By Jenny Strasburg 

LONDON -- AstraZeneca PLC told European Union officials that fewer doses of its Covid-19 vaccine will be ready for the bloc's planned rollout in early February, blaming an unspecified manufacturing issue.

The shortfall comes as European leaders face heightened scrutiny over what critics say has been a slower rollout of several Western-developed vaccines than in the U.S. and U.K. It also comes after European officials clashed this week with Pfizer Inc. and BioNTech SE over the companies' decision to cut their own planned deliveries of Covid-19 vaccines to the bloc.

The dual shortfalls put the Continent's plans to accelerate its vaccine drive at risk. EU nations have placed big orders for the AstraZeneca shot, partly because it doesn't require the cold storage needed for the Pfizer-BioNTech vaccine. Officials have been banking on the arrival of their AstraZeneca orders next month to speed up bloc-wide vaccinations.

The AstraZeneca disclosure also threatens a fresh reputational hit to the British pharmaceutical giant, which partnered with the University of Oxford in developing the vaccine. AstraZeneca is responsible for manufacturing and distribution of the vaccine, as well as regulatory approvals.

The company has previously faced criticism over how it initially communicated results of the vaccine's late-stage human trials.

Europe's commissioner for health and food safety, Stella Kyriakides, said on Twitter Friday night that EU member states expressed deep dissatisfaction with AstraZeneca's vaccine-delivery delays. The European Commission will press AstraZeneca on precise delivery volumes and schedules so that countries can plan vaccinations, she said.

Austria's health-care minister Rudolf Anschober said that AstraZeneca's move was unacceptable. The company's commitments to delivery must be honored, Mr. Anschober said Friday. A spokesman for the European Commission said that AstraZeneca confirmed a "change of its delivery schedule" and that the commission was working to find out more details.

AstraZeneca said it would still be able to start delivering vaccines upon anticipated approval of the shot in Europe, a spokesman said Friday evening. The European Medicines Agency is scheduled to review the AstraZeneca vaccine next week. If approved, the vaccine could start rolling out in early February.

An AstraZeneca spokesman said Friday, however, that "initial volumes will be lower than originally anticipated." He declined to specify the size of the shortfall or the reason, except to say it was because of reduced yields at a manufacturing site in the company's European supply chain.

He said AstraZeneca still expects to ship tens of millions of doses to the EU in February and March as it ramps up production volumes.

The AstraZeneca-Oxford vaccine hasn't been approved yet in the U.S. It was first administered in the U.K. starting in early January and has since been authorized in a handful of other countries, including India.

A number of top drug regulators are set to issue recommendations on the AstraZeneca vaccine around the same time. The EU's regulator will reach a judgment on Jan. 29. Switzerland is set to issue its own decision on the vaccine that same week. The World Health Organization said Friday it would announce its own judgment on whether to authorize the vaccine within the next three weeks.

Last week, Canadian Health Minister Patty Hajdu said the country's national health department would make a decision on the AstraZeneca vaccine in the near future.

The WHO said Friday it expects to secure nearly 150 million doses of the AstraZeneca-Oxford vaccine by the end of March -- 100 million doses from AstraZeneca's major manufacturing partner in India and another 50 million doses through AstraZeneca itself. Distribution is aimed at poorer countries that otherwise would struggle for vaccines.

AstraZeneca has built a global web of manufacturing partners and contract sites, designed to produce shots regionally where they are meant to be distributed. Avoiding bottlenecks from trying to ship vaccines across the globe was a key goal outlined by AstraZeneca executives last year. But the European shortfall -- even before authorization of the vaccine on the Continent -- shows how fragile production supply lines can be.

AstraZeneca has agreed to make 3 billion doses of the vaccine this year and not profit from it during the pandemic, or ever in the case of poorer countries. The ambitious volume goals and low-cost promise set AstraZeneca apart from other big pharmaceutical companies rolling out vaccines, but it also brings massive challenges. AstraZeneca has agreed to supervise a network of vaccine production, in increasing volumes, simultaneously across far-flung parts of the world. Supply shortages or hiccups at a single manufacturing plant can stall the three- to four-month process of manufacturing the vaccine.

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

 

(END) Dow Jones Newswires

January 22, 2021 15:34 ET (20:34 GMT)

Copyright (c) 2021 Dow Jones & Company, Inc.