June 30, 2020 / 4:01 PM / a month ago

BRIEF-U.S. FDA Releases Guidance For COVID-19 Vaccine Approval

June 30 (Reuters) -

* FDA - TO ENSURE COVID-19 VACCINE IS EFFECTIVE, PRIMARY EFFICACY ENDPOINT POINT ESTIMATE FOR PLACEBO-CONTROLLED EFFICACY TRIAL SHOULD BE AT LEAST 50%

* FDA - USE OF CONTROLLED HUMAN INFECTION MODEL MAY BE CONSIDERED TO SHOW COVID-19 VACCINE EFFECTIVENESS

* FDA - USE OF HUMAN INFECTION MODEL MAY BE CONSIDERED IF NO LONGER POSSIBLE BY CONDUCTING CLINICAL DISEASE ENDPOINT EFFICACY STUDIES FOR COVID-19 VACCINE

* FDA - IN SOME CASES, MAY NOT BE NECESSARY TO PERFORM NONCLINICAL SAFETY STUDIES FOR COVID-19 VACCINE PRIOR TO FIH CLINICAL TRIALS

* FDA - AT THIS TIME NO CONTROLLED HUMAN INFECTION MODELS FOR SARS-COV-2 HAVE BEEN ESTABLISHED OR CHARACTERIZED

* FDA-MAY NOT BE NECESSARY TO PERFORM NONCLINICAL SAFETY STUDIES FOR COVID-19 VACCINE AS DATA TO SHOW PRODUCT SAFETY MAY BE AVAILABLE FROM OTHER SOURCES

* FDA- TOXICITY STUDIES DATA MAY BE SUBMITTED AS UNAUDITED DRAFT TOXICICOLOGIC REPORTS TO PROCEEDING TO FIH TRIALS WITH COVID-19 VACCINE CANDIDATES

* FDA - USE OF COVID-19 PREVENTIVE VACCINES IN PREGNANCY & IN WOMEN OF CHILDBEARING POTENTIAL WILL BE IMPORTANT CONSIDERATION FOR VACCINATION PROGRAMS

* FDA - IF POSSIBLE, EARLY CLINICAL STUDIES FOR VACCINE SHOULD EXCLUDE PARTICIPANTS AT HIGH RISK OF SARS-COV-2 EXPOSURE

* FDA - FOR COVID-19 VACCINES, FDA RECOMMENDS EARLY PLANNING OF PHARMACOVIGILANCE ACTIVITIES BEFORE LICENSURE

* FDA - INCLUDING PLACEBO CONTROL & BLINDING ARE NOT REQUIRED FOR EARLY PHASE STUDIES OF COVID-19 VACCINE

* FDA - FOR COVID-19 VACCINES, LIKELY THAT DURING EARLY POSTMARKETING PERIOD, LARGE POPULATION MIGHT BE VACCINATED IN RELATIVELY SHORT TIMEFRAME

* FDA - IN VACCINE TRIALS, SARS-COV-2 INFECTION SHOULD BE EVALUATED AS A SECONDARY OR EXPLORATORY ENDPOINT, IF NOT EVALUATED AS A PRIMARY ENDPOINT

* FDA-EITHER LABORATORY-CONFIRMED COVID-19/LABORATORY-CONFIRMED SARS-COV-2 INFECTION IS ACCEPTABLE PRIMARY ENDPOINT FOR COVID-19 VACCINE EFFICACY TRIAL

* FDA - ADEQUATE DATASET EVALUATING SAFETY OF COVID-19 VACCINE IN HUMANS WOULD NEED TO BE PROVIDED FOR CONSIDERATION OF LICENSURE

* FDA - FOR INVESTIGATIONAL VACCINES BEING DEVELOPED FOR COVID-19 PREVENTION, ANY ASSESSMENT REGARDING AN EUA WOULD BE MADE ON CASE BY CASE BASIS Source text: [bit.ly/2Vxz6Di]

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