Saturday July 22, 2023
The group of researchers from Conicet, the University of San Martín and the private laboratory Cassará, which has been working for a couple of years to develop an effective local vaccine against covid-19, took the final steps this week for the approval of Arvac. They submitted essential product documentation to Anmat, Argentina’s drug regulatory body.
Specifically, on Tuesday they delivered to the agency documentation that summarizes the most recent results of phase III of the trial.
The researchers confirmed to PROFILE: “We hope that in a couple of months it can be approved and, from then on, it could be used as reinforcement in future preventive campaigns.” This is so since the Argentine vaccine fulfills the objective of awakening an adequate immune response against the three proven viral variants that are in circulation.
These data were released after finishing a meeting in which the researchers, the Ministers of Health and Science of the Nation, the director of the Agency for the Promotion of Research – which was the one who financed a large part of this local scientific development – and the team in charge of the clinical trial participated. Specifically, it was announced that the fundamental instances of this phase have already been completed and therefore progress is being made towards their eventual registration and approval.
One of the central interventions of the meeting was in charge of the development coordinator, Dr. Juliana Cassataro, who reviewed the results obtained and stressed: “The vaccine meets the objective in terms of immune response, and we are presenting that to Anmat”. They noted that, if the process follows the planned path, within two months the Arvac vaccine could be approved for use in various risk age groups, although – for now – under 60 years of age, since the specific protocol for this subgroup of older adults is still running.
During this meeting held at the Ministry of Health, the possibility of presenting the Arvac to the technical authorities of the Pan American Health Organization (PAHO) was also analyzed so that it could be evaluated internationally. This would allow this product to enter a prequalification process and would make it possible, in the immediate future, to think about a horizon for the entry of this product to those who make up the PAHO “revolving fund” that is in charge of making massive purchases of doses and distributing them among different countries that need them.
That would be one of the possible strategies to be able to export the “Arvac” made in Argentina to the region.
Anyone over the age of 60 who wishes to participate in the study can do so, as the Arvac project researchers continue to look for candidates in that age group to complete that part of the development.
2023-07-22 06:50:55
#Argentine #vaccine #closer #achieving #approval #Perfil.com
