Coronavirus (COVID-19)—EMA gives update on review of AstraZeneca vaccine

Coronavirus (COVID-19)—EMA gives update on review of AstraZeneca vaccine

The European Medicines Agency (EMA) has provided an update on its rolling review of AstraZeneca and Oxford University’s coronavirus (COVID-19) vaccine. The EMA is currently assessing data on the vaccine, with some evidence being assessed on safety and efficacy coming from a pooled analysis of interim clinical data from four ongoing clinical trials in the UK, Brazil and South Africa. The EMA also explained that the Committee for Medicinal Products for Human Use has ‘already assessed data from laboratory studies (non-clinical data) and is currently assessing data on the vaccine’s quality (on its ingredients and the way it is manufactured)’.

The EMA has requested additional scientific information on issues related to quality, safety and efficacy of the vaccine from AstraZeneca and Oxford University as this is thought necessary to ‘support the rigour required for a conditional marketing authorisation’. 

The EMA is expecting further information from the ongoing clinical trials in January 2021 and interim data from a large trial ongoing in the USA is expected in Q1 2021.

Source: Update on rolling review of AstraZeneca’s COVID-19 vaccine

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