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
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:
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).
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.
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.
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.
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.
WHO has issued a Medical Product Alert on 31 March 2020 regarding falsified medical products, including in vitro diagnostics, that claim to prevent, detect, treat or cure COVID-19
