AZN Astrazeneca Plc

By Jenny Strasburg 

LONDON -- AstraZeneca PLC has applied for emergency-use authorization in Europe of the Covid-19 vaccine it developed with the University of Oxford, a step toward the rollout of more shots across the region as infections and hospitalizations rise.

The European Union's drug regulator said Tuesday it could authorize the vaccine as soon as Jan. 29 after completing a review of clinical-trial data. The European Medicines Agency's key scientific committee will meet that day after additional analysis of the trial results and safety and manufacturing data. Any recommendation to green light the vaccine would likely be formalized by the European Commission within a day or two.

That timeline eventually could add 400 million doses to Europe's vaccine arsenal as the region battles a deadly winter surge of the virus, exacerbated by the spread of a variant first discovered in the U.K. The EU has preordered 300 million doses of the Oxford-AstraZeneca vaccine, with an option for 100 million more.

Last week, Europe cleared a vaccine developed by Moderna Inc. for emergency use, giving the region a second Covid-19 shot. The bloc is struggling to distribute the doses it has, after authorizing a vaccine from Pfizer Inc. and German partner BioNTech SE in December.

Distribution across 27 member states has been hurt by logistical bottlenecks and challenges with ultracold storage requirements that complicate widespread distribution. Some governments in Europe early on were expecting the Oxford-AstraZeneca vaccine to be first to market, leaving them unprepared for the freezer logistics of the Pfizer-BioNTech shot, resulting in slow, uneven rollouts.

The Oxford-AstraZeneca vaccine requires only normal refrigeration for both short- and longer-term storage and distribution. AstraZeneca has promised to make as many as three billion doses available in 2021 -- more than any other Covid-19 vaccine maker -- and at a cheaper price. The U.K. company says it won't profit from the shot during the pandemic.

Like the other two vaccines, it is intended to be administered in two doses, in its case roughly one month apart. Some countries led by the U.K. have opted to delay second doses to get more first shots to vulnerable people more quickly.

The EMA so far has advised countries to stick to original dosing schedules, though some countries such as Belgium, Germany and Denmark have discussed or adopted longer intervals to stretch the supply of doses.

The Oxford-AstraZeneca vaccine was authorized for emergency use by the U.K. first, in late December. In early January, India cleared the vaccine for use.

AstraZeneca has a manufacturing and distribution agreement with the Serum Institute of India to provide more than one billion doses to developing countries.

The vaccine's efficacy against symptomatic Covid-19 ranged from 62% to 90% in late-stage clinical trials, with most trial results in the lower end of that range. The shots made by Moderna and Pfizer-BioNTech were more than 90% effective. But U.K. authorities have said the results are difficult to compare because of the different technologies behind the vaccines and the complexities particular to the clinical trials of the Oxford-AstraZeneca shot.

The U.K.'s medicines regulator has said the Oxford-AstraZeneca vaccine is about 70% effective at three weeks after the first dose and stretching to the time of the second dose, even if that is around about 12 weeks later.

Write to Jenny Strasburg at jenny.strasburg@wsj.com

(END) Dow Jones Newswires

January 12, 2021 06:35 ET (11:35 GMT)

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