COVID-19 viral vector vaccine (Janssen)

COVID-19 Disease Prevention

Emergency use authorization (EUA) issued by FDA for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals aged >18 years injection, suspension 5x1010 virus particles/0.5mL (5 doses per vial) 0.5 mL IM as a single dose

<18 years: Safety and efficacy not established

Known history of severe allergic reaction (eg, anaphylaxis) to any component in vaccine

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have diminished immune response to the vaccine Vaccine may not protect all vaccine recipients

Not Classi Pregnancy Data are insufficient to inform of vaccine-associated risks in pregnancy Lactation Data are not available to assess effects on breastfed infants or on milk production/excretion

>10% 7 days post vaccination; aged 18-59 yr Injection site pain (58.6%) Headache (44.4%) Fatigue (43.8%) Myalgia (39.1%) Use of antipyretic or pain medication (26.4%) Nausea (15.5%) Fever (12.8%) 7 days post vaccination; aged >60 yr Injection site pain (33.3%) Headache (30.4%) Fatigue (29.7%) Myalgia (24%) Nausea (12.3%) 1-10% 7 days post vaccination; aged 18-59 yr Injection site erythema (9%) Injection site swelling (7%) Myalgia, Grade 3 (1.4%) Fatigue, Grade 3 (1.2%) 7 days post vaccination; aged >60 yr Use of antipyretic or pain medication (9.8%) Injection site erythema (4.6%) Fever (3.1%) Injection site swelling (2.7%)

Vaccine is composed of a recombinant, replication-incompetent human adenovirus type 26 vector that after entering human cells, expresses the SARS-CoV-2 spike (S) antigen without virus propagation An immune response elicited to the S antigen protects against COVID-19