The EU on Monday called for tight controls on coronavirus vaccine exports after top officials all but accused U.K.-based AstraZeneca of cutting supplies intended for EU countries in order to sell doses to other nations at higher prices.
The move came after two contentious vaccine steering board meetings on Monday between EU and national officials and representatives of the British-Swedish pharmaceutical conglomerate, which informed Brussels on Friday that vaccine production would fall far short of its contractual obligations to the EU.
Furious EU officials said the company had failed to explain the situation.
“Discussions with @AstraZeneca today resulted in dissatisfaction with the lack of clarity and insufficient explanations,” EU Health Commissioner Stella Kyriakides tweeted after the second meeting attended shortly before 10 p.m. “EU Member States are united: vaccine developers have societal and contractual responsibilities they need to uphold.”
She announced that another meeting will take place Wednesday. Earlier in the day, Kyriakides announced the plans for the next export controls, while making clear the Commission’s suspicions that AstraZeneca had shipped vaccine elsewhere.
“The European Union wants to know exactly which doses have been produced by AstraZeneca and where exactly so far and if or to whom they have been delivered,” Kyriakides said, adding that the Commission’s proposed export mechanism would require any company to disclose in advance any intended international shipments of vaccine doses manufactured in the EU.
A Commission official said the proposal for a new export control would require companies to seek approval before shipping vaccines internationally, except for humanitarian reasons. The restriction would be similar to limitations the EU imposed last spring on exports of personal protective equipment when supplies were scarce.
AstraZeneca did not issue any statement on Monday in response to the Commission’s criticism, nor did it respond to repeated requests for comment about the production shortfall.
The Commission’s swift move to impose the new export oversight, and the willingness of officials to go public with their anger at the company, highlighted how access to vaccines has become the highest-voltage political issue for public leaders as the pandemic continues to rage, with record numbers of infections and extended or renewed lockdown measures in many countries.
In a further sign of how urgent the issue has become, AstraZeneca’s vaccine has yet to be formally approved by the European Medicines Agency. That formal step is expected later this week, but the arrival of the vaccine is so highly-anticipated that some EU leaders had pushed during a European Council tele-summit on Thursday for shipments to begin in expectation of approval.
One EU diplomat said AstraZeneca gave two reasons for the production shortfall, related to materials sourcing and manufacturing problems at a plant in Belgium, but the diplomats said the company had failed to substantiate those claims with evidence. That led to speculation among Commission officials and EU national officials that AstraZeneca had shipped doses manufactured in Belgium to other customers, only to realize that production was not moving fast enough to meet contractual obligations to the EU, which had made a prepayment running into the hundreds of millions of euros.
“Trust has been severely shaken,” a Commission official said, adding: “To this day, it has not been fully explained what happened to the money and what has the company done on its obligation to manufacture at risk.”
Another Commission official said that throughout Monday, the company repeated they’re “doing their best” again and again without any further details to increase the production. The official called their explanations “nonsense.”
Showdown over slowdown
Word of AstraZeneca’s inability to meet its contract terms was the second big setback for the EU in terms of vaccine supplies in recent days.
Pfizer, which manufactures a vaccine in partnership with the German company BioNTech, announced on January 15 that it was temporarily reducing deliveries to the EU until late January in order to make changes to its production site in Belgium to increase manufacturing. Some EU leaders voiced anger over the slowdown even as Pfizer insisted that deliveries were expected to ramp up again beginning the week of February 15. Italy sent Pfizer the company a formal warning on Monday as well.
The blow from AstraZeneca, however, is both worse in its scale and its ramifications. Many EU countries chose not to order their full pro-rata allocation of mRNA vaccines from BioNTech/Pfizer and Moderna because they were too difficult to use and costly, choosing instead to bet on the British vaccine, which is cheaper and logistically easier to handle.
For most of the global vaccine race, Oxford/AstraZeneca was viewed as the frontrunner, being one of the first to start clinical trials, pledging to sell its vaccine at cost, and promising EU capitals a far easier serum to use compared to mRNA jabs.
But AstraZeneca is now looking like an increasingly bad bet, and new questions have been raised about the vaccine’s efficacy in people over the age of 65.
Germany’s health ministry has decided to hold off administering the AstraZeneca vaccine to seniors until there is proof of its efficacy among the over-65s, according to a person familiar with the ministry’s thinking. That means Germany will be forced to rely more on the BioNTech/Pfizer vaccine, which is in short supply, to protect its most vulnerable population.
Still, the company pushed back in a statement Monday night, saying such accusations are “completely incorrect” and pointing out its use in such populations had been supported by U.K. authorities. A spokesperson cited Phase 2 data published in The Lancet journal, showing that older adults generated “strong immune responses,” although this data does not show how effective the vaccine is for older people.
AstraZeneca was awarded the EU’s first and most anticipated vaccine contract in August, and in exchange received a giant prepayment. It was also granted far greater indemnification protections than its rivals, meaning governments would help pay parts of the legal costs should problems arise with the vaccine.
Kyriakides on Monday said the EU had yet to see dividends. “The European Union has pre-financed the development of the vaccine and the production and wants to see the return,” she said in a brief appearance between the two meetings with AstraZeneca.
The company has said it will now deliver 60 percent fewer doses to the bloc during the first quarter than initially projected, and there were initial reports of varying production difficulties. One EU official said a bad batch of vaccines had to be discarded and the company was struggling to source enough raw materials for mass production.
But after an initial meeting with company officials on Friday and another that lasted most of Monday afternoon, Kyriakides, visibly furious, delivered a statement, saying the company had failed to adequately explain why its supply would fall short.
“The European Union wants to know exactly which doses have been produced by AstraZeneca and where exactly so far and if or to whom they have been delivered,” Kyriakides said, adding: “The answers of the company have not been satisfactory so far.”
Matthew Karnitschnig, Jakob Hanke Vela and Carlo Martuscelli contributed reporting.