Upset by AstraZeneca over deficit calls for EU vaccine export controls – POLITICO

The EU on Monday called for strict controls on coronavirus vaccine exports after top officials, however, accused Britain’s AstraZeneca of cutting supplies to EU countries to sell doses to other nations at higher prices.

The move comes after two controversial meetings of the Vaccine Steering Committee on Monday between EU and national officials and representatives of the British-Swedish pharmaceutical conglomerate, which informed Brussels on Friday that vaccine production would not meet contractual obligations to the EU.

Angry EU officials said the company had failed to explain the situation.

“Discussions with @AstraZeneca today led to dissatisfaction with the lack of clarity and insufficient explanations, “European Health Commissioner Stella Kyriakides said on Twitter after the second meeting she attended shortly before 10pm.” The EU is united: vaccine developers have societal and contractual responsibilities that they must uphold. ”

She announced that another meeting would take place on Wednesday. Earlier in the day, Kyriakides announced plans for the next export controls, while clarifying the Commission’s suspicions that AstraZeneca had shipped the vaccine elsewhere.

“The European Union wants to know exactly what doses have been produced by AstraZeneca and where exactly so far and whether or to whom they have been delivered,” said Kyriakides, adding that the export mechanism proposed by the Commission would require any company to disclose in advance any 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 dispatching vaccines internationally, except for humanitarian reasons. The restriction would be similar to the restrictions the EU imposed last spring on exports of personal protective equipment when supplies were depleted.

AstraZeneca did not issue a statement on Monday in response to the Commission’s criticisms, nor did it respond to repeated requests for comments on the production deficit.

The Commission’s swift move to impose new export surveillance and officials’ willingness to anger the company highlighted how access to vaccines has become the most tense political issue for public leaders as the pandemic continues to escalate. unleashes, registers a number of infections and blocking measures extended or renewed in many countries.

As a further sign of how urgent the problem has become, the AstraZeneca vaccine has not yet been officially approved by the European Medicines Agency. This formal step is expected later this week, but the arrival of the vaccine is so anticipated that some EU leaders lobbied during a European Council telesimit on Thursday for transfers to begin pending approval.

An EU diplomat said AstraZeneca gave two reasons for the production shortfall, related to the supply of materials and manufacturing problems at a factory in Belgium, but diplomats said the company had failed to substantiate the allegations. This has led to speculation between Commission officials and EU national officials that AstraZeneca has delivered doses made in Belgium to other customers, only to realize that production is not moving fast enough to meet contractual obligations to the EU. , which made an advance payment in the hundreds of millions of euros.

“Confidence has been shaken sharply,” a Commission official said, adding: “So far, it has not been fully explained what happened to the money and what the company has done about its obligation to manufacture in jeopardy.”

Another Commission official said that throughout Monday, the company repeated that it was “doing its best” again and again, without further details to increase production. The official called their explanations “nonsense.”

Confrontation over slowing down

The word about AstraZeneca’s inability to meet its contractual terms was the EU’s second major failure in terms of vaccine supply in recent days.

Pfizer, which produces a vaccine in partnership with German company BioNTech, announced on January 15 that it would temporarily reduce deliveries to the EU by the end of January, to make changes to the Belgian production site to increase production. Some EU leaders have expressed anger over the slowdown, although Pfizer has insisted that deliveries should rise again from the week of 15 February. Italy also sent an official warning to Pfizer on Monday.

However, the blow from AstraZeneca is even worse both in scale and in ramifications. Many EU countries have chosen not to order their full proportional allocation of BioNTech / Pfizer and Moderna mRNA vaccines because they were too difficult to use and expensive, instead choosing to bet on the British vaccine, which is cheaper and easier to use. handled logistically.

For most of the global vaccine race, Oxford / AstraZeneca was considered the leader, being one of the first to start clinical trials, committed to selling its vaccine at low prices and promising EU capitals a much easier serum. to be used compared to mRNA punctures.

AstraZeneca now looks like a worse bet and new questions have been raised about the effectiveness of the vaccine in people over 65 years of age.

The German Ministry of Health has decided to stop administering the AstraZeneca vaccine to the elderly until there is evidence of its effectiveness among people over the age of 65, according to a person familiar with the ministry’s thinking. This means that Germany will have to rely more on the low-dose BioNTech / Pfizer vaccine to protect its most vulnerable population.

However, the company denied in a statement on Monday evening that such allegations were “completely incorrect” and stressed that its use in such populations was supported by the British authorities. A spokesman cited phase 2 data published in The Lancet, which shows that older adults have generated “strong immune responses”, although these data do not show how effective the vaccine is for the elderly.

AstraZeneca received the EU’s first and long-awaited vaccination contract in August and received a huge advance payment in return. It has also been granted much higher compensation protections than its rivals, which means that governments would help pay for some of the legal costs in the event of vaccine problems.

Kyriakides said on Monday that the EU had not yet seen dividends. “The European Union has pre-financed the development of the vaccine and production and wants to 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 block in the first quarter than originally planned, and there have been initial reports of various production difficulties. An EU official said a bad batch of vaccines had to be thrown away, 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 Monday afternoon, Kyriakides, visibly angry, made a statement, saying the company had failed to adequately explain 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 and Vela Carlo Martuscelli contributed to the reporting.

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