driven by high rates of disease, such as diarrhoea, respiratory tract infections and cholera, and rising rates of food insecurity. Among the worst hit governorates are Aden, Al Dhale, Hajjah, Hodeida, Lahj, Taiz and Sana'a City, which account for over half of expected acute malnutrition cases in 2021.

Today, Yemen is one of the most dangerous places in the world for children to grow up. The country has high rates of communicable diseases, limited access to routine immunization and health services for children and families, poor infant and young child feeding practices, and inadequate sanitation and hygiene systems.  

Meanwhile, the already fragile health care system is facing the collateral impact of COVID-19, which has drained meagre resources and resulted in fewer people seeking medical care.

The dire situation for Yemen’s youngest children and mothers means any disruptions to humanitarian services – from health to water, sanitation and hygiene, to nutrition, food assistance and livelihoods support – risk causing a deterioration in their nutrition status.

The humanitarian response remains critically underfunded. In 2020, the Humanitarian Response plan received US$1.9 billion of the US$3.4 billion required.

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Notes for editors:

Multimedia materials available here: https://weshare.unicef.org/Package/2AM40805FSQX

IPC Report Links:


About WFP: The United Nations World Food Programme is the 2020 Nobel Peace Prize Laureate. We are the world’s largest humanitarian organization, saving lives in emergencies and using food assistance to build a pathway to peace, stability and prosperity for people recovering from conflict, disasters and the impact of climate change.

About FAO: The Food and Agriculture Organization (FAO) is a specialized agency of the United Nations that leads international efforts to defeat hunger. Our goal is to achieve food security for all and make sure that people have regular access to enough high-quality food to lead active, healthy lives. With over 194 members, FAO works in over 130 countries worldwide.

About UNICEF: UNICEF works in some of the world’s toughest places, to reach the world’s most disadvantaged children. Across more than 190 countries and territories, we work for every child, everywhere, to build a better world for everyone.

About WHO: The World Health Organization provides global leadership in public health within the United Nations system. Founded in 1948, WHO works with 194 Member States, across six regions and from more than 150 offices, to promote health, keep the world safe and serve the vulnerable. Our goal for 2019-2023 is to ensure that a billion more people have universal health coverage, to protect a billion more people from health emergencies, and provide a further billion people with better health and wellbeing. 

WHO Executive Board stresses need for improved response to mental health impact of public health emergencies

11 Feb

The importance of integrating mental health into preparedness and response plans for public health emergencies was emphasized by WHO Member States at the WHO Executive Board meeting held in January 2021. Delegates expressed their strong support for the adoption of a Decision on this topic, proposed by Thailand, and co-sponsored by more than 40 Member States, at the 74th session of the World Health Assembly, due to meet in May 2021. 

“The COVID-19 pandemic has been a stark reminder of the importance of integrating mental health into preparedness and response plans for public health emergencies,” said Dévora Kestel, Director of the Department of Mental Health and Substance Use at the World Health Organization, after the discussions had taken place. “The inclusion of this issue at the next session of the World Health Assembly is an important next step towards being better prepared to provide people with the support they need for their mental health during future public health emergencies.” 

During the discussions, a number of specific requests were made of the WHO Director-General: 

  • that technical support be provided to Member States for monitoring changes in and disruptions to mental health services;
  • that WHO assist Member States in promoting and expanding access to inclusive, integrated, evidence-based primary and community mental health services and psychosocial support, including during public health emergencies; 
  • that WHO’s capacity in respect of work on mental health at global, regional and country levels be strengthened; and
  • that mental health be systematically integrated into all aspects of the work of the WHO Secretariat on universal health coverage. 

The Executive Board also encouraged Member States: 

  • to develop and strengthen, as appropriate, and as part of a whole-of-society approach, the timely and quality provision of the full range of mental health services and psychosocial support as an integral part of the health system; and
  • to allocate adequate funding for mental health, to mainstream knowledge of mental health among other health professionals, and to study the impact of COVID-19 on mental, neurological and substance use conditions and their consequences, sharing lessons learned with both the Secretariat and Member States. 

Member States talked with concern of the particular impact of the COVID-19 pandemic on adolescents, women (partly due to increases in domestic abuse and sexual assault), people living in humanitarian settings, and people with substance abuse issues. They also reported on the stigma, discrimination and human rights infringements that people infected with COVID-19, particularly frontline workers, had faced during the pandemic. They highlighted approaches that are they felt are key to addressing the rising demand for mental health support in their countries, including: community-based approaches that are both affordable and accessible; provision of support through telehealth and digital means; and training for health-care workers and other frontline personnel in psychosocial support. 

Both the proposal relating to preparedness for and response to the mental health consequences of humanitarian emergencies and the updated implementation options and indicators for the Comprehensive Mental Health Action Plan 2013-2030 will be considered by the World Health Assembly in May.