The first vaccine against COVID-19 developed in Argentina is to be tested on humans during phase 1 trials, it was announced Wednesday in Buenos Aires.
The Argentine Government said the drug named ARVAC Cecilia Grierson will move on to Phase 1, according to a joint announcement from Health Minister Carla Vizzotti Science Minister Daniel Filmus.
Vizzotti said the National Medications Agency (ANMAT) had given the green light for the new step. The serum has been developed by the National University of San Martín (Unsam), the National Science Institute (CONICET), and the Pablo Cassará laboratory.
Project Director Juliana Cassataro said that the vaccine that we are going to evaluate in humans is intended as a booster vaccine.
From phase 1, the most important and central objective is to evaluate the safety of the vaccine, then the immune response and its efficacy, she added.
ARVAC is a recombinant vaccine intended, in principle, as a booster dose for the population already vaccinated and to combat new variants of the coronavirus, aimed therefore at the majority of the Argentines, who have already been injected.
The developers also hope to someday be able to export the drug regionally. They had received funding from Filmus' ministry for the production of ARVAC. Phase 1 trials will be on 80 participants, half men, and half women.
In order to reach the approval it requires a process, all the data and the proposal were presented throughout last year. ANMAT was in contact with the Cassará laboratory, Vizzotti explained.
On December 31 the dossier was submitted to evaluate the clinical trial. Until March 2, the evaluation and the observations were generated. On March 23, with the satisfactory response from the researchers, the study was approved, she added.