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BRIEF-EMA Says It Has Started 'Rolling Review' Of Data On Moderna's Covid-19 Vaccine

Nov 16 (Reuters) - EMA:

* EMA’S HUMAN MEDICINES COMMITTEE (CHMP) HAS STARTED A ‘ROLLING REVIEW’ OF DATA ON A VACCINE FOR COVID-19 KNOWN AS MRNA-1273

* CHMP’S DECISION TO START ROLLING REVIEW BASED ON PRELIMINARY RESULTS FROM NON-CLINICAL STUDIES AND EARLY CLINICAL STUDIES IN ADULTS

* ROLLING REVIEW WILL CONTINUE UNTIL ENOUGH EVIDENCE IS AVAILABLE TO SUPPORT A FORMAL MARKETING AUTHORISATION APPLICATION

* SAYS LARGE-SCALE CLINICAL TRIALS INVOLVING SEVERAL THOUSANDS OF PEOPLE ARE ONGOING, AND RESULTS ARE EXPECTED SHORTLY

* COMMITTEE HAS STARTED EVALUATING THE FIRST BATCH OF DATA ON THE VACCINE, WHICH COME FROM LABORATORY STUDIES (NON-CLINICAL DATA)

* ROLLING REVIEW TO CONTINUE UNTIL ENOUGH EVIDENCE IS AVAILABLE TO SUPPORT FORMAL MARKETING AUTHORISATION APPLICATION FOR MODERNA'S MRNA-1273 Source text: (bit.ly/3lA4bBn)

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