Nuvaxovid: which risks did reviewers probe?

“The findings were considered consistent with immune system stimulation consequent to administration of an active adjuvant, and comprised: local injection site inflammation, reversible enlargement of the lymph nodes draining the injection sites (but not elsewhere), and chemical markers of inflammation (i.e., CRP, fibrinogen, and globulin).”

“As the Matrix-M1 adjuvant is not currently marketed in a human vaccine in the EU market, Novavax is planning to conduct a biodistribution study in mice to evaluate the Matrix-M1 adjuvant, which may be of value in further understanding the mode of action of the adjuvant.”

“In animals vaccinated with low doses (i.e., 0.01 µg, 0.1 µg or 1 µg) of Wuhan rS prior to challenge with SARS-CoV-2, no evidence of exacerbation of disease was found in necropsy and histopathology, thus alleviating earlier concerns about potential occurrence of vaccine-induced enhanced disease in vaccine recipients after a subsequent exposure to SARS-CoV-2.”

“SARS-CoV-2 rS vaccine was administered on day 1, 8, 15, and 36 and induced high anti-S IgG titers. Addition of Matrix-M1 adjuvant significantly enhanced anti-S IgG responses.”

“Clinical phase 3 data confirm that the vaccine is immunogenic and the studied two dose schedule resulted in seroconversion in almost all participants.”