ANMAT, ARVAC Argentina's bivalent vaccine against coronavirus II/III.  Phased out: when will clinical trials begin

ANMAT, ARVAC Argentina’s bivalent vaccine against coronavirus II/III. Phased out: when will clinical trials begin

Argentina's vaccine against COVID,
Argentina’s vaccine against COVID “ARVAC Cecilia Grierson” is responsible for CONICET, the National University of San Martín (UNSAM) and the Pablo Cassará Laboratory.

It Monday, January 9National Drug, Food and Medical Technology Administration (ANMAT) allowed work to start Phase II and II between bivalent vaccine National “ARVAC Cecilia Grierson” was developed between CONICET, the National University of San Martín (UNSAM) and the Pablo Cassará Laboratory. At this next stage, the objectives will be to “evaluate safety, tolerability, and immunogenicity,” as described by the US. Ministry of Health this is an explanation.

As mentioned, this new phase first quarter of the yearso the vaccine was finally approved by ANMAT in 2023. Clinical trials at this stage “will be carried out in adult volunteers who have been previously vaccinated against the virus. SARS COV-2″, reported from the leading portfolio. Carla Vizzotti.

“The search for this population (volunteers) is aimed at individuals aged 18 years and older who are healthy and have received two doses of the primary vaccine against COVID-19. The booster scheme of the vaccine under consideration. Inter-dose periods, vaccination published by the Ministry of Health There will be recommended times in their programs,” they added.

Argentine bivalent vaccine advancing to a new phase in clinical trials /
Argentine bivalent vaccine advancing to a new phase in clinical trials /

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

in that tone, Vizzotti Have a nationally produced vaccine against COVID-19 developed by Argentine researchers, It is a concrete example of what we can achieve when the public and private sectors work hand in hand.”. “This is a collective achievement that includes the commitment of many actors and makes us proud, as it not only marks a milestone for our healthcare sovereignty, but affects the entire region.”

This new phase is based on the partial results of Phase I where “preliminary safety information has been obtained” showing that the “ARVAC Cecilia Grierson” vaccine is safe and highly immunogenic. In contrast, because this immunization is based on recombinant protein technology, the booster dose was found to increase neutralizing antibodies against Ómicron and Gamma virus variants by up to 30 times, with “Can Be Done” among its benefits. Storing between 2 and 8°C (refrigerator temperature) will make it easier to produce and distribute doses of ARVAC more cheaply.”

Juliana Cassataro (UNSAM - CONICET) and Juan Manuel Rodríguez (coordinator of the Pablo Cassará Laboratory and Foundation's biopharmaceutical R&D area) during their presence at Infobae studios
Juliana Cassataro (UNSAM – CONICET) and Juan Manuel Rodríguez (coordinator of the Pablo Cassará Laboratory and Foundation’s biopharmaceutical R&D area) during their presence at Infobae studios

It should be noted that the “ARVAC-Cecilia Grierson” vaccine is one of the most advanced national developments in this field. This immunization is based on recombinant protein technology that has been applied in other formulations against Hepatitis B in newborn children. From the healthcare space, “This is a platform that has proven safe and is easily adaptable to the emergence of new variants at the regional or global level.”

In December 2022, Nation’s Ministry of Science and Technology Provided financial support of 1,100 million pesos to the project to complete Phases II and III. Now, with the above-mentioned ANMAT approval, development of this national vaccine can be continued.

Juliana Cassataro, formerly a biologist (UNSAM), PhD in Immunology and leader of the UNSAM-CONICET team, data base: “At the time of the pandemic, Argentina had to wait for vaccine manufacturers to supply the vaccines to the countries where they were installed. It is very important that we have our own platform for the region so that it does not happen again if there is a new pandemic or if the variants circulating in our region are not the same as in the north.”

Phases II and III will be developed in the first quarter of 2023
Phases II and III will be developed in the first quarter of 2023

As stated by the leading Science portfolio Movies, this vaccination proceeds in a context dominated by the Ómicron variant and its derivatives, according to the latest report of the PAIS Project (Argentine Interagency SARS-CoV-2 Genomic Project), published on 13 December 2022. “In the field of development, we continue to create a bivalent vaccine that will contain two antigens, two recombinant proteins (combining the Gamma and Omicron variants BA4 and BA5).” data base Juan Manuel Rodríguez, biologist (UBA) and R&D field coordinator of biopharmaceuticals at the Pablo Cassará Laboratory and Foundation.

Basic research and development of this project was carried out by Cassataro and his team; the scale and equipment of Cassará, Juan Manuel Rodríguez and their team during production. Selected by the National Agency for the Promotion of Research, Technological Development and Innovation (I+D+ Agency i), this ARVAC-CG study group consists of more than 100 people, including scientists, technicians and researchers. The agency itself is within the framework of the Coronavirus Unit, an initiative coordinated by the Ministry of Science and Technology and CONICET.

“This is a project that focuses Argentina’s scientific-technological capacity on solving specific needs with high health and economic impact. The project will establish a platform for the development and production of recombinant vaccines that can be used for new vaccines in the future.” data base Jorge Cassará is the director of the Laboratory of the same name.

This project is trying to solve
According to Jorge Cassará, one of the lab’s directors, this project aims to address “special needs with high health and economic impact.”

The aforementioned Rodríguez, for his part, underlined: “This type of technology (product based on recombinant proteins) is stored in the refrigerator (2 – 8 °C) and can last for a year, so it is important for distribution to remote locations without access to a -70 degree freezer. “Another issue is that this platform already has a production capacity in the region. There are already plants producing monoclonal antibodies and they can produce them throughout the country,” he said.

During its development, this project received different reinforcements and support from various organizations and contributions from the Cassará Laboratory to resolve the scaling, production and funding issues of the phase 1 clinical trial. Throughout the process, ANMAT supervised the design of the tests. and evaluated the results.

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