The EU on Monday called for strict control of coronavirus vaccine exports after senior officials but accused UK-based AstraZeneca of cutting supplies to EU countries to sell doses to other countries at higher prices. high.
The move came after two controversial vaccine board meetings on Monday between EU and national officials and representatives of the British-Swedish pharmaceutical conglomerate, which reported in Brussels on Friday that vaccine production would be well below its contractual obligations with the EU.
Furious EU officials said the company had not explained the situation.
“Discussions with @AstraZeneca today has caused dissatisfaction with the lack of clarity and insufficient explanations, “tweeted EU Health Commissioner Stella Kyriakides after the second meeting she attended shortly before 10pm. EU member states are united: vaccine developers have contractual and social responsibilities that they must maintain. ”
He announced that another meeting will take place on Wednesday. Earlier in the day, Kyriakides announced plans for upcoming export controls, making clear the Commission’s suspicions that AstraZeneca had sent the vaccine elsewhere.
“The European Union wants to know exactly what 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 export mechanism proposed by the Commission would require any company disclose in advance any planned 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 sending vaccines internationally, except on humanitarian grounds. The restriction would be similar to the limitations the EU imposed last spring on exports of personal protective equipment when supplies were scarce.
AstraZeneca did not issue a statement on Monday in response to criticism from the Commission, nor did it respond to repeated requests for comment on the lack of production.
The Commission’s rapid move to impose new export surveillance and the willingness of officials to make public their anger against the company revealed how access to vaccines has become the political problem of more voltage for public leaders, as the pandemic continues to record the number of infections and blockade measures expanded or renewed in many countries.
As a further sign of the urgency of the problem, the AstraZeneca vaccine has not yet been formally approved by the European Medicines Agency. This formal step is expected later this week, but the arrival of the vaccine is so long awaited that some EU leaders had pushed for a European Council summit on Thursday to start waiting for shipments. of approval.
An EU diplomat said AstraZeneca gave two reasons for the production deficit, related to the supply of materials and the problems of manufacturing a plant in Belgium, but diplomats said the company had not justified these statements with evidence. This led to speculation among Commission officials and EU national officials that AstraZeneca had sent doses made in Belgium to other customers, only to realize that production was not moving fast enough to meet contractual obligations towards the EU, which had made a prepayment of hundreds of millions of euros.
“Confidence has been severely shaken,” said a Commission official, who added: “To date it has not been fully explained what happened to the money and what the company has done with the its obligation to manufacture at risk “.
Another Commission official said that over the course of Monday, the company reiterated that they are “doing their best” over and over again without further details to increase production. The official called his explanations “nonsense.”
Clash by deceleration
AstraZeneca’s inability to meet contractual terms was the EU’s second major setback in terms of vaccine supply in recent days.
Pfizer, which manufactures a vaccine in collaboration with German company BioNTech, announced on January 15 that it was temporarily reducing deliveries to the EU until the end of January in order to make changes to its production site in Belgium to increase manufacturing. Some EU leaders expressed anger at the slowdown, even as Pfizer insisted that deliveries were expected to rise again from the week of 15 February. Italy sent Pfizer a formal warning to the company also on Monday.
The AstraZeneca blow, however, is worse in both its scale and its ramifications. Many EU countries chose not to order the full and proportional allocation of mRNA vaccines to BioNTech / Pfizer and Moderna because they were too difficult to use and cost, instead, to the British vaccine, which is cheaper and logistically easier to handle.
For most of the world vaccine race, Oxford / AstraZeneca was considered the leader, being one of the first to start clinical trials, committing to sell its vaccine at an expensive price and promising EU capitals a serum much easier to use compared to mRNA bites.
But AstraZeneca now seems like an increasingly bad bet and new questions have been raised about the effectiveness of the vaccine in people over 65.
The German Ministry of Health has decided to suspend the administration of the AstraZeneca vaccine to the elderly until its effectiveness is demonstrated among those over 65, according to a person familiar with the ministry’s thinking. This means that Germany will be forced to rely more on the missing BioNTech / Pfizer vaccine to protect its most vulnerable population.
However, the company backtracked in a statement Monday night, saying the allegations were “completely incorrect” and that British authorities supported their use in those populations. A spokesman cited Phase 2 data published in The Lancet magazine, which showed that older adults generated “strong immune responses,” although those data do not show the effectiveness of the vaccine for the elderly.
AstraZeneca received the first and most anticipated EU vaccine contract in August and in return received a giant prepayment. It was also granted much greater compensation protections than its rivals, meaning governments would help pay for parts of the legal costs in the event of problems with the vaccine.
Kyriakides said Monday that the EU had not yet seen dividends. “The European Union has previously funded vaccine development and production and wants to see the return,” he said in a brief appearance between the two meetings with AstraZeneca.
The company has said it will now deliver 60% less doses to the block during the first quarter than initially anticipated, and there were initial reports of various production difficulties. An EU official said a bad batch of vaccines had to be ruled out and the company was struggling to get enough raw materials for mass production.
But after a first meeting with company officials on Friday and another that lasted most of Monday afternoon, Kyriakides, visibly furious, issued a statement, saying the company had not adequately explained why. its offer would be short.
“The European Union wants to know exactly what doses have been produced by AstraZeneca and where exactly so far and if or to whom they have been delivered,” Kyriakides said, adding: “The company’s responses have not been satisfactory so far.” .
Matthew Karnitschnig, Jakob Hanke Vela i Carlo Martuscelli has provided reports.