EMA needs more data before decision on COVID-19 Vaccine AstraZeneca

31 December 2020

While the European Medicines Agency late Wednesday confirmed it was progressing the rolling review of AstraZeneca (LSE: AZN) and Oxford University’s COVID-19 vaccine candidate, it also made clear that, despite conditional approval from the UK regulator, it is still awaiting additional data before it could announce its decision.

The vaccine, previously referred to as AZD1222, is now called COVID-19 Vaccine AstraZeneca.

So far, some evidence has been 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 latest clinical package was received on the December 21 and is currently being assessed. The EMA’s advisory committee, the CHMP, 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).

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