EMA begins rolling review of AZ’s COVID-19 vaccine candidate
The Europe Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has begun its first ‘rolling review’ of AstraZeneca/Oxford University’s COVID-19 vaccine candidate.
According the EMA, the ‘rolling review’ has already started, with the agency already evaluating the first batch of data on the vaccine from non-clinical laboratory studies.
This type of review allows the EMA to accelerate the assessment of a promising medicine or treatment within the context of a public health emergency.
In a ‘rolling review’, as opposed to the traditional method of having access to all data on a medicine’s safety, efficacy and quality prior to submission, the CHMP instead reviews data as and when it becomes available from ongoing studies.
The EMA said that it has started to review the vaccine based on preliminary results from non-clinical and early clinical studies of AZ’s AZD1222 candidate, which suggested that the vaccine triggers the production of antibodies and T cells.
Read more: http://www.pmlive.com/pharma_news/ema_begins_rolling_review_of_azs_covid-19_vaccine_candidate_1352396
According the EMA, the ‘rolling review’ has already started, with the agency already evaluating the first batch of data on the vaccine from non-clinical laboratory studies.
This type of review allows the EMA to accelerate the assessment of a promising medicine or treatment within the context of a public health emergency.
In a ‘rolling review’, as opposed to the traditional method of having access to all data on a medicine’s safety, efficacy and quality prior to submission, the CHMP instead reviews data as and when it becomes available from ongoing studies.
The EMA said that it has started to review the vaccine based on preliminary results from non-clinical and early clinical studies of AZ’s AZD1222 candidate, which suggested that the vaccine triggers the production of antibodies and T cells.
Read more: http://www.pmlive.com/pharma_news/ema_begins_rolling_review_of_azs_covid-19_vaccine_candidate_1352396
