Nuvaxovid: what flexibility did regulators accept, and why?

“The administered dose was the maximum volume of clinical formulation (used for the early clinical studies) and, although the dose is smaller than the absolute dose that will be administered to humans, it does exceed the human dosage on a weight-adjusted basis by 40-fold.”

“In addition, the final audited DART report includes data showing that the dose used in this study did induce an immune response. The study design and generated results are therefore considered acceptable.”

“For the evaluation of reproduction toxicology, the applicant has used the rat as animal model. It is noted that placental transfer of antibodies in rabbits is more similar to humans compared to rodents.”

“Titers measured in foetuses were approximately 8.0% of those present in dams, whereas nursing pups had anti-S lgG levels approximately 70-82 % of the IgG levels of the dams, indicating that sufficient antibody transfer occurred via placenta and especially lactation.”

“Considering the extensive clinical package available at the time of initial marketing approval, the safety profile of the adjuvanted vaccine was considered acceptable without finalisation of the biodistribution study.”