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COVAX Announces new agreement, plans for first deliveries

22.01.2021
  • COVAX announced the signing of an advance purchase agreement for up to 40 million doses of the Pfizer-BioNTech vaccine; rollout to commence with successful execution of supply agreements.

  • Additionally, COVAX announced that, pending WHO emergency use listings, nearly 150 million doses of the AstraZeneca/Oxford candidate are anticipated to be available in Q1 2021, via existing agreements with the Serum Institute of India (SII) and AstraZeneca.

  • COVAX is therefore on track to deliver at least 2 billion doses by the end of the year, including at least 1.3 billion doses to 92 lower income economies in the Gavi COVAX AMC.

  • Click here for the latest COVAX supply forecast

 

Geneva/Oslo 22 January 2021 – COVAX, the global initiative to ensure rapid and equitable access to COVID-19 vaccines for all countries, regardless of income level, today announced the signing of an advance purchase agreement with Pfizer for up to 40 million doses of the Pfizer-BioNTech vaccine candidate, which has already received WHO emergency use listing. Rollout will commence with the successful negotiation and execution of supply agreements.

In further support of its mission to expedite early availability of vaccines to lower-income countries and help bring a rapid end to the acute stage of the COVID-19 pandemic, COVAX also confirmed today that it will exercise an option – via an existing agreement with Serum Institute of India (SII) – to receive its first 100 million doses of the AstraZeneca/Oxford University-developed vaccine manufactured by SII.

Of these first 100 million doses, the majority are earmarked for delivery in the first quarter of the year, pending WHO Emergency Use Listing. The WHO review process, which is currently underway, follows approval for restricted use in emergency situations by the Drugs Controller General of India earlier this month, and is a critical aspect of ensuring that any vaccine procured through COVAX is fully quality assured for international use. According to the latest WHO update, a decision on this vaccine candidate is anticipated by the middle of February.  

COVAX also anticipates that, via an existing agreement with AstraZeneca, at least 50 million further doses of the AstraZeneca/Oxford vaccine will be available for delivery to COVAX participants in Q1 2021, pending emergency use listing by WHO of the COVAX-specific manufacturing network for these doses. A decision on this candidate is also anticipated by WHO in February.

“Today marks another milestone for COVAX: pending regulatory approval for the AstraZeneca/Oxford candidate and pending the successful conclusion of the supply agreement for the Pfizer-BioNTech vaccine, we anticipate being able to begin deliveries of life-saving COVID-19 vaccines by the end of February. This is not just significant for COVAX, it is a major step forward for equitable access to vaccines, and an essential part of the global effort to beat this pandemic. We will only be safe anywhere if we are safe everywhere,” said Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance, which leads COVAX procurement and delivery.

Preparations, led by WHO, UNICEF and Gavi, are already well under way for COVAX to deliver vaccines to economies eligible for support via the COVAX AMC, with Gavi making US$ 150 million available from its core funding as initial, catalytic support for preparedness and delivery.

“The urgent and equitable rollout of vaccines is not just a moral imperative, it’s also a health security, strategic and economic imperative,” said Dr Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization. “This agreement with Pfizer will help to enable COVAX to save lives, stabilize health systems and drive the global economic recovery.”

Building on the work of the past months supporting country readiness efforts, a “Country Readiness Portal” will be launched by WHO this month, which will allow AMC participants to submit final national deployment and vaccination plans (NDVPs). This is a vital step before allocations can be made, to ensure that delivered doses are able to be effectively deployed and to identify where, if necessary, further support is needed.

“These purchase agreements open the door for these lifesaving vaccines to become available to people in the most vulnerable countries,” said UNICEF Executive Director Henrietta Fore. “But at the same time we are securing vaccines we must also ensure that countries are ready to receive them, deploy them, and build trust in them.”

The COVAX Facility intends to provide all 190 participating economies with an indicative allocation of doses by the end of this month. This indicative allocation will provide interim guidance to participants – offering a minimum planning scenario to enable preparations for the final allocation of the number of doses each participant will receive in the first rounds of vaccine distribution.

Supply update

COVAX now has agreements in place to access just over two billion doses of several promising vaccine candidates. Negotiations continue for further doses to be secured through existing R&D agreements by COVAX co-lead the Coalition for Epidemic Preparedness Innovations (CEPI), through evaluations of new products with promising results and through contributions from donors.

Based on this, COVAX anticipates being able to provide participating economies doses of safe and effective vaccines – enough to protect health care and other frontline workers as well as some high-risk individuals – beginning in Q1 2021. The aim is to protect at least 20% of each participating population by the end of the year – unless a participant has requested a lower percentage of doses. At least 1.3 billion of these doses will be made available to the 92 economies eligible for the Gavi COVAX AMC by the end of 2021.

To meet its goal of securing two billion safe and effective vaccines in 2021, COVAX has built a diverse portfolio of vaccine candidates which mitigates the risk of a product failing development, production or regulatory processes, and ensures availability of products suitable for various contexts and settings. This work will continue at pace to enable further supply of vaccines suitable for use across a wide range of populations and settings in 2021 and beyond.

“The progress in vaccine development so far has been extraordinary, and it is clear that we are now assembling the tools we need to bring the acute phase of the pandemic to an end. But we cannot afford to slow our efforts given the speed with which this pandemic continues to wreak havoc,” said Dr Richard Hatchett, CEO of CEPI. “The emergence of new variants of COVID-19 puts into sharp focus the need for us to be one step ahead of the virus by continuing to invest in vaccine R&D - specifically for next-generation vaccine candidates and to be ready for strain changes in existing vaccines - to ensure we have the tools to meet the needs of all populations in all countries for the long term.”

 

Notes to editors

About COVAX

COVAX, the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator, is co-led by CEPI, Gavi and WHO – working in partnership with developed and developing country vaccine manufacturers, UNICEF, the World Bank, and others. It is the only global initiative that is working with governments and manufacturers to ensure COVID-19 vaccines are available worldwide to both higher-income and lower-income countries.

CEPI is leading on the COVAX vaccine research and development portfolio, investing in R&D across a variety of promising candidates, with the goal to support development of three safe and effective vaccines which can be made available to countries participating in the COVAX Facility. As part of this work, CEPI has secured first right of refusal to potentially over one billion doses for the COVAX Facility to a number of candidates, and made strategic investments in vaccine manufacturing, which includes reserving capacity to manufacture doses of COVAX vaccines at a network of facilities, and securing glass vials to hold 2 billion doses of vaccine. CEPI is also investing in the ‘next generation’ of vaccine candidates, which will give the world additional options to control COVID-19 in the future.  

Gavi is leading on procurement and delivery for COVAX, coordinating the design and implementation of the COVAX Facility and the COVAX AMC and working with Alliance partners UNICEF and WHO, along with governments, on country readiness and delivery. The COVAX Facility is the global pooled procurement mechanism for COVID-19 vaccines through which COVAX will ensure fair and equitable access to vaccines for all 190 participating economies, using an allocation framework formulated by WHO. The COVAX Facility will do this by pooling buying power from participating economies and providing volume guarantees across a range of promising vaccine candidates. The Gavi COVAX AMC is the financing mechanism that will support the participation of 92 low- and middle-income countries in the Facility, enabling access to donor-funded doses of safe and effective vaccines. UNICEF and the Pan-American Health Organisation (PAHO) will be acting as procurement coordinators for the COVAX Facility, helping deliver vaccines to all participants.

WHO has multiple roles within the COVAX: among other things it supports countries as they prepare to receive and administer vaccines and does so in partnership with UNICEF. It provides normative guidance on vaccine policy, regulation, safety, R&D, allocation, and country readiness and delivery. Its Strategic Advisory Group of Experts (SAGE) on Immunization develops evidence-based immunization policy recommendations. Its Emergency Use Listing (EUL)/prequalification programmes ensure harmonized review and authorization across member states. It provides global coordination and member state support on vaccine safety monitoring. It developed the target product profiles for COVID-19 vaccines and provides R&D technical coordination. Along with COVAX partners, it is developing a no-fault compensation scheme for indemnification and liability issues. COVAX is part of the Act accelerator which WHO launched with partners in 2020.

About Gavi, the Vaccine Alliance

Gavi, the Vaccine Alliance is a public-private partnership that helps vaccinate half the world’s children against some of the world’s deadliest diseases. Since its inception in 2000, Gavi has helped to immunise a whole generation – over 822 million children – and prevented more than 14 million deaths, helping to halve child mortality in 73 lower-income countries. Gavi also plays a key role in improving global health security by supporting health systems as well as funding global stockpiles for Ebola, cholera, meningitis and yellow fever vaccines. After two decades of progress, Gavi is now focused on protecting the next generation and reaching the unvaccinated children still being left behind, employing innovative finance and the latest technology – from drones to biometrics – to save millions more lives, prevent outbreaks before they can spread and help countries on the road to self-sufficiency. Learn more at www.gavi.org and connect with us on Facebook and Twitter.

The Vaccine Alliance brings together developing country and donor governments, the World Health Organization, UNICEF, the World Bank, the vaccine industry, technical agencies, civil society, the Bill & Melinda Gates Foundation and other private sector partners. View the full list of donor governments and other leading organizations that fund Gavi’s work here.

About CEPI

CEPI is an innovative partnership between public, private, philanthropic, and civil organisations, launched at Davos in 2017, to develop vaccines to stop future epidemics. CEPI has moved with great urgency and in coordination with WHO in response to the emergence of COVID-19. CEPI has initiated 11 partnerships to develop vaccines against the novel coronavirus. The programmes are leveraging rapid response platforms already supported by CEPI as well as new partnerships. 

Before the emergence of COVID-19, CEPI’s priority diseases included Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever and Chikungunya virus. CEPI also invested in platform technologies that can be used for rapid vaccine and immunoprophylactic development against unknown pathogens (Disease X).

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.   For updates on COVID-19 and public health advice to protect yourself from coronavirus, visit www.who.int and follow WHO on TwitterFacebookInstagramLinkedInTikTokPinterestSnapchatYouTube

About ACT-Accelerator

The Access to COVID-19 Tools ACT-Accelerator, is a new, ground-breaking global collaboration to accelerate the development, production, and equitable access to COVID-19 tests, treatments, and vaccines. It was set up in response to a call from G20 leaders in March and launched by the WHO, European Commission, France and The Bill & Melinda Gates Foundation in April 2020.

The ACT-Accelerator is not a decision-making body or a new organisation, but works to speed up collaborative efforts among existing organisations to end the pandemic. It is a framework for collaboration that has been designed to bring key players around the table with the goal of ending the pandemic as quickly as possible through the accelerated development, equitable allocation, and scaled up delivery of tests, treatments and vaccines, thereby protecting health systems and restoring societies and economies in the near term. It draws on the experience of leading global health organisations which are tackling the world’s toughest health challenges, and who, by working together, are able to unlock new and more ambitious results against COVID-19. Its members share a commitment to ensure all people have access to all the tools needed to defeat COVID-19 and to work with unprecedented levels of partnership to achieve it.

The ACT-Accelerator has four areas of work: diagnostics, therapeutics, vaccines and the health system connector. Cross-cutting all of these is the workstream on Access & Allocation.

GACVS COVID-19 Vaccine Safety subcommittee meeting to review reports of deaths of very frail elderly individuals vaccinated with Pfizer BioNTech COVID-19 vaccine, BNT162b2

22.01.2021

The GACVS COVID-19 Vaccine Safety subcommittee met virtually on Tuesday, 19 January 2021, to review available information and data on deaths reported in frail, elderly individuals who had received the Pfizer BioNTech COVID-19 mRNA vaccine, BNT162b2 (hereafter, BNT162b2). Experts invited from the European Medicines Agency (EMA) and the Uppsala Monitoring Center (UMC) provided an overview of deaths reported in Europe and in the WHO global database (VigiBase) following vaccination with BNT162b2.

 

Based on a careful scientific review of the information made available, the subcommittee came to the following conclusions:

 

The current reports do not suggest any unexpected or untoward increase in fatalities in frail, elderly individuals or any unusual characteristics of adverse events following administration of BNT162b2. Reports are in line with the expected, all-cause mortality rates and causes of death in the sub-population of frail, elderly individuals, and the available information does not confirm a contributory role for the vaccine in the reported fatal events. In view of this, the committee considers that the benefit-risk balance of BNT162b2 remains favourable in the elderly, and does not suggest any revision, at present, to the recommendations around the safety of this vaccine.

 

Countries should continue to monitor the safety of vaccines, and promote routine after-care following immunization, consistent with good immunization practices for any vaccine. The committee recommends that data on suspected adverse events should be collected and reviewed continuously - nationally, regionally, and globally - as the COVID-19 vaccines are rolled out, world-wide[1].

 

The GACVS subcommittee will continue to monitor the safety data from these vaccines and update any advice as necessary.

 


[1] The WHO COVID-19 vaccine safety surveillance manual provides guidance to countries on the safety monitoring and adverse events data sharing for the new COVID-19 vaccines, and can be accessed here.

WHO Information Notice for IVD Users 2021/01

19.01.2021

Product type: All in vitro diagnostic medical devices (IVDs) for detection of SARS-CoV-2

Date: 18 January 2021                                                                   

WHO-identifier: 2021/01, version 1  

Target audience: Laboratory professionals and users of IVDs.  

Purpose of this notice: To request that IVD users monitor mutations of SARS-CoV-2 and their impact on diagnosis. 

Description of the problem: 

Following the detection of SARS-CoV-2 variants containing mutations, including SARS-CoV-2 VOC 202012/01, and SARS-CoV-2 501Y.V2, WHO reminds users of IVDs to monitor detection rates for SARS-CoV-2 at their site.  

IVD users should routinely review test results to detect unexpected increases or decreases in test results, including positivity rate, target detection rate, invalid or unreturnable result rate, etc. These variations may be early indicators of impact on the safety, quality or performance of the IVD products. Certain mutations may increase the risk of delayed diagnosis (due to inconclusive or invalid results), and misdiagnosis. 

Manufacturers of IVDs listed by WHO (through Emergency Use Listing) must proactively scan literature and other sources for any documented mutations that might impact the safety, quality or performance of their product. This should be incorporated as part of their post-market surveillance plan and will be supplemented by feedback reported by IVD users in the form of unexpected results, as well as other product problems and adverse events. All gathered information must be reviewed in a timely fashion, using risk management principles to determine any necessary actions. 

Advice on action to be taken by IVD users:  

IVD users should notify the IVD manufacturer in the following circumstances: 

  1. Increased discrepancies in cycle threshold (Ct) values between different gene targets. 

  1. Failure to detect specific gene targets, including those containing gene sequences that coincide with documented mutations.  

  1. Misdiagnosis (for example, false negative).  

See WHO website for reporting form for IVD users to give feedback to manufacturers  

https://www.who.int/health-topics/substandard-and-falsified-medical-products/safety-info-medical-devices-in-vitro-diagnostics  

Contact person for further information: 

Anita SANDS, Regulation and Prequalification, World Health Organization,  
e-mail: rapidalert@who.int 

Reference: 

Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics. Geneva: World Health Organization; 2020. Licence: CC BY-NC-SA 3.0 IGO.  

 

 

Statement to the 148th Executive Board by the Chair of the Review Committee on the Functioning of the International Health Regulations (2005) during the COVID-19 Response

19.01.2021

Honorable Chair, Excellencies, Director-General, Ladies and Gentlemen

Thank you once again for the opportunity to provide you with an update on the work of the Review Committee on the Functioning of the International Health Regulations (2005) during COVID-19.

As you know, this Committee was convened by the Director-General on 8 September 2020, in line with World Health Assembly Resolution WHA73.1. The Committee is composed of experts with a wide range of expertise and with adequate gender and geographical representation. I have the honour to be the Chair of this Committee and am ably supported by our Vice-Chair, Professor Lucille Blumberg of South Africa and our Rapporteur, Professor Preben Aavitsland, from Norway.

Our mandate is to review the functioning of the International Health Regulations (2005) during the COVID-19 response and the status of implementation of the relevant recommendations of previous IHR Review Committees and to make technical recommendations to the Director-General, including any potential amendments.

We convened for 16 closed meetings so far, and we continue to work through three sub-groups: preparedness, alert, and response. I take this opportunity to reiterate my thanks to our three subgroup leads. We also convened 5 open meetings, when we provided updates on our work and listened to the submissions and questions raised by Member States, international agencies and non-governmental organizations in official relation to WHO. These open meetings continue to be attended by numerous designated representatives.

I reported on our progress to the 73rd World Health Assembly on 9 November 2020. And I continue to interact regularly with the Co-Chairs of the Independent Panel for Pandemic Preparedness and Response and the Chair of the Independent Oversight Advisory Committee.

Let me now turn to the substance of our work. I invite you to read our Interim Progress Report, document EB148/19. It details our preliminary findings as of December 2020, which were reached following numerous interviews, discussions and the review of a wealth of documentation.

Let me point out the most important ones:

  1. Member States and experts overwhelmingly support the IHR as a cornerstone of international public health and health security law, but several areas need improving if we are to be better prepared for the next pandemic. While we have not finalized our article-by-article assessment, there is a growing belief in the Committee that most of the necessary improvements can be achieved through more effective implementation of the existing provisions of the IHR, and do not require at this point changes to the design of the IHR.

     

  2. National IHR Focal Points need to be further empowered, including where necessary through national legislation. National Focal Points play a critical role in the timely sharing of information, but their limited authority and status often lead to delays in notification. The Committee noted that effective IHR implementation requires many functions that are not within the narrow mandate of the national IHR focal points, such as multisectoral coordination for preparedness and response and collaborative risk assessment. The absence of a dedicated national entity with sufficient authority and a clear mandate to take ownership and leadership is considered a significant limitation to effective implementation of the IHR at national and subnational levels. At country level, national IHR focal points need to be integrated in the national emergency plan as well as the national health committee or similar body.

     

  3. The possible need for an intermediate level of alert before a Public Health Emergency of International Concern (PHEIC) is declared, is also under consideration. The previous review committee on the Ebola response recommended such an intermediate level, but this recommendation was not taken up. The 5th open meeting of the Committee on 12 January 2021 discussed issues surrounding the possible introduction of a grading system. The different views expressed by Member States and the advantages and potential disadvantages of a new system will be further studied by the Committee. It is clear, that global preparedness, alert and response actions need to start much earlier and more decisively than they did during COVID-19. But it is far from certain, that introducing an intermediate level of alert would result in such earlier action. The Committee is considering how regular global and regional risk assessments can be used better to drive earlier and more targeted response measures at all levels. The aim, the Committee feels, should be to react early and strongly enough so as to prevent the need to declare a PHEIC.

     

  4. Compliance with IHR provisions remains a challenge in several areas, from setting up core capacities to implementing travel measures during health emergencies. The Committee is mindful of the lack of teeth in the IHR. We are therefore looking at new ways to monitoring and evaluating adherence to the IHR – both in preparedness and response – and to strengthen existing tools without overburdening countries. Considering a peer-review mechanism similar to the Universal Periodic Review used by the Human Rights Council, may be useful in improving preparedness and response. For example, the Universal Periodic Review has been shown to foster intersectoral coordination and whole-of-government approaches, to encourage good practices, and to link implementation of its recommendations with other government agendas – all of which are vital to strengthening IHR implementation. It is in this context that the Director-General has proposed the Universal Health and Preparedness Review initiative which is currently being pilot tested.

     

  5. Last but far from least, political support and resources for IHR implementation remain insufficient and irregular at all levels. In this context, the Committee is awaiting further detailed information on the funding mechanisms for IHR implementation.

I would like to clearly state my conviction that we need more meaningful cooperation during and in-between health emergencies; more transparency, more regular detailed exchange of real-time data and experiences at all levels, more reliability of interaction, and greater speed in sharing data and samples. Fortunately, digital technology supporting such developments is increasingly becoming available, from data mining to find disease outbreaks early, to next generation sequencing to follow a pathogen around the globe, to virtual conferencing that makes human interaction easier.

To come to the conclusion, the deadline for our final report is the 74th World Health Assembly in May 2021. However, as we all know, the COVID-19 pandemic will be far from over in 4 months’ time, and therefore our findings and recommendations will not necessarily be complete. Further deliberations may be needed later.

Let me reiterate what I said in November 2020 on the occasion of the 73rd Health Assembly: The IHR are your instrument, our instrument, of international public health law. Making them work requires giving WHO the tools and the resources it needs to better prepare and protect humanity against public health risks, through an effective, coordinated, multisectoral and evidence-based public health response.


Thank you again for the opportunity to speak to you today and let me also thank the Director-General for the excellent support provided by the WHO Secretariat to this Review Committee.

 

WHO Guidelines for establishing a poison centre

18.01.2021
The Guidelines for establishing a poison centre provides information on the services that may be offered by a poison centre as well as detailed practical guidance on planning and operations.