The experts in charge of the Argentine bivalent vaccine against him COVID-19 “ARVAC Cecilia Griersonwill start the monday february 6 the Phase II/III of the process, shaping the final stage with the vaccination of the first volunteer in this stage of the clinical study. At the same time, following the recommendations of specialists and local and international health agencies. The evaluation of a new bivalent version of the formula will begin, with a antigen of Omicron BA.4 and BA.5.
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This vaccine is developed entirely in the country by scientists of CONICETof the National University of San Martin (UNSAM) and of the laboratory Pablo Cassara. The Phase II/III study will be conducted at more than 10 research sites. researchwith the incorporation and contribution of the working group of the doctor and researcher Gonzalo Perez Marc.
As they advanced to infobae from the Pablo Cassará laboratory, at this institution they already have the industrial capacity to produce up to 5 million monthly doses of vaccine antigen, and they plan to start manufacturing them in parallel to the development of the aforementioned Phase II/III studies.
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A few days after the arrival of these new doses in Argentina, the laboratory expert for Latin America detailed to Infobae the results of the latest efficacy studies and what the future annual application would be like.
In the early days of 2023, the National Administration for Drugs, Food, and Medical Technology (ANMAT) had authorized initiation of Phase II/III studies of the project to assess safety, tolerability, and immunogenicity. It should be remembered that ARVAC is a protein vaccine produced by biotechnology, a very safe technological platform that has been used for decades in inoculations for newborn children and adolescents. In fact, Cassará developed and launched the first Hepatitis B vaccine produced in the region in 1997.
This project is the result of the coordinated effort of more than 200 people from different disciplines, belonging to more than 20 public and private institutions and 12 other clinical research sites.
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“During the pandemic, Argentina had to wait for vaccine producers to supply the countries in which they were installed. Having our own platform for the region is very important so that this does not happen again, in case there is a new pandemic or that the variants that circulate in our region are not the same as in the north, ”he had highlighted in dialogue. with infobae Juliana Cassataro, Biologist (UNSAM), PhD in Immunology and leader of the UNSAM-CONICET team working on this vaccine.
For his part, another of the researchers in charge of this development, Juan Manuel Rodriguez, who is a biologist (UBA), and coordinator of the R&D area of biopharmaceuticals at the Pablo Cassará Laboratory and Foundation, had told this medium: “This type of technology (product based on recombinant proteins) is kept in the refrigerator ( 2 – 8 °C) and can last a year; therefore, for distribution to remote locations where they do not have access to a -70 freezer is substantial. And another issue is that this platform already has manufacturing capacity in the region. There are already plants that produce monoclonal antibodies and they can make them throughout the country”.
During ARVAC’s industrial-scale technological process, which began in 2021, 5 antigen production technologies were developed in SARS-CoV-2 Wuhan, Gamma, Delta, Omicron B1 and Omicron BA.4 and BA variants. 5. In the Phase I study it was found that the formula is safe and that it increases up to 30 times the neutralizing antibodies against Wuhan, Gamma and Ómicron. ARVAC is designed as a booster vaccine, it can be stored and transported refrigerated between 2°C and 8°C and, in addition, its active ingredient can be updated to deal with new sublineages of the virus that escape the immune response.
This project began with initial funding from the National Agency for the Promotion of Research, Technological Development and Innovation (R+D+i Agency) of the Ministry of Science and Technology of the Nation, and continued with the investment of the Cassará Laboratory in technological development and in Phase I studies. 4. It is the first time that a vaccine against infectious diseases designed and fully developed in Argentina manages to complete Phase I clinical studies.
Jorge Cassara, director of the homonymous laboratory, had assessed: “This is a project that focuses the Argentine scientific-technological capacity on solving specific needs with a high health and economic impact. The project will install a platform for the development and production of recombinant vaccines that can be used for new vaccines in the future.”
“The vaccine is progressing solidly and is a source of pride for Argentine science. Having a national vaccine designed by our scientists and produced by a private company represents a successful case of public-private articulation with an impact on people’s quality of life”, added the Minister of Science and Technology, Daniel Filmus.
In summary, Phase II/III of the project will begin in the next few days so that, finally, the vaccine is approved by ANMAT during 2023. The clinical studies in this stage “will be carried out in adult volunteers previously vaccinated against the virus SARS-CoV-2″had reported from the Ministry of Health that leads Carla Vizzotti. People who want to participate in this part of the research as volunteers must be over 18 years of age, must be healthy and have received two doses of the primary schedule of the vaccine against COVID-19. The participants will be given the booster scheme of the vaccine under study.
Recently, the Central Bank of the Argentine Republic confirmed the launch of a new $2,000 bill It will go into circulation in the coming months. The color data is that it will carry as images in the form of tributes to Cecilia Grierson, which gives its name to the aforementioned vaccine and is considered the first Argentine medical; to the former Minister of Health and benchmark of sanitaryism, Ramon Carrillo; and to the facade of Malbrán Institute.
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