A new milestone for Argentine science: lThe ARVAC vaccine, created and designed by scientists from Conicet, the National University of San Martín (Unsam) and the Pablo Cassará Foundation, and approved by Anmat, begins its commercialization stage and will be available throughout the countryand can be prescribed by doctors as a booster dose against circulating variants of the Sars-CoV-2 virus.
Four years after the start of the pandemic, The virus continues to be the respiratory virus that most infects the population. In 2023, deaths from causes linked to covid exceeded deaths from flu five timesaccording to data from the National Epidemiological Bulletin of the Ministry of Health of the Nation.
According to the Argentine Society of Infectious Diseases (SADI), since it was established as a respiratory virus, the new coronavirus has been the most frequent among respiratory infections in patients requiring hospitalization. The majority of those hospitalized for respiratory infections have a diagnosis of Covid-19.
“Even if one is already vaccinated, a booster must be given to keep the immune response high and for the body to recognize the new variants of Sars-CoV-2,” explains Juliana Cassataro, director of the ARVAC project and researcher at Concet and the Unsam. And she adds: “With this project, a dream we had came true since we were able to see how a scientific development that began on our laboratory counter became a medicine that is transferred to society to care for the health of the population.”.
“Unlike newer technology pandemic vaccines, Arvac is based on the same technology we used in the company 30 years ago to develop the AgB vaccine against Hepatitis Bwhich has been applied since that time in newborn children. These types of vaccines, based on recombinant proteins, have very low reactogenicity, that is, what people perceive as more frequent adverse effects.. This feature, added to its temperature stability from 2 to 8°Cthe definitive registration of Anmat and its availability in pharmacies make it the ideal vaccine for this new post-pandemic stage”says Jorge Cassará, Commercial Director of the Pablo Cassará Laboratory that produces and markets the development.
“This availability facilitates the population’s access to vaccination, since pharmacies are widely distributed throughout the country. Pharmacists are trained to provide this service and to generate a vaccination record through the Siafar System,” highlights Ricardo Pesenti, president of the Argentine Pharmaceutical Confederation (Cofa). And he adds: “It is important to know that ARVAC can be applied together with the flu vaccine (influenza)”.
Regarding coverage, the Pablo Cassará Laboratory clarifies that “As the State still has current contracts for the purchase of pandemic vaccines, ARVAC will initially be available on the private market at a price of $23,000and we are carrying out the necessary steps for social security to provide significant coverage, especially for risk groupseven before its incorporation into the national vaccination calendar scheduled for 2025.”
At the meeting of the National Immunization Commission (CoNaIn) on April 11 of this year, The incorporation of the Covid-19 vaccine into the National Vaccination Calendar was recommended (CNV). Furthermore, this commission recommended consider the use of ARVAC according to programmatic analysis. He also considered it convenient to unify the indications for the flu vaccine and the coronavirus vaccine.
The presence of this Argentine vaccine in pharmacies occurs in a context in which the World Health Organization (WHO) declares that despite the end of the public health emergency due to COVID-19, The pathology remains a global public health priority and recommends a booster dose for risk groups (people with multiple comorbidities, immunosuppressed and other cases) and also for people over 50 years of age.
“Clinical studies have shown that ARVAC generates seroconversion (antibodies) in more than 90% of those vaccinated. Regarding security, no serious adverse events have been observednor laboratory modifications of clinical relevance, and its local and systemic adverse effects are very low,” explains Roberto Gómez, medical director of the Pablo Cassará Laboratory and a doctor who graduated from the UBA.
The process of developing the ARVAC vaccine and conducting clinical trials involved a public-private network with more than 600 scientists and professionals from 18 institutions in the country.. The preclinical studies to develop ARVAC were financed by the National Agency for Scientific Promotion (R+D+i Agency), while the development and industrial scaling of the biotechnological process under GMP quality standards (good manufacturing practices) were in charge of the Cassará Laboratory. The clinical trials were financed by the R&D&i Agency, the Ministry of Science and Technology and the Cassará Laboratory..
The Phase I, II and III clinical trials, in which more than 2 thousand volunteers participated, revealed that The ARVAC vaccine is safe and effective as a booster against different variants of the virus Sars-CoV-2.
At the moment the virus continues to mutate and many of these mutations cause it to escape the immune response that has been generated by the vaccine. “That is why, as with the flu virus, the vaccine has had to be adapted to new variants that are circulating, it is very possible that the same will have to be done with ARVAC periodically or when a new variant of concern appears. The vaccine is already adapted and the laboratory is prepared for new adaptations if necessary“We are in contact with the virus surveillance centers and as soon as a variant of concern circulating in our region appears, we begin the process of including it in the vaccine,” explains Cassataro. And he continues: “In 4 months we know that we will be able to have the adaptation process completed. So far, 7 new variants of the vaccine have been produced and in the same phase III trial, three vaccine arms were tested with different variants of the virus in monovalent and bivalent versions. So we are prepared.”
