The National Administration of Medicines, Food and Medical Technology (ANMAT) authorized this Monday the start of the studies of Phases II and III to assess the safety, tolerability and immunogenicity of the national vaccine “ARVAC Cecilia Grierson” against the coronavirus, developed jointly by the Conicet, the National University of San Martín (UNSAM) and the Pablo Cassará Laboratory.
“Having a nationally produced vaccine against Covid-19, developed by Argentine researchers, is a concrete example of what we can achieve when the public and private sectors join forces and work together,” said the Minister of Health, Carla Vizzottiwho also highlighted the boost given to this initiative by President Alberto Fernández.
Vizzotti clarified that this achievement would not have been achieved without the synergy achieved between the Ministry of Science, Technology and Innovation, of Productive Development, the Conicet, the National Agency for the Promotion and Research, Technological Development and Innovation, the universities and the pharmaceutical industry.
Meanwhile, the Minister of Science, Technology and Innovation, Daniel Filmuscelebrated “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.”
“It is the first time that Phase II and III studies have been carried out in the country for a nationally developed vaccine”added
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After the approval of ANMAT, the “ARVAC Cecilia Grierson” (ARVAC CG) vaccine is in a position to advance with Phase II and III clinical studies, which will be carried out in adult volunteers previously vaccinated against the SARS-CoV-2 virus, he added. the official statement.
The search for this population is aimed at people who have already reached 18 years of age or older, who are healthy and who have received two doses of the primary scheme of the Covid-19 vaccine, to whom the scheme will be applied. booster of the study vaccine.
The interdose periods will be those recommended by the Ministry of Health in the published vaccination schedules.
The official statement highlights that from the partial results of Phase I, preliminary safety information was obtained that demonstrated that the “ARVAC Cecilia Grierson” vaccine is safe and highly immunogenic.
In turn, it was found that a booster dose increases up to 30 times the neutralizing antibodies against the Omicron and Gamma virus variants.
Juan Carlos Cisnerosinfectious disease doctor and deputy director of the Muñiz Hospital, told Télam that what was announced this Monday “is a very important advance because it shows that in the future this vaccine can be tested in people to evaluate its effectiveness. This, in the future, can be used both from the sanitary and commercial point of view”
For his part, lautaro de vediainfectious disease doctor at Hospital Muñiz and former president of the Argentine Society of Infectious Diseases (SADI) indicated: “Although it represents progress, this is not the end of the investigation. The vaccine study lasts for four phases. In the first phase is checked if the medication or vaccine is safe”
De Vedia added that, in this phase, the ARVAC vaccine will be compared with others developed abroad, in order to check its effectiveness.
“This is good news, since the first phase demonstrated that the vaccine safely generated immune responses against the virus and this measure opens the door to continue research,” he completed.
For his part, the doctor Omar Tobaccoformer president of the Argentine Society of Pediatrics, said that “it is good news that the development of phases 2 and 3 of a clinical study has been approved by Anmat. The applied technology is very safe and effective in the vaccines used up to now with this platform.
Tabacco pointed out that this advance reminds him of the development of the hepatitis B vaccine in the 1990s, and emphasized that this “could end the vertical transmission from mother to child during childbirth, with the application in the delivery room of the first dose to newborn
Designed for booster doses in people already immunized, the “Arvac-Cecilia Grierson” vaccine is based on recombinant protein technology, a safe technology that has already been applied in Hepatitis B vaccines in newborn children for more than 20 years. years or more recently, HPV. It is a platform that has demonstrated security and can be easily adapted to the emergence of new variants at a regional or global level.
In addition, this vaccine can be stored between 2 and 8°C (refrigerator temperature), which will allow the doses of ARVAC Cecilia Grierson, unlike the first vaccines against COVID-19, to be cheaper, easier to produce and to distribute.
