The Ministers of Health, Carla Vizzotti, and of Science, Technology and Innovation, Daniel Filmus, announced that the National Administration of Medicines, Food and Medical Technology (Anmat) approved the start of Phase 1 of the ‘Arvac Cecilia Grierson’ vaccine against Covid-19 and supported by these ministries together with the Productive Development Ministry.
Both ministers considered it as “a historical fact that we have been developing with great pride”, and highlighted “research with development and the positive impact on the health of Argentines,” they stated in a joint conference at the Ministry of Science, Technology and Innovation.
The Covid-19 vaccine developed entirely in Argentina by researchers from Unsam and Conicet in conjunction with the Pablo Cassará Foundation and the Cassará Laboratoryenters, in this way, in Phase 1 in humans “to evaluate the safety, tolerability and immunogenicity of the recombinant protein vaccine” with trials authorized by Anmat”, confirmed from the Ministry of Science and Technology.
From the agency they also clarified that “that these trials are necessary to advance in the objective that the Arvac Cecilia Grierson vaccine is available as a reinforcement of current vaccines.”
“We are in a historic moment. The #vaccine Argentina against the coronavirus has achieved the approval of @ANMATsalud and advances to the last stretch: clinical studies. It is an example of synergy with research and development”, says Minister @carlavizzotti https://t.co/0zvBOwRCOV
— Ministry of Science, Technology and Innovation (@ciencia_ar) March 30, 2022
This process of technological and scientific development was considered as “a historical fact of Argentine science. In Argentina, most of the population is vaccinated, and the focus of the group of researchers developing the vaccine (Unsam/Conicet) is currently on the prototype booster vaccine and change of variant”.
Scientists began the development of this vaccine in June 2020, and in December 2021 they concluded preclinical studies in non-humans, “and it was found that the vaccine prototype, in addition to being safe, induces neutralizing antibodies against the variants that circulate in the country, as well as a T cell response and protection against the experimental challenge with SARS-CoV-2. This is why Anmat has made it possible to advance with studies in humans”, they explained.
This vaccine prototype is the first designed in an Argentine public university that gets to conduct Phase 1 trials.
They also explained that this phase “will involve 80 healthy volunteers who have already received a complete previous vaccination schedule and who, if it is found that they meet all the criteria established by protocol (eligibility criteria), will receive a booster schedule of the vaccine in study”.
The vaccine “Arvac-Cecilia Grierson” It is based on recombinant proteins, a safe technology that has been used in Hepatitis B vaccines for more than 20 years. or more recently, HPV, and can be stored at 2 to 8 degrees, a “refrigerator” temperature
Finally, it was reported that the preclinical studies were financed by the R&D&i Agency (in the framework of a Fonasec project) of the Ministry of Science, Technology and Innovation, and the development and industrial scaling of the biotechnological process, as well as the Phase 1 clinical study, are financed by the Pablo Cassará Laboratory.
