Personnel specialized in the development of the anti covid-19 vaccine / Télam
The Argentine vaccine against the coronavirus enters the last stage of trials and they are looking for volunteers, also our city, to test it. It is the first time that a phase 3 clinical trial of a local vaccine has been carried out in our country. The safety and immunogenicity of three formulas of the national vaccine will be evaluated in volunteers, it was reported. The results it produces will be presented to the ANMAT for its approval as a booster vaccine.
For now, ARVAC Cecilia Grierson is the first Argentine vaccine to reach phases 2 and 3 of evaluation.
After successfully passing phase 1, demonstrating that it generates an important response of neutralizing antibodies, the Argentine vaccine -developed by Conicet, the University of San Martín and the Cassará laboratory-, begins a call to reach the 2,014 volunteers it needs to complete phase 2/3.
The first stage of phase 2/3 has been taking place since February 6 in two health centers in the City of Buenos Aires (Cemic and Clinical Pharma) where 180 volunteers have already received the vaccine. In the final stage, the vaccine will be tested on more than 1,800 volunteers over the age of 18 who have had at least one booster dose of at least 4 months.
The results of the first stage of the investigation showed that the ARVAC vaccine is “safe and the preliminary values of immune response are promising”; now the most advanced phase of vaccine development must continue to generate the results that will be presented to the National Administration of Medicines, Food and Medical Technology (ANMAT) for approval as a booster vaccine.
THE SILVER CHOSEN FOR THE TEST
Unlike the first stage of this final phase, the clinical trial of the second of the ARVAC Cecilia Grierson will include 10 health centers from different provinces, including: the Clinical Research Center in Salta, the Clínica Privada del Sol in Córdoba , the Platense Medical Institute in La Plata, the Clinical Research Institute and the Children and Family Clinic in Mar del Plata and the Belgrano Clinical Research Center, Vaccinate, the Barrio Parque Medical Center and a prepaid, all in the city from Buenos Aires.
This second stage of phase 2/3 will allow the evaluation of the safety and immunogenicity (ability to generate neutralizing antibodies) of the ARVAC-Grierson vaccine developed based on the Gamma variant, the Ómicron and also a Gamma-Omicron bivariate formulation, common in Argentina.
Intended 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 or more. HPV recently.
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 to distribute.
The development of this vaccine is important, specialists say. due to the possibility in the future of replacing its imports and, in turn, being able to open the doors to foreign markets.
Registration for volunteers is at www.arvac.com.ar, then the Health Centers to which they will be referred will be informed.
