On 5 April 2023, the National IHR Focal Point for the United Kingdom informed WHO of an increase in severe myocarditis in neonates and infants associated with enterovirus infection in Wales compared with 2021. Between June 2022 and March 2023, 15 neonates and young infants presented with a picture consistent with neonatal sepsis in Wales and Southwest England. Enterovirus Polymerase Chain Reaction (PCR) testing of nine cases confirmed the presence of either coxsackie B3 or coxsackie B4. As of 20 April 2023, three patients were hospitalized, four patients were being managed as outpatients and two had died.
Although enterovirus infections are common in neonates and young infants, the reported increase in myocarditis with severe outcomes in neonates and infants associated with enterovirus infection is unusual.
Link: https://www.who.int/emergencies/disease-outbreak-news/item/2023-DON465
On 5 April 2023, the National IHR Focal Point for the United Kingdom informed WHO of an increase in severe myocarditis in neonates and infants associated with enterovirus infection in Wales compared with 2021.
Between June 2022 and March 2023, a total of 15 neonates and young infants, aged up to 28 days, presented with a picture consistent with neonatal sepsis from two regions of the United Kingdom: South Wales (10 cases) and Southwest England (five cases). Eight cases were treated in intensive care, and one case died before transfer to tertiary care. Further details on the remaining six cases which were identified through retrospective and prospective case finding are pending. In all cases alive at presentation, myocarditis was a presenting feature. The peak incidence of cases was in November 2022 (five cases), with sporadic cases in other months.
Enterovirus PCR testing of the nine cases that presented at the hospital (with either throat swab, nose swab, nasopharyngeal aspirate or cerebrospinal fluid samples) confirmed the presence of an enterovirus, subtyping to either coxsackie B3 or coxsackie B4. Critical care support including intubation, ventilation and circulatory support was given to the eight patients who went to intensive care.
As of 20 April 2023, three patients were hospitalized, four patients were being managed as outpatients and two had died.
Reported increase in severe myocarditis in neonates and infants associated with enterovirus infection is unusual. In the same hospital (covering the South Wales region) over the previous six years, only one other similar case has been identified.
Myocarditis is an inflammation of the heart muscle (myocardium). The most common cause of myocarditis is a viral infection (e.g., Enteroviruses), but it can also be caused by a bacterial infection, a reaction to a drug, or an autoimmune disease. Myocarditis symptoms include acute and persistent chest pain, shortness of breath, and heart palpitations (racing or pounding heartbeat).
Enteroviruses can cause a number of infectious illnesses and are responsible for annual epidemics. These are usually mild but have been found to affect neonates differently, and often more severely, than older children. There are multiple transmission routes, particularly in the neonatal period. The reported incident represents an increase in both the number and severity of enterovirus (coxsackieviruses) infections in infants under the age of one month. There is increased morbidity and mortality associated with the current incident.
On 28 February 2023, pediatricians in the South Wales region were alerted about the recent cases, with advice to consider myocarditis in infants and neonates presenting with shock.
A nationwide Incident Management Team (IMT) was set up and is reviewing the evidence from all English Regions and United Kingdom countries to determine the next steps for the response. Epidemiological investigations are ongoing.
Following the IMT meeting on 28 April 2023, the United Kingdom authorities have raised awareness of the enterovirus cluster among healthcare practitioners and to test for enteroviruses in suspected cases. Hospital laboratories have been reminded to submit positive enterovirus samples to the national reference laboratory for viral characterization and typing. Clinicians and hospital laboratories have been asked to report suspected cases of neonatal enterovirus myocarditis identified since 1 June 2022 to the United Kingdom Health Security Agency.
Public Health Wales published a written statement on 3 May 2023 regarding this event to further notify the public and healthcare practitioners.
According to the United Kingdom Health Security Agency, a review of past data from the previous six years from the same tertiary care centre in Wales has identified only one similar case in 2021 (which may or may not be linked to the current incident) and no further cases which match this clinical picture.
Preliminary investigations from the national United Kingdom IMT have not identified any other clusters in any other region beyond those in South Wales and Southwest England in the United Kingdom in the past 12 months.
Based on the limited information available at this point, WHO assesses the public health risk as low. However, asymptomatic carriage and shedding of infectious virus is a feature of enterovirus infection and there was little evidence in this case series of maternal infection prior to or during delivery. As enterovirus infection is often not among the notifiable diseases in Member States, additional cases of severe, neonatal enterovirus infections might have gone undiagnosed and/or unreported elsewhere.
Non-polio enteroviruses are common and distributed worldwide. Although infections often are asymptomatic, others present with mild to moderate respiratory tract infections. Symptoms include fever, runny nose and body weakness. These viruses are also associated with occasional outbreaks in which an unusually high proportion of patients develop clinical disease, sometimes with serious and fatal consequences – in this instance myocarditis. Clinicians seeing infants and neonates presenting with shock may consider a diagnosis of myocarditis and consider testing for enteroviruses.
No specific antiviral therapy is available, and treatment focuses on prevention of complications. As there is no vaccine for this virus, control measures during outbreaks are focused on classical hygiene measures including frequent handwashing and disinfection of soiled clothing and surfaces. In certain situations, it may be advisable to close child-care facilities and schools to reduce the intensity of transmission.
WHO does not recommend any travel and/or trade restrictions to the United Kingdom based on the information available for this event.
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.
The World Health Organization (WHO) has released a new guideline on non-sugar sweeteners (NSS), which recommends against the use of NSS to control body weight or reduce the risk of noncommunicable diseases (NCDs).
The recommendation is based on the findings of a systematic review of the available evidence which suggests that use of NSS does not confer any long-term benefit in reducing body fat in adults or children. Results of the review also suggest that there may be potential undesirable effects from long-term use of NSS, such as an increased risk of type 2 diabetes, cardiovascular diseases, and mortality in adults.
"Replacing free sugars with NSS does not help with weight control in the long term. People need to consider other ways to reduce free sugars intake, such as consuming food with naturally occurring sugars, like fruit, or unsweetened food and beverages,” says Francesco Branca, WHO Director for Nutrition and Food Safety. "NSS are not essential dietary factors and have no nutritional value. People should reduce the sweetness of the diet altogether, starting early in life, to improve their health."
The recommendation applies to all people except individuals with pre-existing diabetes and includes all synthetic and naturally occurring or modified non-nutritive sweeteners that are not classified as sugars found in manufactured foods and beverages, or sold on their own to be added to foods and beverages by consumers. Common NSS include acesulfame K, aspartame, advantame, cyclamates, neotame, saccharin, sucralose, stevia and stevia derivatives.
The recommendation does not apply to personal care and hygiene products containing NSS, such as toothpaste, skin cream, and medications, or to low-calorie sugars and sugar alcohols (polyols), which are sugars or sugar derivatives containing calories and are therefore not considered NSS.
Because the link observed in the evidence between NSS and disease outcomes might be confounded by baseline characteristics of study participants and complicated patterns of NSS use, the recommendation has been assessed as conditional, following WHO processes for developing guidelines. This signals that policy decisions based on this recommendation may require substantive discussion in specific country contexts, linked for example to the extent of consumption in different age groups.
The WHO guideline on NSS is part of a suite of existing and forthcoming guidelines on healthy diets that aim to establish lifelong healthy eating habits, improve dietary quality and decrease the risk of NCDs worldwide.
The World Health Organization provides global leadership in public health within the United Nations system. Founded in 1948, WHO works with 194 Member States, across six regions and from more than 150 offices, to promote health, keep the world safe and serve the vulnerable. Our goal for 2019-2023 is to ensure that a billion more people have universal health coverage, to protect a billion more people from health emergencies, and provide a further billion people with better health and wellbeing.
WHO’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 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.
Once approved, Columvi will be the first CD20xCD3 T-cell-engaging bispecific antibody available to treat people in Europe with this aggressive lymphoma
The recommendation is based on results from the phase I/II NP30179 study, where Columvi given as a fixed course induced early and long-lasting complete responses in people with heavily pre-treated or refractory diffuse large B-cell lymphoma
Columvi is part of Roche’s industry-leading CD20xCD3 T-cell-engaging bispecific development programme, which aims to transform the treatment experience for people with blood cancers using off-the-shelf and fixed-duration options
Basel, 26 April 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Columvi® (glofitamab), for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Columvi has the potential to change the current standard of care in DLBCL. As well as inducing early and long-lasting responses in people with heavily pre-treated or refractory DLBCL, potentially allowing patients a treatment free period, Columvi is designed to be given for a fixed period of time so that people know when their treatment will end. It is also an off-the-shelf therapy, meaning that people do not have to wait for cell collection and genetic engineering before starting treatment, which could be particularly important for patients who are at a high-risk of their disease progressing. A final decision is expected from the European Commission (EC) in the near future.
“New therapeutic options that are readily and broadly available are urgently needed for people with relapsing diffuse large B-cell lymphoma, which can become fatal without immediate treatment,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “The CHMP’s recommendation for Columvi brings us closer to providing a new, fixed-duration therapy for people with diffuse large B-cell lymphoma that induces early and long-lasting responses.”
DLBCL is an aggressive (fast-growing) type of lymphoma and is one of the most prevalent types of blood cancer among adults.2 Each year in Europe, an estimated 36,000 people are diagnosed with DLBCL.3 While many people with DLBCL are responsive to initial treatment, four out of ten are not cured with the current frontline standard of care, and the majority of those who require subsequent lines of therapy have poor outcomes.4,5 Once approved, fixed-duration Columvi will be the first CD20xCD3 T-cell-engaging bispecific antibody available to treat people in Europe with this aggressive type of lymphoma following multiple prior lines of therapy.
The CHMP recommendation is based on positive results from a pivotal cohort in the phase I/II NP30179 study, where Columvi given as a fixed-course induced early and long-lasting responses in people with R/R DLBCL. Overall, 83.3% of patients were refractory to their most recent therapy, 90% were refractory to any previous line of therapy, and about one-third (35.2%) had received prior CAR T-cell therapy. Results showed that Columvi given as a fixed course induced a complete response (CR; a disappearance of all signs of cancer) in 35.2% (n =38/108) of people and 50% (n=54/108) achieved an overall response (OR; the combination of CR and partial response, a decrease in the amount of cancer in their body). Among those who achieved a CR, 74.6% (95% CI: 59.19-89.93) continued to experience a response at 12 months, while the median duration of CR was not reached. The median follow-up for duration of response (DOR) was 12.8 months. Median time to first CR was 42 days (95% CI: 41-47). The most common adverse events (AEs) were cytokine release syndrome (CRS; 64.3%), neutropenia (a reduction in white blood cells [37.7%]), anaemia (30.5%) and thrombocytopenia (low blood platelet count [24.7%]). CRS was generally low grade (Grade 1: 48.1%; Grade 2: 12.3%). One patient discontinued treatment due to CRS.1
Additional data from a larger cohort in the NP30179 study, published in the New England Journal of Medicine, reinforce the durability of Columvi. Fixed-duration Columvi resulted in early and long-lasting responses in people with heavily pre-treated or refractory DLBCL, with 39.4% of patients (n=61/155) achieving a CR and a median DOR of 18.4 months. Median time to first CR was 42 days (95% CI: 42-44), with the majority of responses reported at the first scheduled response assessment (approximately 1.4 months after the start of treatment). Half of patients (51.6%; n=80/155) achieved an OR. The most common AE was CRS, which was generally low grade (Grade 1: 47.4%; Grade 2: 11.7%) and occurred at initial doses. Columvi-related AEs leading to treatment discontinuation occurred in 3.2% of patients.6
Columvi was recently approved by Health Canada for the treatment of adult patients with R/R DLBCL not otherwise specified, DLBCL arising from follicular lymphoma, or primary mediastinal B-cell lymphoma, who have received two or more lines of systemic therapy and are ineligible to receive or cannot receive CAR T-cell therapy or have previously received CAR T-cell therapy. Additionally, the U.S. Food and Drug Administration (FDA) accepted Genentech’s Biologics License Application and granted priority review for glofitamab for the treatment of people with R/R large B-cell lymphoma. The U.S. FDA is expected to make a decision on approval by 1 July 2023. Submissions to additional health authorities worldwide are ongoing.
Columvi is part of Roche’s broad and industry-leading CD20xCD3 T-cell-engaging bispecific antibody clinical development programme. Roche’s portfolio also includes Lunsumio® (mosunetuzumab), which was granted accelerated approval by the U.S. FDA in December 2022 and conditional marketing authorisation by the EC in June 2022 for the treatment of adult patients with R/R follicular lymphoma after two or more lines of systemic therapy.
In an effort to help more patients in need of new treatment options, Roche continues to expand Columvi’s clinical development programme, which includes the phase III STARGLO trial, evaluating Columvi in combination with gemcitabine and oxaliplatin (GemOx) versus rituximab in combination with GemOx in people with second-line plus DLBCL who are ineligible for autologous stem cell transplant. Additional phase III studies are also planned, including in first-line DLBCL.
Columvi is an investigational CD20xCD3 T-cell-engaging bispecific antibody designed to target CD3 on the surface of T-cells and CD20 on the surface of B-cells. Columvi was designed with a novel 2:1 structural format. This T-cell-engaging bispecific antibody is engineered to have one region that binds to CD3, a protein on T-cells, a type of immune cell, and two regions that bind to CD20, a protein on B-cells, which can be healthy or malignant. This dual-targeting brings the T-cell in close proximity to the B-cell, activating the release of cancer cell-killing proteins from the T-cell. A robust clinical development programme for Columvi is ongoing, investigating the molecule as a monotherapy and in combination with other medicines for the treatment of people with B-cell non-Hodgkin lymphomas, including diffuse large B-cell lymphoma and other blood cancers.
The NP30179 study [NCT03075696] is a phase I/II, multicentre, open-label, dose-escalation and expansion study evaluating the safety, efficacy and pharmacokinetics of Columvi® (glofitamab) in people with relapsed or refractory diffuse large B-cell lymphoma. Outcome measures include complete response rate by an independent review committee (primary endpoint), overall response rate, duration of response, progression-free survival, safety, and tolerability (secondary endpoints).
DLBCL is the most common form of non-Hodgkin lymphoma (NHL), accounting for about one in three cases of NHL. DLBCL is an aggressive (fast-growing) type of NHL.2 While it is generally responsive to treatment in the frontline, as many as 40% of people will relapse or have refractory disease, at which time salvage therapy options are limited and survival is short.4,5 Each year in Europe, it is estimated that 36,000 people are diagnosed with DLBCL.
Roche has been developing medicines for people with malignant and non-malignant blood diseases for more than 20 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, Hemlibra® (emicizumab), Lunsumio® (mosunetuzumab) and Columvi® (glofitamab). Our pipeline of investigational haematology medicines includes a T-cell-engaging bispecific antibody cevostamab, targeting both FcRH5 and CD3; Tecentriq® (atezolizumab), a monoclonal antibody designed to bind with PD-L1 and crovalimab, an anti-C5 antibody engineered to optimise complement inhibition. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan
WHO launches its first-ever comprehensive framework on reducing anaemia, calling on countries to accelerate action to halve anaemia prevalence in women of reproductive age by 2025. Progress on reducing anaemia has been slow and the world is not on track to reach the global target. Anaemia is a serious global public health problem, affecting 571 million women and 269 million young children worldwide.
In 2019, anaemia affected 40% of children between 6 months and 5 years of age, 37% of pregnant women and 30% of women 15–49 years of age. It is most prevalent in low- and middle-income countries. Anaemia increases the risk of infections and death, impairs cognitive performance, and causes extreme fatigue, poor pregnancy outcomes, loss of earnings, and poor growth and development. It is a strong indicator of overall health.
“Most work on addressing anaemia has been focused on the prevention and treatment of iron deficiency,” says Francesco Branca, the Director of WHO's Department of Nutrition and Food Safety. “However, anaemia is a complex condition with multiple causes – including other nutritional deficiencies, infections, inflammation, gynaecological and obstetric conditions, and inherited red blood cell disorders.” All must be addressed to effectively prevent and treat anaemia.
The new framework sets forth ways to address the direct causes, risk factors and broad social inequities that are fundamental drivers for anaemia. It describes the necessarily comprehensive approach that brings together multiple sectors and actors, and lays out key action areas to improve the coverage and uptake of interventions
Acknowledging that health remains the predominant sector for delivering many of the recommended interventions, the framework also proposes actions that other societal stakeholders can take. These include governments, civil society, academia, researchers, funding agencies, international organizations and media. Each has its particular role to perform in reducing anaemia and keeping people healthy.
The framework is launched during the International Maternal Newborn Health Conference.
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.
Geneva, 6 April 2023-- Countries of the World Health Organization have mapped out how negotiations on a global accord on pandemic prevention, preparedness and response will move forward with a view to presenting a draft accord for approval by the World Health Assembly in May 2024.
Ending Thursday, discussions on the draft pandemic accord took place during the fifth meeting of the Intergovernmental Negotiating Body (INB), which includes WHO’s 194 countries.
Ms Precious Matsoso, Co-Chair of the INB Bureau, from South Africa, said: “Countries from all parts of the world were able to discuss their ideas, concerns and suggestions in a forum for all countries to hear and consider.”
Countries agreed to keep a window open for additional written proposals until 22 April and that those proposals will be compiled with all others made over recent weeks into a package that will be made available to all drafting group participants.
The INB Bureau will then provide, by 22 May, in addition to this package, for consideration of the Drafting Group, a Bureau’s Text, including options where feasible, based on all submissions received and included in the compilation document.
The Drafting Group of the INB will then meet in June to continue negotiations.
INB Bureau Co-Chair, Mr Roland Driece of the Netherlands, said: “The world realises that what we want and need to achieve is an accord that will help us not to repeat the mistakes of the COVID-19 pandemic response. There are many proposals and constructive suggestions on the table for how to do this.”
According to the process agreed by governments at a special session of the World Health Assembly in late 2021, negotiations on the draft pandemic accord will aim to produce a final draft for consideration by the 77th World Health Assembly in May 2024.
In parallel with the pandemic accord negotiations, governments are also discussing more than 300 amendments to the International Health Regulations (2005) (IHR) in an effort to strengthen those regulations and make the world safer from communicable diseases while ensuring greater equity in the global response to public health emergencies.
Governments have been working to ensure consistency and alignment across the INB and IHR processes. The proposed IHR amendments will also be presented to the World Health Assembly in 2024, and would together, with a future pandemic accord, provide a comprehensive, complementary, and synergistic set of global health agreements.
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.
On 7 February 2023, the Ministry of Health and Social Welfare of Equatorial Guinea reported the deaths of a number of individuals with suspected hemorrhagic fever.
On 12 February 2023, one sample was confirmed positive for Marburg virus by real-time polymerase chain reaction (RT-PCR), at the Institute Pasteur in Dakar, Senegal.
Investigations are ongoing to find additional cases. WHO is supporting the response by strengthening contact tracing, case management, infection prevention and control, laboratory, risk communication and community engagement.
WHO assesses the risk posed by the outbreak as high at the national level, moderate at the regional level and low at the global level.
This is the first Marburg virus disease (MVD) outbreak reported in Equatorial Guinea.
On 7 February 2023, the Ministry of Health and Social Welfare of Equatorial Guinea reported at least eight deaths that occurred between 7 January and 7 February 2023, in two villages located in the district of Nsock Nsomo, eastern province of Kie-Ntem, Río Muni Region. According to the ongoing epidemiological investigation, the cases presented with fever, followed by weakness, vomiting, and blood-stained diarrhoea; two cases also presented with skin lesions and otorrhagia (bleeding from the ear).
On 9 February 2023, eight blood samples were collected from contacts and sent to the Centre Interdisciplinaire de Recherches Médicales de Franceville (CIRMF) in Gabon, where they tested negative for both Ebola and Marburg viruses by real-time polymerase chain reaction (RT-PCR).
An additional eight blood samples were collected from other contacts and sent to the Institute Pasteur in Dakar, Senegal, on 12 February 2023. One of these samples was taken from a suspected case that was confirmed positive for Marburg virus by RT-PCR. This case presented with fever, non-bloody vomiting, bloody diarrhoea, and convulsions and died on 10 February 2023 at Ebebiyin District Hospital. The case also had epidemiological links to four deceased cases from one of the villages in Nsoc-Nsomo district.
As of 21 February 2023, the cumulative number of cases is nine, including one confirmed case, four probable cases and four suspected cases. All the cases have died, one in a health facility and the other eight in the community. There are no cases among healthcare workers. Thirty-four contacts are currently under follow-up.
Marburg virus is the causative agent of Marburg virus disease (MVD), which has a case-fatality ratio of up to 88%. Marburg virus disease was initially detected in 1967 after simultaneous outbreaks in Marburg and Frankfurt in Germany, and in Belgrade, Serbia.
Rousettus aegyptiacus fruit bats are considered natural hosts for Marburg virus, from which the virus is then transmitted to people.
Marburg spreads through human-to-human transmission via direct contact (through broken skin or mucous membranes) with the blood, secretions, organs or other bodily fluids of infected people, and with surfaces and materials (e.g. bedding, clothing) contaminated with these fluids. Healthcare workers have previously been infected while treating patients with suspected or confirmed MVD. Burial ceremonies that involve direct contact with the body of the deceased can also contribute to the transmission of Marburg.
The incubation period varies from two to 21 days. Illness caused by Marburg virus begins abruptly, with high fever, severe headache and severe malaise. Severe watery diarrhoea, abdominal pain and cramping, nausea and vomiting can begin on the third day. Severe haemorrhagic manifestations appear between five and seven days from symptoms onset, and fatal cases usually have some form of bleeding, often from multiple areas. In fatal cases, death occurs most often between eight and nine days after symptom onset, usually preceded by severe blood loss and shock.
In the early course of the disease, the clinical diagnosis of MVD is difficult to distinguish from many other tropical febrile illnesses due to the similarities in the clinical symptoms. Other viral haemorrhagic fevers need to be excluded, including Ebola virus disease, as well as malaria, typhoid fever, leptospirosis, rickettsial infections, and plague. Laboratory confirmation can be made by different tests, such as antibody-capture enzyme-linked immunosorbent assay (ELISA), antigen-capture detection tests, serum neutralization test, reverse transcriptase polymerase chain reaction (RT-PCR) assay, electron microscopy, and virus isolation by cell culture.
Although no vaccines or antiviral treatments are approved to treat the virus, supportive care – rehydration with oral or intravenous fluids – and treatment of specific symptoms improve survival. A range of potential treatments are being evaluated, including blood products, immune therapies, and drug therapies.
This is the first time that Equatorial Guinea has reported an outbreak of MVD. The most recently reported outbreak of MVD was in Ghana in 2022 (three confirmed cases). Other MVD outbreaks have been previously reported in Guinea (2021), Uganda (2017, 2014, 2012, 2007), Angola (2004-2005), the Democratic Republic of the Congo (1998 and 2000), Kenya (1990, 1987, 1980) and South Africa (1975).
In-depth epidemiological investigations are underway to determine the source of the outbreak.
National teams have been deployed to the affected districts for active case finding, contact tracing, isolating and providing medical care to cases.
WHO has deployed experts in epidemiology, case management, infection prevention, laboratory and risk communication to support national response efforts and ensure community engagement.
WHO is also facilitating the shipment of tents, materials for sample collection and analysis, and a viral haemorrhagic fever kit including personal protective equipment for 500 health workers.
WHO is supporting the transportation of samples to laboratories in Senegal and Gabon as plans are underway to set up laboratory facilities in-country.
Equatorial Guinea is facing an outbreak of MVD for the first time and the country's capacity to manage the outbreak is insufficient.
Based on available information, all nine deceased cases were in contact with a relative with the same symptoms or participated in a burial of a person with symptoms compatible with MVD. At this stage it cannot be ruled out that all MVD cases have been identified, therefore there could be transmission chains that have not been tracked. To date, most of the contacts of the nine deceased cases have not been identified.
It should also be noted that with the exception of one case who died in a health facility, the other eight died in the community and their burial conditions are unknown.
Cross-border population movements are frequent, and the borders are very porous, between Ebebiyin and Nsock Nsomo districts (Equatorial Guinea), Cameroon and Gabon. This constitutes a risk of cross-border spread.
Considering the above described scenario, the risk is considered high at the national level, moderate at the regional level and low at the global level.
Marburg virus disease outbreak control relies on using a range of interventions, namely case management, surveillance including contact tracing, a good laboratory service, infection prevention and control including safe and dignified burials, and social mobilization. Community engagement is key to successfully controlling MVD outbreaks. Raising awareness of risk factors for Marburg infection and protective measures that individuals can take is an effective way to reduce human transmission.
Communities affected by Marburg should make efforts to ensure that the population is well informed, both about the nature of the disease itself and about necessary outbreak containment measures.
Outbreak containment measures include prompt, safe and dignified burial of the deceased cases, identifying people who may have been in contact with someone infected with Marburg and monitoring their health for 21 days, isolating and providing care to confirmed patients and maintaining good hygiene and a clean environment.
Healthcare workers caring for patients with or suspected of MVD should apply additional infection control measures in addition to standard precautions to avoid contact with patients’ blood and body fluids and with surfaces and objects contaminated.
WHO recommends that male survivors of MVD practice safer sex and hygiene for 12 months from onset of symptoms or until their semen twice tests negative for Marburg virus. Contact with body fluids should be avoided and washing with soap and water is recommended. WHO does not recommend isolation of male or female convalescent patients whose blood has tested negative for Marburg virus.
WHO advises against any restrictions on travel and/or trade to Equatorial Guinea based on available information for the current outbreak.
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.
Governments agreed on a way forward for updating the WHO International Health Regulations 2005 (IHR), holding the first round of intensive discussions on more than 300 amendments proposed by countries to this globally agreed instrument. The IHR set out agreed approaches and obligations for countries to prepare for, and respond to, disease outbreaks and other acute public health risks. The proposed amendments come in response to the challenges posed by the COVID-19 pandemic.
The Second meeting of the Working Group on Amendments to the International Health Regulations (2005) took place from 20-24 February, during which the proposed amendments were discussed for the first time. The Group heard the intent behind the 307 amendments proposed by governments and shared views on each. They also agreed on next steps to tackle more in-depth negotiations on the proposed amendments, and plans for its next meeting running from 17-20 April.
Co-Chair of the IHR Working Group, Dr Ashley Bloomfield, said in discussing amendments to the Regulations, governments focused on making their countries, and the international community, better prepared for future emergencies.
“COVID-19 showed us that having a good, strong set of International Health Regulations is essential, and showed where the current Regulations need to be improved,” said Dr Bloomfield, former Director-General of Health, New Zealand. “The ongoing pandemic has underscored the importance of countries working together collaboratively, and supporting WHO in its vital work, to make the world safer. The tone of the discussions and progress made during this week’s meeting clearly show that countries understand the responsibility they have to ensure this process is successful.”
Throughout the weeklong meeting, the 194 Member States of WHO, who are also States Parties to the IHR, stressed the importance of enhancing capacity building, especially in low-income countries; access to benefits arising from sharing pathogens; equitable access to medical countermeasures; and enhanced cooperation and information sharing.
Fellow IHR Working Group Co-Chair, Dr Abdullah M. Assiri, deputy minister of health, Kingdom of Saudi Arabia, said governments were committed to leading the process to strengthening the IHR to, in turn, make the world safer and healthier.
“Countries are in the driving seat of this process as they need to implement the International Health Regulations, deliver on the obligations, and make the key decisions needed to respond to public health threats,” said Dr Assiri. “During the pandemic, the world faced the urgent need for functioning international instruments, and placed increasing importance in international organizations, such as WHO. Updated Regulations will enable the world to better detect outbreaks early, and prevent them from developing into public health emergencies of international concern. This is about strengthening our collective ability to do that and to better protect everybody.”
In the leadup to the meeting, an independent and diverse team of experts prepared a technical assessment of the proposed amendments to assist countries in their negotiations.
In parallel with the IHR amendments process, governments are also negotiating the drafting of an WHO instrument on pandemic prevention, preparedness and response, also referred to as a pandemic accord. Governments will meet from 27 February-3 March 2023 to consider the zero draft of the accord.
Dr Bloomfield said the two processes are complementary, as they are both guided by the imperative of making the world safer from communicable diseases and ensuring equitable responses to public health threats. “The efforts to update the International Health Regulations and draft a pandemic accord share a number of common themes, including the importance of equity in access to health, collaboration and capacity building,” he said. “It is important that there is consistency and alignment across the two processes.”
WHO Member States issued the International Sanitary Regulations in 1951, the precursor to the IHR, which came into being in 2005. The IHR are an instrument of international law that is legally-binding on 196 States Parties, including the 194 WHO Member States. The IHR create rights and obligations for countries, including the requirement to report to WHO public health events with risk of international spread. They also outline the criteria to determine if a particular event constitutes a public health emergency of international concern, WHO’s highest level of alarm under the IHR, which in turn triggers specific response actions for countries to prevent the further spread of the epidemics and reduce their impact on population health and societies at large.
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.
In response to the devastating earthquakes impacting Türkiye and the Syrian Arab Republic, the World Health Organization delivered 72 metric tons of trauma and emergency surgery supplies, including treatments, to both countries to support ongoing response efforts.
A first charter flight departed to Türkiye on 9 February carrying 37 metric tons of life-saving supplies, and a second flight is scheduled to deliver 35 metric tons of supplies to the Syrian Arab Republic today.
In total, these life-saving supplies from both flights will be used to treat and care for 100 000 people as well as for 120 000 urgent surgical interventions in both countries.
A third flight is scheduled to reach the Syrian Arab Republic on 12 February and expected to carry 37 metric tons of emergency health supplies to reach an additional 300 000 people.
The trauma and emergency surgery supplies are designed to treat those injuries sustained during an earthquake as well as to treat illnesses such as pneumonia that are expected to rise over the next days and weeks as people are exposed to cold temperatures and many are sheltering outside or in temporary shelters. The supplies also follow WHO’s immediate release, on Monday 6 February, of prepositioned medical and surgical supplies in Syria to 16 hospitals treating survivors of the earthquake in the northwest of the country.
WHO has released US$ 3 million from the Contingency Fund for Emergencies for the response in both countries, including for these chartered flights. These 110 metric tons of supplies, valued at USD 826 000 in total, are being sent from the WHO Global Logistics Hub located within the International Humanitarian City (IHC) in Dubai, United Arab Emirates. The flights, donated by the International Humanitarian City, are providing a vital link to those impacted by this devastating event.
“These life-saving health supplies are critical for treating the wounded and providing urgent care to all those affected by this tragedy in both countries,” said WHO Director-General, Dr Tedros Adhanom Ghebreyesus. “Survivors are facing freezing conditions, continuing aftershocks and very limited access to shelter, food, water, heat and medical care. We’re in a race against time to save lives.”
Working around the clock, the Global Logistics Hub immediately mobilized the dispatch of 110 metric tons to answer the call to a major public health disaster. WHO is grateful for the support and partnership with the IHC, the Dubai Government, and the Government of the United Arab Emirates to transport these supplies quickly to those in greatest need.
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.
From 1 November 2022 to 27 January 2023, a total of 559 cases of meningitis (of which 111 are laboratory confirmed), including 18 deaths (overall CFR 3.2%), have been reported from Zinder Region, southeast of Niger, compared to the 231 cases reported during 1 November 2021 to 31 January 2022. The majority of laboratory-confirmed cases (104/111; 93.7%) are due to Neisseria meningitidis serogroup C (NmC). Reactive vaccination campaigns with the trivalent ACW meningococcal polysaccharide vaccine have been implemented.
Niger is located largely in the African meningitis belt with seasonal outbreaks recurring every year. However, the ongoing outbreak shows both an increased number of cases and an increased growth rate compared to the previous seasons.
Zinder region shares an international border with Jigawa State in Nigeria where a NmC outbreak is also ongoing, confirming the risk of international spread. Moreover, the simultaneous occurrence of other epidemics, insecurity and population displacement, all in the context of a protracted humanitarian crisis, are likely to contribute to the spread of the outbreak in other countries of the West African subregion.
WHO assesses the risk posed by the current meningitis outbreak in Niger as high at the national level, moderate at the regional level, and low at the global level.
Being located in the African meningitis belt, Niger has been affected by several meningitis epidemics resulting in 20 789 cases and 1369 deaths (CFR 6.6%) reported since 2015.
From 1 November 2022 to 27 January 2023, a total of 559 cases of meningitis (of which 111 are laboratory confirmed), including 18 deaths (overall CFR 3.2%) have been reported from Zinder region, southeast of Niger, compared to the 231 cases reported during 1 November 2021 to 31 January 2022.
The last meningitis outbreak in the Zinder region, occurred in the 2021/2022 season, with a total of 372 cases, including 12 deaths (CFR 3%).
Figure 1. Epicurve of cases of meningitis reported in Niger by month, 1 October 2021 - 27 January 2023.
Of the 228 samples collected from suspected cases, 154 (67.5%) have been analyzed by Niamey's Center for Medical and Health Research (CERMES). Neisseria meningitidis serogroup C was identified in the majority of confirmed cases (n=104; 93.7%), followed by Streptococcus pneumoniae (n=5; 4.5%) and Haemophilus influenzae (n=2; 1.8%). The remaining 43 samples tested negative.
Males represent 53% of all cases. Among the total of 559 cases of meningitis, people under 20 years of age are the most affected by the outbreak (n=538; 96.3%), with 202 cases (36.2%) reported in the 10-14 years age group, followed by the 5-9 years age group with 153 cases (27.4%), the 15-19 years age group with 107 cases (19.1%), and the 0-4 years age group with 76 cases (13.6%).
The most affected health district of Zinder region is Dungass (342 cases, 6 deaths), followed by Matamèye (98 cases, 3 deaths), Mirriah (72 cases, 3 deaths), Magaria (38 cases, 5 deaths), Zinder ville (7 cases, 1 death) and Gouré (2 cases, 0 deaths).
Figure 1. Distribution of reported meningitis cases by health district, Zinder region, Niger, 1 November 2022 – 27 January 2023.
Meningitis is a serious infection of the meninges, the membranes covering the brain and spinal cord. Several different bacteria can cause meningitis, however, Streptococcus pneumoniae, Haemophilus influenzae, Neisseria meningitidis (N. meningitis) are the most frequent ones, and are transmitted from person to person through droplets of respiratory or throat secretions from infected people.
A total of 12 serogroups of N. meningitidis have been identified, six of which (A, B, C, W, X and Y) can cause meningococcal meningitis epidemics.
The average incubation period is 4 days but can range between 2 and 10 days. The most common symptoms of meningitis are a stiff neck, high fever, sensitivity to light, confusion, headaches and vomiting. Even with early diagnosis and adequate treatment, 5% to 10% of patients die, typically within 24 to 48 hours after the onset of symptoms. Bacterial meningitis may result in brain damage, hearing loss or a learning disability in 10% to 20% of survivors. A less common, but even more severe (and often fatal), form of meningococcal disease is meningococcal septicaemia, which is characterized by a haemorrhagic rash and rapid circulatory collapse.
The highest burden of disease is seen in a region of sub-Saharan Africa, known as the African Meningitis Belt, which is especially recognised to be at high risk of meningococcal but also pneumococcal meningitis epidemics.
Niger is located largely in the African meningitis belt, where meningitis epidemics typically follow a seasonal pattern (usually from January to June), with a size that varies from year to year. In 2015, a large meningitis outbreak attributed to NmC occurred, affecting nearly 10 000 people. In 2009 and 2006, meningitis outbreaks caused by N. meningitidis serogroups A (NmA) and X (NmX), respectively, were also reported. Haemophilus influenzae and Streptococcus pneumoniae are two other important pathogens that contribute significantly to the bacterial meningitis burden within Niger.
Licensed vaccines against meningococcal, pneumococcal and haemophilus influenzae diseases have been available for many years. These bacteria have several different strains (known as serotypes or serogroups) and vaccines are designed to protect against the most harmful strains. Over time, there have been major improvements in strain coverage and vaccine availability, but no universal vaccine against these infections exists.
In the African meningitis belt, meningococcus serogroup A accounted for 80–85% of meningitis epidemics before the introduction of a meningococcal A conjugate vaccine through mass preventive campaigns (since 2010) and into routine immunization programmes (since 2016). Among vaccinated populations, incidence of serogroup A meningitis has declined by more than 99%, and no serogroup A case has been confirmed since 2017.
However, cases of meningitis and outbreaks due to other meningococcal serogroups, apart from serogroup B, continue to strike.
A technical committee has been established in the Zinder region to coordinate the response to the epidemic. The meningitis response plan has been finalized and implemented. An international team from WHO and other partners including MSF and UNICEF has been deployed to support the response.
Surveillance system activities have been reinforced in the Zinder region especially in Dungass health district, including case investigations. Laboratory activities are ongoing, including sample collection and confirmation from suspected meningitis cases.
Case management activities have been strengthened, including procurement of the antibiotic ceftriaxone, cases isolation, deployment of health workers for case management, distribution of case management guidelines and provision of free treatment to cases.
A request for 608 960 doses of trivalent ACW polysaccharide vaccine was approved and delivered by the International Coordinating Group (ICG) on Vaccine Provision in two batches of approximately 300 000 doses each on 31 December 2022 and 9 January 2023.
Reactive vaccination campaigns with the trivalent ACW meningococcal polysaccharide vaccine have been implemented by the MoH with the support of WHO and The Global Alliance for Vaccines and Immunization (GAVI) in the Health Districts of Dungass, Gouré, Mirriah and Matamèye, targeting the age group 2 to 29 years. The overall vaccination coverage reached is 99.8%.
Risks communication and community engagement activities are ongoing in close cooperation with administrators and community leaders in affected districts, delivering health advice and infection, prevention and control recommendations through community radios and other channels, including door-to-door sensitisation on the need to immediately seek medical assistance if symptoms occur to promptly start treatment.
The ongoing outbreak shows both an increased number of cases and an increased growth rate compared to the previous seasons.
Moreover, the meningitis epidemic season (usually from January to June, marked by high temperatures and dry winds combined with heavy dust, a period known as the harmattan), the mixing of populations, the simultaneous occurrence of other epidemics in the same region (measles, diphtheria and COVID-19), insecurity and population displacement, all in the context of a protracted humanitarian crisis, are likely to contribute to the spread of the outbreak.
The Zinder region borders Jigawa State in Nigeria, where a NmC outbreak is also ongoing, confirming the risk of international spread to other countries of the West African subregion.
WHO assesses the risk posed by the current meningitis outbreak in Niger as high at the national level, moderate at the regional level, and low at the global level.
Meningococcal meningitis remains a public health concern with a high case fatality rate and leading to serious long-term complications.
Preventing meningitis through vaccination is the most effective way to reduce the burden and impact of the disease by delivering long-lasting protection. The rollout of multivalent meningococcal conjugate vaccines is a public health priority to eliminate bacterial meningitis epidemics in the African meningitis belt. Introduction into routine immunization programmes and maintaining high coverage will be critical to avoid the resurgence of epidemics.
Antibiotics for close contacts of meningococcal cases, when given promptly, decrease the risk of transmission. Outside the African meningitis belt, chemoprophylaxis is recommended for close contacts within the household. Within the meningitis belt, chemoprophylaxis for close contacts is recommended in non-epidemic situations. Ciprofloxacin is the antibiotic of choice, and ceftriaxone an alternative.
Admission to a hospital or health centre is necessary. Isolation of the patient is not usually advised after 24 hours of treatment.
Appropriate antibiotic treatment must be started as soon as possible. Ideally, lumbar puncture should be done first as antibiotics can make it more difficult to grow bacteria from the spinal fluid. However, blood sampling can also help to identify the cause and the priority is to start treatment without delay. A range of antibiotics is used to treat meningitis, including penicillin, ampicillin, and ceftriaxone. During epidemics of meningococcal and pneumococcal meningitis, ceftriaxone is the drug of choice.
The response to epidemics consists of appropriate case management, active community-based case-finding and reactive mass vaccination of affected populations. Surveillance, from case detection to investigation and laboratory confirmation is essential to the control of meningitis.
Reactive vaccination campaigns have been implemented in Zinder region, and monitoring the spread to new areas is crucial to guide further response activities, including considering further vaccine requests if appropriate. Timeliness of the reactive campaign is critical, ideally within four weeks of crossing the epidemic threshold.
WHO does not recommend any restriction on travel and trade to Niger on the basis of the information available on the current event.
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.