AstraZeneca PLC has warned European Union officials it no longer expects to supply the bloc with around 100 million Covid-19 shots it pledged to bring in from overseas in coming months, worsening a vaccine-supply crisis on the continent as cases rise again and governments consider new lockdown measures.
The shortfall represents enough of the two-dose shots to vaccinate 50 million people, or well over 10% of the bloc’s population. It threatens to sap the EU’s already strained ability to roll out effective vaccine drives among its 27 member states.
“It’s time for AstraZeneca’s Board to exercise its fiduciary responsibility and now do what it takes to fulfill AZ’s commitments,” Thierry Breton, France’s European Commissioner who is leading the bloc’s vaccine strategy, said on Twitter on Thursday.
U.K.-based AstraZeneca earlier this year had already greatly reduced its estimate of doses it expected to deliver to Europe in the first quarter of the year because of manufacturing problems it experienced in a plant in Europe. Its backup plan involved trying to supplement European-made supply with doses the company and its partners have been making overseas.
Production has been humming in the U.K. and India. In the U.S., a stockpile of doses that AstraZeneca says should reach 50 million by the end of April has gone unused because the shot isn’t yet approved by the Food and Drug Administration.
AstraZeneca on Friday said unspecified export restrictions now rendered plans to bring in large amounts of doses made outside Europe unlikely. It said it now expects to provide 100 million doses to the EU in the first half of this year, down from earlier commitments of around 270 million.
The EU said this week it expects to receive a total of 100 million doses of vaccines a month from the vaccine makers with which it has supply contracts during the second quarter. The bloc is sticking to that estimate, an EU official said after AstraZeneca’s announcement. “We will certainly look into all possible measures to ensure the company complies with its contract,” the official said.
The bloc has also bought shots from Pfizer Inc. and Moderna Inc. On Thursday, Europe’s top medicines agency approved another vaccine, delivered in a single shot, made by Johnson & Johnson.
Amid AstraZeneca’s production woes in January, company executives debated the possibility of sending U.S.-made shots to Europe as a temporary measure, ahead of any U.S. authorization of the vaccine, The Wall Street Journal previously reported. But the company at the time considered that unlikely because it would require U.S. government permission.
EU officials told member states this week that U.S.-made shots wouldn’t be available to Europe in the short term, a person briefed on the discussions said.
The White House’s coordinator for Covid-19, Jeff Zients, told reporters on Friday that the AstraZeneca doses in the U.S. are being kept in the country.
“We have a small inventory of AstraZeneca so that, if approved, we can get that inventory out to the American people as quickly as possible,” he said. AstraZeneca is expecting results of large-scale U.S. clinical trials this month, a step in preparing to apply for U.S. regulatory approval.
The EU, which has sent 9 million vaccine doses to the U.K. since late January, has accused the U.K. of banning vaccine exports to Europe. U.K. officials have denied that. The U.K. government has said it is up to manufacturers whether doses are exported, and hasn’t said whether any have.
AstraZeneca, which developed its shot with the University of Oxford, promised to deliver 3 billion doses to countries around the world this year, at no profit. That scale and pricing pledge set it apart from other vaccine makers. That has also made it a key plank in many countries’ vaccine rollout plans.
But the vaccine has been beset by early confusion over results of late-stage human trials. The AstraZeneca shot was shown to work against Covid-19 less effectively than Pfizer and Moderna shots. France and Germany initially restricted its distribution to older people because of a lack of trial data.
More recently, real world data in the U.K. showed the shot to be about as effective as Pfizer’s in older Britons. Germany and France, struggling with vaccine rollouts, reversed themselves and allowed the shot to be used in older people.
The manufacturing setbacks in Europe also dented AstraZeneca’s credibility. AstraZeneca Chief Executive Pascal Soriot has repeatedly pushed back against doubts about the shot’s efficacy compared with others, and criticism of its rollout. AstraZeneca said last month it would roughly double global vaccine production to 200 million doses a month by April.
“Is it perfect?” Dr. Soriot told journalists in an earnings briefing. “No, it’s not perfect, but it’s great, and tell me who else is making 100 million doses in the month of February.”
While Brussels faces pressure from EU capitals to speed up delivery of doses, the European Commission has highlighted the bloc’s contributions to global supplies. Officials said Thursday that member states had shipped out 34 million doses of vaccines to the U.K., the U.S. and other countries since late January.
The bloc, too, has faced criticism for restricting shipments of doses overseas. Last week, Italy, with EU backing, blocked the export of 250,700 AstraZeneca doses to Australia, exercising an optional export ban for the first time since its introduction in late January. The doses had been bottled at a factory near Rome that is part of the drugmaker’s supply chain.
Italian officials framed the move as a response to AstraZeneca’s European supply shortfall. AstraZeneca didn’t comment at the time. Italian officials said the company had delivered 1.5 million doses to Italy.
On Thursday, the EU said it was extending the export ban option until the end of June.
—Sabrina Siddiqui contributed to this article.
Write to Jenny Strasburg at [email protected] and Laurence Norman at [email protected]
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