The assessment of AstraZeneca and Oxford University’s vaccine known as COVID-19 Vaccine AstraZeneca will proceed under an accelerated timeline, the EU’s health authorities said on Tuesday.
And an opinion on the marketing authorisation could be issued by January 29 during the meeting of European Medicines Authority’s scientific committee for human medicines.
“Provided that the data submitted on the quality, safety and efficacy of the vaccine are sufficiently robust and complete and that any additional information required to complete the assessment is promptly submitted,” a press release also said.
“Such a short timeframe for evaluation is only possible because EMA has already reviewed some data on the vaccine during a rolling review,” it added.
During this phase, EMA assessed data from laboratory studies (non-clinical data), data on the vaccine’s quality (on its ingredients and the way it is manufactured) and some evidence on safety and efficacy from a pooled analysis of interim clinical data.
This is from four ongoing clinical trials in the United Kingdom, Brazil and South Africa.
Additional scientific information on issues related to quality, safety and efficacy of the vaccine was also provided by the company at the request of CHMP and is currently being assessed.
During the review, and throughout the pandemic, EMA and its scientific committees are supported by the COVID-19 EMA pandemic task force.
This is a group that brings together experts from across the European medicines regulatory network to facilitate rapid and coordinated regulatory action on medicines and vaccines for COVID-19.