BRIEF-Johnson & Johnson's COVID-19 vaccine effective, safe - FDA staff's briefing docs

Johnson & Johnson: * U.S. FDA STAFF PUBLISHES BRIEFING DOCUMENTS ON JOHNSON & JOHNSON COVID-19 VACCINE AHEAD OF ADVISORY COMMITTEE MEETING ON FRIDAY

* U.S. FDA DOCS- VACCINE SAFETY ANALYSIS SUPPORTED FAVORABLE SAFETY PROFILE WITH NO SPECIFIC SAFETY CONCERNS THAT WOULD PRECLUDE ISSUANCE OF EUA * AS OF FEB 5, THERE WERE 7 COVID-19 RELATED DEATHS IN PLACEBO GROUP AND NO COVID-19 RELATED DEATHS IN VACCINE GROUP- U.S. FDA DOCS

* US FDA DOCS SAYS 3 J&J VACCINE RECIPIENTS HAD SEVERE ADVERSE EVENTS * REPORTS OF BELL’S PALSY WERE OVERALL BALANCED BETWEEN J&J VACCINE AND PLACEBO RECIPIENTS; 2 IN VACCINE GROUP, 2 IN PLACEBO GROUP - U.S. FDA DOCS

* THERE WERE SINGLE REPORTS OF GUILLAIN-BARRE SYNDROME IN 60-YEAR-OLD VACCINE RECIPIENT AND 75-YEAR-OLD PLACEBO RECIPIENT - FDA DOCS * ADDITIONAL EVALUATIONS WILL BE NEEDED TO ASSESS EFFECT OF JOHNSON & JOHNSON'S VACCINE IN PREVENTING ASYMPTOMATIC INFECTION ---- FDA DOC

* ONE SERIOUS EVENT OF HYPERSENSITIVITY REACTION, NOT CLASSIFIED AS ANAPHYLAXIS, BEGINNING TWO DAYS FOLLOWING VACCINATION WAS LIKELY RELATED TO JNJ VACCINE- U.S. FDA DOC * IN SOUTH AFRICA, EFFICACY AGAINST SEVERE/CRITICAL COVID-19 OCCURRING AT LEAST 14 DAYS AFTER VACCINATION WAS 73.1% AND INCREASED TO 81.7% AT LEAST 28 DAYS AFTER VACCINATION - JNJ IN FDA DOCS

* NO SPECIFIC SAFETY CONCERNS SEEN IN SUBGROUP ANALYSES BY AGE, RACE, ETHNICITY, MEDICAL COMORBIDITIES, OR PRIOR SARS-COV-2 INFECTION -- FDA DOCS ON J&J VACCINE * JNJ IN FDA DOCS SAYS DATA SUGGESTS COVID-19 VACCINE EFFECT AGAINST ASYMPTOMATIC INFECTION

* IN PRELIMINARY ANALYSIS OF ASYMPTOMATIC COVID-19 INFECTION, 16 CASES IN PLACEBO GROUP VERSUS 2 CASES IN VACCINE GROUP RESULTING IN EFFICACY OF 87.8% - JNJ IN FDA DOCS Source text: (https://bit.ly/3aPnvrl) Further company coverage: