EMERGENCIES Coronavirus [2019-nCoV]

EMERGENCIES

 

Coronavirus [2019-nCoV]
Public Health Emergency of International Concern (PHEIC)

Situation report – 18
Novel Coronavirus (2019-nCoV)
7 February 2020
[Excerpt]
SITUATION IN NUMBERS
Globally :: 31,481 confirmed [3205 new]
China :: 31,211 confirmed
:: 4821 sever [962 new]
:: 637 deaths [73 new]
Outside of China
:: 270 confirmed [54 new]
:: 24 countries

 

WHO RISK ASSESSMENT
China – Very High
Regional Level – High
Global Level – High

 

HIGHLIGHTS
:: No new countries reported cases of 2019-nCoV in the past 24 hours.
:: To date, a total of 72 States Parties were identified to be implementing travel restrictions through official reports, official statements and the media. Of these 72 States Parties, WHO received 23 (32%) official reports from States Parties about their travel restrictions.
:: “The Pandemic Supply Chain Network (PSCN)” has commissioned a market assessment of the personal protective equipment market which will be distributed shortly to stakeholders of the PSCN as it continues to monitor the market. Additionally, senior management of WHO spoke with the stakeholders of the PSCN to ensure the private sector’s continued engagement to distribute supplies to those countries in most need. The PSCN will encourage manufacturers to increase production, commit supplies to frontline health emergency responders, and expand the number of stakeholders who are involved in the PSCN to gain a critical mass of suppliers to mitigate the operational risks within the market. WHO will continue to provide the technical guidance and coordination of supplies to those countries in most need.

 

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Feb 8: Daily briefing on novel coronavirus cases in China
National Health Commission of the People’s Republic of China
News
2020-02-08
As of 24:00 on Feb 7, the National Health Commission had received 34,546 reports of confirmed cases (reduced by 14 by Heilongjiang province after verification) and 722 deaths in 31 provincial-level regions on the Chinese mainland and the Xinjiang Production and Construction Corps, and in all 2,050 patients had been cured and discharged from hospital. There still remained 31,774 confirmed cases (including 6,101 in serious condition) and 27,657 suspected cases. So far, 345,498 people have been identified as having had close contact with infected patients. 189,660 are now under medical observation.

 

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WHO to accelerate research and innovation for new coronavirus
News release 6 February 2020
WHO is convening a global research and innovation forum to mobilize international action in response to the new coronavirus (2019-nCoV).
“Harnessing the power of science is critical for bringing this outbreak under control,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus. “There are questions we need answers to, and tools we need developed as quickly as possible. WHO is playing an important coordinating role by bringing the scientific community together to identify research priorities and accelerate progress.”
The forum, to be held 11-12 February in Geneva, is organized in collaboration with the Global Research Collaboration for Infectious Disease Preparedness.
The forum will bring together key players including leading scientists as well as public health agencies, ministries of health and research funders pursuing 2019-nCoV critical animal health and public health research and the development of vaccines, therapeutics and diagnostics, among other innovations…

 

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US$675 million needed for new coronavirus preparedness and response global plan
News release 5 February 2020
To fight further spread of the new coronavirus (2019-nCoV) outbreak in China and globally, and protect states with weaker health systems, the international community has launched a US$675 million preparedness and response plan covering the months of February through to April 2020.
“My biggest worry is that there are countries today who do not have the systems in place to detect people who have contracted with the virus, even if it were to emerge,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “Urgent support is needed to bolster weak health systems to detect, diagnose and care for people with the virus, to prevent further human to human transmission and protect health workers.”
The Strategic Preparedness and Response Plan (SPRP) for the new coronavirus lays out activities and resources needed by international health organizations globally, including WHO, to implement priority public health measures in support of countries to prepare and respond to nCoV-2019 for a period February-April 2020. The objectives of the plan are to  limit human-to-human transmission of the virus, particularly in countries most vulnerable if they were to face an outbreak; identify, isolate and care for patients early; communicate critical risk and event information; minimize social and economic impact; reduce virus spread from animal sources; and address crucial unknowns.
The plan focuses on:
:: Rapidly establishing international coordination and operational support;
:: Scaling up country readiness and response operations;
:: Accelerating priority research and innovation…
The Strategic Preparedness and Response Plan (SPRP) for the 2019 novel coronavirus

 

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Bill & Melinda Gates Foundation Dedicates Additional Funding to the Novel Coronavirus Response
The foundation will provide up to $100 million to improve detection, isolation and treatment efforts; protect at-risk populations in Africa and South Asia; and accelerate the development of vaccines, drugs and diagnostics.
SEATTLE, February 5, 2020 – The Bill & Melinda Gates Foundation today announced that it will immediately commit up to $100 million for the global response to the 2019 novel coronavirus (2019-nCoV). The funding will help strengthen detection, isolation and treatment efforts; protect at-risk populations; and develop vaccines, treatments and diagnostics. The new funding is inclusive of $10 million the foundation committed to the outbreak in late January.

“Multilateral organizations, national governments, the private sector and philanthropies must work together to slow the pace of the outbreak, help countries protect their most vulnerable citizens and accelerate the development of the tools to bring this epidemic under control,” said Gates Foundation CEO Mark Suzman. “Our hope is that these resources will help catalyze a rapid and effective international response. This response should be guided by science, not fear, and it should build on the steps that the World Health Organization has taken to date.”

The Gates Foundation is contributing more resources – in close coordination with other donors – to assist the World Health Organization (WHO), Chinese frontline responders and others at the global and national levels. WHO declared the 2019-nCoV outbreak a public health emergency of international concern on January 30, citing the risks the virus poses globally and the need for a worldwide coordinated effort to enhance preparedness, especially in fragile settings. The Government of China has also declared a national public health emergency and mobilized a nationwide effort to contain the virus and treat those who are infected.

 

Accelerating 2019-nCoV Detection, Isolation and Treatment
The foundation will immediately commit up to $20 million to accelerate the detection, isolation and treatment of people diagnosed with the virus with the goal of interrupting transmission and containing the disease. This funding will be directed to multilateral organizations such as WHO and the U.S. Centers for Disease Control and Prevention. Support will also be directed to national public health authorities in China and other countries that have reported confirmed cases. Current national-level partners include the National Health Commission of China and the Chinese Center for Disease Control and Prevention.

The release of fast and flexible funding is intended to help multilateral organizations and national public health authorities rapidly scale up their virus detection capabilities and implement disease modeling analytics so that they can target resources where they can have the greatest impact in arresting disease spread. This funding is intended to help public health authorities cover the initial cost of labor and supplies while international agencies and national governments appropriate the resources necessary to fund ongoing operations.

 

Enhancing Protections for At-Risk Populations in Africa and South Asia
Recent epidemics, such as the H1N1 influenza pandemic of 2009, have had a disproportionate impact on populations living in extreme poverty, and sub-Saharan Africa and South Asia together account for 85 percent of the estimated 629 million people worldwide who live on less than $1.90 per day. Many people living in sub-Saharan Africa and South Asia also have limited access to quality primary health care, which is another factor that increases their health risks.
The foundation will provide up to $20 million to help public health authorities in these regions strengthen their emergency operations centers, implement effective disease surveillance efforts and improve their capacity to safely isolate and treat confirmed cases.

Among African Union member states, these efforts will be supported by the African Field Epidemiology Network (AFENET) in collaboration with the Africa Centers for Disease Control and Prevention (Africa CDC) and WHO-AFRO. AFENET is a non-profit service alliance of field epidemiology and laboratory training programs that currently operates in more than 30 African countries.

 

Developing Vaccines, Treatments and Diagnostics for a Sustained Response
The foundation will commit up to $60 million to accelerate the discovery, development and testing of vaccines, treatments and diagnostics for 2019-nCoV. If 2019-nCoV transmission continues for several months or more, safe and effective vaccines and therapeutics will be needed to help sustain long-term approaches to disease control and to prevent severe disease and deaths.

The foundation will use its R&D funding to help global partners, such as the Coalition for Epidemic Preparedness Innovations, identify and prioritize research needs, address gaps in the R&D landscape, incentivize product development by biotechnology and pharmaceutical companies and ensure that resulting products are safe, effective and made widely available. This effort will include support already underway for Chinese public- and private-sector research partners focused on the discovery, development and testing of candidate vaccines, treatments and diagnostics…

 

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Shipping of CDC 2019 Novel Coronavirus Diagnostic Test Kits Begins
Thursday, February 6, 2020

Transcript for CDC Telebriefing: CDC Update on Novel Coronavirus
Wednesday, February 5, 2020

HHS and CDC Receive Additional Flights Carrying Passengers from China
Wednesday, February 5, 2020

Initial Public Health Response and Interim Clinical Guidance for the 2019 Novel Coronavirus Outbreak — United States, December 31, 2019, February 3, 2020

 

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FDA Takes Significant Step in Coronavirus Response Efforts, Issues Emergency Use Authorization for the First 2019 Novel Coronavirus Diagnostic
February 4, 2020
Today, the U.S Food and Drug Administration issued an emergency use authorization (EUA) to enable emergency use of the Centers for Disease Control and Prevention’s (CDC) 2019-nCoV Real-Time RT-PCR Diagnostic Panel. To date, this test has been limited to use at CDC laboratories; today’s authorization allows the use of the test at any CDC-qualified lab across the country.

“Since this outbreak first emerged, we’ve been working closely with our partners across the U.S government and around the globe to expedite the development and availability of critical medical products to help end this outbreak as quickly as possible. This continues to be an evolving situation and the ability to distribute this diagnostic test to qualified labs is a critical step forward in protecting the public health,” said FDA Commissioner Stephen M. Hahn, M.D. “Our collaboration with the CDC has been vital to rapidly developing and facilitating access to this diagnostic test. The FDA remains deeply committed to utilizing our regulatory tools and leveraging our technical and scientific expertise to advance the availability of critical medical products to respond to this outbreak in the most expeditious, safe and effective manner possible.”

The 2019-novel coronavirus (2019-nCoV), identified in Wuhan, China in December 2019, is a new type of coronavirus that can cause severe respiratory illness in humans. Most patients with confirmed 2019-nCoV infection have developed fever and/or symptoms of acute respiratory illness (e.g., cough, difficulty breathing). However, limited information is currently available to characterize the full spectrum of clinical illness associated with 2019-nCoV infection. To date most reported cases of 2019-nCoV infection outside of China have been linked to residence in or travel to Wuhan, China. At this time, federal health officials continue to believe that the threat to the general American population from this virus is relatively low.

Under this EUA, the use of 2019-nCoV Real-Time RT-PCR Diagnostic Panel is authorized for patients who meet the CDC criteria for 2019-nCoV testing. Testing is limited to qualified laboratories designated by the CDC and, in the U.S., those certified to perform high complexity tests. The diagnostic is a reverse transcriptase polymerase chain reaction (PCR) test that provides presumptive detection of 2019-nCoV from respiratory secretions, such as nasal or oral swabs. A positive test result indicates likely infection with 2019-nCoV and infected patients should work with their health care provider to manage their symptoms and determine how to best protect the people around them. Negative results do not preclude 2019-nCoV infection and should not be used as the sole basis for treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history and epidemiological information.

The FDA can issue an EUA to permit the use, based on scientific data, of certain medical products that may be effective in diagnosing, treating or preventing such disease or condition when there is a determination, by the Secretary of Health and Human Services (HHS), that there is a public health emergency or a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens, and a declaration that circumstances exist justifying the medical products’ emergency use.
On Jan. 31, HHS Secretary Alex Azar declared a public health emergency recognizing the potential threat that 2019-nCoV poses and reiterating the government’s dedication to leveraging all available resources to help prevent, mitigate and respond to this threat. As there are no commercially available diagnostic tests cleared or approved by the FDA for the detection of 2019-nCoV it was determined that an EUA is crucial to ensure timely access to diagnostics. The HHS Secretary accordingly today made the necessary EUA determination and declaration and the FDA issued this EUA in response to a request from the CDC. This action is the result of the close collaboration between the FDA, the CDC and the Centers for Medicare and Medicaid Services, which provides oversight for U.S. laboratories, to prioritize the efficient development and implementation of critical medical products in response to emerging infectious disease outbreaks, such as novel coronavirus.

The FDA outlined its approach to expediting the development and availability of critical medical products to prevent, diagnose and treat 2019-nCoV using all applicable regulatory authorities to respond to this outbreak on Jan. 27. The agency remains committed to working with developers, international partners and the U.S. government to help support this public health response. The FDA is dedicated to actively working with other 2019-nCoV diagnostic developers to help accelerate development programs and requests for EUAs, in fact several have already requested and received the EUA template for this outbreak. The FDA, among other steps, is providing its highest level of attention to helping expedite the development and review of a variety of medical products being developed to diagnose, treat and prevent the spread of this outbreak.

 

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EMA to support development of vaccines and treatments for novel coronavirus
Press release 04/02/2020
To contribute to the global response to the outbreak of the novel coronavirus (2019-nCoV) infections, EMA is taking concrete actions to accelerate the development and availability of medicinal products for the treatment and prevention of the new coronavirus.

“EMA has activated its plan for managing emerging health threats,” says Guido Rasi, the Agency’s Executive Director. “The new coronavirus has been declared a public health emergency of international concern by the World Health Organization, and we are drawing on the strong expertise of the European medicines network to provide fast-track scientific advice and give prompt feedback on any proposed medicine developments.”

The Agency is surveying the landscape for potential antivirals or vaccines to treat or prevent novel coronavirus infections. EMA is also analysing all available information on developers’ drug pipelines. As with any emerging public health threat, EMA collaborates and exchanges information with EU public health authorities, notably the European Commission, the Health Security Committee and the European Centre for Disease Prevention and Control (ECDC), the World Health Organization and other international regulators, in particular through the International Coalition of Regulatory Authorities (ICMRA).

There are currently no commercially available medicinal products that are authorised to detect, treat or prevent infections with the novel coronavirus. EMA is ready to support medicine developers with all available regulatory tools to advance and expedite the development of effective measures to fight and prevent the spread of this virus.

Developers working on medicinal products or vaccines that could be used for treatment or prevention of novel coronavirus 2019-nCoV infections are encouraged to contact the Agency and discuss their strategy for evidence generation as soon as possible…

 

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