CECMED Authorizes Intervention Trial with Abdala Vaccine Candidate

HAVANA, Cuba, Mar 29 (ACN) The State Center for the Control of Medicines and Medical Devices (CECMED) authorized on Saturday the Intervention Trial with the Abdala vaccine candidate, whose first stage will be carried out on Monday, March 29.

According to information from the institution, the general objective of the trial is to evaluate the direct and indirect effects of vaccination with the vaccine candidate CIGB-66 in population cohorts at high risk of contracting the infection, of disease and of dispersing the COVID-19 epidemic.

Specific objectives of the population-based controlled intervention study with candidate Abdala include demonstrating the direct and indirect effects on the prevention of symptomatic COVID-19 disease, evaluating the effect on preventing severe COVID-19 disease in the selected cohorts and the effect on SARS-CoV-2 mortality in the selected cohorts.

Also to identify and characterize adverse events attributable to immunization with the Abdala vaccine candidate, supported by the surveillance system of the National Immunization Program, and to determine changes in hospitalization rates in the immunized population. Inclusion criteria: Subjects of both sexes, between 19 and 80 years of age who give their consent to participate.

Exclusion criteria in the controlled intervention study population with Vaccine Candidate #Abdala are individuals previously vaccinated with a vaccine candidate or anti-SARS-CoV-2 vaccine, documented history of previous COVID-19 infection by medical questioning, and allergy to any of the vaccine components.

These also include administration of immunomodulators in the 30 days prior to vaccination, decompensated chronic diseases that limit vaccination, pregnancy, puerperium and lactation, acute illness that contraindicates vaccination and HIV-positive subject with detectable viral load.

This trial will begin in its first stage this Monday, March 29, with the inclusion of volunteers belonging to the risk group of health workers, the biopharmaceutical sector and other sectors defined by the Ministry of Public Health.