Latest Development

WHO and MPP announce agreement with NIH for COVID-19 health technologies

12 May 2022

News release

Geneva

WHO’s COVID-19 Technology Access Pool (C-TAP) and the Medicines Patent Pool (MPP) today finalized a licensing agreement with the United States National Institutes of Health (NIH) for the development of several innovative therapeutics, early-stage vaccines and diagnostic tools for COVID-19.

The licenses, which are transparent, global and non-exclusive, will allow manufacturers from around the world to work with MPP and C-TAP to make these technologies accessible to people living in low- and middle-income countries and help put an end to the pandemic.

The 11 COVID-19 technologies offered under two licences include the stabilized spike protein used in currently available COVID-19 vaccines, research tools for vaccine, therapeutic and diagnostic development as well as early-stage vaccine candidates and diagnostics. The full list of the NIH COVID-19 technologies covered in the agreement is here.

“I welcome the generous contribution NIH has made to C-TAP and its example of solidarity and sharing,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “Whether it’s today’s pandemic or tomorrow’s health emergency, it’s through sharing and empowering lower-income countries to manufacture their own health tools that we can ensure a healthier future for everyone.”

“We are honoured to sign these public health-driven licence agreements with NIH under the auspices of C-TAP with the goal of providing equitable access to life-saving health products for the most vulnerable in the world,” said Charles Gore, MPP Executive Director.

“NIH were the first to share their patents with MPP for an HIV product back in 2010 when we were created, and we are delighted to continue strengthening our partnership. It is clear that MPP’s model works across different health technologies.”

The announcement was made today by the US Government at the second Global COVID-19 Summit, co-hosted by the United States, Belize, Germany, Indonesia and Senegal.

Licensing the NIH technologies to MPP under the auspices of C-TAP will allow greater access to these technologies and hopefully lead to the development of commercial products that can address current and future public health needs. In most circumstances, NIH will not collect royalties on sales of products licensed in 49 countries classified by the United Nations as Least Developed Countries.

Launched in 2020 by the WHO Director-General and the President of Costa Rica, and supported by 43 Member States, C-TAP aims to facilitate timely, equitable and affordable access to COVID-19 health products by boosting their production and supply through open, transparent and non-exclusive licensing agreements. MPP provides the licensing expertise to this initiative and holds the licences.

The 11 technologies include:

1. Prefusion spike proteins (Vaccine Development)

2. Structure-Based Design of Spike Immunogens (Research Tool for Vaccine Development)

3. Pseudotyping Plasmid (Research Tool for Vaccine Development)

4. ACE2 Dimer construct (Research Tool for Drug Development)

5. Synthetic humanized llama nanobody library and related use (Research Tool for Drug and Diagnostic Development)

6. Newcastle Disease Virus-Like Particles Displaying Prefusion-Stabilized Spikes (Vaccine Candidate)

7. Parainfluenza virus 3 based vaccine (Vaccine Candidate)

8. A VSV-EBOV-Based Vaccine (Vaccine Candidate)

9. RNASEH-Assisted Detection Assay for RNA (Diagnostic)

10. Detection of SARS-CoV-2 and other RNA Virus (Diagnostic)

11. High-Throughput Diagnostic Test (Diagnostic)

14.9 million excess deaths associated with the COVID-19 pandemic in 2020 and 2021

5 May 2022

News release

New estimates from the World Health Organization (WHO) show that the full death toll associated directly or indirectly with the COVID-19 pandemic (described as “excess mortality”) between 1 January 2020 and 31 December 2021 was approximately 14.9 million (range 13.3 million to 16.6 million).

“These sobering data not only point to the impact of the pandemic but also to the need for all countries to invest in more resilient health systems that can sustain essential health services during crises, including stronger health information systems,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “WHO is committed to working with all countries to strengthen their health information systems to generate better data for better decisions and better outcomes.”

Excess mortality is calculated as the difference between the number of deaths that have occurred and the number that would be expected in the absence of the pandemic based on data from earlier years.

Excess mortality includes deaths associated with COVID-19 directly (due to the disease) or indirectly (due to the pandemic’s impact on health systems and society). Deaths linked indirectly to COVID-19 are attributable to other health conditions for which people were unable to access prevention and treatment because health systems were overburdened by the pandemic. The estimated number of excess deaths can be influenced also by deaths averted during the pandemic due to lower risks of certain events, like motor-vehicle accidents or occupational injuries.

Most of the excess deaths (84%) are concentrated in South-East Asia, Europe, and the Americas. Some 68% of excess deaths are concentrated in just 10 countries globally. Middle-income countries account for 81% of the 14.9 million excess deaths (53% in lower-middle-income countries and 28% in upper-middle-income countries) over the 24-month period, with high-income and low-income countries each accounting for 15% and 4%, respectively.

The estimates for a 24-month period (2020 and 2021) include a breakdown of excess mortality by age and sex. They confirm that the global death toll was higher for men than for women (57% male, 43% female) and higher among older adults. The absolute count of the excess deaths is affected by the population size. The number of excess deaths per 100,000 gives a more objective picture of the pandemic than reported COVID-19 mortality data.


“Measurement of excess mortality is an essential component to understand the impact of the pandemic. Shifts in mortality trends provide decision-makers information to guide policies to reduce mortality and effectively prevent future crises. Because of limited investments in data systems in many countries, the true extent of excess mortality often remains hidden,” said Dr Samira Asma, Assistant Director-General for Data, Analytics and Delivery at WHO. “These new estimates use the best available data and have been produced using a robust methodology and a completely transparent approach.”

“Data is the foundation of our work every day to promote health, keep the world safe, and serve the vulnerable. We know where the data gaps are, and we must collectively intensify our support to countries, so that every country has the capability to track outbreaks in real-time, ensure delivery of essential health services, and safeguard population health,” said Dr Ibrahima Socé Fall, Assistant Director-General for Emergency Response.

The production of these estimates is a result of a global collaboration supported by the work of the Technical Advisory Group for COVID-19 Mortality Assessment and country consultations.

This group, convened jointly by the WHO and the United Nations Department of Economic and Social Affairs (UN DESA), consists of many of the world’s leading experts, who developed an innovative methodology to generate comparable mortality estimates even where data are incomplete or unavailable.

This methodology has been invaluable as many countries still lack capacity for reliable mortality surveillance and therefore do not collect and generate the data needed to calculate excess mortality. Using the publicly available methodology, countries can use their own data to generate or update their own estimates.

“The United Nations system is working together to deliver an authoritative assessment of the global toll of lives lost from the pandemic. This work is an important part of UN DESA’s ongoing collaboration with WHO and other partners to improve global mortality estimates,” said Mr Liu Zhenmin, United Nations Under-Secretary-General for Economic and Social Affairs.

Mr Stefan Schweinfest, Director of the Statistics Division of UN DESA, added: “Data deficiencies make it difficult to assess the true scope of a crisis, with serious consequences for people’s lives. The pandemic has been a stark reminder of the need for better coordination of data systems within countries and for increased international support for building better systems, including for the registration of deaths and other vital events.”

WHO recommends highly successful COVID-19 therapy and calls for wide geographical distribution and transparency from originator

22 April 2022

Statement

Geneva

Today, WHO made a strong recommendation for nirmatrelvir and ritonavir, sold under the name Paxlovid, for mild and moderate COVID-19 patients at highest risk of hospital admission, calling it the best therapeutic choice for high-risk patients to date. However, availability, lack of price transparency in bilateral deals made by the producer, and the need for prompt and accurate testing before administering it, are turning this life-saving medicine into a major challenge for low- and middle-income countries.

Pfizer’s oral antiviral drug (a combination of nirmatrelvir and ritonavir tablets) is strongly recommended for patients with non-severe COVID-19 who are at highest risk of developing severe disease and hospitalization, such as unvaccinated, older, or immunosuppressed patients.

This recommendation is based on new data from two randomized controlled trials involving 3078 patients. The data show that the risk of hospitalization is reduced by 85% following this treatment. In a high-risk group (over 10% risk of hospitalization), that means 84 fewer hospitalizations per 1000 patients.

WHO suggests against its use in patients at lower risk, as the benefits were found to be negligible.

One obstacle for low- and middle-income countries is that the medicine can only be administered while the disease is at its early stages; prompt and accurate testing is therefore essential for a successful outcome with this therapy. Data collected by FIND show that the average daily testing rate in low-income countries is as low as one-eightieth the rate in high-income countries. Improving access to early testing and diagnosis in primary health care settings will be key for the global rollout of this treatment.

WHO is extremely concerned that -- as occurred with COVID-19 vaccines -- low- and middle-income countries will again be pushed to the end of the queue when it comes to accessing this treatment.

Lack of transparency on the part of the originator company is making it difficult for public health organizations to obtain an accurate picture of the availability of the medicine, which countries are involved in bilateral deals and what they are paying. In addition, a licensing agreement made by Pfizer with the Medicines Patent Pool limits the number of countries that can benefit from generic production of the medicine.

The originator product, sold under the name Paxlovid, will be included in the WHO prequalification list today, but generic products are not yet available from quality-assured sources. Several generic companies (many of which are covered by the licensing agreement between the Medicines Pool and Pfizer) are in discussion with WHO Prequalification but may take some time to comply with international standards so that they can supply the medicine internationally.

WHO therefore strongly recommends that Pfizer make its pricing and deals more transparent and that it enlarge the geographical scope of its licence with the Medicines Patent Pool so that more generic manufacturers may start to produce the medicine and make it available faster at affordable prices.

Along with the strong recommendation for the use of nirmatrelvir and ritonavir, WHO has also updated its recommendation on remdesivir, another antiviral medicine.

Previously, WHO had suggested against its use in all COVID-19 patients regardless of disease severity, due to the totality of the evidence at that time showing little or no effect on mortality. Following publication of new data from a clinical trial looking at the outcome of admission to hospital, WHO has updated its recommendation. WHO now suggests the use of remdesivir in mild or moderate COVID-19 patients who are at high risk of hospitalization.

The recommendation for use of remdesivir in patients with severe or critical COVID-19 is currently under review.

Statement on the eleventh meeting of the International Health Regulations (2005) Emergency Committee regarding the coronavirus disease (COVID-19) pandemic

13 April 2022

Statement

The eleventh meeting of the Emergency Committee convened by the WHO Director-General under the International Health Regulations (2005) (IHR) regarding the coronavirus disease (COVID-19) pandemic took place on Monday 11 April 2022 from 12:00 to 16:30 Geneva time (CEST).

Proceedings of the meeting

Members and Advisors of the Emergency Committee were convened by videoconference.

The Director-General welcomed the Committee members and advisers. The Director-General explained that the world has tools to limit transmission, save lives, and protect health systems. He expressed hope in the current epidemiological situation, noting that the world is currently experiencing the lowest number of reported deaths in two years. However, the unpredictable behavior of the SARS-CoV-2 virus and insufficient national responses are contributing to the continued global pandemic context. The Director-General emphasized the importance of States Parties using available medical countermeasures and public health and social measures (PHSM). He highlighted the publication of the updated Strategic Preparedness, Readiness, and Response Plan which provides a roadmap for how the world can end the COVID-19 emergency in 2022 and prepare for future events.

Representatives of the Office of Legal Counsel (LEG) and the Department of Compliance, Risk Management, and Ethics (CRE) briefed the members on their roles and responsibilities. The Ethics Officer from CRE provided the members and advisers with an overview of the WHO Declaration of Interests process. The members and advisers were made aware of their individual responsibility to disclose to WHO, in a timely manner, any interests of a personal, professional, financial, intellectual or commercial nature that may give rise to a perceived or direct conflict of interest. They were additionally reminded of their duty to maintain the confidentiality of the meeting discussions and the work of the Committee. Each member who was present was surveyed. No conflicts of interest were identified.

The Secretariat turned the meeting over to the Chair, Professor Didier Houssin, who reviewed the objectives and agenda of the meeting.

The Secretariat presented on the current status of the COVID-19 pandemic and a vision for how to optimize the ongoing response to the COVID-19 pandemic for 2022. The presentation focused on:

the global epidemiological context and factors that continue to drive transmission;

updates on international traffic as well as COVID-19 proof of vaccination and test result certificates;

the status of COVID-19 vaccination; and

the strategic objectives for countries to incorporate in their COVID-19 response.

The Committee discussed key issues including SARS-CoV-2 variants; use and equitable access to antivirals; vaccine protection and global shifts in the supply and demand for COVID-19 vaccines; hybrid immunity; potential future scenarios for SARS-CoV-2 transmission and challenges posed by concurrent health emergencies; and how Member States are responding to the COVID-19 pandemic. The Committee also noted with concern the growing fatigue among communities worldwide in response to the COVID-19 pandemic and challenges posed by the lack of trust in scientific guidance and governments.

The Committee recognized that SARS-CoV-2 is a novel respiratory pathogen that has not yet established its ecological niche. SARS-CoV-2 continues to have unpredictable viral evolution, which is compounded by its wide-spread circulation and intense transmission in humans, as well as widespread introduction of infection to a range of animal species with potential for animal reservoirs to be established. SARS-COV-2 is continuing to cause high levels of morbidity and mortality, particularly among vulnerable human populations. In this context, the Committee raised concerns that the inappropriate use of antivirals may lead to the emergence of drug-resistant variants. In addition, Committee members acknowledged national, regional, and global capacities to respond to the COVID-19 pandemic context, but noted with concern that some States Parties have relaxed PHSM and reduced testing, impacting thus the global ability to monitor evolution of the virus. The Committee also noted with concern the inconsistency of global COVID-19 requirements for international travel and the negative impact that inappropriate measures may have on all forms of international travel. In this context, the Committee noted that offering vaccination to high-risk groups of international travelers on arrival could be considered a means to mitigate the risk of severe disease or death due to COVID-19 among these individuals.

The Committee stressed the importance of maintaining PHSM to protect vulnerable populations, and maintaining the capacity to scale up PHSM if the epidemiological situation changes. States Parties are advised to regularly adjust their response strategies by monitoring their epidemiological situation (including through use of rapid tests), assessing their health system capacity, and considering the adherence to and attributable impact of individual and combined PHSM.

In addition, the Committee reinforced the continued need for international cooperation and coordination for surveillance, as well as for robust and timely reporting to global systems (such as the Global Influenza Surveillance and Response System) to inform national, regional, and global response efforts. Surveillance activities require coordination between the human and animal sectors and more global attention on the detection of animal infections and possible reservoirs among domestic and wild animals. Timely and systematic monitoring and data sharing on SARS-CoV-2 infection, transmission and evolution in humans and animals will assist global understanding of the virus epidemiology and ecology, the emergence of new variants, their timely identification, and assessment of their public health risks. Continued provision of technical support and guidance from all three levels of the WHO can enable States Parties’ adjustment of COVID-19 surveillance and its integration into respiratory pathogen surveillance systems.

The Committee acknowledged that COVID-19 vaccination is a key tool to reduce morbidity and mortality and reinforced the importance of vaccination (primary series and booster doses, including through heterologous vaccine schedules). The Committee expressed appreciation for WHO and partners’ work to enhance global vaccine supply and distribution. Committee members highlighted the challenges posed by limited vaccination protection, particularly in low-income countries, as well as by waning population-level immunity. As outlined in the SAGE roadmap, vaccination should be prioritized for high-risk groups such as health workers, older adults, and immune-compromised populations, refugees, and migrants. To enhance vaccine uptake, States Parties are encouraged to address national and sub-national barriers for vaccine deployment and to ensure COVID-19 response measures align with and strengthen immunization activities and primary health services.

In addition, the Committee noted the continued importance of WHO’s provision of guidance, training, and tools to support States Parties’ recovery planning process from the COVID-19 pandemic and future respiratory pathogen pandemic preparedness planning.

The Committee unanimously agreed that the COVID-19 pandemic still constitutes an extraordinary event that continues to adversely affect the health of populations around the world, poses an ongoing risk of international spread and interference with international traffic, and requires a coordinated international response. The Committee stressed the importance for States Parties to prepare for future scenarios with the assistance of WHO and to continue robust use of the essential tools (e.g. vaccines, therapeutics, and diagnostics). The Committee concurred that the COVID-19 pandemic remains a PHEIC and offered its advice to the Director-General.

The Director-General determined that the COVID-19 pandemic continues to constitute a PHEIC. He accepted the advice of the Committee and issued the Committee’s advice to States Parties as Temporary Recommendations under the IHR.

The Emergency Committee will be reconvened within three months or earlier, at the discretion of the Director-General. The Director-General thanked the Committee for its work.

Temporary Recommendations to States Parties

The Committee identified the following actions as critical for all countries:

1. NEW: Strengthen national response to the COVID-19 pandemic by updating national preparedness and response plans in line with the priorities and potential scenarios outlined in the 2022 WHO Strategic Preparedness and Response Plan (SPRP). States Parties should conduct assessments (e.g. intra action and after action reviews) to inform current and future response and preparedness efforts. WHO Strategic Preparedness and Response Plan (SPRP)

2. MODIFIED: Achieve national COVID-19 vaccination targets in line with global WHO recommendations of at least 70% of all countries’ populations vaccinated by the start of July 2022. States Parties are requested to support global equitable access to vaccines and to prioritize vaccination of high-risk populations through a primary series and booster schedule. These populations include health workers, older people, people with underlying conditions, immune-compromised, refugees, migrants, people living in fragile settings, and individuals with insufficient access to treatment. States Parties should continually assess their vaccine coverage and epidemiological situation in relation to the COVID-19 pandemic and modify their national responses accordingly. WHO SAGE Prioritization Roadmap

3. MODIFIED: Continue to use evidence-informed and risk-based PHSM. State Parties should be prepared to scale up PHSM rapidly in response to changes in the virus and the population immunity, if COVID-19 hospitalizations, intensive care admissions, and fatalities increase and compromise the health system’s capacity. States Parties are advised to continue the risk-based use of basic PHSM (e.g. wearing masks, staying home when sick, increased hand washing, and improving ventilation of indoor spaces, even in periods of low circulation of SARS-CoV-2). Considerations for implementing and adjusting public health and social measures in the context of COVID-19

4. MODIFIED: Take a risk-based approach to mass gathering events by evaluating, mitigating, and communicating risks. Recognizing that there are different drivers and risk tolerance for mass gatherings, it is critical to consider the epidemiological context (including the prevalence of variants of concern and the intensity of transmission), surveillance, contact tracing and testing capacity, as well as adherence to PHSM when conducting this risk assessment and planning events, in line with WHO guidance. Key planning recommendations for mass gatherings in the context of COVID-19

5. MODIFIED: Adjust COVID-19 surveillance to focus on the burden and impact and prepare for sustainable integration with other surveillance systems. States Parties should collect and publicly share indicators to monitor the burden of COVID-19 (e.g. new hospitalizations, admissions to intensive care units, and deaths). States Parties should integrate respiratory disease surveillance by leveraging and enhancing the Global Influenza Surveillance and Response System (GISRS). States Parties should be encouraged to 1) maintain representative testing strategies; 2) focus on early warning and trend monitoring, such as use of wastewater surveillance; 3) monitor severity in vulnerable groups; and 4) enhance genomic surveillance to detect potential new variants and monitor the evolution of SARS-COV-2. Guidance for surveillance of SARS-CoV-2 variants; WHO global genomic surveillance strategy for pathogens with pandemic and epidemic potential 2022–2032

6. MODIFIED: Ensure availability of essential health, social, and education services. States Parties should enhance access to health, including through the restoration of health services at all levels and strengthening of social systems to cope with the impacts of the pandemic, especially on children and young adults. Within this context, States Parties should maintain educational services by keeping schools fully open with in-person learning. In addition, essential health services, including COVID-19 vaccination, should be provided to migrants and other vulnerable populations as a priority. Building health systems resilience for universal health coverage and health security during the COVID-19 pandemic and beyond: WHO position paper; The State of the Global Education Crisis | UNICEF

7. MODIFIED: Lift international traffic bans and continue to adjust travel measures, based on risk assessments. The failure of travel bans introduced after the detection and reporting of Omicron variant to limit international spread of Omicron demonstrates the ineffectiveness of such measures over time. The implementation of travel measures (such as vaccination, screening, including via testing, isolation/quarantine of travelers) should be based on risk assessments and should avoid placing the financial burden on international travelers, in accordance with Article 40 of the IHR. WHO advice for international traffic in relation to the SARS-CoV-2 Omicron variant

8. MODIFIED: Do NOT require proof of vaccination against COVID-19 for international travel as the only pathway or condition permitting international travel. States Parties should consider a risk-based approach to the facilitation of international travel. Interim position paper: considerations regarding proof of COVID-19 vaccination for international travelers; Policy considerations for implementing a risk-based approach to international travel in the context of COVID-19

9. MODIFIED: Address risk communications and community engagement challenges, proactively counter misinformation and disinformation, and include communities in decision making. To re-build trust and address pandemic fatigue, States Parties should explain clearly and transparently changes to their response strategy. WHO risk communications resources

10. MODIFIED: Support timely uptake of WHO recommended therapeutics. Local production and technology transfer should be encouraged and supported as increased production capacity can contribute to global equitable access to therapeutics. States Parties should provide access to COVID-19 treatments for vulnerable populations, particularly immunosuppressed people as this can also reduce the likelihood of new variants’ emergence. Therapeutics and COVID-19: living guideline

11. MODIFIED: Conduct epidemiological investigations of SARS-CoV-2 transmission at the human-animal interface and targeted surveillance on potential animal hosts and reservoirs. Investigations at the human animal interface should use a One Health approach and involve all relevant stakeholders, including national veterinary services, wildlife authorities, public health services, and the environment sector. To faciliate international transparency, and in line with international reporting obligations, findings from joint investigations should be reported publicly. Statement from the Advisory Group on SARS-CoV-2 Evolution in Animals

SAGE April 2022 meeting highlights

11 April 2022

Departmental news

The highlights of the SAGE plenary 4-7 April 2022 meeting have been published.

The Full report will be published in the Weekly Epidemiological Record on 10.06.2022, and only the wording of the full report should be considered as final

Suspension of supply of COVID-19 vaccine (COVAXIN®)

2 April 2022

Departmental news

Today, WHO confirmed the suspension of supply of Covaxin (Bharat Biotech) through UN procurement agencies, and recommended that countries using the vaccine take action as appropriate.

The suspension is in response to the outcome of a WHO inspection on 14–22 March 2022, and the need to conduct process and facility upgrade to address recently identified deficiencies in good manufacturing practices (GMP).

Bharat Biotech has committed to addressing the GMP deficiencies and is developing a corrective and preventive action plan for submission to the Drugs Controller General of India (DCGI) and WHO. In the interim and as a precautionary measure, the company has indicated that it will suspend production of Covaxin for export. As a consequence, supply will be interrupted for the foreseeable future.

The risk assessment to date does not indicate changes in the risk–benefit ratio. The data, available to WHO, indicate the vaccine is effective and no safety concerns exist.

For continuation of vaccination with alternative sources of COVID-19 vaccines, countries should refer to the respective SAGE recommendation: Considerations for the Assessment of COVID-19 Vaccines for Listing by WHO

WHO launches guidance on digitally documenting SARS-CoV-2 test results

31 March 2022

Departmental news

On 31 March 2022, WHO published Digital Documentation of COVID-19 Certificates: Test Result technical specifications and guidance document for countries and implementing partners on the technical requirements for issuing digital certificates for SARS-CoV-2 diagnostic test result. The full guidance can be found here. This document is the second of two guidance documents on digital documentation of COVID-19 related data of interest: vaccination status and test result.

Similar to the Digital Documentation of COVID-19 Certificates: Vaccination Status Technical Specifications and Implementation Guidance document, this guidance on test results aims to guide countries and technologist in how to develop or adopt digital systems in support of verifiable proof of test results for domestic and cross-border purpose. It provides technical specifications and implementation guidance that details

interoperability standards, facilitated by a common digital architecture, for a digitized test result certificate which can be used as proof of negative test results or proof of previous SARS-CoV-2 infection for international travel, or as a means for protection policies that reduce public health risk in public or private venues – in accordance with individual Member States’ public health policy and their risk-based approach to addressing COVID-19. Additional technical details to support the adoption of open standards for interoperability and approaches for implementing a DDCC:TR solution can be found in the WHO DDCC Health Level Seven (HL7) Fast Healthcare Interoperability Resources (FHIR) implementation guide.

A SARS-CoV-2 diagnostic test result certificate can be purely digital (for example, stored in a smartphone application) and replace the need for a paper test result certificate; or it can be implemented as a digital augmentation of the traditional paper-based record. A digital certificate should never require individuals to have a smartphone or computer.

Future directions

Digital Documentation of COVID-19 Certificates’ (DDCC) specifications (for vaccination status and test results) set the foundations for secure personal health records based on the international patient summary standard. DDCC records contain the most important health and care information needed to demonstrate verifiable proof of vaccination and test results. As countries consider adopting personal health records including digital health wallets, the HL7 FHIR international patient summary standard (IPS) is at the foundation of the DDCC; serving as an expandable approach that will evolve with the needs of the individual, the public health policies, and the health system. The specifications are designed using the IPS and architected for future use, such as preparation for future pandemics.

DDCC provides an “umbrella” specification that can be used to generate multiple representations of a test result certificate or vaccination certificate. However, a global framework to enable convenient use and interoperability of these credentials between systems – while also allowing domestic autonomy over their use – does not exist and is critically needed. Under the current G20 Indonesian presidency, G20 countries are working together on a goal for a harmonized interoperable framework for COVID-19 certificates.

To enable the establishment of interoperable trust networks and allow for trusted exchange of COVID-19 certificates and other health data (e.g. routine immunization data, home-based records) consistent with IPS between systems, the WHO will convene, in collaboration with The Organization for Economic Cooperation and Development (OECD) and the Global Digital Health Partnership (GDHP), a technical consultation on interoperability between digital health trust networks for digital COVID-19 credentials. This technical consultation will inform the development of guidance and technical artifacts to address priority needs of Member States and regional networks that are implementing digital health trust networks for COVID-19. The focus of this consultation will be on the technical underpinning of trust networks, protocols for interoperability, and the health content (including core data sets and business rules).

For any additional inquiries, please contact smartvaccination@who.int.


WHO releases 10-year strategy for genomic surveillance of pathogens

One in three countries do not have the capacity to use this critical tool

30 March 2022

News release

WHO is releasing a strategy to strengthen and scale up genomic surveillance around the world.

Historically, few countries have routinely done genomic surveillance in-country, a technology considered complicated and expensive. But COVID-19 changed that.

Genomic surveillance is the process of constantly monitoring pathogens and analyzing their genetic similarities and differences. It helps researchers, epidemiologists and public health officials to monitor the evolution of infectious diseases agents, alert on the spread of pathogens, and develop counter measures like vaccines.

The Global genomic surveillance strategy for pathogens with pandemic and epidemic potential 2022–2032 is not specific to a single pathogen or disease threat. It provides a high-level unifying framework to leverage existing capacities, address barriers and strengthen the use of genomic surveillance worldwide.

Data collected by WHO show that in March 2021, 54% of countries had this capacity. By January 2022, thanks to the major investments made during the COVID-19 pandemic, the number had increased to 68%. Even greater gains were made in the public sharing of sequence data: in January 2022, 43% more countries published their sequence data compared to a year before.

Despite this fast progress, much remains to be done. Any new technology comes with the risk of increasing inequity, which is one of the gaps this strategy targets.

Various public health programmes – from Ebola to cholera – use genomic surveillance to understand a pathogen at its molecular level, but COVID-19 has highlighted the challenges of bringing genomics to scale.

The complexities of genomics and the challenges of sustaining capacities in different settings, including workforce needs, means that most countries cannot develop these capabilities on their own. The global strategy helps keep our eyes on the horizon and provides a unifying framework for action. WHO looks forward to working with countries and partners in this important and highly dynamic field.

- Dr Tedros Adhanom Ghebreyesus

WHO Director-General

“The complexities of genomics and the challenges of sustaining capacities in different settings, including workforce needs, means that most countries cannot develop these capabilities on their own. The global strategy helps keep our eyes on the horizon and provides a unifying framework for action. WHO looks forward to working with countries and partners in this important and highly dynamic field,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “We will do best if we work together.”

The COVID-19 pandemic has shown that health systems need genomic surveillance so that risks are rapidly detected and addressed. This technology has been critical in this response, from the identification of a novel coronavirus, to the development of the first diagnostic tests and vaccines, to the tracking and identification of new virus variants.

“Genomic surveillance is critical for stronger pandemic and epidemic preparedness and response,” said Dr Michael Ryan, Executive Director, WHO Health Emergencies Programme. “This pandemic has laid bare the fact that we live in an interconnected world and that we are only as strong as our weakest link. Improving global disease surveillance means improving local disease surveillance. That is where we need to act, and this strategy will provide us with the foundation.”

Read more about the strategy here.

Interim Statement on COVID-19 vaccines in the context of the circulation of the Omicron SARS-CoV-2 Variant from the WHO Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC)

8 March 2022

Key messages:

The TAG-CO-VAC is reviewing available data to optimize vaccine mediated protection against prevalent circulating variants. The TAG-CO-VAC strongly supports urgent and broad access to current COVID-19 vaccines for primary series and booster doses, particularly for groups at risk of developing severe disease, given that current COVID-19 vaccines continue to provide high levels of protection against severe disease and death, even in the context of the circulation of Omicron.

However, to ensure COVID-19 vaccines provide optimal protection into the future, they may need to be updated as new, antigenically distinct variants emerge. The updated vaccines may be monovalent targeting the predominant circulating variant, or multivalent based on different variants.

Ideally, COVID-19 vaccines will prevent infection and transmission, in addition to providing protection against severe disease and death. The development of pan SARS-CoV-2 or pansarbecovirus vaccines, as well as the development of vaccines that are able to elicit mucosal immunity, may be desirable options, but the timeframe for their development and production is uncertain.

The TAG-CO-VAC continues to encourage COVID-19 vaccine manufacturers to generate and provide data to WHO on performance of current and variant-specific COVID-19 vaccines so that they can be considered as part of a broad decision-making framework on COVID-19 vaccine composition, allowing the TAG-CO-VAC to issue more specific advice to WHO on adjustments needed to COVID-19 vaccine strain composition.

The World Health Organization, with the support of the Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC), continues to review and assess the public health implications of emerging SARS-CoV-2 Variants of Concern (VOC) on the performance of COVID-19 vaccines. Since the publication of the interim statement on COVID-19 vaccines on 11 January 2022, Omicron has become the dominant VOC globally, rapidly replacing other circulating variants. This statement highlights the global epidemiological situation, challenges of updating vaccine composition and provides the current position of the TAG-CO-VAC.

Epidemiological situation

The current global epidemiological situation is characterized by rapid and relatively synchronous dominance of Omicron variant in all six WHO regions. While global cases are declining, there are reduced testing resources and capacities in some areas and the epidemiological situation remains heterogeneous, with a number of regions and countries reporting increases in new weekly cases, while others are now reporting declines.

Omicron is comprised of several genetically related sublineages, including BA.1, BA.2 and BA.3, each of which is being monitored by WHO and partners. At a global level, BA.1 has been the predominant Omicron lineage, however, the proportion of reported sequences designated as BA.2 has been increasing relative to BA.1 in recent weeks, and is the predominant Omicron lineage in several countries. BA.1 and BA.2 have some genetic differences, which may make them antigenically distinct. Reinfection with BA.2 following infection with BA.1 has been documented, however, initial data from population-level studies suggest that infection with BA.1 provides substantial protection against reinfection with BA.2, at least for the limited period for which data are available. For more details on the Omicron sublineages, please refer to the statement by WHO on the Omicron sublineage BA.2 , published on 22 February 2022.

Updating current COVID-19 vaccines

The public health goal of COVID-19 vaccination prioritizes protection against severe disease and death. Current vaccines appear to confer high levels of protection against severe disease outcomes associated with Omicron infection. The TAG-CO-VAC therefore strongly supports urgent and broad access to current COVID-19 vaccines for primary series and booster doses, particularly for groups at risk of developing severe disease. The near- and medium-term supply of the available vaccines has increased substantially, however, vaccine equity remains an important challenge and all efforts to address such inequities are strongly encouraged.

The first interim statement from the TAG-CO-VAC highlighted the need for the development of vaccines that provide protection against infection and prevent transmission, in addition to the protection from severe disease and death, as a means to achieve a greater public health impact from COVID-19 vaccination. In this context, vaccines that are able to elicit mucosal immunity, in addition to systemic immunity, are an important goal. One of the options proposed in the first statement was the development of pan SARS-CoV-2 or pansarbecovirus vaccines. Such vaccines would provide protection that would effectively be variant-proof, and work in this area should be accelerated.

Current vaccines are based on the virus that circulated early in the pandemic (ancestral virus e.g. GISAID: hCoV-19/Wuhan/WIV04/2019). Since then, there has been continuous and substantial virus evolution and it is likely that this evolution will continue, resulting in the emergence of new variants. The composition of current COVID-19 vaccines may therefore need to be updated. Any update to current COVID-19 vaccine composition would aim to, at a minimum, retain protection against severe disease and death, while ensuring the breadth of the immune response against circulating and emerging variants, which may be antigenically distinct.

The TAG-CO-VAC considered a number of issues, all of which are important in any decision on COVID-19 vaccine composition:

There are heterogeneous levels of population immunity between countries due to different waves of VOCs and different types, levels and timing of vaccination, but robust data on the global immunologic landscape are limited. The performance of any updated vaccine(s) may vary depending on the nature and magnitude of previously acquired immunity.

When updated vaccines become available, a substantial proportion of the global population will have been exposed to SARS-CoV-2, either as a result of vaccination and/or prior infection. As above, the performance of any updated vaccine(s) may vary depending on the nature and magnitude of previously acquired immunity.

There are also considerable uncertainties as to how the virus will continue to evolve and the antigenic characteristics of future variants. Given widespread transmission of Omicron globally, the possibility of its continued evolution is high and a new variant may emerge before an updated vaccine can be produced and delivered at scale.

WHO is tracking lineages under the ‘umbrella’ of Omicron, including BA.1 and BA.2. Though data are emerging, additional antigenic and virologic characterization of these lineages is needed both independently and in comparison, to the other lineages.

While the body of evidence on the immune response to Omicron following infection is rapidly growing, data on breadth, magnitude, and durability of humoral and cell-mediated immune responses to variants from variant-specific candidate vaccines using different vaccine platforms remain limited.

In addition to the current COVID-19 vaccines, there are many other COVID-19 vaccines in various stages of clinical and preclinical development. Any decision from the TAG-CO-VAC on COVID-19 vaccine composition would apply primarily to current COVID-19 vaccines.

Position of the TAG-CO-VAC

The TAG-CO-VAC welcomes, where feasible, the development and initiation of clinical trials on variant-specific candidate vaccines against WHO-designated VOCs, including Omicron. In this context, the TAG-CO-VAC is seeking evidence of robust homologous immune responses in primed and unprimed individuals and cross-reactivity data in primed individuals. The TAG-CO-VAC encourages collection of data following one and two doses of any modified vaccine across a variety of relevant vaccine platforms.

The TAG-CO-VAC continues to encourage COVID-19 vaccine manufacturers to generate and provide data to WHO on the performance of current and variant-specific candidate COVID-19 vaccines, including the breadth, magnitude, and durability of humoral and cell-mediated immune responses to variants through monovalent and/or multivalent vaccines. The TAG-CO-VAC will carefully consider these data as part of a broader decision-making framework on COVID-19 vaccine composition, allowing the TAG-CO-VAC to issue more specific advice on any adjustments that may be needed to COVID-19 vaccine strain composition, developed either as a monovalent vaccine targeting the predominant circulating variant(s) or a multivalent vaccine derived from different variants.

The TAG-CO-VAC recognizes the independent role and procedures of relevant regulatory authorities in establishing the necessary requirements for evaluation under the currently established regulatory pathways, and the role of WHO in ensuring alignment, collaboration and a continuous exchange of information between WHO and its expert groups, the TAG-CO-VAC, regulatory authorities, and COVID-19 vaccine manufacturers.

The statement reflects the current vaccine performance and landscape of vaccine development. The statement will therefore be updated as data become available.

Joint statement on the prioritization of monitoring SARS-CoV-2 infection in wildlife and preventing the formation of animal reservoirs

By Food and Agriculture Organization (FAO), World Organisation for Animal Health (OIE) and World Health Organization (WHO)

7 March 2022

As we enter the third year of the pandemic, SARS-CoV-2, the virus that causes COVID-19, is spreading between people at an intense level globally. There are many factors that are driving transmission. One of these is the emergence of highly transmissible variants of concern, the latest being Omicron. The virus continues to evolve and the risk of future emergence of variants is high.

Although the COVID-19 pandemic is driven by human-to-human transmission, the SARS-CoV-2 virus is also known to infect animal species. Current knowledge indicates that wildlife does not play a significant role in the spread of SARS-CoV-2 in humans, but spread in animal populations can affect the health of these populations and may facilitate the emergence of new virus variants.

In addition to domestic animals, free-ranging, captive or farmed wild animals such as big cats, minks, ferrets, North American white-tailed deer and great apes have thus far been observed to be infected with SARS-CoV-2. To date, farmed mink and pet hamsters have been shown to be capable of infecting humans with the SARS-CoV-2 virus and a potential case of transmission between white-tailed deer and a human is currently under review.

The introduction of SARS-CoV-2 to wildlife could result in the establishment of animal reservoirs. For example, it has been reported that, approximately one-third of wild white-tailed deer in the United States of America have been infected with SARS-CoV-2, initially via several human-to-deer transmission events. The SARS-CoV-2 lineages detected in white-tailed deer have also been circulating in close-by human populations. White-tailed deer have been shown to shed virus and transmit it between each other.

FAO, OIE and WHO call on all countries to take steps to reduce the risk of SARS-CoV-2 transmission between humans and wildlife with the aim of reducing the risk of variant emergence and for protecting both humans and wildlife. We urge authorities to adopt relevant regulations and disseminate previously released recommendations by FAO, OIE and WHO to (1) people working in close contact with or handling wildlife, including hunters and butchers; and (2) the public.

Personnel working closely with wildlife should be trained to implement measures that reduce the risk of transmission between people and between people and animals, using WHO advice on how to protect oneself and prevent the spread of COVID-19, and OIE and FAO guidelines on the use of personal protective equipment (PPE) and good hygiene practices around animals, including good hygiene practices for hunters and butchers.

Current evidence suggests that humans are not infected with the SARS-CoV-2 virus by eating meat. However, hunters should not track animals that appear sick or harvest those that are found dead. Appropriate butchering and food preparing techniques, including proper hygiene practices, can limit transmission of coronaviruses, including SARS-CoV-2, and other zoonotic pathogens.

FAO, OIE and WHO stress that the public should be educated about contact with wildlife. Some wild animals may come close to human settlements and residential areas. As a general precaution, people should not approach or feed wild animals or touch or eat those that are orphaned, sick or found dead (including road kills). Instead, they should contact local wildlife authorities or a wildlife health professional.

It is also crucial to safely dispose of uneaten food, masks, tissues, and any other human waste to avoid attracting wildlife, especially to urban areas and, if possible, keep domestic animals away from wildlife and their droppings.

We furthermore encourage countries’ national animal and human health services to adopt the following measures:

Encourage collaboration between national veterinary services and national wildlife authorities, whose partnership is key to promoting animal health and safeguarding human and environmental health.

Promote monitoring of wildlife and encourage sampling of wild animals known to be potentially susceptible to SARS-CoV-2.

Share all genetic sequence data from animal surveillance studies through publicly available databases.

Report confirmed animal cases of SARS-CoV-2 to the OIE through the World Animal Health Information System (OIE-WAHIS).

Craft messages about SARS-CoV-2 in animals with care so that inaccurate public perceptions do not negatively impact conservation efforts. No animal found to be infected with SARS-CoV-2 should be abandoned, rejected, or killed without providing justification from a country- or event-specific risk assessment.

Suspend the sale of captured live wild mammals in food markets as an emergency measure.

Our organizations emphasize the importance of monitoring mammalian wildlife populations for SARS-CoV-2 infection, reporting results to National Veterinary Services (who report these findings to the OIE) and sharing genomic sequencing data on publicly available databases. Countries should also adopt precautions to reduce the risk of establishment of animal reservoirs and potential acceleration of virus evolution in novel hosts, which could lead to the emergence of new SARS-CoV-2 variants. Such measures will preserve the health of precious wildlife as well as humans.

We invite governments and other stakeholders to bring the contents of this joint statement to the attention of competent authorities and all parties concerned.

Eighth Meeting of the Multilateral Leaders Task Force on COVID-19, 1 March 2022: "Third Consultation with the CEOs of leading vaccine manufacturers"

7 March 2022

The heads of the International Monetary Fund, World Bank Group, World Health Organization, and World Trade Organization held high-level consultations with UNICEF, Gavi, the Vaccine Alliance, the Global Lead Coordinator for the COVID-19 Vaccine Country Readiness and Delivery and the CEOs of leading vaccine manufacturers on 1 March 2022 aimed at ensuring the rapid delivery of vaccines to where they are needed the most and putting those vaccines into arms.

The Multilateral Leaders Task Force issued the following statement:

"In the past few months, we have seen unprecedented levels of disease transmission across the world due to the Omicron variant. Still, unequal access to COVID-19 vaccines, tests and treatments is rampant, prolonging the pandemic. 23 countries are yet to fully vaccinate 10% of their populations, 73 countries are yet to achieve 40% coverage and many more are projected to miss the 70% target by middle of this year.

The biggest challenges are in low-income countries (LICs), which are concentrated in Africa. Only 7% of people in LICs have been fully vaccinated, compared with 73% in high-income countries. Safeguarding the health of people living in the world’s poorest countries in the face of a changing pandemic is a key priority. We must and can ensure that these countries have the access, the means, and the capacity to vaccinate their populations, especially those who are most at risk.

Despite the challenges, there has been progress. The vaccine supply constraints from last year have eased, and export restrictions are not currently an issue. Our efforts must now focus on supporting countries to increase vaccination rates. There is no "one-size-fits-all" approach as each country faces different political, administrative, and capacity challenges.

Insufficient health care infrastructure, including warehouses, cold chain capacity; lack of trained vaccinators; complexities associated with the management of multiple vaccines; lack of data systems to support vaccination campaigns; and misinformation and vaccine hesitancy are common hurdles that governments must confront. But we have good lessons to draw on from countries around the world that have managed to overcome obstacles and rollout vaccination campaigns, including from low-income countries.

Sustained investment in geographically diversified manufacturing capacity and new technologies for vaccines, therapeutics, and diagnostics is key for ensuring more equitable, affordable, and timely access to tools for developing countries. In this context, we welcome the work of the leading vaccine manufacturers in exploring and undertaking new partnerships and call for them to work closely with international organizations (IOs) and countries to capitalize on practical solutions, sharing licenses, technology and know-how.

A top priority to end the pandemic is deploying financing quickly to accelerate the development, production, and equitable access to COVID-19 tests, treatments and vaccines in low- and middle-income countries. Fully funding the Access to COVID-19 Tools (ACT) Accelerator is critical.

As vaccine supply increases in 2022, close coordination among all stakeholders will be crucial to aligning supply with demand, reducing supply fragmentation, and deploying vaccines in the most effective way. We must adjust to constantly evolving challenges and keep working together. As the late Dr Paul Farmer said: "Any time there's a new tool developed – whether they are vaccines or therapeutics – there must also be a delivery plan."

Let us acknowledge the importance of delivery, as this is where lives are saved, families are kept whole, children continue their education, communities stay strong, and economies grow."

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About the Multilateral Leaders Task Force

This joint initiative of the International Monetary Fund, World Bank Group, World Health Organization, and World Trade Organization aims to support the roll out of COVID-19 tools by leveraging multilateral finance and trade solutions, particularly for low and middle-income countries. It supports the goals of the ACT-Accelerator and complementary initiatives in the delivery of COVID-19 diagnostics, vaccines, therapeutics, and PPE.

WHO and MPP welcome NIH’s offer of COVID-19 health technologies to C-TAP

3 March 2022


The World Health Organization (WHO) and the Medicines Patent Pool (MPP) jointly welcome the announcement that the United States National Institutes of Health (NIH) will offer several technologies to the COVID-19 Technology Access Pool (C-TAP) for potential licensing through MPP. The announcement was made today at the U.S. COVID-19 Dialogue with Ministers of Health meeting in the presence of WHO Director-General, Dr Tedros Adhanom Ghebreyesus, and NIAID Director and Chief Medical Advisor to the President of United States, Anthony Fauci.

“I thank NIH for its offer of innovative therapeutics, vaccines and diagnostic methods for COVID-19,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus. “Voluntary sharing of technologies through non-exclusive agreements will not only help us put the pandemic behind us; it will also empower low- and middle-income countries to produce their own medical products and achieve equitable access.”

“NIH were the first to share their patents with MPP for an HIV product back in 2010 when we were created,” said Charles Gore, MPP Executive Director. “We will be honoured to sign public health-driven transparent non-exclusive licence agreements with NIH under the auspices of C-TAP when the negotiations have concluded, with the goal to provide access of these innovative technologies to people in need around the world and help put an end to the pandemic.”

Launched in 2020 by the WHO Director-General and the President of Costa Rica, and supported by 43 Member States, C-TAP aims to facilitate timely, equitable and affordable access to COVID-19 health products by boosting their production and supply through open, non-exclusive licensing agreements. MPP provides the licensing expertise to this initiative and holds the licences.

Ukraine due to crisis, warn WHO Director-General and WHO Regional Director for Europe

Dr Tedros Adhanom Ghebreyesus and Dr Hans Henri P. Kluge call for critical medical supplies to safely reach those who need them, and are working with partners to establish safe transit for shipments through Poland

27 February 2022

During the crisis in Ukraine, health must remain a priority pillar of the humanitarian response, with health systems and facilities remaining protected, functional, safe and accessible to all who need essential medical services, and health workers protected so they can continue to save lives.

This must include the safe and reliable provision of essential medical supplies, including life-saving medicinal oxygen supplies, which are crucial for patients with a range of conditions, including those with COVID-19 (which number 1700 in hospital now), and those with other critical illnesses (from neonates to older persons) stemming from complications of pregnancy, childbirth, chronic conditions, sepsis, and injuries and trauma.

The oxygen supply situation is nearing a very dangerous point in Ukraine. Trucks are unable to transport oxygen supplies from plants to hospitals across the country, including the capital Kyiv. The majority of hospitals could exhaust their oxygen reserves within the next 24 hours. Some have already run out. This puts thousands of lives at risk.

Further, medical oxygen generator manufacturers in several areas are also facing shortages of zeolite, a crucial, mainly imported chemical product necessary to produce safe medical oxygen. Safe deliveries of zeolite from outside Ukraine to these plants is also needed.

Compounding the risk to patients, critical hospital services are also being jeopardized by electricity and power shortages, and ambulances transporting patients are in danger of getting caught in the crossfire.

In recent years, with WHO support, Ukraine had made significant strides in strengthening its health systems under an ambitious health reform programme. This included the rapid scale-up of oxygen therapy capacity for severely ill patients during the COVID-19 pandemic. Of the over 600 health facilities nationwide assessed by WHO during the pandemic, close to half were directly supported with supplies, technical know-how and infrastructure investments, enabling health authorities to save tens of thousands of lives.

This progress is now at risk of being derailed during the current crisis.

WHO is helping health authorities identify the country’s immediate oxygen supply surge needs, assuming a 20–25% increase over previous needs before the crisis escalated last week.

Despite the challenges posed by the current situation, WHO is working to ensure a supply of oxygen-related medical devices and trauma treatment supplies.

To achieve this, WHO is actively looking at solutions to increase supplies that likely would include the importation of oxygen (liquid and cylinders) from regional networks. These supplies would need safe transit, including via a logistics corridor through Poland. It is imperative to ensure that lifesaving medical supplies – including oxygen – reach those who need them.

WHO Director-General: Deeply concerned over escalating health crisis in Ukraine

WHO releases emergency funds to purchase desperately needed medical supplies

24 February 2022

The World Health Organization (WHO) is deeply concerned for the health of the people of Ukraine in the escalating crisis. The health system must continue to function to deliver essential care to people for all health issues, from COVID-19 to cancer, diabetes and tuberculosis, to mental health issues, especially for vulnerable groups such as older persons and migrants.

Maximum care must be taken by all parties to ensure that health facilities, workers, patients, transport, and supplies are not targeted. As part of WHO’s role to document attacks on health, we will continue to monitor and report such incidents.

I also call for sustained and safe access for the delivery of humanitarian assistance.

WHO has for decades worked closely with health authorities across Ukraine. We have a deep knowledge of the capacities and needs of the country’s health system.

Today I released a further US$3.5 million from WHO’s Contingency Fund for Emergencies (CFE) to purchase and deliver urgent medical supplies. This humanitarian health support is expected to rise following further needs assessments. This new support complements the trauma and medical supplies which we prepositioned in health facilities.

We will continue to deliver care and support the people across Ukraine affected by this crisis.

Statement on Omicron sublineage BA.2

22 February 2022

As part of its on-going work to track variants, WHO's Technical Advisory Group on SARS-CoV-2 Virus Evolution (TAG-VE) met yesterday to discuss the latest evidence on the Omicron variant of concern, including its sublineages BA.1 and BA.2.

Based on available data of transmission, severity, reinfection, diagnostics, therapeutics and impacts of vaccines, the group reinforced that the BA.2 sublineage should continue to be considered a variant of concern and that it should remain classified as Omicron. The group emphasized that BA.2 should continue to be monitored as a distinct sublineage of Omicron by public health authorities.

The Omicron variant of concern is currently the dominant variant circulating globally, accounting for nearly all sequences reported to GISAID. Omicron is made up of several sublineages, each of them being monitored by WHO and partners. Of them, the most common ones are BA.1, BA.1.1 (or Nextstrain clade 21K) and BA.2 (or Nextstrain clade 21L). At a global level, the proportion of reported sequences designated BA.2 has been increasing relative to BA.1 in recent weeks, however the global circulation of all variants is reportedly declining.

BA.2 differs from BA.1 in its genetic sequence, including some amino acid differences in the spike protein and other proteins. Studies have shown that BA.2 has a growth advantage over BA.1. Studies are ongoing to understand the reasons for this growth advantage, but initial data suggest that BA.2 appears inherently more transmissible than BA.1, which currently remains the most common Omicron sublineage reported. This difference in transmissibility appears to be much smaller than, for example, the difference between BA.1 and Delta. Further, although BA.2 sequences are increasing in proportion relative to other Omicron sublineages (BA.1 and BA.1.1), there is still a reported decline in overall cases globally.

Studies are evaluating the risk of reinfection with BA.2 compared to BA.1. Reinfection with BA.2 following infection with BA.1 has been documented, however, initial data from population-level reinfection studies suggest that infection with BA.1 provides strong protection against reinfection with BA.2, at least for the limited period for which data are available.

While reaching the above determination, the TAG-VE also looked at preliminary laboratory data from Japan generated using animal models without any immunity to SARS-CoV-2 which highlighted that BA.2 may cause more severe disease in hamsters compared to BA.1. They also considered real-world data on clinical severity from South Africa, the United Kingdom, and Denmark, where immunity from vaccination or natural infection is high: in this data, there was no reported difference in severity between BA.2 and BA.1.

WHO will continue to closely monitor the BA.2 lineage as part of Omicron and requests countries to continue to be vigilant, to monitor and report sequences, as well as to conduct independent and comparative analyses of the different Omicron sublineages.

The TAG-VE meets regularly and continues to discuss available data on transmissibility and severity of variants, and their impact on diagnostics, therapeutics, and vaccines.