BRIEF-U.S. FDA staff raises no new concerns with Moderna's coronavirus vaccine

Moderna Inc: * U.S. FDA STAFF PUBLISHES BRIEFING DOCUMENTS ON MODERNA COVID-19 VACCINE AHEAD OF ADVISORY COMMITTEE MEETING ON THURSDAY

* U.S. FDA DOCS SAYS SAFETY DATA SUPPORTED A FAVORABLE SAFETY PROFILE, WITH NO SPECIFIC SAFETY CONCERNS IDENTIFIED THAT WOULD PRECLUDE ISSUANCE OF EUA * U.S. FDA DOCS SAYS MEETING BEING CONVENED TO PROVIDE RECOMMENDATIONS ON WHETHER BENEFITS OF MODERNA COVID-19 VACCINE OUTWEIGH RISKS FOR USE IN INDIVIDUALS 18 YEARS OF AGE AND OLDER.

* U.S. FDA DOCS SAYS PROPOSED USE OF MODERNA VACCINE UNDER AN EUA IS FOR PREVENTION OF COVID-19 IN ADULTS 18 YEARS OF AGE AND OLDER. * FDA REVIEWED CHEMISTRY MANUFACTURING & CONTROL DATA SUBMITTED FOR MODERNA'S VACCINE & DETERMINED THAT INFORMATION IS CONSISTENT WITH EUA RECOMMENDATIONS

* U.S. FDA DOCS SAYS 2-DOSE MODERNA VACCINATION REGIMEN WAS HIGHLY EFFECTIVE IN PREVENTING COVID-19 OCCURRING AT LEAST 14 DAYS AFTER RECEIPT OF SECOND DOSE * FDA ASKS FOR POST AUTHORIZATION SAFETY AND EFFECTIVENESS STUDIES ON MODERNA VACCINES AS WELL AS IMMUNE MARKERS OF PROTECTION - FDA DOCS

* U.S. FDA DOCS SAYS MODERNA REPORTED BELL'S PALSY IN 3 VACCINE RECIPIENTS AND 1 PLACEBO RECIPIENT, 3 OF WHICH RESOLVED THEMSELVES * SAFETY PROFILE OF MRNA-1273 WAS GENERALLY SIMILAR ACROSS AGE GROUPS, GENDERS, ETHNIC & RACIAL GROUPS, PARTICIPANTS WITH/WITHOUT COMORBIDITIES - FDA DOCS

* VACCINE EFFICACY IN PARTICIPANTS AFTER ONE DOSE OF MODERNA'S VACCINE WAS 80.2% AT TIME OF INTERIM ANALYSIS - FDA DOCS * FDA SAYS THERE APPEARS TO BE SOME PROTECTION AFTER ONE DOSE OF MODERNA'S VACCINE, NOT ENOUGH INFORMATION ABOUT LONGER TERM PROTECTION Source text: (https://bit.ly/2IP7CFZ) Further company coverage:

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