WHO – R&D Blueprint
Novel Coronavirus R&D
WHO R & D Blueprint – Novel Coronavirus pdf, 375kb
Outline of designs for experimental vaccines and therapeutics – draft 17 January 2020
WHO R & D Blueprint – Novel Coronavirus
WHO Consultation on Cross-Reactivity with other coronaviruses – 24 January 2020
WHO R & D Blueprint – Novel Coronavirus pdf, 526kb
WHO Consultation on Cross-Reactivity with other coronaviruses – 27 January 2020
Prospects for evaluating cross-reactivity of nCoV with SARS-CoV
Informal consultation on prioritization of candidate therapeutic agents for use in novel coronavirus 2019 infection
Overview of the types/classes of candidate therapeutics pdf, 223kb
Informal consultation on trial design for treatment evaluation pdf, 506kb
Outline of designs for experimental vaccines and therapeutics – 21 January 2020
Outline of designs for experimental vaccines and therapeutics – 27 January 2020
FDA Announces Key Actions to Advance Development of Novel Coronavirus Medical Countermeasures
January 27, 2020
(Silver Spring, MD) – Today, the U.S. Food and Drug Administration (FDA) announced critical actions to advance development of novel coronavirus medical countermeasures.
As with any emerging public health threat, the FDA will collaborate with interagency partners, product developers, international partners and global regulators to expedite the development and availability of medical products needed to diagnose, treat, mitigate and prevent such outbreaks.
“We have a vital mission to protect and promote public health and the FDA is closely collaborating with our domestic and international public health partners to mitigate the impact of the novel coronavirus that emerged in Wuhan, China,” said FDA Commissioner Stephen M. Hahn, M.D. “We are actively leveraging the vast breadth of the FDA’s expertise and have begun employing the full range of our public health authorities to facilitate the development and availability of investigational medical products to help address this urgent public health situation.”
As part of FDA’s ongoing commitment to prepare and respond to infectious disease outbreaks, the agency is sharing updates on processes in place to help developers understand the pathways, including Emergency Use Authorization (EUA), that may be available to more rapidly advance and make medical countermeasures available for this virus, including diagnostic tests.
The FDA is also issuing key information for the public to help support the timely development of medical products to respond to the current outbreak. In order to support efficient medical product development for novel coronavirus medical countermeasures, today the FDA is launching a landing page that provides key information for the public, including product developers, on the FDA’s efforts in response to this outbreak.
“We are committed to keeping the American people informed as we prepare and respond to emerging public health threats, including the novel coronavirus,” said FDA Deputy Commissioner of Policy, Legislation and International Affairs Anna Abram. “The agency is committed to ensuring safe and effective medical countermeasures are available as quickly as possible to protect public health.”
Being able to quickly and accurately diagnose patients infected with the novel coronavirus is an essential step in helping patients identify the need for care and mitigate the spread of the virus to additional individuals. Currently, there are no commercially available products that are authorized to detect novel coronavirus; however, the FDA is actively working to facilitate the development and availability of diagnostics that can detect this virus. The agency is working with public health partners to advance and share the reference materials necessary to facilitate diagnostic development.
The FDA is also requesting that diagnostic test sponsors interested in potential EUA for tests to detect 2019-nCoV contact CDRH-EUA-Templates@fda.hhs.gov for further information and templates.
Sponsors wishing to develop therapeutics for 2019-nCoV are encouraged to submit information and questions via the FDA’s Pre-IND Consultation program…
CureVac and CEPI extend their Cooperation to Develop a Vaccine against Coronavirus nCoV-2019
31 Jan 2020
CEPI funds CureVac’s development of a vaccine against coronavirus nCoV-2019. The aim of the partnering agreement is to rapidly advance a vaccine candidate into clinical testing.
Wellcome pledges £10 million to tackle novel coronavirus epidemic
News | 31 January 2020
Wellcome is making a pledge of up to £10 million to accelerate research and support global efforts to tackle the ongoing novel coronavirus epidemic.
UNICEF ships 6 metric tons of supplies to support China’s response to Novel Coronavirus outbreak
Shipment includes masks and protective suits to help contain virus
NEW YORK, 29 January 2020 – A UNICEF shipment of respiratory masks and protective suits for health workers landed in Shanghai, China, today to support China’s response to the novel coronavirus (2019-nCoV) outbreak.
Weighing 6 metric tons, the supplies were sent from UNICEF’s global supply hub in Copenhagen and will be dispatched to Wuhan. UNICEF will be sending more items in the coming days and weeks.
“This coronavirus is spreading at a breakneck speed and it is important to put all the necessary resources into halting it,” said UNICEF Executive Director Henrietta Fore. “We may not know enough about the virus’s impact on children or how many may be affected – but we do know that close monitoring and prevention are key. Time is not on our side.”
Nearly 6,000 people have been infected so far, and the numbers are rising rapidly. Most cases are in China and there have been reports of infections among children.
UNICEF is in close contact with the Chinese authorities, including the Ministry of Commerce and the National Health Commission, the World Health Organization (WHO), and other UN agencies to monitor developments and needs as the situation further unfolds.
UNICEF is also working with WHO and partners for a coordinated multi-sectoral response in China and other affected countries…
Johnson & Johnson Launches Multi-Pronged Response to Coronavirus Global Public Health Threat
Initiating Vaccine Development and Providing Supplies of Antiviral Medicines to China for Investigational Use
NEW BRUNSWICK, N.J., Jan. 29, 2020 /PRNewswire/ — Johnson & Johnson (NYSE: JNJ) today announced that it is mobilizing resources at its Janssen Pharmaceutical Companies to launch a multi-pronged response to the novel coronavirus (also known as 2019-nCoV or Wuhan coronavirus) outbreak. As part of this work, the Company has initiated efforts to develop a vaccine candidate against 2019-nCoV and broadly collaborate with others to screen a library of antiviral therapies. Identifying compounds with antiviral activity against 2019-nCoV may contribute to providing immediate relief to the current outbreak.
“J&J has a long-standing commitment to fight established and emerging epidemics and is supporting global efforts where we can make the greatest impact. We are collaborating with regulators, healthcare organizations, institutions and communities worldwide to help ensure our research platforms, existing science and outbreak expertise can be maximized to stem this public health threat,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. “This latest outbreak of a novel pathogen once again reinforces the importance of investing in preparedness, surveillance and response to ensure the world remains ahead of potential pandemic threats.”
The vaccine program will leverage Janssen’s AdVac® and PER.C6® technologies that provide the ability to rapidly upscale production of the optimal vaccine candidate. These are the same technologies that were used in the development and manufacturing of Janssen’s investigational Ebola vaccine, which is currently deployed in the Democratic Republic of the Congo and Rwanda. They were also used to construct the Company’s Zika, RSV and HIV vaccine candidates.
Johnson & Johnson’s multi-pronged approach also includes a review of known pathways in coronavirus pathophysiology to determine whether previously tested medicines can be used to help patients survive a 2019-nCoV infection and reduce the severity of disease in non-lethal cases. In addition, Janssen has donated 300 boxes of its HIV medication PREZCOBIX® (darunavir/cobicistat) to the Shanghai Public Health Clinical Center and Zhongnan Hospital of Wuhan University for use in research to support efforts in finding a solution against the 2019-nCoV. Furthermore, another 50 boxes have been provided to the Chinese Center for Disease Control and Prevention for laboratory-based investigations (drug-screening for antiviral properties against 2019-nCoV). All shipments have been delivered and, if further donations are required, the Company is open to cooperating with all healthcare institutions and agencies to support efforts in finding a solution against 2019-nCoV.
The requests from the Shanghai Public Health Clinical Center and Zhongnan Hospital of Wuhan University follow a recommendation from the Shanghai Institute of Materia Medica, Chinese Academy of Sciences for investigation of 30 potentially effective compounds, including darunavir – the protease inhibitor component of PREZCOBIX – against 2019-nCoV. Based on anecdotal findings, a protease inhibitor has previously shown a potential favorable clinical response against severe acute respiratory syndrome (SARS) associated coronavirus.1 …
Feb 01, 2020 Volume 395Number 10221p311-388, e16-e18
Emerging understandings of 2019-nCoV
[See Journal Watch before for full text]