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Phase II and III clinical studies of the ARVAC CG vaccine will be carried out in adult volunteers previously vaccinated against the SARS-CoV-2 virus.
The Ministries of Science and Health announced that the Argentine National Administration of Medicines, Food and Medical Technology (ANMAT) authorized the start of Phase II and III studies to evaluate the safety, tolerability and immunogenicity of a nationally produced vaccine.
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The national vaccine against COVID-19: “ARVAC Cecilia Grierson” (ARVAC CG), is now able to advance with Phase II and III clinical studies. It is intended for booster doses in people already immunized.
The studies in phases II and III will be carried out in adult volunteers previously vaccinated against the SARS-CoV-2 virus. Thus, healthy people over 18 years old, having received two doses of the preliminary schedule of the vaccine against COVID-19, will get the booster schedule of the vaccine in the study.
The Ministry of Health said that from the partial results of Phase I, preliminary safety information was obtained showing the vaccine "is safe and very immunogenic. In turn, it was found that a booster dose increases up to 30 times the neutralizing antibodies against the Omicron and Gamma virus variants."
La vacuna argentina contra COVID-19 sigue avanzando: la @anmatsalud autorizó el inicio de los estudios de fases II y III. La ARVAC Cecilia Grierson es desarrollada por la UNSAM, el @CONICETdialoga y el Laboratorio Cassará. Enterate los detalles acá ���� pic.twitter.com/dnpfjivloy
— UNSAM (@unsamoficial) January 10, 2023
The Argentine vaccine against COVID-19 continues to advance: the
ANMAT authorized the start of phase II and III studies. The ARVAC Cecilia Grierson is developed by UNSAM, the CONICET and the Cassará Laboratory.
"Having a nationally produced vaccine against COVID-19, developed by Argentine researchers, is a concrete example of what we can achieve when the public and private sectors join forces and work together," said the Minister of Health, Carla Vizzotti.
"It is the first time that Phase II and III studies have been carried out in the country for a nationally developed vaccine," said the Minister of Science, Technology and Innovation, Daniel Filmus, who calebrated the good news noting that this "allows us to continue with this project necessary for the health of Argentines and health sovereignty."
According to official information, the vaccine can be stored between 2° and 8 °C, which will make the doses "more economical, easier to produce and distribute."
The ARVAC CG based on recombinant protein technology is developed jointly by the Argentine Scientific and Technical Research Council (CONICET), the National University of San Martín (UNSAM) and the Pablo Cassará Laboratory.
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