The safety and efficacy of FINLAY-FR-2/1A, a new protein-based COVID-19 vaccine FINLAYFR2 Soberana02 FINLAYFR1A SoberanaPlus COVID19 Phase3trial clinicaltrial vaccination immunization publichealth pandemic JAMANetworkOpen
By Dr. Priyom Bose, Ph.D.May 7 2023Reviewed by Benedette Cuffari, M.Sc. The severe acute respiratory syndrome coronavirus 2 , responsible for the coronavirus disease 2019 pandemic, has claimed more than 6.92 million lives and infected over 765 million individuals. Most COVID-19 vaccines target the SARS-CoV-2 spike glycoprotein receptor-binding domain to prevent the binding of SARS-CoV-2 to the host angiotensin-converting enzyme 2 receptor.
Several countries, including Iran, Cuba, Venezuela, Belarus, Mexico, and Nicaragua, have approved FINLAY-FR-2 and FINLAY-FR-1A vaccines for emergency use. These vaccines were developed in the Finlay Vaccine Institute of Cuba, manufactured by the Pasteur Institute of Iran, and branded as Pastocovac and Pastocovac Plus.
About the study A recent JAMA Network Open study discusses the results of the randomized, multicenter, double-blind, placebo-controlled Phase III vaccine trial that assessed the safety profile, immunogenicity, and efficacy of FINLAY-FR-1A in Iran. To this end, Cohort 1 was used to evaluate the two-dose regimen of FINLAY-FR-2 , whereas Cohort 2 was administered a two-dose regimen of FINLAY-FR-2 with a third dose of FINLAY-FR-1A .
Two doses of FINLAY-FR-2 were administered intramuscularly, 28 days apart. In cohort 2, FINLAY-FR-1A was introduced as a third dose on day 56. Enzyme-linked immunosorbent assay was performed to measure anti-S1 IgG levels. For cohort 2, VE was significantly higher after the third vaccine dose. More specifically, this vaccine regimen was associated with a VE of 64.9% for preventing symptomatic infection and 96.6% against severe infection and hospitalization.
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