AZN AstraZeneca PLC

By Jenny Strasburg and Laurence Norman 

AstraZeneca PLC expects to deliver tens of millions fewer Covid-19 vaccine doses than planned to the European Union in coming months, according to people familiar with the matter, threatening the continent's plans to ramp up vaccinations and delivering a fresh reputational blow to the drugmaker.

AstraZeneca disclosed the shortfall late Friday after briefing European officials earlier in the day. It blamed a manufacturing issue in Europe, but didn't disclose the magnitude of the shortfall.

According to people familiar with the matter, the company told European officials that in a worst-case scenario, AstraZeneca may be able to provide only around 30 million of roughly 80 million doses EU countries had anticipated for February and March, a roughly 60% decline from the company's earlier estimates. AstraZeneca is working to significantly reduce that potential shortfall and says the roughly 30 million doses is the minimum it should be able to deliver, these people said.

The root cause of the problem is a manufacturing facility in Belgium owned by Novasep Holding SAS that has been unable to make as much bulk vaccine as projected, the people said. The facility's so-called yield, or the amount of vaccine it can make from base ingredients, is running at about a third of AstraZeneca's expectations, one of the people said. Novasep didn't respond to requests for comment Saturday.

Vaccine yields can vary widely depending on "seeding" steps, taken over weeks, to grow cells needed to make the vaccine and later-stage processes to filter and purify the substance before it's packed into vials. AstraZeneca has found yields varying among its many manufacturing partners and has been working to boost production where it is lagging, the person said. The process is labor- and time-intensive. Reuters first reported the number of doses AstraZeneca may no longer be able to deliver.

The size of the expected shortfall has raised alarms in European capitals, which are racing to accelerate vaccination drives that have fallen behind other Western countries, including the U.K. and U.S. The bad news came 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.

It also demonstrates the delicate supply lines that vaccine producers rely on to push out the hundreds of millions of vaccine doses they have promised to deliver. AstraZeneca partnered with the University of Oxford to get its vaccine candidate to market. 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 target and no-profit promise set AstraZeneca apart from other big pharmaceutical companies rolling out vaccines, but it also brings massive logistical challenges and reputational risks. The company, which has relatively little experience in vaccines, is relying on its own manufacturing facilities and those of contractors and other partners around the world.

Complicating the massive distribution effort: different drug approval procedures AstraZeneca has had to navigate to get its vaccine authorized for use. The company, alongside Oxford, initially stumbled in efforts to communicate results of the shot's late-stage human trials, sowing confusion about the vaccine's effectiveness.

The U.K. approved it for emergency use in late December, and others, including India, have followed suit. The Food and Drug Administration, however, is waiting for full U.S. trial data before reviewing it for authorization, data expected as soon as February. The European Medicines Agency, which approves new drugs for the bloc, will consider it next week.

The U.K. had a head start with AstraZeneca, agreeing to buy hundreds of millions of doses earlier than Europe and working closely with the drugmaker to set up a U.K. supply chain to begin churning out those vaccines. European agreements and manufacturing arrangements took longer to pull together, according to people familiar with the process. What's more, the U.K. authorized the AstraZeneca vaccine before any other Western countries -- and almost a month before the anticipated European signoff.

As AstraZeneca ramped up to supply the U.K., it used production capacity available in Europe -- and not needed yet there -- to prepare doses and ship them to the U.K., according to people familiar with the matter. The vaccines coming from Europe early on supplemented doses manufactured and packaged within the U.K. itself, they said. Now AstraZeneca's European manufacturing chain is set up to serve Europe, while doses made in the U.K. are staying in the U.K.

Europe is relying heavily on the AstraZeneca vaccine to reach broad swaths of its population. The bloc has ordered 300 million doses of the AstraZeneca vaccine with an option for 100 million more.

AstraZeneca has told some officials it is tailoring deliveries according to contracts and regulatory authorizations, according to one of the people close to the discussions. Some European officials want to know how AstraZeneca is deciding where and when to route doses and whether orders from outside Europe are directly impacting resources devoted to deliveries to the bloc, according to people familiar with the deliberations.

European Health Commissioner Stella Kyriakides said Friday on Twitter that AstraZeneca's expected delivery shortfall is putting at risk the delivery schedule the company had pledged. She said the European Commission will press AstraZeneca for more information so countries can plan vaccinations. Officials will meet with the company Monday.

In anticipation of clearance for the AstraZeneca shot across the bloc, the drugmaker and partners have been planning required labels that must accompany every shipment. The labels must be provided in multiple languages, and what they say depends in large part on advice from the European medicines regulator that isn't yet finalized, a person close to the process said. Preparing the labels could take more than a week, but the person said AstraZeneca is trying to cut that down to a few days in the hopes of making doses available in the first week of February, pending expected regulatory signoff.

Write to Jenny Strasburg at jenny.strasburg@wsj.com and Laurence Norman at laurence.norman@wsj.com

(END) Dow Jones Newswires

January 23, 2021 12:49 ET (17:49 GMT)

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