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.
【저자키워드】 COVID-19, convalescent plasma, SARS-CoV-2, BNT162b2 vaccine, IVIG, Hyperimmune plasma, Passive immunotherapy, hyperimmune polyclonal antibodies, 【초록키워드】 neutralizing antibody, Intravenous immunoglobulin, Vaccine, COVID-19 pandemic, Immunosuppression, in vitro, anti-SARS-CoV-2, immunization, BNT162b2, Concordance, Characteristics, Immunoglobulin, therapeutic, Patient, Effectiveness, plasma, Efficacy and safety, Pfizer-BioNTech, Donor, Concentration, Precipitation, anti-RBD, caprylic acid, biochemical, profile, individual, inhibitory concentration, ACE2-RBD, plaque reduction neutralization, immunological, immunized, produced, feasible, COVID-19 convalescent donor, physicochemical, prophylactically, 【제목키워드】 Formulation, BNT162b2, characterization,