Revised: March/13/2023
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6 OVERALL SAFETY SUMMARY
It is MANDATORY for vaccination providers to report to the Vaccine Adverse Event
Reporting System (VAERS) all vaccine administration errors, all serious adverse events,
cases of myocarditis, cases of pericarditis, cases of Multisystem Inflammatory Syndrome
(MIS) in adults, and hospitalized or fatal cases of COVID-19 following vaccination with the
Janssen COVID-19 Vaccine. To the extent feasible, provide a copy of the VAERS form to
Janssen Biotech, Inc. Please see the REQUIREMENTS AND INSTRUCTIONS FOR
REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS
section for details on reporting to VAERS or Janssen Biotech, Inc.
Adverse Reactions in Clinical Trials
In study COV3001, the most common local solicited adverse reaction (≥10%) reported was
injection site pain (48.6%). The most common systemic adverse reactions (≥10%) were headache
(38.9%), fatigue (38.2%), myalgia (33.2%), and nausea (14.2%) (see Tables 1 to 4).
Severe allergic reactions, including anaphylaxis, have been reported following administration of
the Janssen COVID-19 vaccine.
Adverse Reactions Identified during Post Authorization Use
Anaphylaxis and other severe allergic reactions, thrombosis with thrombocytopenia, immune
thrombocytopenia, Guillain-Barré syndrome, myocarditis, pericarditis, and capillary leak
syndrome have been reported following administration of the Janssen COVID-19 Vaccine during
mass vaccination outside of clinical trials.
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates
observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of
another drug and may not reflect the rates observed in practice.
Safety Primary vaccination
The safety of the Janssen COVID-19 Vaccine has been assessed in an ongoing Phase 3 Study,
COV3001 (NCT04505722) (Study 1). A total of 43,783 individuals were enrolled in this study, of
whom 21,895 adults aged 18 years and older received the Janssen COVID-19 Vaccine [Full
Analysis Set (FAS)]. This study is being conducted in the United States (n=19,302), Brazil
(n=7,278), South Africa (n=6,576), Colombia (n=4,248), Argentina (n=2,996), Peru (n=1,771),
Chile (n=1,133), Mexico (n=479). In this study, 45.0% were female, 54.9% were male, 58.7%
were White, 19.4% were Black or African American, 45.3% were Hispanic or Latino, 3.3% were
Asian, 9.5% were American Indian/Alaska Native and 0.2% were Native Hawaiian or other Pacific
Islander, 5.6% were from multiple racial groups and 1.4% were unknown races (see Table 5). The
median age of individuals was 52.0 years (range: 18-100). There were 4,217 (9.6%) individuals
who were SARS-CoV-2 seropositive at baseline and who were included in the study. In the United
States, 838 of 19,302 (4.3%) individuals were SARS-CoV-2 seropositive. Demographic
characteristics were similar among individuals who received the Janssen COVID-19 Vaccine and
those who received saline placebo.