AUTHOR=Rojas-Jiménez Gabriel , Solano Daniela , Segura Álvaro , Sánchez Andrés , Chaves-Araya Stephanie , Herrera María , Vargas Mariángela , Cerdas Maykel , Calvo Gerardo , Alfaro Jonathan , Molina Sebastián , Bolaños Kimberly , Moreira-Soto Andrés , Villalta Mauren , Sánchez Adriana , Cordero Daniel , Durán Gina , Solano Gabriela , Gómez Aarón , Hernández Andrés , Sánchez Laura , Vargas Marco , Drexler Jean Felix , Alape-Girón Alberto , Díaz Cecilia , León Guillermo TITLE=In vitro Characterization of Anti-SARS-CoV-2 Intravenous Immunoglobulins (IVIg) Produced From Plasma of Donors Immunized With the BNT162b2 Vaccine and Its Comparison With a Similar Formulation Produced From Plasma of COVID-19 Convalescent Donors JOURNAL=Frontiers in Medical Technology VOLUME=3 YEAR=2022 URL=https://www.frontiersin.org/journals/medical-technology/articles/10.3389/fmedt.2021.772275 DOI=10.3389/fmedt.2021.772275 ISSN=2673-3129 ABSTRACT=

Despite vaccines are the main strategy to control the ongoing global COVID-19 pandemic, their effectiveness could not be enough for individuals with immunosuppression. In these cases, as well as in patients with moderate/severe COVID-19, passive immunization with anti-SARS-CoV-2 immunoglobulins could be a therapeutic alternative. We used caprylic acid precipitation to prepare a pilot-scale batch of anti-SARS-CoV-2 intravenous immunoglobulins (IVIg) from plasma of donors immunized with the BNT162b2 (Pfizer-BioNTech) anti-COVID-19 vaccine (VP-IVIg) and compared their in vitro efficacy and safety with those of a similar formulation produced from plasma of COVID-19 convalescent donors (CP-IVIg). Both formulations showed immunological, physicochemical, biochemical, and microbiological characteristics that meet the specifications of IVIg formulations. Moreover, the concentration of anti-RBD and ACE2-RBD neutralizing antibodies was higher in VP-IVIg than in CP-IVIg. In concordance, plaque reduction neutralization tests showed inhibitory concentrations of 0.03–0.09 g/L in VP-IVIg and of 0.06–0.13 in CP-IVIg. Thus, VP-IVIg has in vitro efficacy and safety profiles that justify their evaluation as therapeutic alternative for clinical cases of COVID-19. Precipitation with caprylic acid could be a simple, feasible, and affordable alternative to produce formulations of anti-SARS-CoV-2 IVIg to be used therapeutically or prophylactically to confront the COVID-19 pandemic in middle and low-income countries.