The Argentine bivalent ARVAC vaccine against COVID advances steadily and promises to stop Ómicron and its subvariants

The ARVAC Cecilia Grierson vaccine is made on Argentine soil in all its stages: research, development, production, packaging and completion.

The Argentine bivalent vaccine ARVAC Cecilia Grierson is a clear example of the joint efforts between public and private actors in the Argentine scientific system: the formula is a joint development between CONICET, the National University of San Martín (UNSAM) and the Pablo Cassará Laboratory. It is a second generation vaccine for booster doses in people already immunized.

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The good news is that this national development continues to advance: the National Administration of Medicines, Food and Medical Technology (ANMAT) authorized the start of Phase II and III studies.

In this next stage, the objectives will be to “evaluate the safety, tolerability and immunogenicity”, according to what was announced by the Ministry of Health of the Nation this Monday.

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Previous results (from Phase I in humans) demonstrated that the ARVAC-Cecilia Grierson vaccine is safe at the tested doses of 25 and 50 micrograms and highly immunogenic against the original variant of SARS-CoV-2 first identified in Wuhan. (the ancestral variant of COVID-19), and also against Gamma and Ómicron, since it induced up to 30-fold increases in the titer of neutralizing antibodies against the virus.

The scientists Cassataro and Rodríguez told Infobae the details of the results of Phase I of the Argentine vaccine against COVID ARVAC-Cecilia Grierson

Among its comparative advantages, the ARVAC-Cecilia Grierson vaccine uses a technological platform of recombinant proteins that makes it a flexible product to adapt the antigen to the new variants of the SARS-CoV-2 virus in a short time, available to the country and the Latin America region; and also offers a longer period of immunity against the SARS-CoV-2 virus than has been demonstrated so far by messenger RNA vaccines. The name of this vaccine, moreover, is loaded with meaning for the scientific universe and for the entire population: Cecilia Grierson was the first Argentine doctor.

Phase II/III would begin in the first quarter of the year, so that, finally, the vaccine is approved by ANMAT during 2023. Clinical studies in this stage “will be carried out in adult volunteers previously vaccinated against the SARS-CoV-2 virus ″, reported from the portfolio led by Carla Vizzotti.

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People who want to participate in this stage 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.

The Argentine vaccine against COVID, “ARVAC Cecilia Grierson” is developed by CONICET, the National University of San Martín (UNSAM) and the Pablo Cassará Laboratory

“This is the first time that Phase II and III studies have been carried out in the country for a nationally developed vaccine,” said the Minister of Science, Technology and Innovation, Daniel Filmus. Who also celebrated “the effort of our scientists, the articulation between different public and private actors, and the joint work with the Ministry of Health, which allows us to continue with this necessary project for the health of Argentines and for health sovereignty.”

ARVAC Cecilia Grierson’s formula is based on recombinant protein technology and, among the key benefits for dose distribution logistics, does not require ultracold. “It can be stored between 2 and 8°C (refrigerator temperature), which will make the ARVAC doses cheaper, easier to produce and distribute,” the National Ministry of Health highlighted.

Recombinant protein technology is already used in other immunizing formulations. as against Hepatitis B in newborn children. “It is a platform that has demonstrated its safety and that can be easily adapted to the emergence of new variants at a regional or global level,” they highlighted from the Health area.

Juliana Cassataro (in the center) and the UNSAM-CONICET team. ARVAC is a second generation vaccine designed to be used as a booster dose.

In December 2022, the Ministry of Science and Technology of the Nation allocated financial support of 1,100 million pesos to the project, in order to carry out Phases II and III. Now, with the aforementioned ANMAT approval, the development of this national vaccine can go ahead.

“Today it is known that the immunity period offered by current COVID vaccines is not long-term, so boosters will be needed to extend immunity. In the future, vaccination against COVID will be annual, similar to that of the flu; this is still under discussion in the world. The technology exists in Argentina and the industrial capacity to produce it, the capacity already installed in our region”, Juliana Cassataro, biologist (UNSAM), doctor in Immunology and leader of the UNSAM-CONICET team, explained to Infobae.

As specified by the Science portfolio led by Filmus, this immunization is advancing in a context where, according to the latest report of the PAIS Project (Argentine Inter-Institutional Project for SARS-CoV-2 Genomics), issued on December 13, 2022, predominates the Omicron variant and its derivatives.

When the results of the Phase I studies were known, Juan Manuel Rodríguez, biologist and coordinator of the R&D area of ​​biopharmaceuticals at the Pablo Cassará Laboratory and Foundation, had pointed out to Infobae: “The platform we have already allows us to make a change of variant or genetic construct in approximately four months. We are working to improve the times of obtaining clones through more modern technologies. And that could shorten our times even more and it is something that will remain as a platform to be able to generate other vaccines, from COVID or from another infection of the coronavirus family, such as the respiratory syncytial virus ”.

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

The basic research and development of this project was carried out by Cassataro and team; while of the production in scale and equipment of Cassará, Juan Manuel Rodríguez and team. In turn, more than 100 people including scientists, technicians and researchers make up the groups of this ARVAC-CG work, which was selected by the National Agency for the Promotion of Research, Technological Development and Innovation (I+D+ Agency i) within the framework of the Coronavirus Unit, an initiative coordinated by the Agency itself, the Ministry of Science and Technology and CONICET.

“This is a project that focuses Argentina’s scientific-technological capacity on solving specific needs with a high health and economic impact. The project is going to install a platform for the development and production of recombinant vaccines that can be used for new vaccines in the future,” Jorge Cassará, director of the homonymous Laboratory, had told Infobae.

The ARVAC Cecilia Grierson project is the sum of the coordinated effort of more than 100 people from different disciplines belonging to nine public and private institutions: National University of San Martin (UNSAM), CONICET, Pablo Cassará Foundation, Pablo Cassará Laboratory, Center for Comparative Medicine from the National University of the Coast (CMC UNL), FP Clinical Pharma, Nobeltri, Institute for Biomedical Research in Retroviruses and AIDS of the University of Buenos Aires (INBIRS) and CEMIC.

Keep reading:

The Argentine ARVAC vaccine Cecilia Grierson against COVID seen in three fundamental keys ANMAT authorized Phase II/III of the Argentine ARVAC bivalent vaccine against coronavirus: when do clinical trials begin What do the results of Phase I in humans say about the 100% vaccine Argentina ARVAC-Cecilia Grierson against COVID? The new variants of Omicron that are worrying the world in 2023: what is known about them and what symptoms do they cause?

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