Finally, in three years of the pandemic, a team of scientists presented the complete results of Phase I of the first vaccine trials against covid developed in Argentina. If the data from the Arvac are preliminary, there are promising indications: the vaccine proved to be safe, in terms of adverse effects and an effective immune response to the virus in the eight people that was tested was initiated. This is the first time that a preventive drug for infectious diseases “made in Argentina” has made it through Phase I clinical studies.
The next step will take place at the beginning of 2023, facing Phase II, and 3 thousand volunteers. If it works, as has now been suggested, the Argentine “Arvac” could become an excellent candidate to be used as an annual booster that will surely be added to the vaccination calendars around the world.
In the presentation, to which PROFILE attended, Juliana Cassataro –researcher who coordinated this initiative– recalled that “this is a joint public-private development, which sums up the efforts and laboratories of the Universidad de San Martín, the Conicet and the private company Cassara. In total, experts worked to achieve the product that, in this first instance, was applied to eight healthy adults previously vaccinated against Sars-CoV-2.
“The results we obtained”, says Cassataro, “demonstrated that it is a safe and also very immunogenic option, and that it induces increases up to three times in the titles of neutralizing antibodies”. These data, as well as other characteristics such as its stability, the fact that the biotechnological platform has a wide area and can be easily preserved in medical refrigerators, define some of its positive points. But its great strength lies in the fact that it is a vaccine that is easily adaptable to future mutations that can experience the virus in a global or local form. This is an ideal candidate for converting it into a periodical resource that can be used in Argentina and other countries, starting next year.
Anyway, what comes out is not simple. Going through Phase II involves testing between 2 and 3 thousand adults, in a dozen cities across the country. Yes, it implies an investment of –at least– US$ 15 million, funds that are not being sought and that, in part, could contribute to the Ministry of Science.
From biology and infectology, Arvac has shown its effectiveness as a possible dose of refouerzo in several ways: in a dose of 50 micrograms it has significantly increased the amount of neutralizing antibodies that had people before and after receiving the vaccine. Neutralizing agents are those that prevent viruses from entering cells and replicating. “This has been tested repeatedly against three coronavirus variants: Omicron, Gamma and Wuhan”, explained Cassataro.
However, the effectiveness was also measured by analyzing the immune response at the cellular scale before and after applying it. “This indicator also gave us very good results: Arvac increased the frequency of T cells that produce IFN-gamma”, said the expert in the presentation talk.
It is worth remembering that this vaccine is based on the technology known as “recombinant proteins”, a safe option that has been used –for decades– to manufacture vaccines against Hepatitis B (used in babies) and against HPV that is applied in teenagers.
“The most interesting thing is that this project, apart from its direct use and the possibility of being able to export, has also installed a platform for the development and the know-how of manufacturing recombinant products that can be used in future vaccinations, against Sars. -CoV-2 or against other respiratory viruses”, commented Jorge Cassará, director of the laboratory. “Having the possibility of producing in our region could be key in the event that there is a new pandemic or if the variants that can circulate in our region are not the same as in the northern hemisphere”, concluded Cassataro.
◆ Until now it has been tried among ochenta adults, who have been vaccinated.
◆ Up to thirty times increase in the titers of neutralizing antibodies against Sars-CoV-2.
◆ Phase II/III will be completed in the first quarter of 2023.
◆ For this, funding close to the US$ 15 million that could be provided by the Ministry of Science is needed.
◆ Can be stored at fridge temperature (2 to 8 degrees centigrade).
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