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

• Published in: Frontiers in medical technology Vol. 3; p. 772275
• Main Authors: 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
• Format: Journal Article
• Language: English
• Published: Switzerland Frontiers Media S.A 05.01.2022
• Subjects: BNT162b2 vaccine; convalescent plasma; COVID-19; hyperimmune plasma; hyperimmune polyclonal antibodies; IVIg; Medical Technology; COVID-19; BNT162b2 vaccine; SARS-CoV-2; hyperimmune polyclonal antibodies; IVIg; hyperimmune plasma; passive immunotherapy; convalescent plasma
• ISSN: 2673-3129; 2673-3129
• DOI: 10.3389/fmedt.2021.772275

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.