Milestones :: Perspectives :: Research
IFPMA Backgrounder – COVID-19
03 April 2020
… Vaccine development
While vaccines and small molecule treatments are approved through different regulatory pathways and their development programs vary, they generally both must complete three phases of clinical trials. However, there are differences in the data required to show the safety of vaccines and the size of clinical trials for vaccines relative to small molecules.
Experts are hoping it will take as little as 12 to 18 months before there is a vaccine available. This is a best-case estimate that assumes one or two of the first few vaccines that enter development will be successful. Typically, only approximately one in ten experimental vaccines make it all the way through to regulatory approval. Therefore, the more companies taking different approaches to find a vaccine, the more “shots on goal” and significantly greater chances of success.
:: CEPI and GSK will collaborate to help the global effort to develop a vaccine for the novel coronavirus. GSK is making its adjuvant technology available to support rapid development of candidate vaccines and is working with The University of Queensland, Australia.
:: CSL Limited/ Seqirus is providing scientific and technical expertise and its established MF59® adjuvant technology to the University of Queensland in Australia to help fast-track the development of their CEPI-funded COVID-19 vaccine candidate, which uses novel molecular-clamp technology.
:: GSK announced it would partner with the Chinese biotech company Clover Biopharmaceuticals. Under the partnership, GSK will provide Clover with its proprietary adjuvants – compounds that enhance the effectiveness of vaccines. By mid-March, GSK expanded their collaborations and is now working with five partner companies and research groups across the world, including in the USA and China.
:: Johnson & Johnson expanded its collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of U.S. Department of Health & Human Services (HHS), and established a new collaboration with Beth Israel Deaconess Medical Center (BIDMC), to accelerate development of a potential novel coronavirus vaccine.
:: Johnson & Johnson announced the selection of a lead COVID-19 vaccine candidate from constructs it has been working on since January 2020; the significant expansion of the existing partnership between the Janssen Pharmaceutical Companies of Johnson & Johnson and the Biomedical Advanced Research and Development Authority (BARDA); and the rapid scaling of the Company’s manufacturing capacity with the goal of providing global supply of more than one billion doses of a vaccine.
:: Pfizer and BioNTech have entered into a partnership to jointly develop BioNTech’s mRNA-based vaccine candidate BNT162 to prevent COVID-19 infection. The collaboration aims to accelerate global development of BNT162, which is expected to enter clinical testing by the end of April 2020.
:: Sanofi announced a collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services (HHS), to advance a novel COVID-19 vaccine candidate. Work is underway to leverage previous development of a SARS vaccine candidate using Sanofi’s recombinant DNA technology. Sanofi is also coordinating with the Coalition for Epidemic Preparedness Innovations (CEPI) and sharing its vaccine R&D experience and expertise to advance vaccine solutions.
:: Sanofi and U.S. company Translate Bio announced plans to collaborate on developing a vaccine to treat the coronavirus. The companies said Translate Bio would work on discovering, designing, and manufacturing a number of SARS-CoV-2 vaccine candidates, while Sanofi would provide its expertise in the field of vaccines and support from its research networks.
Currently a number of existing and new treatments are in various research phases and clinical trials to test their efficiency and safety for treating COVID-19. Listed below is a snapshot of the different areas of research focused on finding an effective treatment.
:: AbbVie announced it is partnering with global authorities to determine the effectiveness of HIV drugs in treating COVID-19. AbbVie is supporting clinical studies and basic research with lopinavir/ritonavir, working closely with European health authorities and the U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention, National Institutes of Health and the Biomedical Advanced Research and Development Authority to coordinate these efforts.
International Ch. des Mines 9 Tel: +41 22 338 32 00 Federation of P.O. Box 195 Fax: +41 22 338 32 99 Pharmaceutical 1211 Geneva 20 http://www.ifpma.org Manufacturers & Switzerland Associations
:: AstraZeneca’s Research and Development (R&D) teams have also been working expeditiously to identify monoclonal antibodies to progress towards clinical trial evaluation as a treatment to prevent COVID-19. More than 50 virology, immunology, respiratory, and protein engineering experts across research, clinical, regulatory, and manufacturing are placing the highest priority on developing a treatment to minimise the global impact of the disease.
:: Eli Lilly and AbCellera (Canadian biotech firm) have entered into an agreement to co-develop antibody products for the treatment and prevention of COVID-19. The collaboration will leverage AbCellera’s rapid pandemic response platform, developed under the DARPA Pandemic Prevention Platform (P3) Program, and Lilly’s global capabilities for rapid development, manufacturing and distribution of therapeutic antibodies.
:: EFPIA is working with the Innovative Medicines Initiative (IMI) on potential actions to support collaborative research programs in order to fast-track the development of therapeutics.
:: Gilead has initiated two Phase 3 clinical trials of remdesivir in countries with high prevalence of COVID-19. The company is also supporting two Phase 3 trials in China and a global Phase 2 trial led by the U.S. National Institute of Allergy and Infectious Diseases. Gilead donated drug and provided scientific input for these studies. Gilead has provided remdesivir to physicians for compassionate use to treat several hundred severely ill patients with confirmed COVID-19, and has accelerated manufacturing of remdesivir at risk, in anticipation of potential future supply needs.
:: GSK is entering into the new collaborative research effort, the COVID-19 Therapeutics Accelerator. The aim of the Accelerator is to bring pharmaceutical companies and expert academic institutions into coordinated research programs, with the aim of bringing the most promising molecules forward that could be used to treat cases of COVID-19. GSK will contribute by making available compounds from its libraries for screening for activity against COVID-19. In addition, GSK is evaluating its marketed pharmaceutical products and medicines in development to determine if any could be used beyond their current indications in response to the pandemic. Further, GSK is evaluating options to make available specialised laboratory space to help in research and testing of COVID-19.
:: Ipsen donates €2 million to the Institut Pasteur to support research on COVID-19. Since January, the Institut Pasteur has devoted a portion of its research to understanding the emerging COVID-19 virus, in terms of epidemiology, biological characteristics, pathogenicity.
:: Johnson & Johnson, in partnership with the Rega Institute for Medical Research, University of Leuven (Belgium), are working to identify existing or new compounds with antiviral activity against COVID-19 that could contribute to providing immediate relief to the current outbreak.
:: Merck, as part of the global effort to investigate potential therapeutics for COVID-19 and their support of independent research, recently donated a supply of interferon beta-1a (Rebif®) to the French Institut National de la Santé et de la Recherche Médicale (INSERM) following a request for use in a clinical trial. To date, Merck’s interferon beta-1a is not approved by any regulatory authority for the treatment of COVID-19 or for use as an antiviral agent.
:: Novartis announced that it has entered new collaborative research efforts such as the COVID-19 Therapeutics Accelerator, coordinated by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard, as well as a COVID-19 directed partnership organized by the Innovative Medicines Initiative. Novartis is contributing by making available several compounds from its libraries that are considered suitable for in vitro antiviral testing. In addition, the company is rapidly evaluating other existing products to see if any could be utilized beyond their approved indications in response to the pandemic.
:: Novartis plans to initiate a Phase III clinical trial in collaboration with Incyte to evaluate the use of Jakavi® (ruxolitinib) for treatment of a type of severe immune overreaction called cytokine storm that can lead to life-threatening respiratory complications in patients with COVID-19.
:: Pfizer announced that it completed a preliminary assessment of certain antiviral compounds that were previously in development and that inhibited the replication of coronaviruses similar to the one causing COVID-19 in cultured cells. Pfizer is engaging with a third party to screen these compounds under an accelerated timeline and expects to have the results back by the end of March.
:: Pfizer also outlined a detailed 5-point action plan to battle COVID-19. The plan includes a commitment to sharing its clinical development and regulatory expertise to support other smaller biotech companies that are screening compounds or existing therapies for activity against the virus causing COVID-19.
:: Regeneron Pharmaceuticals announced an expanded agreement with the U.S. Department of Health and Human Services (HHS) to develop new treatments combating the novel coronavirus.
:: Regeneron Pharmaceuticals and Sanofi SA started a clinical program evaluating Kevzara, originally a drug to treat arthritis, in patients hospitalized with severe COVID-19. Kevzara is a fully-human monoclonal antibody that inhibits the interleukin-6 (IL-6) pathway by binding and blocking the IL-6 receptor. IL-6 may play a role in driving the overactive inflammatory response in the lungs of patients who are severely or critically ill with COVID-19 infection.
:: Roche’s Actemra was approved by China on March 5 to treat Covid-19 patients with lung complications. Roche has donated nearly $2m-worth of Actemra to China to help the country manage the COVID-19 outbreak”. Actemra has been on the European market since 2010 for treatment of several kinds of arthritis.
:: Roche announced that they are working with the Food & Drug Administration (FDA) to initiate a Phase III clinical trial to evaluate the safety and efficacy of Actemra in hospitalised adult patients with severe COVID-19 pneumonia. This is the first global
study of Actemra in this setting and is expected to begin enrolling as soon as possible in early April with a target of approximately 330 patients globally, including the US.
:: Takeda announced that it is initiating the development of a drug to treat people infected with the novel coronavirus. The experimental drug would be derived from the blood of coronavirus patients who have recovered from the respiratory disease. In parallel, Takeda is also exploring whether currently marketed and pipeline products may be an effective treatment option for infected patients.
Rolling out diagnostics to detect whether patients are genuinely infected with the new coronavirus is a key step in preventing or slowing its spread. However, the rapid spread of COVID-19 has drastically increased the demand for testing kits around the world, especially in the United States and Europe, and governments are trying to ramp up their testing capacities.
:: AstraZeneca is accelerating the development of its diagnostic testing capabilities to scale-up screening and is also working in partnership with governments on existing screening programmes to supplement testing.
:: Roche announced that the FDA issued an Emergency Use Authorization for its diagnostic kit cobas® SARS-CoV-2 Test, advancing coronavirus testing to meet urgent medical needs. Roche is committed to delivering as many tests as possible and is going to the limits of production capacity.
:: Takeda is partnering with public entities and other pharmaceutical companies through the Innovative Medicines Initiative (IMI) in Europe to leverage collective expertise in the hope of developing diagnostics for COVID-19 as well as inhibitors to help prevent future outbreaks…
WHO :: Global research on coronavirus disease (COVID-19)
:: International Clinical Trials Registry Platform
:: COVID-19 Emergency Use Listing Procedure (EUL)
:: “Solidarity” clinical trial for COVID-19 treatments – WHO
“Solidarity” is an international clinical trial to help find an effective treatment for COVID-19, launched by the World Health Organization and partners.
The Solidarity trial will compare four treatment options against standard of care, to assess their relative effectiveness against COVID-19. By enrolling patients in multiple countries, the Solidarity trial aims to rapidly discover whether any of the drugs slow disease progression or improve survival. Other drugs can be added based on emerging evidence.
Until there is sufficient evidence, WHO cautions against physicians and medical associations recommending or administering these unproven treatments to patients with COVID-19 or people self-medicating with them. WHO is concerned by reports of individuals self-medicating with chloroquine and causing themselves serious harm. WHO guidance on compassionate use can be found here. [below]
WHO :: Off-label use of medicines for COVID-19
31 March 2020
No pharmaceutical products have yet been shown to be safe and effective for the treatment of COVID-19. However, a number of medicines have been suggested as potential investigational therapies, many of which are now being or will soon be studied in clinical trials, including the SOLIDARITY trial co-sponsored by WHO and participating countries.
In many countries, doctors are giving COVID-19 patients medicines that have not been approved for this disease. The use of licensed medicines for indications that have not been approved by a national medicines regulatory authority is considered “off-label” use. The prescription of medicines for off-label use by doctors may be subject to national laws and regulations. All health care workers should be aware of and comply with the laws and regulations governing their practice. Further, such prescribing should be done on a case-by-case basis. Unnecessary stockpiling and the creation of shortages of approved medicines that are required to treat other diseases should be avoided.
It can be ethically appropriate to offer individual patients experimental interventions on an emergency basis outside clinical trials, provided that no proven effective treatment exists; it is not possible to initiate clinical studies immediately; the patient or his or her legal representative has given informed consent; and the emergency use of the intervention is monitored, and the results are documented and shared in a timely manner with the wider medical and scientific community.
The decision to offer a patient an unproven or experimental treatment is between the doctor and the patient but must comply with national law. Where it is possible and feasible for the treatment to be given as part of a clinical trial, this should be done unless the patient declines to participate in the trial.
If it is not possible to give the treatment as part of a clinical trial, appropriate records of the use of the medicine must be kept, in compliance with national law, and outcomes for patients should be monitored and recorded.
If early results from an unproven or experimental treatment are promising, the treatment should be studied in the context of a formal clinical trial to establish its safety, efficacy, risks, and benefits.
World Health Organization. Monitored emergency use of unregistered and experimental interventions (MEURI), http://www.who.int/ethics/publications/infectious-disease-outbreaks/en/.
WHO continues to monitor the situation closely for any changes that may affect this interim guidance. Should any factors change, WHO will issue a further update. Otherwise, this scientific brief will expire 2 years after the date of publication.
WHO reference number: WHO/2019-nCoV/Sci_Brief/Off-label_use/2020.1
Johnson & Johnson Announces a Lead Vaccine Candidate for COVID-19; Landmark New Partnership with U.S. Department of Health & Human Services; and Commitment to Supply One Billion Vaccines Worldwide for Emergency Pandemic Use
Mar 30, 2020, 07:22 ET
:: Johnson & Johnson and BARDA Together Commit More than $1 Billion to Novel Coronavirus Vaccine Research and Development; Company Expects to Initiate Phase 1 Human Clinical Studies of Vaccine Candidate at Latest by September 2020
:: Johnson & Johnson Will Establish New U.S. Vaccine Manufacturing Capabilities and Additional Production Capacity Outside the U.S. to Begin Production at Risk to Help Ensure Global Vaccine Supply
NEW BRUNSWICK, N.J., March 30, 2020 /PRNewswire/ — Johnson & Johnson (NYSE: JNJ) (the Company) today announced the selection of a lead COVID-19 vaccine candidate from constructs it has been working on since January 2020; the significant expansion of the existing partnership between the Janssen Pharmaceutical Companies of Johnson & Johnson and the Biomedical Advanced Research and Development Authority (BARDA); and the rapid scaling of the Company’s manufacturing capacity with the goal of providing global supply of more than one billion doses of a vaccine. The Company expects to initiate human clinical studies of its lead vaccine candidate at the latest by September 2020 and anticipates the first batches of a COVID-19 vaccine could be available for emergency use authorization in early 2021, a substantially accelerated timeframe in comparison to the typical vaccine development process.
Through a landmark new partnership, BARDA, which is part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services, and Johnson & Johnson together have committed more than $1 billion of investment to co-fund vaccine research, development, and clinical testing. Johnson & Johnson will use its validated vaccine platform and is allocating resources, including personnel and infrastructure globally, as needed, to focus on these efforts. Separately, BARDA and the Company have provided additional funding that will enable expansion of their ongoing work to identify potential antiviral treatments against the novel coronavirus.
As part of its commitment, Johnson & Johnson is also expanding the Company’s global manufacturing capacity, including through the establishment of new U.S. vaccine manufacturing capabilities and scaling up capacity in other countries. The additional capacity will assist in the rapid production of a vaccine and will enable the supply of more than one billion doses of a safe and effective vaccine globally. The Company plans to begin production at risk imminently and is committed to bringing an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use.
Alex Gorsky, Chairman and Chief Executive Officer, Johnson & Johnson, said, “The world is facing an urgent public health crisis and we are committed to doing our part to make a COVID-19 vaccine available and affordable globally as quickly as possible. As the world’s largest healthcare company, we feel a deep responsibility to improve the health of people around the world every day. Johnson & Johnson is well positioned through our combination of scientific expertise, operational scale and financial strength to bring our resources in collaboration with others to accelerate the fight against this pandemic.”
Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson, said, “We greatly value the U.S. government’s confidence and support for our R&D efforts. Johnson & Johnson’s global team of experts has ramped up our research and development processes to unprecedented levels, and our teams are working tirelessly alongside BARDA, scientific partners, and global health authorities. We are very pleased to have identified a lead vaccine candidate from the constructs we have been working on since January. We are moving on an accelerated timeline toward Phase 1 human clinical trials at the latest by September 2020 and, supported by the global production capability that we are scaling up in parallel to this testing, we expect a vaccine could be ready for emergency use in early 2021.”…
Medical Product Alert N°3/2020
Falsified medical products, including in vitro diagnostics, that claim to prevent, detect, treat or cure COVID-19
31 March 2020 News release Geneva
This Medical Product Alert warns consumers, healthcare professionals, and health authorities against a growing number of falsified medical products that claim to prevent, detect, treat or cure COVID-19.
The Coronavirus disease (COVID-19) pandemic (caused by the virus SARS-CoV-2) has increased demand for medicines, vaccines, diagnostics and reagents, all related to COVID-19, creating an opportunity for ill-intended persons to distribute falsified medical products
Due diligence is required from all actors in the procurement, use and administration of medical products, in particular those affected by the current crisis of, or related to, COVID-19.
- FALSIFIED IN VITRO DIAGNOSTICS AND LABORATORY REAGENTS
WHO has received multiple reports regarding falsified in vitro diagnostics (IVDs) and laboratory reagents for the detection of SARS-CoV-2. Please refer to WHO’s Emergency Use Listing for a list of diagnostics approved for clinical use by WHO. To date, eight countries (Australia, Brazil, Canada, PR China, Russian Federation, Singapore, Republic of Korea, United States of America) have listed IVDs for COVID-19 diagnosis based on expedited regulatory assessments. Please note that, in the European Union, regulatory compliance for SARS-CoV-2 diagnostics are self-declared by the manufacturer.
To assist Member States and stakeholders, WHO has published the links to these emergency lists, together with contact details. These links provide information on IVDs authorized for use in the jurisdictions of the International Medical Device Regulators Forum, as well as policies and guidance. WHO will provide updated versions as new information becomes available.
End-users are encouraged to check the labelling against the information posted by regulatory authorities upon listing to ensure they are in possession of the genuine product. This information might include product name, product code, expiry date, instructions for use and manufacturer details.
Unregulated websites supplying medicines and/or vaccines, particularly those concealing their physical address or landline telephone number, are frequently the source of unlicensed, substandard and falsified medical products. WHO has been made aware of various unregistered websites claiming that products on sale can treat or prevent COVID-19. Such products are likely to be falsified medicines. In addition, some websites may appear to provide easy access to legitimate medicines that are otherwise not readily available. End-buyers and consumers should be especially wary of such online scams and exert due diligence when purchasing any medical product, whether online or not.
- FALSIFIED MEDICINES AND VACCINES
At this stage, WHO does not recommend any medicines to treat or cure COVID-19. However, the SOLIDARITY trial, led by WHO, is reviewing potential treatments for COVID-19.
WHO requests increased vigilance from national health authorities, healthcare professionals, members of the public and supply chain stakeholders worldwide to prevent the distribution of these falsified medical products. Increased vigilance should focus on hospitals, clinics, health centres, clinical laboratories, wholesalers, distributors, pharmacies and any other suppliers of medical products. All medical products must be obtained from authentic and reliable sources. Their authenticity and condition of the product should be carefully checked. Consumers are advised to seek advice from a healthcare professional in case of doubt.
National health authorities are requested to immediately notify WHO if these falsified products are discovered in their country. If you have any information concerning the manufacture, distribution, or supply of these products, please contact firstname.lastname@example.org
International Generic and Biosimilar Medicines Association [IGBA]
IGBA urgent recommendations to keep medicine supply chains flowing
27 March 2020
The current operating model of medicines supply requires transparent global collaboration to provide access to medicines for patients around the world.
IGBA firmly believes that any restrictions on the export of pharmaceutical products are counter-productive in responding to a global public health crisis. We therefore discourage countries from implementing any policies that could disrupt the pharmaceutical supply chain, including the use of export bans and stockpiling measures. To do so would hamper the industry’s response to COVID-19. If countries impose such export restrictions, however, communication must be clear on their scope to prevent an escalation of reactive measures publicly.
To keep medicine supply chains flowing and to avoid shortages, it is critical to:
:: support global cooperation, which is essential to maximise production levels for all countries under WHO leadership, involving Health Ministries and industry;
:: keep international borders open, secure trade flows and oppose export bans for medicines and the key ingredients for their manufacture;
:: maintain air freight capacity at predictable and reasonable cost by making use of available commercial aircraft not currently in use or banned from flying. Military planes could also be :: reserve cargo capacity to transport medicines, active pharmaceutical ingredients, intermediates, key starting materials and medical equipment;
:: ensure that airports remain open for these essential goods;
:: coordinate the approach to maintain the airport traffic flow in all global pharmaceutical hubs (such as the EU, India, US and China) – creating open routes or “green lanes” for these essential goods between countries around the world.
As governments take measures to protect their populations from the unrestricted spread of COVID-19, clear coordinated communication is critical to ensure appropriate action by the global community. IGBA therefore welcomes statements affirming commitment to medicines access and supply chain connectivity by the G20 and the joint ministries of Australia, Brunei Darussalam, Canada, Chile, Myanmar, New Zealand and Singapore, recognizing the importance of collaboration and solidarity.
Public Health Emergency of International Concern (PHEIC)
We certainly recognize the velocity of global developments in the COVID-19 pandemic. While we have concentrated the most current key reports just below, COVID-19 announcements, analysis and commentary will be found throughout this issue, in all sections.
Beyond the considerable continuing coverage in the global general media, the WHO’s authoritative guidance is available here:
:: Daily WHO situation reports here: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/situation-reports
:: WHO Coronavirus disease (COVID-2019) daily press briefings here: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/media-resources/press-briefings
Situation report – 75 [WHO]
Novel Coronavirus (COVID-19)
4 April 2020
SITUATION IN NUMBERS
1 051 635 confirmed (79 332)
56 985 deaths (6664)
Western Pacific Region
110 362 confirmed (1432)
3809 deaths (49)
583 141 confirmed (41 333)
42 334 deaths (5231)
South-East Asia Region
6528 confirmed (647)
267 deaths (22)
Eastern Mediterranean Region
65 903 confirmed (3667)
3592 deaths (154)
Region of the Americas
279 543 confirmed (32 070)
6802 deaths (1202)
5446 confirmed (183)
170 deaths (6)
WHO RISK ASSESSMENT
Global Level – Very High
:: One new country/territory/area reported cases of COVID-19 in the past 24 hours: Bonaire, Sint Eustatius and Saba.
:: As worldwide cases climb above 1 million and deaths over 50 000, Dr Tedros stressed that the best way for countries to end restrictions and ease their economic effects was to attack the virus with an aggressive and comprehensive package of measures. His speech can be found here.
:: WHO has released new technical guidance recommending universal access to public hand hygiene stations and making their use obligatory on entering and leaving any public or private commercial building and any public transport facility. It also recommends that healthcare facilities improve access to and practice of hand hygiene. Find more here.
:: WHO/Europe has received a €30 million contribution from the European Commission for 6 WHO European Region Member States – Armenia, Azerbaijan, Belarus, Georgia, the Republic of Moldova and Ukraine – to meet immediate needs in their responses to COVID-19. More information is available here.
Ebola – DRC+
Public Health Emergency of International Concern (PHEIC)
Ebola Outbreak in DRC 86: 31 March 2020
Situation Update WHO Health Emergencies Programme Page 2
There have been no new cases of Ebola virus disease (EVD) reported since 17 February 2020. The last individual confirmed to have Ebola was discharged from an Ebola Treatment Centre on 3 March after recovering and testing negative for the virus twice. On 9 March, the last contacts finished their follow-up period. These developments are significant milestones in this outbreak. However, there is still a high risk of re-emergence of EVD, and it is critical to maintain response activities to rapidly detect and respond to any new cases, and to continue ongoing support and health monitoring operations for EVD survivors – as outlined in the WHO recommended criteria for declaring the end of the EVD outbreak.
There is ongoing surveillance, pathogen detection, and clinical management activities in previously affected areas, including alert validation, rapid diagnosis of suspected cases, and building partnerships with community members to strengthen investigation of potential EVD deaths in communities. Insecurity remains a challenge in continuing response activities, which could delay the detection of potential flare-ups.
Due to challenges related to continued insecurity and population displacement in previous hotspots and potential shortages of resources required to carry out response activities amidst other local and global emergencies, there remains a high risk of re-emergence of EVD in the period leading up to the declaration of the end of the outbreak, as well as for several months following that declaration. In order to mitigate the risk of re-emergence, it is critical to maintain surveillance and rapid detection and response capacities, prioritize survivor care, and maintain cooperative relationships with survivors’ associations.
Public Health Emergency of International Concern (PHEIC)
Polio this week as of 01 April 2020
Summary of new viruses this week (AFP cases and ES positives):
:: Afghanistan: one WPV1 case
:: Pakistan: four WPV1 cases, nine WPV1 positive environmental samples and eight cVDPV2 cases
:: Benin: one cVDPV2 case
:: Democratic Republic of the Congo (DR Congo) – two cVDPV2 cases
:: Ethiopia: five cVDPV2 cases
:: Ghana: five cVDPV2 cases and four cVDPV2 positive environmental samples
:: Malaysia: 15 cVDPV1 positive environmental samples and four cVDPV2 positive environmental samples
:: Togo: five cVDPV2 cases
Call to action to support COVID-19 response
Polio Oversight Board Statement
The COVID-19 pandemic response requires worldwide solidarity and an urgent global effort. The Global Polio Eradication Initiative (GPEI) stands ready to respond.
GPEI’s response to COVID-19 is driven by two principles. The first is our public health imperative to ensure that the polio programme fully plays its part in the COVID-19 response, supported by our second, underlying principle that when the emergency ends we will be ready to end polio with urgency and determination.
GPEI assets at service of COVID-19 response
The Polio Oversight Board (POB) has agreed that for the next four to six months, GPEI programmatic and operational assets and human resources, from global to country level, will be made available to enable a strong response to COVID-19, while maintaining critical polio functions, such as surveillance and global vaccine supply management.
GPEI will continue to deploy polio-funded personnel to the COVID-19 response and make available coordination mechanisms, such as emergency operations centers, and physical assets such as transportation or IT hardware. Through our extensive front-line worker networks in many countries, we will ensure the collection of information to provide evidence-informed guidance in line with WHO recommendations. At country level, the polio surveillance network is being trained on COVID-19 case detection, case and contact tracing, laboratory testing and data management. Our data management systems and front-line staff are already ramping up action in many countries, and wherever the polio programme has a presence we will continue to serve the response.
GPEI will also seek assurances that when GPEI staff is supporting COVID-19 front line activities, they will be provided with the necessary training, materials, equipment and logistics support to do so safely, in line with infection prevention and control measures. The GPEI is conscious that women, who make up most caregivers and health workers, are likely to bear a heavier burden as the pandemic plays out in polio-affected countries. Their health and safety are a priority and we are working on ways to mitigate impact including making sure that their voices are heard in management and leadership positions.
Pause in immunization campaigns
All countries planning to conduct poliovirus preventative campaigns are advised to temporarily postpone these campaigns until the second half of 2020. Countries which were planning to conduct poliovirus outbreak response campaigns are advised to postpone these campaigns until 1 June 2020 and then reevaluate based on the status of the COVID-19 pandemic…
WHO Grade 3 Emergencies [to 28 Mar 2020]
Nigeria – No new digest announcements identified
Somalia – No new digest announcements identified
South Sudan – No new digest announcements identified
Syrian Arab Republic – No new digest announcements identified
Yemen – No new digest announcements identified
Afghanistan – No new digest announcements identified
Angola – No new digest announcements identified
Burkina Faso [in French] – No new digest announcements identified
Burundi – No new digest announcements identified
Cameroon – No new digest announcements identified
Central African Republic – No new digest announcements identified
Ethiopia – No new digest announcements identified
HIV in Pakistan – No new digest announcements identified
Iran – No new digest announcements identified
Libya – No new digest announcements identified
Malawi – No new digest announcements identified
Measles in Europe – No new digest announcements identified
MERS-CoV – No new digest announcements identified
Myanmar – No new digest announcements identified
Niger – No new digest announcements identified
occupied Palestinian territory – No new digest announcements identified
Sudan – No new digest announcements identified
Ukraine – No new digest announcements identified
Zimbabwe – No new digest announcements identified
WHO Grade 1 Emergencies [to 28 Mar 2020]
Chad – No new digest announcements identified
Djibouti – No new digest announcements identified
Kenya – No new digest announcements identified
Mali – No new digest announcements identified
Namibia – viral hepatitis – No new digest announcements identified
Tanzania – No new digest announcements identified
UN OCHA – L3 Emergencies
The UN and its humanitarian partners are currently responding to three ‘L3’ emergencies. This is the global humanitarian system’s classification for the response to the most severe, large-scale humanitarian crises.
Syrian Arab Republic
:: Syrian Arab Republic: COVID-19 Update No. 04 – 2 April 2020
:: Number of people confirmed by the Ministry of Health to have COVID-19: 16 (including two fatalities)
:: Areas of concern: Densely populated areas, notably Damascus/Rural Damascus and those living in camps, collective shelters and informal settlements in northeast Syria (NES), as well as areas where hostilities may be ongoing making sample collection more challenging.
:: Populations of concern: All groups are susceptible to the virus. However, the elderly (those 60 years and above) and people with underlying health conditions are particularly at risk; as are vulnerable refugee and IDP populations and healthcare workers with inadequate personal protective equipment (PPE).
UN OCHA – Corporate Emergencies
When the USG/ERC declares a Corporate Emergency Response, all OCHA offices, branches and sections provide their full support to response activities both at HQ and in the field.
CYCLONE IDAI and Kenneth – No new digest announcements identified
EBOLA OUTBREAK IN THE DRC – No new digest announcements identified
WHO & Regional Offices [to 28 Mar 2020]
3 April 2020 News release
WHO and UNICEF to partner on pandemic response through COVID-19 Solidarity Response Fund
31 March 2020 News release
Medical Product Alert N°3/2020
[See Milestones above for detail]
30 March 2020 News release
WHO releases guidelines to help countries maintain essential health services during the COVID-19 pandemic
The COVID-19 pandemic is straining health systems worldwide. The rapidly increasing demand on health facilities and health care workers threatens to leave some health systems overstretched and unable to operate effectively.
Previous outbreaks have demonstrated that when health systems are overwhelmed, mortality from vaccine-preventable and other treatable conditions can also increase dramatically. During the 2014-2015 Ebola outbreak, the increased number of deaths caused by measles, malaria, HIV/AIDS, and tuberculosis attributable to health system failures exceeded deaths from Ebola [1,2].
“The best defense against any outbreak is a strong health system,” stressed WHO Director-General Tedros Adhanom Ghebreyesus. “COVID-19 is revealing how fragile many of the world’s health systems and services are, forcing countries to make difficult choices on how to best meet the needs of their people.”
To help countries navigate through these challenges, the World Health Organization (WHO) has updated operational planning guidelines in balancing the demands of responding directly to COVID-19 while maintaining essential health service delivery, and mitigating the risk of system collapse. This includes a set of targeted immediate actions that countries should consider at national, regional, and local level to reorganize and maintain access to high-quality essential health services for all…
30 March 2020 Statement
Joint Statement by QU Dongyu, Tedros Adhanom Ghebreyesus and Roberto Azevedo, Directors-General of the Food and Agriculture Organization of the United Nations (FAO), the World Health Organization (WHO) and the World Trade Organization (WTO)
29 March 2020 Statement
Information sharing on COVID-19 [Taiwan]
Weekly Epidemiological Record, 3 April 2020, vol. 95, 14/15 (pp. 133–144)
Control of epidemic meningitis in countries in the African meningitis belt, 2019
WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
No new digest content identified.
WHO Region of the Americas PAHO
:: PAHO Director calls for private sector cooperation in COVID-19 response in the Americas (04/03/2020)
:: PAHO launches searchable database on COVID-19 guidance and research (04/02/2020)
:: PAHO appeals for $95 million to help Latin America and the Caribbean cope with the COVID-19 pandemic (04/02/2020)
:: Time is of the essence – Countries of the Americas must act now to slow the spread of COVID-19 (03/31/2020)
WHO South-East Asia Region SEARO
:: COVID19: WHO calls for stronger whole of society approach in South-East Asia Region
3 April 2020 News release Amidst rapid spread of COVID19 and continuing challenges, the World Health Organization today emphasized on a stronger whole of society and whole of government effort in South-East …
WHO European Region EURO
:: “China shows COVID-19 responses must be tailored to the local context” 03-04-2020
:: WHO project on cultural contexts of health and well-being adopted in the United States 03-04-2020
:: Supporting older people during the COVID-19 pandemic is everyone’s business 03-04-2020
:: WHO releases guidelines to help European countries maintain essential health services during the COVID 19 pandemic 02-04-2020
:: Health System Response Monitor: new tool to analyse COVID-19 response measures across European countries launched 02-04-2020
WHO Western Pacific Region
:: Virtual press conference on COVID-19 in the Region 31 March 2020
Opening remarks of Dr Takeshi Kasai, WHO Regional Director for the Western Pacific