WHO today listed the Sinopharm COVID-19 vaccine for emergency use, giving the green light for this vaccine to be rolled out globally. The Sinopharm vaccine is produced by Beijing Bio-Institute of Biological Products Co Ltd, subsidiary of China National Biotec Group (CNBG).
“The addition of this vaccine has the potential to rapidly accelerate COVID-19 vaccine access for countries seeking to protect health workers and populations at risk,” said Dr Mariângela Simão, WHO Assistant-Director General for Access to Health Products. “We urge the manufacturer to participate in the COVAX Facility and contribute to the goal of more equitable vaccine distribution.”
WHO’s Emergency Use Listing (EUL) 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.
The EUL assesses the quality, safety and efficacy of COVID-19 vaccines, as well as risk management plans and programmatic suitability, such as cold chain requirements. The assessment is performed by the product evaluation group, composed by regulatory experts from around the world and a Technical Advisory Group (TAG), in charge of performing the risk-benefit assessment for an independent recommendation on whether a vaccine can be listed for emergency use and, if so, under which conditions.
In the case of the Sinopharm vaccine, the WHO assessment included on-site inspections of the production facility.
The Sinopharm product is an inactivated vaccine called SARS-CoV-2 Vaccine (Vero Cell). Its easy storage requirements make it highly suitable for low-resource settings. It is the also first vaccine that will carry a vaccine vial monitor, a small sticker on the vaccine vials that change color as the vaccine is exposed to heat, letting health workers know whether the vaccine can be safely used.
WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) has also completed its review of the vaccine. On the basis of all available evidence, WHO recommends the vaccine for adults 18 years and older, in a two-dose schedule with a spacing of three to four weeks. Vaccine efficacy for symptomatic and hospitalized disease was estimated to be 79%, all age groups combined.
Few older adults (over 60 years) were enrolled in clinical trials, so efficacy could not be estimated in this age group. Nevertheless, WHO is not recommending an upper age limit for the vaccine because preliminary data and supportive immunogenicity data suggest the vaccine is likely to have a protective effect in older persons. There is no theoretical reason to believe that the vaccine has a different safety profile in older and younger populations. WHO therefore recommends that countries using the vaccine in older age groups conduct safety and effectiveness monitoring to make the recommendation more robust.
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; two AstraZeneca/Oxford COVID-19 vaccines on 15 February 2021, produced by AstraZeneca-SKBio (Republic of Korea) and the Serum Institute of India; and COVID-19 vaccine Ad26.COV2.S developed by Janssen (Johnson & Johnson) on 12 March 2021.
See EUL listings
SAGE is the principal advisory group to WHO for vaccines and immunization. It is charged with advising WHO on overall global policies and strategies, ranging from vaccines and technology, research and development, to delivery of immunization and its linkages with other health interventions. SAGE is concerned not just with childhood vaccines and immunization, but all vaccine-preventable diseases.
SAGE has issued recommendations on Pfizer (8 January 2021), Moderna (25 January 2021), AstraZeneca (21 April 2021), and Janssen COVID (17 March 2021) vaccines, as well as issued a framework for access and population prioritization roadmap.
SAGE and EUL are complementary but independent processes. The EUL process is centered on determining if a manufactured product is quality-assured, safe and effective. SAGE is policy oriented. Policy recommendations for a vaccine are only of value to a vaccination campaign when the product has been listed or authorized for use.
In the context of COVID-19 and due the pressing need for vaccines, the Secretariat of SAGE and the EUL team have been working in parallel to allow WHO EUL and policy recommendations, based on the available evidence, to be issued in a synchronized manner.
The SAGE Interim Recommendations can be found at this location: https://www.who.int/groups/strategic-advisory-group-of-experts-on-immunization/covid-19-materials
Joint Statement on transparency and data integrity International Coalition of Medicines Regulatory Authorities (ICMRA) and WHO
ICMRA1 and WHO call on the pharmaceutical industry to provide wide access to clinical data for all new medicines and vaccines (whether full or conditional approval, under emergency use, or rejected). Clinical trial reports should be published without redaction of confidential information for reasons of overriding public health interest.
The COVID-19 pandemic has brought into sharp focus the need for information and data to support academics, researchers and industry in developing vaccines and therapeutics; to support regulators and health authorities in their decision-making; to support healthcare professionals in their treatment decisions; and to support public confidence in the vaccines and therapeutics being deployed.
While some initiatives have met with stakeholder support (e.g. WHO International Clinical Trials Registry Platform, US NIH ClinicalTrials.gov database, Health Canada Clinical Information Portal, EMA Clinical Trials Register and Japan Registry of Clinical Trials), not all past efforts have been successful. Often this was because they were unsustainable due to reliance on goodwill or lack of appropriate resourcing.2
The common aim of these initiatives is to ensure that results of research are accessible to all those involved in health care decision-making. The priority should be for new innovative medicines and vaccines. This improves transparency and strengthens the validity and value of the scientific evidence base. To succeed, initiatives need multi-stakeholder engagement aimed at finding solutions that deliver benefits for public health.
Regulators continue to spend considerable resources negotiating transparency with sponsors. Both positive and negative clinically relevant data should be made available, while only personal data and individual patient data should be redacted. In any case, aggregated data are unlikely to lead to re-identification of personal data and techniques of anonymisation can be used.
The first benefit is public trust. Regulators are opening their decisions to public scrutiny demonstrating confidence in their work.
Another benefit is the possible check of data integrity, a scientific necessity and an ethical must. Data must be robust, exhaustive and verifiable, through peer-review. Data integrity is priceless. Wrong regulatory decisions, made on selected or unreliable data, will affect the patients who receive that medicine.
Lack of public access to negative trials has been identified as a source of bias, which weakens the conclusions of systematic reviews and provides a false sense of reassurance on the safety or efficacy of the medicine.
Publication of data allows science to advance faster, by avoiding repetition of unnecessary trials and waste of resources (human and financial). This also brings benefits by improving the efficiency of development programmes and reducing both development costs and time. Publication of data also allows secondary analyses (and meta-analysis) which have a different or complementary focus.
Many public bodies have made open access a requirement as data are a common good. Providing access to data is also owed to trial participants who contributed physically and took the potential research risks.
Not all data are of high quality, and increased public scrutiny should eventually improve the overall quality of data. Resources however are needed for data sharing, and systems for such access need to be established. Standardisation of data will allow better analyses but is not a requirement.
While there may be a small risk of misuse of data (piracy or data mining for unfair commercial purpose) and misinterpretation, trial data can be put in context when published with the regulatory review of such data.
Data must be published at the time of finalisation of the regulatory review. It cannot be justified to keep confidential efficacy and safety data of a medicine available on the market, or which has been refused access to the market. Some regulators regularly publish the data that support positive approvals, but fewer do this for rejections, while this should avoid false expectations, misuse (accidental or not) and safety issues. Many completed trials on publication platforms only disclose protocols while results remain partial, outdated or unpublished.
ICMRA and WHO are conscious of concerns that some stakeholders may have as regulators move to greater levels of transparency, but we remain confident of the overwhelming positive public health benefits of doing so.
Providing systematic public access to data supporting approvals and rejections of medicines reviewed by regulators, is long overdue despite existing initiatives, such as those from the European Medicines Agency and Health Canada. The COVID-19 pandemic has revealed how essential to public trust access to data is. ICMRA and WHO call on the pharmaceutical industry to commit, within short timelines, and without waiting for legal changes, to provide voluntary unrestricted access to trial results data for the benefit of public health.
__________________________________________________________1 ICMRA is a voluntary coalition of leaders of medicines regulatory authorities that provides strategic directions for enhanced cooperation, improved communication and effective global crisis response mechanisms.2 E.g. Past declarations and private initiatives abandoned or not followed through include: -- Walsh F (26 February 2013), "Drug firm Roche pledges greater access to trials data" -- Alltrials Campaign, https://www.alltrials.net/ (most recent data from March 2019) -- WHO and multi-party Joint statement on public disclosure of results from clinical trials, 18 May 2017 (accessed here, March 2021).
- Initial 11 members are distinguished experts in economics, health, government, finance and development from around the world.
- Council’s focus is on new strategies to shape economies and financial systems with the objective of building healthy societies that are just, inclusive, equitable and sustainable. It will incorporate lessons learned during the COVID-19 pandemic.
- Council will hold its first meeting on 6 May 2021 led by Chair Mariana Mazzucato, Professor of the Economics of Innovation and Public Value and Founding Director in the Institute for Innovation and Public Purpose at University College London.
WHO is convening 11 leading figures in economics, health and development from around the world as the first members of the WHO Council on the Economics of Health for All. The Council’s role is to provide independent advice to the Director-General on addressing interrelated health and economic challenges and mapping out a way forward that supports communities and countries to build healthy societies. To do so, it will provide recommendations for a new approach to shape the economy that supports health for all as an overall goal, including more equitable and effective health systems.
“I am delighted that WHO is convening this talented and driven group of global experts as the WHO Council on the Economics of Health for All, which is Chaired by the distinguished economist Professor Mariana Mazzucato,” said Dr Tedros. “I established this Council precisely to gather leading experts in economics, policy development and health, and to benefit from their knowledge and skill. I urge them to advise on a new way forward that ensures health is at the heart of all government action and investment decisions. We must value and invest in health as our most important commodity. ”
The Council is holding its inaugural meeting today, kickstarting a robust and wide-ranging process to gather insights and develop actionable plans and forward looking practices built on real-world examples and lessons learned from the COVID-19 pandemic.
Patron of the Council, H.E. Sanna Marin, Prime Minister of Finland, said the new body will provide strong support to WHO and countries in addressing the interconnected issues of public health and the economy.
Prime Minister Marin said: “The pandemic has had a momentous impact on health, economies and societies around the world. At the same time, it has shown that, with the right approach, it is possible to protect the vulnerable, to safeguard both health and the economy. It has underlined the meaning of global solidarity and the importance of putting people at the centre of decision-making. The participation of women in the policy design and at the heart of response and recovery is essential.”
She added: “We strongly believe that this Council will provide invaluable advice to both to the Secretariat and the Member States.”
In addition to Professor Mariana Mazzucato, as Chair, the inaugural members of the council are Professor Senait Fisseha, Professor Jayati Ghosh, Vanessa Huang, Professor Stephanie Kelton, Professor Ilona Kickbusch, Linah Kelebogile Mohohlo, Dr Zélia Maria Profeta da Luz, Kate Raworth and Dame Marilyn Waring. Additional members may be appointed. Dr Vera Songwe will join as a special guest.
“The COVID-19 pandemic has shone the brightest light ever on the great lack of capacity and alignment among essential sectors in society in how they respond to the interlinked health and economic challenges people face in their daily lives,” said Professor Mazzucato, Council Chair, Professor of the Economics of Innovation and Public Value and Founding Director in the Institute for Innovation and Public Purpose at University College London. “Government capacities for protecting public health and, in turn, safeguarding and boosting economies require interlinked strategies, investment and political commitment. Health for all must be at the heart of government investment and innovation decisions—and it must be governed with the common good in mind. The Council will work to address these many challenges and offer the world a path forward.”
The WHO Council aims to reframe health for all, as a global objective, and ensure that national and global economies and finance are structured in such a way to deliver on this ambitious goal. This includes advice on what can be done and practical tools in four important areas: new ways to measure and value health for all, build up public sector capacity to drive transformative change and innovate towards achieving population health goals, and, to ensure financial systems invest in creating health. This requires a transformation in financing for health, not as a cost but a long-term investment for a “healthy society,” grounded in the fundamental truth that health and the economy are interdependent.
WHO Director-General commends United States decision to support temporary waiver on intellectual property rights for COVID-19 vaccines
- The WHO Hub for Pandemic and Epidemic Intelligence will be a global platform for pandemic and epidemic intelligence, creating shared and networked access to vital multi-sectoral data, driving innovations in data analytics and building the communities of practice needed to predict, prevent, detect, prepare for and respond to worldwide health threats.
- The WHO Hub will be a new global collaboration of countries and partners worldwide, driving innovations to increase availability and linkage of diverse data; develop tools and predictive models for risk analysis; and to monitor disease control measures and infodemics.
- The WHO Hub will enable partners from around the world to collaborate and co-create the tools and data access that all countries need to prepare, detect and respond to pandemic and epidemic risks.
The World Health Organization (WHO) and the Federal Republic of Germany will establish a new global hub for pandemic and epidemic intelligence, data, surveillance and analytics innovation. The Hub, based in Berlin and working with partners around the
world, will lead innovations in data analytics across the largest network of global data to predict, prevent, detect prepare for and respond to pandemic and epidemic risks worldwide.
H.E. German Federal Chancellor Dr Angela Merkel said: "The current Covid-19 pandemic has taught us that we can only fight pandemics and epidemics together. The new WHO Hub will be a global platform for pandemic prevention, bringing together various governmental,
academic and private sector institutions. I am delighted that WHO chose Berlin as its location and invite partners from all around the world to contribute to the WHO hub."
The WHO Hub for Pandemic and Epidemic Intelligence is part of WHO’s Health Emergencies Programme and will be a new collaboration of countries and partners worldwide, driving innovations to increase availability and linkage of diverse data; develop
tools and predictive models for risk analysis; and to monitor disease control measures, community acceptance and infodemics. Critically, the WHO Hub will support the work of public health experts and policy-makers in all countries with insights so
they can take rapid decisions to prevent and respond to future public health emergencies.
“We need to identify pandemic and epidemic risks as quickly as possible, wherever they occur in the world. For that aim, we need to strengthen the global early warning surveillance system with improved collection of health-related data and inter-disciplinary
risk analysis,” said Jens Spahn, German Minister of Health. “Germany has consistently been committed to support WHO’s work in preparing for and responding to health emergencies, and the WHO Hub is a concrete initiative that will
make the world safer.”
Working with partners globally, the WHO Hub will drive a scale-up in innovation for existing forecasting and early warning capacities in WHO and Member States. At the same time, the WHO Hub will accelerate global collaborations across public and private sector organizations, academia, and international partner networks. It will help them to collaborate and co-create the necessary tools for managing and analyzing data for early warning surveillance. It will also promote greater access to data and information.
“One of the lessons of COVID-19 is that world needs a significant leap forward in data analysis to help leaders make informed public health decisions,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “This requires harnessing the potential of advanced technologies such as artificial intelligence, combining diverse data sources, and collaborating across multiple disciplines. Better data and better analytics will lead to better decisions.”