WHO announces updates on new molecular assays for the diagnosis of tuberculosis (TB) and drug resistance
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:
- Moderate complexity automated Nucleic Acid Amplification Tests (NAATs), for detection of TB and resistance to rifampicin and isoniazid;
- Low complexity automated NAATs for detection of resistance to isoniazid and second-line anti-TB agents;
- High complexity hybridization-based NAATs for detection of resistance to pyrazinamide.
“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.”
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.
List of COVID-19 Resources for Organizations Working with Persons Who Use Drugs or Have Substance Use Disorder
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
“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.
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
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.