LONDON (Reuters) – AstraZeneca said it has sent full information to pursue conditional marketing authorisation from the European Medicines Firm for its COVID-19 vaccine, but the regulator said it still requires more info for approval.
An EMA authorities stated previously in the week that more data was required and that AstraZeneca had not offered adequate information to necessitate a conditional marketing licence for the shot it has actually developed with Oxford University.
” We can verify that we have sent a full information plan to support an application for conditional marketing authorisation for the AstraZeneca COVID-19 vaccine to the European Medicines Company,” an AstraZeneca spokesman stated.
” AstraZeneca has been sending information on a rolling basis and will continue to work carefully with the EMA to support the start of an official CMA application process.”
However the EMA said that it still did not have sufficient details to assess the shot, which was approved for emergency situation usage in Britain on Wednesday.
” The most recent clinical plan was received on 21 December and is currently being evaluated,” the EMA stated in a declaration.
” Extra clinical info on concerns related to quality, safety and efficacy of the vaccine is deemed needed to support the rigour needed for a conditional marketing authorisation and this has actually been asked for from the business.”
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https://covid19globalcases.com/astrazeneca-says-has-sent-complete-data-for-european-approval-of-covid-shot/
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