Safety and Humoral Immunity at 24 Months in Infants Following Maternal Vaccination with Abdala Against COVID-19
Keywords:
Abdala vaccine; pregnancy; infant; humoral immunity; SARS CoV 2; neutralising antibodies.Abstract
Introduction: SARS-CoV-2 infection during pregnancy increases severe maternal morbidity and adverse perinatal outcomes. Vaccination is an essential preventive strategy, yet there is limited evidence regarding safety and long-term passive immunity in infants born to mothers vaccinated with protein subunit vaccines.
Objective: To evaluate safety and functional humoral immune response in infants at 24 months following maternal vaccination with Abdala (CIGB 66).
Methods: A prospective observational cohort study was conducted at Ramón González Coro Hospital (Havana, Cuba). The study included 34 mother-infant dyads; the mothers had received three doses of Abdala (50 μg of RBD protein on days 0, 14, and 28) during pregnancy or the preconception period, with a 24-month follow-up and paired blood samples. Severe maternal morbidity was defined according to National Committee criteria. Primary outcomes included adverse events, anti-RBD IgG (BAU/mL), and neutralizing activity (% inhibition) in maternal blood at delivery and at 24 months, as well as in cord blood at birth and infant peripheral blood at 24 months. Wilcoxon tests, Mann-Whitney U tests, and Spearman correlation were used.
Results: No serious adverse events were attributed to the vaccine. 100% of the infants showed detectable IgG at birth (geometric mean 1288.5 BAU/mL). At 24 months, IgG levels had decreased by 79.6% (95% CI: 74.8–84.4) to 353.5 BAU/mL (p < 0.001), and neutralization capacity by 70.6% (95% CI: 64.8–76.4), dropping from 68.0% to 20.0% (p < 0.001). Infants who developed COVID-19 showed lower cord blood IgG levels (median 49.6 vs. 1782.6 BAU/mL in uninfected infants; p = 0.223). Maternal obesity correlated with lower IgG levels at delivery (ρ = 0.323; 95% CI: 0.596 to 0.018; p = 0.048).
Conclusions: Maternal vaccination with Abdala is safe and confers functional passive immunity to infants, although antibody levels decline markedly by 24 months. These results support direct immunization in infancy, though studies with larger sample sizes are needed.
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Copyright (c) 2026 Jorge Antonio Aguilar Estrada, Iván Campa Legrá, Yudisay Reyes Pelier2 , Raúl Mendoza Quiñones, Verena L. Muzio-González, Idania Baladrón Castrillo, Kenia Almenares Rodríguez, Marel Alonso Valdés, Francisco Hernández-Bernal, Julio Esmir Baldomero Hernández
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