AstraZeneca seeks EU approval for COVID-19 vaccine

pharmafile | January 12, 2021 | News story | Manufacturing and Production AstraZeneca, COVID-19, Vaccine 

AstraZeneca has applied for conditional marketing authorisation (CMA) from the EMA for its COVID-19 vaccine.

CMA is used as the fast-track authorisation procedure to speed up approval of treatments and vaccines during public health emergencies. CMAs allow for the authorisation of medicines that fulfil an unmet medical need on the basis of less complete data than normally required, but only if the benefit of a medicine or vaccine’s immediate availability to patients outweighs the risk inherent in the fact that not all the data are yet available.

The EMA has confirmed that assessment of the vaccine will proceed under an accelerated timeline, and that an opinion on the authorisation could be issued by 29 January – 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.

This speedy evaluation is only possible because the EMA has already reviewed some data on the vaccine during a rolling review. The EMA said that during this phase, it assessed data from laboratory studies, data on the vaccine’s quality, and some evidence on safety and efficacy from a pooled analysis of interim clinical data 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 Committee for Medicinal Products for Human Use and is currently being assessed.

The Oxford University-AstraZeneca vaccine was first approved for use in the UK in December, and has also received emergency authorisation in a number of countries, including India, Mexico, and Morocco.

Darcy Jimenez

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