J&J Initiates COVID-19 Vaccine Approvals in Canada and Europe

December 3, 2020
Pharmaceutical Technology Editors

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.

Janssen reported in the statement that the company “is committed to bringing an affordable COVID-19 vaccine to the public on a not-for-profit basis for emergency pandemic use.”

Sources: Johnson & Johnson and Johnson & Johnson