Cuban Vaccines Abdala and Mambisa against Covid-19

Intro: With the first case of COVID-19 in Cuba on March 11, 2020, the Center for Genetic Engineering and Biotechnology in Havana began an extensive vaccine program. Two vaccines based on RBD recombinant protein were developed, one for systemic administration "Abdala" and one mucosal vaccine "Mambisa". Abdala received the EUA in July 2021 and "Mambisa" completed its clinical development as a booster dose for convalescent subjects. Method(s): Two doses (25 and 50 microg) and two schedules (0-14-28 and 1-28-56 days) were evaluated in phase I clinical trials with volunteers 19 to 54 years old. The phase II and III clinical trials were also double-blind, randomized, and placebo-controlled, and included respectively 660 and 48,000 volunteers from 19 to 80 years. The anti-RBD titers were evaluated using a quantitative ELISA system developed at the Center for Immunoassay, Havana Cuba, and ELECSYS system from Roche. The RBD to ACE2 plate-based binding competitive ELISA was performed to determine the inhibitory activity of the anti-RBD polyclonal sera on the binding of the hFc-ACE2 coated plates. The neutralization antibody titers were detected by a traditional virus microneutralization assay (MN50). Finding(s): The Abdala vaccine reached 92.28% efficacy. The epidemic was frankly under control in Cuba after the vaccine introduction having reached the highest levels of cases and mortality in July 2021 with the dominance of the Delta strain. The peak of the Omicron wave, unlike other countries, did not reach half of the cases of the Delta wave with a significant reduction in mortality. The mucosal vaccine candidate "Mambisa" completed its clinical development as a booster dose for convalescent subjects reaching the trial end-point. Conclusion(s): Vaccine composition based on RBD recombinant antigen alone is sufficient to achieve high vaccine efficacy comparable to mRNA and live vaccine platforms. The vaccine also protects against different viral variants including Delta and Omicron strains.Copyright © 2023

Lithium salts as a treatment for COVID-19: Pre-clinical outcomes.

INTRODUCTION: Identifying effective drugs for Coronavirus disease 2019 (COVID-19) is urgently needed. An efficient approach is to evaluate whether existing approved drugs have anti-SARS-CoV-2 effects. The antiviral properties of lithium salts have been studied for many years. Their anti-inflammatory and immune-potentiating effects result from the inhibition of glycogen synthase kinase-3. AIMS: To obtain pre-clinical evidence on the safety and therapeutic effects of lithium salts in the treatment of COVID-19. RESULTS: Six different concentrations of lithium, ranging 2-12 mmol/L, were evaluated. Lithium inhibited the replication of SARS-CoV-2 virus in a dose-dependent manner with an IC50 value of 4 mmol/L. Lithium-treated wells showed a significantly higher percentage of monolayer conservation than viral control, particularly at concentrations higher than 6 mmol/L, verified through microscopic observation, the neutral red assay, and the determination of N protein in the supernatants of treated wells. Hamsters treated with lithium showed less intense disease with fewer signs. No lithium-related mortality or overt signs of toxicity were observed during the experiment. A trend of decreasing viral load in nasopharyngeal swabs and lungs was observed in treated hamsters compared to controls. CONCLUSIONS: These results provide pre-clinical evidence of the antiviral and immunotherapeutic effects of lithium against SARS-CoV-2, which supports an advance to clinical trials on COVID-19's patients.

Educating health professionals about COVID-19 with ECHO telementoring

Background: When the COVID-19 pandemic began, primary care clinicians had almost no knowledge regarding best practices COVID-19 treatment. Project ECHO developed a COVID-19 Infectious Disease Office Hours (Office Hours) program to respond to the needs of clinicians seeking COVID-19 information. Methods: This mixed-methods evaluation analyzed weekly post-session data and focus group results from the weekly Office Hours ECHO sessions during June 1, 2020-May 31, 2021. Results: A total of 1,421 participants attended an average of 4.9 sessions during the 45 Office Hours sessions studied. The most common specialties included: nurses= 530 (37%), physicians= 284 (20%), and 493 (34%) having other degrees. The participants stated that they were definitely (68.2%) or probably (22.0%) going to use what they learned in their work, especially vaccination information. Focus group results identified these themes: 1) quality information, 2) community of practice, 3) interprofessional learning, and 4) increased knowledge, confidence, and practice change. Conclusions: This evaluation demonstrates that the Office Hours program was successful in bringing a large group of health professionals together each week in a virtual community of practice. The participants acknowledged their plans to use the information gained with their patients. This diffusion of knowledge from clinician to patient amplifies the response of the program, changes practice behavior and may improve patient care. (c) 2021 The Author(s). Published by Elsevier Inc. on behalf of Association for Professionals in Infection Control and Epidemiology, Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/)

Implementation and providers' views of a pharmacist clinician on an inpatient infectious diseases consult service at an academic medical center

Introduction With the ongoing physician shortage in the field of infectious diseases (ID), innovative models to care are needed to satisfy health care requirements, especially as we face the growing demand of the current coronavirus disease 2019 (COVID-19) pandemic. In New Mexico, Pharmacist Clinicians (PhC) are uniquely fitted to aid ID physicians through additional training and licensing that allows for a collaborative practice model. Objectives The primary objective of this study is to describe the integration of a PhC with a rounding ID attending, utilizing an innovative practice model at an academic medical center, and report providers' views as related to this new position. Methods This was a survey study directed toward primary treating teams and ID attendings, conducted after six months of the creation of the PhC position. One survey was designed specifically for primary treating teams and another survey for ID attendings only. Primary team providers were identified through a log kept by the PhC for every patient intervention. All providers were contacted via e-mail using the REDCap system to evaluate the PhC's communication and ID knowledge by answering three to five multiple choice questions. A quantitative method was used for data analysis. Results Sixty-one (56.5%) providers responded to the surveys. Overall, primary team respondents gave a positive valuation of the position. ID attendings also generally approved of the position and had a similar view to that of the primary teams. The PhC was found to be effective by 92.5% of respondents. The lowest scoring area was the physical exam. There was no significant difference when comparing responses between primary teams and ID attendings. Conclusion An inpatient pharmacist clinician is able to manage complex ID patients to the satisfaction of both ID physicians and members of the primary treating teams in an academic medical center.

Organizational experience of the civil defense scientific research center in the diagnosis of COVID-19

Facing the COVID-19 epidemic in Cuba has required the development of new capacities for its diagnosis in the molecular biology laboratories of different scientific and health institutions. The objective of this work is to show the experience of the Cuban Civil Defense Scientific Research Center in organizing the diagnosis of COVID-19. Guiding documents for the Center's work, its biosafety program, and those reported by the World Health Organization for dealing with the pandemic were reviewed. The experience of the structure adopted by the entity to ensure an uninterrupted diagnosis, the functions of the Steering Group and the sequence of activities carried out is exposed;highlighting the training of personnel in the management of biological risks and the prevention measures adopted. The proper use of collective and individual protection means, the safe handling of biological samples and cooperation with other entities, have allowed the fulfillment of the entrusted task, without the occurrence of accidents that compromise the health of the personnel working in the diagnosis, nor effects on the community and the environment. © 2021, Editorial Ciencias Medicas. All rights reserved.