The European Medicines Agency (EMA) is currently assessing data on the COVID-19 vaccine being developed by AstraZeneca and Oxford University as part of a rolling review, a press release said on Thursday.
A rolling review is one of the regulatory tools that EMA uses to speed up the assessment of a promising medicine or vaccine during a public health emergency, it added.
“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 press release said.
“The latest clinical package was received on December 21 and is currently being assessed. 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),” it added.
EMA also noted that additional scientific information on issues related to quality, safety and efficacy of the vaccine is deemed necessary to support the rigour required for a conditional marketing authorisation. And that this has been requested from the company.
Further information from the ongoing clinical trials is also expected from January. Interim data from a large trial ongoing in the USA are expected in the first quarter of 2021.
EMA is aware that the UK Medicines and Healthcare products Regulatory Agency has granted a temporary authorisation of supply of the vaccine in the emergency use setting, which is distinct from a marketing authorisation.
EMA, its European experts and the European Commission are working towards conditional marketing authorisation of COVID-19 vaccines, with all the safeguards, controls and obligations that this imposes.
It guarantees that the vaccine meets rigorous EU standards for safety, efficacy and quality, it said.
