Colombia to Test Johnson & Johnson Covid-19 Vaccine in September
Colombia Health Minister Fernando Ruiz announced August 24 that 60,000 volunteers here will participate in a test next month of a Covid-19 vaccine developed by U.S.-based health-care giant Johnson & Johnson’s Janssen subsidiary.
“With this [Janssen] company we have been working for more than a month in conversations about the possibility of conducting phase-3 clinical studies in Colombia, which is the last stage with which to verify whether a vaccine can be effective,” Ruiz said.
Janssen “has already shortlisted a significant number of research centers in Colombia which will be carrying out this study,” according to the Health Ministry.
“The clinical study will be carried out with a single dose in up to 60,000 healthy volunteers between 18 and 60 years old, and will be conducted by local research centers that will be in charge of convening the participants,” the Ministry added.
The trial aims to determine “the feasibility and efficacy of this vaccine,” according to Ruiz.
“We continue to work with other pharmaceutical companies, in accordance with the instructions of the President [Ivan Duque], with the support of the Foreign Ministry and with the support of other ministries, to have clarity and to be able to continue effectively in defining possibilities for the country of access to the vaccine,” he added.
The Colombian clinical study will begin “once the provisional data are available from the phase-1 and phase-2 clinical studies, which are underway in the United States and Belgium,” he said.
A confidentiality agreement has already been signed for access to the vaccine. “Additionally, the Ministry has been conducting other conversations with other pharmaceutical companies privately,” he said.
“Scientific data analysis was used for this decision to plan where these studies should take place, and the final selection of countries was determined in close collaboration with local governments and health authorities.
“The current prevalence of the disease, the demographics of the population and the requirements of regulatory authorities were taken into account to ensure that the study can be carried out properly and provide relevant data to inform about its potential use of emergency,” the Ministry added.