The EU called for strict controls on coronavirus vaccine exports on Monday after top officials nearly accused UK-based AstraZeneca of reducing supplies meant for EU countries to sell doses to other countries at higher prices.
The move came after two controversial vaccines steering committee meetings on Monday between EU and national officials and representatives of the British-Swedish pharmaceutical conglomerate, which informed Brussels on Friday that vaccine production is falling far short of its contractual obligations to the EU.
Enraged EU officials said the company had not explained the situation.
“Discussions with @AstraZeneca today sparked dissatisfaction with the lack of clarity and insufficient explanation, “tweeted EU Health Commissioner Stella Kyriakides after the second meeting that attended shortly before 10pm.” The EU Member States are united: vaccine developers have social and contractual responsibilities to fulfill. ”
She announced that another meeting will be held on Wednesday. Earlier in the day, Kyriakides announced plans for the next export controls, while highlighting the Commission’s suspicions that AstraZeneca had shipped vaccines elsewhere.
“The European Union wants to know exactly what doses of AstraZeneca have produced and where exactly so far and if and to whom they have been delivered,” said Kyriakides, adding that the export mechanism proposed by the Commission requires each company to advance intended international shipments of vaccine doses. manufactured in the EU.
A Commission official said the proposal for new export controls would require companies to seek approval before any vaccines are shipped internationally, except for humanitarian reasons. The restriction would be similar to the restrictions the EU imposed on exports of personal protective equipment last spring when supplies were scarce.
AstraZeneca did not issue a statement on Monday in response to the Commission’s criticisms, nor responded to repeated requests for comment about the production shortage.
The Commission’s swift move to impose the new export controls, and the willingness of officials to publicize their anger at the company, underscored how access to vaccines has become the political issue of highest tension for public leaders as the pandemic continues raging, with record numbers of infections and extensive or renewed lockdown measures in many countries.
Just to show just how urgent the problem has become, the AstraZeneca vaccine has yet to be formally approved by the European Medicines Agency. That formal move is expected later this week, but the arrival of the vaccine has been anticipated for so long that some EU leaders pushed for the start of the shipment pending approval during a European Council teletop on Thursday.
An EU diplomat said that AstraZeneca gave two reasons for the production shortage, related to the sourcing of materials and production problems at a factory in Belgium, but the diplomats said the company had not substantiated those claims with evidence. This 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 going fast enough to meet contractual obligations to the EU, who had made an advance payment in the hundreds. millions of euros.
“Confidence has been seriously shaken,” said a Commission official, adding: “To this day, it has not been fully explained what happened to the money and what the company has done in relation to its obligation to produce risks. ”
Another Commission official said the company reiterated throughout Monday that they are “doing their best” time and again with no further details to increase production. The official called their statements ‘nonsense’.
Showdown about delay
The report of AstraZeneca’s inability to meet its contract terms was the second major setback for the EU in terms of vaccine supply in recent days.
Pfizer, which manufactures a vaccine in partnership with German company BioNTech, announced on January 15 that it was temporarily halting deliveries to the EU until the end of January to make changes to its manufacturing site in Belgium to increase production. Some EU leaders expressed anger at the delay, even as Pfizer insisted that deliveries were expected to pick up again from the week of February 15. Italy also sent Pfizer a formal warning to the company on Monday.
However, AstraZeneca’s blow is worse both in magnitude and in its consequences. 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 expensive, opting to bet on the UK vaccine instead, which is cheaper and logistically easier to handle.
For most of the global vaccination race, Oxford / AstraZeneca has been seen as the front runner as it was one of the first to initiate clinical trials, promised to sell its vaccine at cost, and promised EU capitals to use a much easier serum in comparison with mRNA shots.
But AstraZeneca now looks like an increasingly bad bet, and new questions have arisen about the vaccine’s efficacy in people over the age of 65.
The German Ministry of Health has decided to delay administering the AstraZeneca vaccine to seniors until there is evidence of its effectiveness in people over 65, said a person familiar with the ministry’s thinking. That means Germany will be forced to rely more on the BioNTech / Pfizer vaccine, which is scarce, to protect the most vulnerable population.
Still, the company pushed back in a statement Monday evening, saying such allegations are “completely false” and their use in such populations has been backed by British authorities. A spokesperson quoted Phase 2 data published in The Lancet Journal showing that older adults elicited “strong immune responses,” although these data do 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 return a massive upfront payment. It also received much greater protection from damages than its rivals, meaning governments would help pay some of the legal costs should problems arise with the vaccine.
Kyriakides said on Monday that the EU should not see a dividend yet. “The European Union has pre-funded the development of the vaccine and production and wants to see the returns,” 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 block during the first quarter than initially planned, and there have been initial reports of several manufacturing issues. An EU official said a bad batch of vaccines had to be thrown away 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, made a statement saying the company had not sufficiently explained why the offer would fall short.
“The European Union wants to know exactly what doses AstraZeneca has produced and where exactly so far and if and to whom they have been delivered,” Kyriakides said, adding, “The company’s responses have so far been unsatisfactory.”
Matthew Karnitschnig, Jakob Hanke Vela and Carlo Martuscelli contributed reporting.