WHO has a public consultation on the following document for the WHO Expert Committee on Biological Standardization (ECBS) is now open.

WHO assessment and accelerated national registration of WHO-prequalified In Vitro Diagnostics (IVDs)

The 1st draft of the Collaborative procedure between the World Health Organization (WHO) and National Regulatory Authorities in the assessment and accelerated national registration of WHO-prequalified In Vitro Diagnostics (IVDs) has been prepared to enhance timely access to WHO-prequalified products in countries, to ensure that the product in countries is the same as the one which is WHO-prequalified and to provide a model for regulatory information exchange between countries. The draft document has been updated based on the informal consultation with experts from the National Regulatory Authorities which was conducted in November 2019 during the WHO Workshop on Collaborative Registration Procedure for Diagnostics.

WHO are now publishing this draft to get the feedback from a broad audience of relevant government authorities, manufacturers, and other experts. DEADLINE for submission of comment: 15 July 2020. Please send comments to: gunlud@who.int. 

You could download the document directly by clicking on the following link: https://www.who.int/biologicals/Collaborative_Procedure_for_IVDs_for_PC.pdf?ua=1

In order to provide your comments, please use the template, https://www.who.int/biologicals/Comment_Form_CRP_diagnostics_June_2020.doc?ua=1

Recently, regulatory entities in the Caribbean have moved to implement the PAHO recommended procedure reliance for Emergency Use Authorization in the COVID-19 pandemic (https://iris.paho.org/handle/10665.2/52027)

The National Regulatory Authority of Guyana (Government Analyst, Food and Drug Department) and the Caribbean Public Health Agency/ Caribbean Regulatory System, have both taken decisions to adopt the procedure for drugs, vaccines, and test kits.

These are important developments for many reasons. Medicines and other health technologies are available (test kits) now, or will potentially become available in the coming months, and it will be important that countries have the tools in place to properly make decisions on authorization in an expeditious manner, while based on a trusted regulator’s best scientific and regulatory judgment.

Additional information: https://carpha.org/What-We-Do/CRS/Operational-Policy and https://www.paho.org/en/news/30-4-2020-new-guideline-use-reliance-emergency-use-authorization-medicines-and-other.

CECMED´s actions on COVID-19 are available at https://www.cecmed.cu/covid-19

CECMED has authorized the SOBERANA 01 clinical trial, entitled “Phase I / II, randomized, controlled, adaptive, double-blind and multicenter study to evaluate the safety, reactogenicity and immunogenicity of the prophylactic FINLAY-FR-1 anti SARS–CoV–2  Vaccine Candidate in a two-dose schedule. (COVID-19) “. Recruitment will be carried out between 24 August and 30 October, in two sites in the province of Havana, until the sample of 676 healthy volunteers between 19 and 80 years old is completed. The site of the Cuban public registry of clinical trials is available at: https://rpcec.sld.cu/ensayos-por-fecha

New publications 

Contact tracing is an important tool for pandemic response. The possibility of conducting it digitally increases its potential and poses new ethical challenges. This is the topic of the following new publications:

Ferreti et al. Quantifying SARS-CoV-2 transmission suggests epidemic control with digital contact tracing, available from https://science.sciencemag.org/content/368/6491/eabb6936

Kahn J (ed). Digital contact tracing for pandemic response: Ethics and governance guidance, available from https://muse.jhu.edu/book/75831 

For WHO guidelines on ethical issues in public health surveillance, which provide relevant guidance and include a guideline focused on public health emergencies, go to https://apps.who.int/iris/bitstream/handle/10665/255721/9789241512657-eng.pdf?sequence=1.

The use of restrictive and physical distancing measures during a pandemic raises a number of important ethical issues. This publication of WHO’s COVID-19 ethics working group is available at the site of the Public Health Emergency Preparedness and Response Ethics Network (PHEPREN): https://epidemicethics.tghn.org/articles/ethics-sars-cov-2-restrictive-measures-and-physical-distancing/.

The document has been developed on the basis of WHO’s Guidance For Managing Ethical Issues In Infectious Disease Outbreaks (available at: https://apps.who.int/iris/bitstream/handle/10665/250580/9789241549837-eng.pdf?sequence=1). The document can be accessed directly at: https://media.tghn.org/articles/Ethics__COVID-19__Restrictive_Measures_-_Apr_14.pdf).

PAHO has published the document on Reliance for Emergency Use Authorization of Medicines and Other Health Technologies in a Pandemic (e.g. COVID-19). This document provides guidance to national regulatory authorities (NRAs) and regulatory systems on practical ways to implement reliance for emergency use of medicines and other health technologies in and around a pandemic. Note that countries use different terminologies for emergency use and the Pan American Health Organization (PAHO) will use the term “Emergency Use Authorization” (EUA).

The publication is available at https://iris.paho.org/handle/10665.2/52027.

FDA Reiterates Importance of Close Patient Supervision for ‘Off-Label’ Use of Antimalarial Drugs to Mitigate Known Risks, Including Heart Rhythm Problems

The US FDA has issued a Drug Safety Communication regarding known side effects of hydroxychloroquine and chloroquine, including serious and potentially life-threatening heart rhythm problems, that have been reported with their use for the treatment or prevention of COVID-19, for which they are not approved by the FDA.

Additional information: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-reiterates-importance-close-patient-supervision-label-use and https://www.fda.gov/drugs/drug-safety-and-availability/fda-cautions-against-use-hydroxychloroquine-or-chloroquine-covid-19-outside-hospital-setting-or

The National Regulatory Authority in Mexico (COFEPRIS) has published on its website its actions to deal with the health emergency derived from COVID-19; among them: measures in relation to clinical trials, technical guidelines for clinical trials protocols related to the therapeutic use of convalescent plasma, regulatory flexibility in import and export processes for all health supplies, and provisions for the acquisition and manufacture of ventilators.

COFEPRIS’ actions to attend to the COVID-19 emergency are available at: https://www.gob.mx/cofepris/acciones-y-programas/acciones-sobre-covid-19?state=published

PAHO publication:

In the event that the available resources (such as ventilators or ICU beds) are not sufficient to meet all the needs of the population in the COVID-19 pandemic, we must proceed ethically. Since we cannot do everything that we should do, what is the most ethical path of action? Responsible action calls for health authorities to establish criteria for the priority-setting decisions that may be necessary.

This brief ethics guidance provides four basic recommendations to guide these decisions. It is available at: https://www.paho.org/en/documents/ethics-guidance-use-scarce-resources-delivery-critical-health-care-during-covid-19

WHO also has a publication on Ethics and COVID-19: resource allocation and priority-setting. Additional information is available at: https://prais.paho.org/en/who-ethics-and-covid-19-resource-allocation-and-priority-setting/

WHO publication:

Ethics and COVID-19: resource allocation and priority-setting

Governments, international agencies and health systems have an obligation to ensure, to the best of their ability, adequate provision of health care for all. However, this may not be possible during a pandemic, when health resources are likely to be limited. Setting priorities and rationing resources in this context means making tragic choices, but these tragic choices can be ethically justified. This is why we have ethics. This document answers a number of questions about the ethics of setting priorities for the allocation of resources during times of scarcity, and provides a high-level ethical framework that can be used to guide decision-making.

It is available at: https://www.who.int/who-documents-detail/ethics-and-covid-19-resource-allocation-and-priority-setting