Regulatory Decision Summary for Janssen COVID-19 Vaccine

The information below summarizes the rationale for approval of the vaccine under the Food and Drug Regulations. Some of this information is already available in previous Summaries of Rationale for Approval that were published when the vaccine was authorized under the Interim Order.

COVID-19 is a serious and potentially fatal or life-threatening human infection. Vaccination is an important way to protect against the disease and help stop the pandemic.

The efficacy and safety of the vaccine was supported by the ongoing Study COV3001. This Phase 3 study was randomized, double-blind and placebo-controlled that was conducted in North America, Latin America and South Africa. A total of 21,895 participants received the Janssen COVID-19 Vaccine and 21,888 participants received a placebo.

Efficacy of the vaccine was evaluated 14 days and 28 days after a single administration of the vaccine. Vaccine efficacy against moderate to severe/critical COVID-19 in individuals who were seronegative (or of unknown serostatus) at baseline was 66.9% at least 14 days after vaccination and 66.1% at least 28 days after vaccination. Higher VE was observed against severe/critical COVID-19 where VE was 76.7% (14 days after vaccination) and 85.4% (28 days after vaccination).

In Study COV3001, 34.6% of participants were ≥60 years of age. The vaccine showed consistent efficacy across age groups against moderate to severe/critical COVID-19, as well as against severe/critical COVID-19. VE was also consistent between genders, between Hispanics and non-Hispanics, and between Black/African Americans and Caucasians. Across geographical regions, VE ranged from 52.0% to 74.4%, due to the impact of variants of concern. Though the presence of variants of concern in certain study sites appear to have impacted the overall vaccine efficacy in those regions, the vaccine seems to have maintained its efficacy against severe and critical COVID-19.

The Janssen COVID-19 vaccine exhibits moderate reactogenicity. The most frequently-reported adverse reactions (ARs) after the single dose were pain at the injection site (48.7%), headache (39.0%), fatigue (38.3%), and myalgia (33.2%). The majority of these ARs were mild to moderate in severity and resolved within 1-3 days. Both local and systemic ARs were less common in participants ≥60 years of age. When COVID-19-related SAEs were excluded, SAEs occurred in 0.4% of participants in both the vaccine and placebo groups. Hypersensitivity AEs were more common in the vaccine group (0.4%) than in the placebo group (0.3%) in Study COV3001, and two cases of anaphylaxis have been reported in an ongoing open-label trial (COV3012). Small imbalances in thromboembolic events (15 vs 10), tinnitus (6 vs 0), vertigo (13 vs 7) and seizures (4 vs 1) were noted at the participant level.

Very rare cases of anaphylactic reactions and/or hypersensitivity reactions, combination of thrombosis and thrombocytopenia including thrombosis with thrombocytopenia syndrome (TTS), capillary leak syndrome, Guillain-Barre syndrome, immune thrombocytopenia and venous thromboembolism following administration of the vaccine have been reported outside of the clinical trials with Janssen COVID-19 Vaccine.

These reported events are managed through labelling and the Risk Management Plan RMP.

The RMP is designed to describe known and potential safety issues, to present the monitoring plan and when needed, to describe measures that will be put in place to minimize risks associated with the product. Upon review, the RMP was considered to be acceptable and identified appropriate monitoring (pharmacovigilance) activities and risk minimization measures based on the safety profile of the product. This included providing information in the product monograph and identifying populations where more data are needed. The RMP will be updated to reflect additional safety information as this is collected. In addition to regulatory requirements for post-market monitoring and prioritized reporting of adverse events following immunization, safety summary reports on the vaccine will be provided to Health Canada. Results related to safety and effectiveness from ongoing and planned studies will be submitted as they become available.

In conclusion, based on the data provided, the risk-benefit profile of Janssen COVID-19 Vaccine [Ad26.COV2.S (recombinant) is considered favourable in adults (18 years of age and older). The efficacy of the vaccine was established and the vaccine was well tolerated by participants. The sponsor will continue to collect and report on the safety and efficacy of the vaccine.

Janssen COVID-19 Vaccine [Ad26.COV2.S (recombinant) is therefore recommended for authorization under Food and Drug Regulations for drugs for use in relation to COVID-19 and is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.