Janssen Inc Announces the Initiation of a Rolling Submission for its Single-dose Janssen COVID-19 Vaccine Candidate with Health Canada

Janssen Inc. the pharmaceutical companies of Johnson & Johnson, has initiated a rolling submission with Health Canada for its investigational single-dose vaccine candidate for the prevention of COVID-19.

Health Canada announced a rolling review of the investigational single-dose Janssen COVID-19 vaccine candidate based principally on positive non-clinical data showing that the vaccine candidate elicits a robust immune response, as demonstrated by neutralizing antibodies. Janssen will continue to work with Health Canada to complete the rolling review process and to facilitate an approval when appropriate.

In addition to the Health Canada submission, Janssen is in discussions with other regulatory authorities worldwide, as it prepares to initiate regulatory review processes for use of its investigational single-dose Janssen COVID-19 vaccine candidate during the pandemic response period, if proven safe and effective.

Janssen is committed to bringing an affordable COVID-19 vaccine to the public on a not-for-profit basis for emergency pandemic use.

THE COMPANY’S INVESTIGATIONAL COVID-19 VACCINE CANDIDATE
The investigational Janssen COVID-19 vaccine candidate leverages Janssen’s AdVac® vaccine platform, which was also used to develop and manufacture Janssen’s European Commission-approved Ebola vaccine regimen and construct its Zika, RSV, and HIV investigational vaccine candidates. Janssen’s AdVac® technology has been used to vaccinate more than 114,000 people to date across Janssen’s investigational vaccine programs.

The safety data profile from an interim analysis of the ongoing Phase 1/2a clinical trial of the investigational Janssen COVID-19 vaccine candidate – studying the safety profile and immunogenicity of both a single-dose and two-dose vaccination – is supportive of further development of the vaccine candidate. Immune responses are similar across the age groups studied, including older adults. Based on these initial findings, the Janssen COVID-19 vaccine candidate is being further evaluated in the Phase 3 ENSEMBLE and Phase 3 ENSEMBLE 2 clinical trials.