The Minister of Health of the Nation, Carla Vizzotti, and her peer of Science, Technology and Innovation, Daniel Filmus, announced the start of clinical safety trials in humans of the Argentine vaccine “ARVAC Cecilia Grierson”. Juliana Cassataro participated in the announcement; leading development scientist, the rector of the National University of San Martín (UNSAM), Carlos Greco, and the head of the Cassará Laboratory, Jorge Cassará.
The Phase I trials that will evaluate the safety, tolerability and immunogenicity of this recombinant protein vaccine were authorized by the National Administration of Medicines, Food and Medical Technology (ANMAT) through provision number 2182/22. It should be noted that these studies are essential to advance the approval process for the ARVAC Cecilia Grierson vaccine and its subsequent availability as a booster for current vaccines.
During the presentation, Vizzotti pointed out that “it is a job that requires a lot of time, articulation, and is part of the synergy that we are carrying out with pride and dedication at the instruction of the President.” In addition, he highlighted the coordination with the Ministry of Science, Technology and Innovation; Productive Development; CONICET; the R+D+i Agency; universities and the pharmaceutical industry to carry out the project.
In this sense, the minister considered that this advance of the ARVAC Cecilia Grierson vaccine is “a historic moment” for Argentine scientific research and development. “It is a fundamental basis for what comes in the future, whether it is other COVID vaccines, or other vaccines, medicines and technological innovations,” explained Vizzotti, who stressed the support and strategic view of the national state in this initiative that may have a “Impact both for the Argentine population, and to export to the entire region.”
For his part, Filmus highlighted the ministerial coordination that this development implied and expressed “it is a pride for Argentine science to have a national vaccine made by our scientists and what it means to bring research and development to the service of people. Before the end of the year we expect a fully developed vaccine in the country to serve our population.”
For his part, the head of the National Agency for the Promotion of Research, Technological Development and Innovation (R+D+i Agency), Fernando Peirano, pointed out that “the project had the support of the Agency from its inception in the framework of the Coronavirus Unit. The capabilities of Argentine science have been translated into a vaccine. This not only gives us sovereignty over a key input, but also opens up economic and productive opportunities.”
The president of CONICET, Ana Franchi, expressed her satisfaction with this important advance and explained: “We are very happy that an Argentine development, of a CONICET researcher at UNSAM, with a large group, has reached this stage, to begin phase 1 of a booster vaccine against COVID. It shows the importance and value of our researchers and the quality of our science. And on the other hand, the joint effort of the three national ministries, together with CONICET, the Cassará laboratory , UNSAM and various actors, to carry out this project and make it a reality. We hope that in a short time it will be available to all our compatriots”.
The Undersecretary of Knowledge Economy of the Ministry of Productive Development, María Apólito, and the director of the Argentine Sectorial Fund (FONARSEC) of the R&D Agency, Laura Toledo, also participated.
Phase 1 will involve 80 healthy volunteers with a complete previous COVID-19 vaccination schedule and who, if it is found that they meet all the criteria established by protocol (eligibility criteria), will receive a booster schedule for the vaccine under study. To carry out studies in humans, it will be carried out in the Autonomous City of Buenos Aires, in a center specially authorized by the ANMAT and whose principal investigator is the pediatric infectologist, Dr. Gustavo Yerino.
“Given that in Argentina most of the population is vaccinated, we are currently focused on the prototype of the booster vaccine and change of variant. In December 2021, we finished the preclinical studies, that is, in ‘non-humans’, finding that our vaccine prototype, in addition to being safe, induces neutralizing antibodies against the variants that circulate in our country, as well as a T cell response and protection against the challenge experimental with SARS-CoV-2. Due to these promising results, the ANMAT has allowed us to advance with studies in humans” explained Juliana Cassataro, doctor in Biological Sciences, CONICET researcher and director of the Laboratory of Immunology, infectious diseases and vaccine development of the Biotechnological Research Institute (IIB- UNSAM) where the vaccine is developed.
It should be noted that the preclinical studies were financed by the R+D+i Agency (within the framework of a FONARSEC project) dependent on the Ministry of Science, Technology and Innovation, while the development and industrial scaling of the biotechnological process under GMP quality standards , as well as the Phase I clinical study, are financed by the Pablo Cassará Laboratory.
“Before industrial production, there are several stages that must be completed: Phase I, which begins now, and whose main objective is to verify the safety of the vaccine, and then phases II and III, which are intended to evaluate not only the safety but also the immunogenicity of the vaccine and that it will include a much larger number of volunteers. This entire process is carried out under the supervision and approval of the ANMAT, the regulatory body for all research studies in clinical pharmacology. We are working to carry out these trials and present the results for evaluation as soon as possible”, added Cassataro.
Vaccine with national seal under public-private articulation. There are currently six COVID-19 vaccine projects designed in Argentina, five of which are financed by the Argentine State; The first to carry out Phase I trials is the “Arvac-Cecilia Grierson” vaccine (UNSAM/CONICET-Cassará), which began its development in June 2020.
“This is the first time that a preventive vaccine designed in an Argentine public university has been able to carry out Phase I trials. It is a milestone for the entire public science and technology system,” said Cassataro.
About the “Arvac-Cecilia Grierson” vaccine. This vaccine is based on recombinant proteins, a safe technology that has already been applied in vaccines against Hepatitis B for more than 20 years or, more recently, HPV. It is a technology that has demonstrated safety and that allows the development of vaccines that are stored between 2 and 8 C (refrigerator temperature). These characteristics could allow the doses of the ARVAC Cecilia Grierson, unlike the first vaccines against COVID-19, to have lower production costs and advantages for distribution logistics.