SARS-CoV-2 spike RBD-specific IgA and IgG antibodies in breast milk after vaccination with the protein subunit vaccine Abdala.

Background: COVID-19 vaccines that trigger a strong secretory antibody response in breast milk may achieve effective passive protection of vulnerable newborns and breastfed infants of immunized mothers. The aim of this work was to investigate the presence of SARS-CoV-2 spike RBD-specific IgA and IgG antibodies in breast milk, 5 and 9 weeks after vaccination with 3 doses of the protein subunit vaccine Abdala, compared to those found in breast milk from COVID-19-recovered women, collected at least 40 days after the infection. Methods: SARS-CoV-2 spike RBD-specific IgA and IgG antibodies were semi-quantified by indirect ELISA, using a homemade standard generated by pooling twenty breast milk samples with high absorbance values according to preliminary data. The validity of the standard curves was proved following the European Medicines Agency Guideline. Two breast milk samples from 2 unvaccinated women who had not been infected with COVID-19 were included as negative controls. Potentially neutralizing antibodies was assessed by a SARS-CoV-2 surrogate virus neutralization test. Results: High levels of anti-RBD IgA antibodies were detected in breast milk samples 9 weeks after vaccination and anti-RBD IgG antibodies rise from the fifth to the ninth week. In the post-COVID-19 time that was evaluated, the IgG-type response was notably higher compared to both post-vaccination periods. Neutralizing antibody titers were similar in breast milk from vaccinated and COVID-19 recovered women. Conclusions: This is the first report about the immune response in breast milk after the administration of a COVID-19 protein subunit vaccine, which could provide analogous protection to that conferred by SARS-CoV-2 infection. This implies a potential passive immunity that breastfed infants receive from their mothers vaccinated with Abdala.

Initial evidence of safety and clinical effect of recombinant streptokinase suppository in acute hemorrhoidal disease: open, proof-of-concept, pilot trial / Evidencia inicial de la seguridad y el efecto clínico del supositorio de estreptoquinasa recombinante en laenfermedad hemorroidal aguda: estudio piloto, abierto, de prueba de concepto

A proof-of-concept, pilot clinical trial was carried out in 2 hospitals, to evaluate the safety of recombinant streptokinase(rSK) administered by the rectal route in patients with acute hemorrhoidal disease (AHD). Suppositories containing 200000 IU rSK were given every 6 hours, up to 4 applications. The patients , after discharge, were seen daily in follow-upvisits up to10 days. Symptoms, lesion size, edema and inflammation were evaluated. Ten patients were included. TherSK suppository was safe and tolerable. The adverse events reported were minimal (only ardor and anal itching inonly one patient), both with minor intensity which did not require treatment, and with low causality relationship ofthe product since they could be explained by the underlying disease as well. Symptoms disappeared at 24 hours in 7patients. Complete recovery was achieved in most of the patients (90 percent) in 5 days. Only one patient needed surgicalthrombectomy. rSK suppositories are safe and showed initial efficacy data. It could become a new therapeutic optionfor hemorrhoidal crisis if results are confirmed in further and controlled studies (AU)