Public Health Emergency of International Concern (PHEIC)
Weekly Epidemiological and Operational updates
last update: 11 September 2020, 20:00 GMT-4
Confirmed cases :: 32 429 965 [week ago: 30 369 778]
Confirmed deaths :: 985 823 [week ago: 948 795]
Weekly Operational Update
Coronavirus disease 2019 (COVID-19)
25 September 2020 :: 13 pages
Weekly Epidemiological Update
Coronavirus disease 2019 (COVID-19)
21 September 2020 : 23 pages
Global epidemiological situation
To date, over 30.6 million COVID-19 cases and 950 000 deaths have been reported to WHO.
From 14 through 20 September, there were almost 2 million new cases of COVID-19, which represents a 6% increase compared to the previous week, and the highest number of reported cases in a single week since the beginning of the epidemic. During the same period, there was a 10% decrease in the number of deaths, with 36 764 deaths reported in the past seven days
With the exception of the African Region, an increase in the weekly case incidence was reported across all WHO regions in the last seven days (Table 1, Figure 2). Overall, the Region of the Americas continues to carry the highest burden of COVID-19 globally, accounting for over 38% of all new cases reported in the past seven days, although the region has reported a 22% decrease in new deaths. The WHO European Region showed the greatest rise in deaths in the past week, with a 27% increase compared to the previous week.
The WHO South-East Asia Region has continued to report an increase in new COVID-19 deaths, with over 9000 deaths in the past week, accounting for 25% of all reported deaths and surpassing 100 000 total COVID-19 deaths since the beginning of the pandemic. In addition, the region accounts for 35% of new cases reported in the past week. The Eastern Mediterranean and Western Pacific regions have both reported a slight increase in reported cases and deaths over the last three weeks. The African Region continues to show a marked decline with decreases of 12% and 16% in reported cases and deaths respectively in the past week.
Key weekly updates
:: As the world comes together at an unprecedented mostly virtual 75th UN General Assembly from 15-31 September, WHO has three messages to share:
1. Equitable access to COVID-19 tools. WHO calls on world leaders to support the Access to COVID-19 Tools (ACT)-Accelerator, a unique international collaboration to fast-track the development, production and equitable access to COVID-19 tests, treatments, and vaccines globally, while strengthening health systems.
2. Maintain the momentum towards achieving the Sustainable Development Goals. The pandemic risks unravelling decades of gains made in health and development. According to a recent WHO survey, 90% of countries are experiencing disruptions to essential health services.
3. We must prepare for the next pandemic together, now. A year ago the independent Global Preparedness Monitoring Board warned of the threat of a pandemic, calling for global leaders to take urgent, united action to prepare. Last week, the Board issued its 2020 report, ‘A World in Disorder’, which outlined five urgent actions to be taken: responsible leadership; engaged citizenship; strong and agile systems for health security; sustained investment; and robust global governance of preparedness.
:: WHO Director-General Dr Tedros, in his regular media briefing on Friday, highlighted that this is a critical moment for countries. As cases and deaths have started to spike again, he called upon leaders to put targeted measures in place which can help suppress the spread of the virus and ensure that health systems and workers are protected. Individuals must also practise physical distancing, clean their hands frequently, wear a mask as advised, cough and sneeze safely away from others, avoid crowds, and keep windows and doors open when they can’t meet friends and family outside.
:: WHO has published new guidance on school-related public health measures that examines considerations for school operations, and the measures needed to minimize the risk to students and staff of COVID-19.
:: On 17 September, we celebrated World Patient Safety Day to raise global awareness of the importance of health worker safety and its interlinkages with patient safety. The COVID-19 pandemic has exerted unprecedented pressure on health systems worldwide. Health systems can only function with health workers, and a knowledgeable, skilled and motivated health workforce is critical for the provision of safe care to patients.
:: WHO has released a slide set on ‘What we know about the long-term effects of COVID-19’. Typically people recover from COVID-19 after two to six weeks; however, for some people, including young adults and persons with no underlying medical conditions who were not hospitalized, symptoms may linger or recur for weeks or months following initial recovery. Some patients develop medical complications that may have lasting health effects. Much is still unknown, and more time and research are needed to understand the long-term effects of COVID-19.
WHO Director-General’s opening remarks at the media briefing on COVID-19 – 25 September 2020
:: Today, WHO and our partners are publishing a detailed strategic plan and investment case for the urgent scale-up phase of the ACT Accelerator, building on the success of the start-up phase.
:: By the end of next year, the ACT Accelerator aims to deliver 2 billion doses of vaccine; 245 million courses of treatment; and 500 million diagnostic tests to low- and middle-income countries.
:: The number of countries joining the COVAX facility grows every day. As of today, 67 high-income countries have formally joined and another 34 are expected to sign, joining 92 lower-income countries who are eligible for financial support through Gavi.
:: The current financing gap for the ACT Accelerator stands at 35 billion dollars. Of the 35 billion dollars, 15 billion dollars is needed immediately to exploit the ACT-A progress to fund research and development, scale up manufacturing, secure procurement and strengthen delivery systems.
WHO Emergencies Press Conference on coronavirus disease outbreak – 25 September 2020
Thank you. First of all let me emphasise that countries have autonomy according to their national regulations and legislation to issue emergency use authorisations for any health product and China and other countries have already done so for different products and WHO has emergency use listing provisions and has listed already several products for diagnostics.
We have not yet issued provisions for EUL of vaccines but today I have good news for you because we have just published, put out for comments the draft criteria for assessment of COVID-19 vaccines for emergency use listing or pre-qualification and this will help manufacturers understand the criteria.
This is up for public comments until 8th October – organisations, manufacturers and individuals – because this will help all partners to understand what’s necessary to put a product that’s both safe and effective into the market and what are the elements that will make it eligible for either an emergency use listing by WHO or a pre-qualification. Thank you.
RO The world is approaching one million deaths from COVID-19. Is it unthinkable that two million might die before a vaccine becomes widely available?
FC Thank you, Robin. Dr Ryan will take your question. Thank you.
MR It’s certainly unimaginable but it’s not impossible because if we look at losing a million people in nine months and then we just look at the realities of getting vaccine out there in the next nine months it’s a big task for everyone involved. Mariangela’s just outlined the issues of listening.
There’s the issue of scale-up; there’s the issue of funding these vaccines; there’s the issue of distributing these vaccines and then the issues of acceptance and beyond that with the work we
still have to do in controlling this disease.
Remember, we have things we can do now to drive transmission down and drive down the number of deaths. We’re seeing clinical case fatality rates slowly drop, we’re seeing doctors and nurses making better use of oxygen, better use of intensive care, better use of dexamethasone, which again was referred to in the DG’s speech and which the ACT Accelerator will provide a lot of focus on, and other therapeutics as they come online.
One million is a terrible number and I think we need to reflect on that before we start considering a second million. There is a lot that can be done to save lives, both in terms of disease control, existing life-saving measures and the innovations that are coming down the pipe.
The real question is, are we prepared collectively to do what it takes to avoid that number, are we prepared to fully engage in the surveillance and testing and tracing, in managing our own risks at society and community level, governments supporting communities to take that action?
Are we willing to make the investments now that are needed in the ACT Accelerator, especially in COVAX? Because these are, number one, the investments we need to make and the actions
we need to take at all levels of our society, sub-nationally, nationally and internationally. Are we willing to take the multilateral action, the collective global action to take control of this virus rather than this virus controlling our destinies?
If we don’t take those actions and we don’t continue to escalate and evolve the nature and scale and intensity of our co-operation then yes, we will be looking at that number and sadly a number much higher.
So the time for action is now on every single aspect of this strategic approach. The DG has said it again and again and again; not just this, not just test and trace, not just clinical care, not just social distancing, not just hygiene, not just masks, not just vaccines; do it all.
Unless we do it all the numbers you speak about are not only imaginable but unfortunately and sadly very likely.
FC Thank you, Dr Ryan. Dr Aylward has something to add.
BA Thank you very much and thanks for the question, Robin. I think we have to be super-clear; whether another million people die of COVID-19 is not a function of whether or not we have a vaccine. It’s a function of whether or not we put the tools, approaches and knowledge that we have today to work to save lives and prevent transmission; it’s as simple as that.
If we start thinking about it as a function of the vaccine people will unnecessarily and unacceptably die as we wait for a vaccine.
We should not be waiting. We have made incredible progress in terms of reducing mortality from this disease, in terms of preventing the most vulnerable and highest-risk from getting
infected by this disease.
It’s unacceptable, it’s unnecessary and it should be unimaginable and it should not be a function of whether or not we have a vaccine. It’s a function of whether or not we as individuals – as Mike emphasised – do what we can, our part to prevent transmission of this disease.
FC Thank you, Dr Aylward.
Public consultation for review of draft Considerations for the Assessment of COVID-19 Vaccines for Listing by WHO
Organizations and individuals are invited to review and provide comments/suggestions on the draft Document “Considerations for the assessment of Covid-19 vaccines”
Please provide your comments in writing to WHO no later than 08 October 2020, 18:00 CEST by email at the following address WHOEUL@who.int.
This document provides advice to manufacturers on both the process and the criteria that will be used by the World Health Organization (WHO) to evaluate COVID-19 vaccines that are submitted either for prequalification (PQ) or for Emergency Use Listing (EUL). The current status of development of a candidate Covid-19 vaccine, the extent of the available quality, safety and efficacy data and regulatory approvals by relevant NRAs will guide WHO’s decision on which pathway (PQ or EUL) to follow for each vaccine.
The submission and review processes are described. Only vaccines that have undergone phase IIb or phase III studies and have received authorization from a reference NRA should be submitted for consideration. Criteria that will be used to assess clinical trial design, endpoints, and statistical criteria are described. Specific data that should be submitted to answer programmatically relevant questions are outlined. Manufacturing, quality control and labelling requirements are summarized, as are non-clinical data to address the potential for vaccine-associated enhanced disease. Post-authorization commitments are specified.
This document should be read in conjunction with the following:
:: “Procedure for assessing the acceptability, in principle, of vaccines for purchase by United Nations agencies”, WHO Technical Report Series 978, Annex 6, 2013 (1)
:: WHO EUL document (2)
:: “Guidelines on clinical evaluation of vaccines: regulatory expectations”, WHO Technical Report Series 1004, Annex 9, 2017 (3)
:: COVAX SAGE Compendium of Covid-19 vaccine research questions (4)
:: “Guidelines for assuring the quality, safety, and efficacy of plasmid DNA vaccines” adopted by the Seventy-first Meeting of the World Health Organization Expert Committee on Biological Standardization, 24–28August 2020. (5)
:: “Points to Consider for assuring the quality, safety and efficacy of RNA vaccines” (6)
:: “WHO Target Product Profiles for COVID-19 Vaccines” (7)
(4) COVAX SAGE Compendium of Covid-19 vaccine research questions
(6) Currently under development and to be published at https://www.who.int/biologicals
NIH [to 26 Sep 2020]
Selected News Releases
Fourth large-scale COVID-19 vaccine trial begins in the United States
September 23, 2020 — Trial evaluating investigational Janssen COVID-19 vaccine.
A fourth Phase 3 clinical trial evaluating an investigational vaccine for coronavirus disease 2019 (COVID-19) has begun enrolling adult volunteers. The trial is designed to evaluate if the investigational Janssen COVID-19 vaccine (JNJ-78436725) can prevent symptomatic COVID-19 after a single dose regimen. Up to 60,000 volunteers will be enrolled in the trial at up to nearly 215 clinical research sites in the United States and internationally.
The Janssen Pharmaceutical Companies of Johnson & Johnson developed the investigational vaccine (also known as Ad.26.COV2.S) and is leading the clinical trial as regulatory sponsor. Janssen, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, are funding the trial.
U.S. and international trial sites part of the NIAID-supported COVID-19 Prevention Network(link is external) (CoVPN) will participate in the trial. The CoVPN is composed of existing NIAID-supported clinical research networks with infectious disease expertise and designed for rapid and thorough evaluation of vaccine candidates and monoclonal antibodies for the prevention of COVID-19.
“Four COVID-19 vaccine candidates are in Phase 3 clinical testing in the United States just over eight months after SARS-CoV-2 was identified. This is an unprecedented feat for the scientific community made possible by decades of progress in vaccine technology and a coordinated, strategic approach across government, industry and academia,” said NIAID Director Anthony S. Fauci, M.D. “It is likely that multiple COVID-19 vaccine regimens will be required to meet the global need. The Janssen candidate has showed promise in early-stage testing and may be especially useful in controlling the pandemic if shown to be protective after a single dose.”…
Johnson & Johnson Initiates Pivotal Global Phase 3 Clinical Trial of Janssen’s COVID-19 Vaccine Candidate
:: First participants dosed in Phase 3 trial (ENSEMBLE) evaluating safety and efficacy of Janssen’s COVID-19 vaccine candidate, JNJ-78436735, also known as Ad26.COV2.S
Sep 23, 2020
Serum Institute of India Initiates Manufacturing of Codagenix’s Intranasal Live-Attenuated COVID-19 Vaccine Candidate
:: Phase 1 clinical trial of CDX-005 expected to initiate prior to year-end 2020
:: Serum Institute to ramp-up manufacturing for large-scale safety and efficacy studies and to meet global vaccine supply requirements
Sep 22, 2020
Canada Exercises Increased Option for 20 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273)
September 22, 2020
:: Canadian Government maintains option for an additional 36 million doses
:: Agreement underscores growing global confidence in mRNA platform and progress of Phase 3 study of mRNA-1273