The EU called on Monday for strict controls on exports of coronavirus vaccines after senior officials accused AstraZeneca, based in the United Kingdom, of cutting supplies to EU countries to sell doses to other nations at higher prices.
The move came after two meetings of the vaccine board on Monday between the EU and national authorities and representatives of the British-Swedish pharmaceutical conglomerate, who informed Brussels on Friday that vaccine production would fall far short of its contractual obligations. with the EU.
Furious EU officials said the company did not explain the situation.
“Discussions with @AstraZeneca today it resulted in dissatisfaction with the lack of clarity and insufficient explanations, “tweeted EU health commissioner Stella Kyriakides after the second meeting, just before 10:00 pm.” EU Member States are united: vaccine developers have social and contractual responsibilities that they need to fulfill. ”
She announced that another meeting will take place on Wednesday. Earlier in the day, Kyriakides announced plans for the next export controls, making clear the Commission’s suspicions that AstraZeneca had shipped the vaccine elsewhere.
“The European Union wants to know exactly what doses were produced by AstraZeneca and where exactly so far and if or to whom they were delivered,” said Kyriakides, adding that the export mechanism proposed by the Commission requires any company to disclose any international shipments in advance. doses of vaccines manufactured in the EU
A Commission official said that the proposal for a new export control would require companies to seek approval before sending vaccines internationally, except for humanitarian reasons. The restriction would be similar to the limitations imposed by the EU 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 production deficit.
The Commission’s swift action to enforce new export supervision and the willingness of employees to publicly publicize their anger at the company highlighted how access to vaccines has become the most stressful political issue for public leaders as the pandemic continues to escalate. spread, with record numbers of infections and extended or renewed blocking measures in many countries.
In yet another sign of how urgent the issue has become, the AstraZeneca vaccine has not yet been formally approved by the European Medicines Agency. This formal measure is expected later this week, but the vaccine’s arrival is so expected that some EU leaders pushed during a European Council conference call on Thursday for shipments to begin pending approval.
An EU diplomat said AstraZeneca gave two reasons for the production deficit, related to material supply and manufacturing problems at a factory in Belgium, but diplomats said the company had not substantiated these claims. This led to speculation between 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 with the EU, which had made a prepayment in the hundreds of millions of euros.
“Trust has been severely undermined,” said a Commission official, adding: “To date, it has not been fully explained what happened to the money and what the company did in its obligation to manufacture at risk.”
Another Commission official said that over the course of Monday, the company repeatedly is “doing the best” continuously, without any additional details to increase production. The official called his explanations “absurd”.
Confrontation over deceleration
The news of AstraZeneca’s inability to comply with the terms of the contract was the second major setback for the EU in terms of vaccine supply in recent days.
Pfizer, which makes a vaccine in partnership with the German company BioNTech, announced on January 15 that it was temporarily reducing deliveries to the EU until the end of January to make changes to its production site in Belgium to increase manufacturing. Some EU leaders expressed anger at the slowdown, even when Pfizer insisted that deliveries should increase again from the week of February 15. Italy sent Pfizer a formal notice to the company on Monday as well.
AstraZeneca’s coup, however, is worse in scale and ramifications. Many EU countries chose not to request their full pro-rata allocation of mRNA vaccines from BioNTech / Pfizer and Moderna because they were very difficult to use and expensive, opting to bet on the British vaccine, which is cheaper and logistically easier to handle. .
During most of the global vaccine race, Oxford / AstraZeneca was seen as the pioneer, being one of the first to start clinical trials, promising to sell its vaccine at cost and promising EU capitals a much easier to use serum in compared to mRNA jabs.
But AstraZeneca now looks like an increasingly bad bet, and new questions have been raised about the vaccine’s effectiveness in people over 65.
Germany’s health ministry has decided to postpone the administration of the AstraZeneca vaccine for the elderly until there is proof of its effectiveness 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.
Still, the company backed down in a statement late on Monday, saying that such charges are “completely incorrect” and pointing out that their use in these populations has been supported by British authorities. A spokesman cited Phase 2 data published in The Lancet, showing that older adults generated “strong immune responses”, although these data do not show how effective the vaccine is for older people.
AstraZeneca won the EU’s first and most anticipated vaccine contract in August and, in return, received a giant prepayment. It has also received much higher compensation protections than its competitors, which means that governments would help pay part of the legal costs if problems arise with the vaccine.
Kyriakides said on Monday that the EU has yet to see dividends. “The European Union has pre-financed vaccine development and production and wants to see a return,” she said in a brief appearance between the two meetings with AstraZeneca.
The company said it will now deliver 60 percent fewer doses to the pack during the first quarter than initially projected, and there have been initial reports of varying production difficulties. An EU official said that a bad batch of vaccines had to be discarded and that the company was struggling to get enough raw materials for mass production.
But after an initial meeting with company executives on Friday and another that lasted most of Monday afternoon, Kyriakides, visibly furious, made a statement, saying the company had not adequately explained why its supply would be insufficient.
“The European Union wants to know exactly what doses were produced by AstraZeneca and where exactly so far and if or to whom they were delivered,” said Kyriakides, adding: “The company’s responses have not been satisfactory so far.”
Matthew Karnitschnig, Jakob Hanke Vela and Carlo Martuscelli contributed reports.