ANMAT authorizes clinical trial for phase 2/3 study of Argentine vaccine against COVID-19

ANMAT authorizes clinical trial for phase 2/3 study of Argentine vaccine against COVID-19

The National Administration of Pharmaceuticals, Food and Medical Technology (ANMAT) has authorized the initiation of Phase II and III studies to evaluate the safety, tolerability, and immunogenicity of the national vaccine “ARVAC Cecilia Grierson” jointly developed by the National University of San CONICET. Martín (UNSAM) and Pablo 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 work hand in hand and work together,” said Carla Vizzotti, the country’s Health Minister. He also underlined the power the President gave to this initiative.

The head of the national health portfolio, Ministry of Science, Technology and Innovation, Productive Development, CONICET, the National Research Promotion Agency, explained that this achievement would not be possible without the synergies achieved between Technological Development and Innovation. universities and the pharmaceutical industry. “It is a collective achievement that includes the commitment of many actors and makes us proud, because it not only marks a milestone for our healthcare sovereignty, but affects the entire region.”

Daniel Filmus, Minister of Science, Technology and Innovation, congratulated “the efforts of our scientists, the articulation between different public and private actors, and the collaboration with the Ministry of Health that has allowed us to continue this.” A necessary project for the health and health sovereignty of Argentines. Phase II and III studies are being conducted for the first time in the country for a nationally developed vaccine.”

After approval by ANMAT, the “ARVAC Cecilia Grierson” (ARVAC CG) vaccine will be able to progress through Phase II and III clinical trials in adult volunteers previously vaccinated against the SARS-CoV-2 virus. The search for this population is aimed at individuals who are currently 18 years of age or older, healthy, and have received two doses of the primary vaccine against COVID-19, and to whom the study’s booster schedule belongs. vaccine. Inter-dose periods will be those recommended by the National Department of Health in published immunization schedules.

It should be noted that, based on partial results from Phase I, preliminary safety information has been obtained showing that the “ARVAC Cecilia Grierson” vaccine is safe and highly immunogenic. In contrast, the booster dose was found to increase neutralizing antibodies against the Omicron and Gamma virus variants by up to 30 times.

The “Arvac-Cecilia Grierson” vaccine, designed for booster doses in people already vaccinated, is based on recombinant protein technology, a safe technology that has been used in hepatitis B vaccines for newborns for over 20 years. HPV. It is a platform that has proven security and is easily adaptable to the emergence of new variants at the regional or global level.

Also, this vaccine can be stored at 2 to 8°C (refrigerator temperature), which will make doses of ARVAC Cecilia Grierson cheaper, easier to manufacture and distribute, unlike the first vaccines against COVID-19.

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