Speaking to I lived the coast for Provincial Radioaffirmed that the phase 2 and 3 studies of the national vaccine “ARVAC Cecilia Grierson” (ARVAC CG) against the coronavirus “have not yet begun” but “have been authorized” by the National Administration of Drugs, Food and Medical Technology (ANMAT).
Within this framework, he explained that of the 10 qualified institutions in the country that will carry out the trials “it will begin in a few days at the first authorized site, which is the CENIC, and then the other sites will be incorporated.” The development of the ARVAC CG will be in conjunction with CONICET, the National University of San Martín (UNSAM) and the Pablo Cassará Laboratory.
On the other hand, Rodríguez gave details of the testing process and stated: “There are approximately a little more than 2,000 volunteers. There will be an initial stage, a phase 2 where the safety and immunogenicity of the vaccine continues to be studied.”
Followed, he added: “A second stage that would be phase 3 that will have the study of three versions of the vaccine: our original vaccine that is formulated with an antigen that represents the Gamma or Manaus variant, then a vaccine that has an antigen with one of the Ómicron variants and also a bivalent vaccine that will contain both gamma and Ómicron antigens”.
Asked about the possibility of the vaccine working as a booster dose, the interviewee said: “From the moment we started working, we knew that if we made progress and had good results, this vaccine would have to be used as a vaccine. of reinforcement and that is how it was thought and that is how it is going to be approved now both in phase one and now in this phase two three ”.
He also indicated that between “four and five months” they hope to start “the regulatory stages to obtain authorization for the commercialization or mass distribution of the vaccine.”
Lastly, he stressed that they also seek to “generate a safe vaccine that can be applied to children” since it is “very similar to that of Hepatitis B in terms of its conception.”
Listen to the full interview:
