ARVAC Cecilia Grierson: A Bivalent Booster Vaccine with Export Potential

ARVAC Cecilia Grierson is a bivalent booster vaccine that will be able to adapt to new variants of the virus and will have export potential to the region and the world. The Minister of Science, Technology and Innovation, Daniel Filmus, highlighted the efforts of those who participated in the entire process, which “began at the most complex moment of the pandemic”

When a disruptive and successful event occurs in science, it is necessary – almost essential in the Argentine case – to reconstruct the value chain, what is known as “the timeline” of a unique project made in Argentina as the creation turned out to be, research and production of the Arvac COVID vaccine – Cecilia Grierson. Thus adding another patent relevant to Argentine science.

This morning, national officials, along with scientists and managers involved in the development of the bivalent vaccine against COVID Arvac Cecilia Grierson, gave details this morning about the approval that the National Administration of Drugs, Food and Medical Technology (ANMAT) granted yesterday —as Infobae announced— to the use of this advance made entirely by Argentine science, although no details were given regarding when it will be available for application in the population over 18 years of age for which it is directed.

Starting at 11, in the Malvinas Argentinas room, located in the Scientific and Technological Pole of the City of Buenos Aires, this first vaccine developed entirely in the country was presented to society, as a reinforcement against COVID-19.

The conference was headed by the Minister of Science, Technology and Innovation (MinCyT), Daniel Filmus; his Health partner, Carla Vizzotti; the leader of basic research and vaccine development, the biologist and doctor in Immunology, Juliana Cassataro, researcher at UNSAM and CONICET; and the director of the Laboratory and the Cassará Foundation, Jorge Cassará.

Filmus, in the meeting with the press, expressed its “excitement and pride” for the historic milestone reached and specified that the State “invested $1.7 billion” to achieve it, to which is added the investment of the Cassará Laboratory that reached “around 7 million dollars,” added Jorge Cassará. This included the cost of the pharma company’s “equipment and development expenses,” he said, and revealed that his team is “working on being able to market the vaccine abroad” where there are already advanced conversations with Brazil, Colombia, Mexico, Cuba, Chile and Uruguay and the future “self-sufficiency” of the country in terms of vaccines is being considered.

The health authorities did not give details about when the new vaccines will begin to be applied, which will be available to the population over 18 years of age.

The minister highlighted the efforts of those who participated in the entire process of generating the formulation, which “began at the most complex moment of the pandemic. They decided that they were in a position to do it and they did it” that is why “this is a historic day, it is a milestone and marks a before and after” for the country’s science.

This development was possible through a public-private consortium that included more than 600 scientists and professionals, 25 institutions and 2,094 volunteers. The ARVAC Cecilia Grierson vaccine, one of the so-called second generation or booster vaccines for people over 18 years of age, was developed entirely with Argentine raw materials and scientific resources by the National University of San Martín, CONICET and the Cassará Laboratory, and promoted from the first moment by the Science, Technology and Innovation portfolio and the National Agency for the Promotion of Research, Technological Development and Innovation (R+D+i Agency).

For his part, Vizzotti said that this development is “a safe and effective, quality tool that will allow imports to be substituted and exports to be made. Each step that was taken paved the way for new research” and recalled that, after the creation of the vaccine against Argentine hemorrhagic fever, in the process of which foreign entities intervened, the ARVAC Cecilia Grierson implied that, “for the first time, in the country the entire route will be carried out, including clinical trials that had never been carried out entirely in the country” that is why the presentation of the vaccine marks a “historic day” for Argentine science.

Within the framework of the satisfaction expressed for this unprecedented achievement, it was avoided to specify when they may be available for application to the population for which it is intended. “We have already learned not to give estimated dates,” she responded to Minister Vizzotti, when the press asked her about it.

Then, he highlighted “the importance of CONICET, of the public university and the support of the State, of the centers that participated in clinical research” in a project that was federal in nature. Vizzotti said that the formulation will be declared of interest by the national government to generate an “open purchasing tender” process while exports will be promoted and it will be presented to the Revolving Vaccine Fund of the Pan American Health Organization so that it can be used in other countries.

As Cassataro reiterated this afternoon, after rigorous testing, the ARVAC – Cecilia Grierson recombinant protein platform formulation against COVID-19 proved to be safe and effective as a booster against the SARS-CoV-2 virus in people over 18 years of age. Currently, it is produced at the Cassará plant in the City of Buenos Aires and will be able to adapt to new variants of SARS-CoV-2 circulating in the region.

As Infobae had published, the vaccine has already shown its immunogenicity against different variants of SARS-CoV-2, from the one originating in Wuhan, through Gamma and Ómicron along with its subvariants. In this way, ARVAC Cecilia Grierson can be updated as new variants emerge, because it combines high security by its design, and also, as it is a purified and isolated recombinant protein, the generation of the antigen is done outside the human body. The vaccine may have a variant update in the event of an “immune escape” or the appearance of a new variant in the country or region.

During the press conference, Cassataro explained that “the three vaccine prototypes” that were experimented with, which were for the Gamma, Ómicron and bivalent variants, “significantly increased” the neutralizing antibodies in the volunteers, but “the bivalent was better” because the seroconversion rate exceeded the reference value of 75%, above which the vaccines were going to be acceptable.

National officials, along with scientists and managers involved in the development of the ARVAC Cecilia Grierson COVID vaccine, gave details this morning about the approval that the National Administration of Drugs, Food and Medical Technology (ANMAT) granted yesterday

The three prototypes, he pointed out, increased antibodies by 83.6% for Gamma, 87.1% for Ómicron and bivalent 92%, meaning that the latter is the one that “induces more antibodies” therefore approval was requested from ANMAT. of this version. Cassataro stressed that the development will allow, “when new variants occur, we can continue updating it without going back” because “new variants that escape the vaccines will continue to appear, so we can prepare booster vaccines.”

For his part, Cassará highlighted the public-private partnership that allowed the vaccine to become a reality, explaining that the laboratory made its “contribution by converting the technology of Juliana’s team at UNSAM to an industrial scale with compliance with GMP standards, the cultivation of cells, purification, process validation, validation of analytical methods, stability studies”, among others.

Argentina, he said, “has a very great potential in science and technology to solve the needs of our entire region” and expressed pride in “having accompanied this path and the hope that it can be replicated in many other” scientific projects because “we cannot “To think that everything comes from outside, where they are thinking about other problems and not regional problems.” For this reason, “our responsibility is to keep this development and production network alive, thinking about the future and thinking about a possible new pandemic.”

Last July, it was announced that the Phase III clinical trial had been completed and the presentation of the corresponding information to the ANMAT that began the evaluation process and the rigorous steps in search of its approval, which finally occurred yesterday. This vaccine is part of the so-called second generation or booster dose intended for people already immunized because it appears at a stage in which most people have received one or two doses.

The process followed by the Argentine development against COVID-19

The ARVAC-Cecilia Grierson vaccine is an export raw material because it is a complete development of a technological platform of recombinant proteins, which makes it a flexible product to adapt the antigen to the new variants of the SARS-CoV-2 virus, in a time brief. And it will allow it to be available for the country and the region, since there will be no need to associate or build new production centers with new technologies, everything is here and there is already a successful history of the platform in vaccines against HPV and Hepatitis B. In addition, ARVAC offers a longer period of immunity against the SARS-CoV-2 virus than has been demonstrated so far by messenger RNA vaccines.

2023-10-18 18:26:33
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