Oxford-Astra Covid Vaccine Review to Start in Europe
European regulators are set to start an accelerated review of a Covid-19 vaccine from Oxford and Astra.
(Bloomberg) -- European regulators started an accelerated review of a Covid-19 vaccine front-runner from the University of Oxford and AstraZeneca Plc in a sign the shot could be the first to seek approval in the region.
The European Medicines Agency announced the start of the so-called “rolling review,” confirming a Bloomberg report from Wednesday. Such assessments are typically used in health emergencies to allow regulators to see clinical trial data while the development is ongoing to speed up approvals.
The move is a key step forward for the Oxford-AstraZeneca shot after trials were halted last month due to concerns about a participant in the U.K. study who became ill. The partners, along with companies such as Pfizer Inc. and Moderna Inc., are sprinting ahead with experimental shots as governments look for a way out of the global crisis.
The EMA said it’s starting the review based on preliminary results and that it doesn’t mean “that a conclusion can be reached yet on the vaccine’s safety and effectiveness.”
A spokesperson for AstraZeneca said the company welcomed the development and will be providing the EMA with access to the vaccine data as it becomes available.
The death toll from the disease exceeded 1 million this week, while the infection rate has rapidly picked up again across Europe.
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