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Janssen announces rolling submissions for its COVID-19 vaccine with Health Canada and EMA.
Johnson & Johnson announced on Dec. 1, 2020, that the company has initiated rolling submissions with Health Canada and the European Medicines Agency for Janssen’s investigational single-dose vaccine candidate for the prevention of COVID-19.
The reviews are based on positive non-clinical data showing that the vaccine candidate elicited a robust immune response, as demonstrated by neutralizing antibodies, in an ongoing Phase I/IIa clinical trial that is studying the safety profile and immunogenicity of a single-dose and two-dose vaccination. Immune responses were similar across the age groups studied, including older adults, the company reported in a press statement. The Janssen COVID-19 vaccine candidate is being evaluated in Phase III clinical trials.
The investigational COVID-19 vaccine candidate uses Janssen’s AdVac vaccine platform, which was also used to develop and manufacture the company’s European Commission-approved Ebola vaccine regimen and construct its Zika, RSV, and HIV investigational vaccine candidates, the company reported.