RIO DE JANEIRO, BRAZIL – Minister of Science, Technology and Innovation Roberto Salvarezza said Tuesday (17) that next year at least one of the vaccines against the coronavirus being developed in Argentina could begin clinical phase trials, i.e. on humans.
“We expect to start phase 1 and 2 human trials next year. This year we are completing the pre-clinical phase,” Salvarezza said.
The Minister recalled that although “there are Argentine vaccine projects in the pre-clinical phase,” one of them is “very advanced, being developed at the San Martín University (UNSAM) with CONICET and Cassará laboratory researchers.”
Salvarezza said that the National Administration of Medicines, Food and Medical Technology (ANMAT) has pointed to “the right path for them to proceed to phase 1 and 2 next year, which is very good news because the unknowns and inconveniences we know will arise” at the time of conducting a trial with humans are gradually being resolved.
The head of the scientific and technological portfolio pointed out that “it is interesting because all vaccine projects employ different technology.”
“One of the projects involves researchers from CONICET and the Leloir Institute, working with adenovirus; another one from the La Plata University; another from INTA Bariloche in collaboration with Bagó; and yet another also from Leloir in collaboration with INTA and INTI.”
Salvarezza recalled that the State “has contributed approximately US$60,000 per project” to enable the completion of pre-clinical phases.
With respect to the most advanced project -called “Arvac Cecilia Grierson” and led by researcher Juliana Cassataro -, he explained that “it consists of a ‘recombinant protein’ vaccine, which uses as an antigen proteins that envelop the virus (S and N).”
On this point, he added that “it is a very safe platform, which is used, for example, in the hepatitis B vaccine.”
Regarding the significance of achieving a national vaccine, he recalled that “it is a question of health sovereignty because the technology is national and because foreign negotiations are not required.”
“It is important to consider that all groups working on their own vaccines, which, as we said before, range from messenger RNA to recombinant protein or adenovirus, would enable Argentina to have vaccines for different types of infectious diseases,” Salvarezza pointed out.
In this respect, he said that “this represents a potential capacity” and cited as an example the case of “the modern Richmond Laboratories plant which can produce millions of doses, and the coronavirus may become secondary, but we will need to tackle other diseases we have and which may emerge.”
On Monday, the president of the National Agency for the Promotion of Research, Technological Development and Innovation Fernando Peirano also pointed out that the ‘Arvac Cecilia Grierson’ project is “the one advancing most rapidly.”
“Work on volunteers, i.e. phase 1, is expected to begin early next year to test the vaccine’s safety and efficacy,” Peirano said.
‘Arvac Cecilia Grierson’ is the first project selected by the National Agency for the Promotion of Research, Technological Development and Innovation within the framework of the Coronavirus Unit it integrates together with the Ministry of Science and CONICET.
Last June, the Agency approved a 60,000,000 pesos (US$617,550) funding to complete the pre-clinical stage of safety and immune capacity studies and to advance to the clinical trials that will assess the safety and efficacy of the ‘Arvac Cecilia Grierson’ in humans.
“It is intended to be a ‘booster’ vaccine,” Peirano explained and said that it could be used to extend the vaccination calendar “including a regular vaccine against the coronavirus.”
In this respect, he stressed the significance of this regular vaccine “being designed, produced and administered in Argentina, and also in Latin America and in other countries of the world.”
The interdisciplinary group of researchers developed two vaccine prototypes that demonstrated the capacity to induce very good levels of virus-neutralizing antibodies and T-cell immune response in animals, in line with the current requirements for vaccines to prevent Covid-19.
“Therefore, Argentina has the potential of a vaccine that undoubtedly represents health, but also development, the capacity to present ourselves to the world and contribute with something that is currently very much needed,” Peirano added.