Establishment of a Reference Material in Quality Control for Use in Infectivity and Identity Assays of Recombinant COVID-19 Vaccine, in Accordance with International Standards Organization Guidance.

The COVID-19 pandemic, caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), began in 2019. One of the strategies for pandemic control was mass vaccination. In Brazil, the recombinant COVID-19 vaccine (RCV) was produced on a large scale and offered at no charge to the population.

Establishment of certified reference material for the potency assay in yellow fever vaccine quality control, in accordance with International Standards Organization guidance.

The attenuated yellow fever vaccine (YFV) is offered free of charge to the Brazilian population through the National Immunization Program (NIP). One of the specifications for quality control analyses of the vaccine is the potency determination. This test determines the number of plaque forming units (PFU) in Vero cells.

Evaluation of hydrogen peroxide virucidal efficacy against yellow fever virus 17DD vaccine strain for application in a vaccine manufacturing industry.

The aim of this study was to evaluate the inactivation performance of hydrogen peroxide to the yellow fever virus 17DD vaccine strain, used for the production of attenuated yellow fever vaccine, in two matrixes: formulated yellow fever vaccine (FYV) and yellow fever viral suspension - active pharmaceutical ingredient (API). The samples were dried on stainless steel and exposed to hydrogen peroxide liquid (HPL) at concentrations of 30, 10, 3 and 1% for 20 and 60 min; and to hydrogen peroxide vapour (HPV) in an isolator. The exposure to HPL 30 and 10 %, within 20 min, reduced the virus titre at least 3.