Outraged by AstraZeneca over shortfall, calls on EU to control vaccine exports – POLITICO

The EU on Monday called for the export of coronavirus vaccines after top officials accused AstraZeneca, but only in the UK, of supplying supplies to EU countries to sell doses to other countries at higher prices.

The move comes after two controversial meetings against vaccine managers on Monday between EU and national officials and representatives of the British-Swedish pharmaceutical conglomerate, which informed Brussels on Friday that vaccine production would cease far from its contractual obligations to the EU.

Angry EU officials said the company could not explain the situation.

Discussions with @AstraZeneca today led to dissatisfaction over the lack of clarity and inadequate explanations, “EU Health Commissioner Stella Kyriakides tweeted after the second meeting, which was attended shortly before 22:00.” EU member states are united: vaccine developers have social and contractual responsibilities that they must uphold.

She announced that another meeting will take place on Wednesday. Earlier in the day, Kyriakides announced plans for the next export control, while clarifying the Commission’s suspicion 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 it has been delivered,” Kyriakides said, adding that the Commission’s proposed export mechanism requires any company to disclose any information in advance. make. 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 sending vaccinations internationally, except for humanitarian reasons. The restriction is similar to the restrictions imposed by the EU last spring on the export of personal protective equipment when supplies were scarce.

AstraZeneca did not issue a statement on Monday in response to criticism from the Commission, nor to repeated requests for comment on the production shortfall.

The Commission’s swift move to enforce the new export controls, and the willingness of officials to go public with their anger over the company, highlighted how access to vaccines has become the political tension for public leaders, as the pandemic continues to rage, with record numbers of infections and extensive or renewed closure measures in many countries.

In a further sign of how urgent the matter has become, the vaccine of AstraZeneca has not yet been formally approved by the European Medicines Agency. The formal move is expected later this week, but the arrival of the vaccine is expected in such a way that some EU leaders insisted on delivery during a European Council teleconference on Thursday pending approval.

One EU diplomat said that AstraZeneca had given two reasons for the production shortage, which was related to the acquisition of materials and problems with the manufacture of a factory in Belgium, but the diplomats said that the company did not succeed in making the allegations. to substantiate with evidence. This has led to speculation among Commission officials and EU officials that AstraZeneca sent doses manufactured in Belgium to other customers, only to realize that production is not moving fast enough to meet contractual obligations to the EU. not, which made a prepayment to hundreds. of millions of euros.

‘Confidence has been severely shaken’, said a Commission official: ‘To date, it has not been fully explained what happened to the money and what the company did on the basis of its obligation to manufacture a risk. ‘

Another Commission official said the company repeated throughout Monday that they were “doing their best again” without any further details to increase production. The official calls their statements ‘nonsense’.

Confrontation over slowdown

The message of AstraZeneca’s inability to meet its contract terms was the second major setback for the EU in terms of vaccine stocks in recent days.

Pfizer, which manufactures a vaccine in partnership with German company BioNTech, announced on January 15 that it would temporarily reduce delivery to the EU until the end of January, making changes to its production work in Belgium to increase production. Some EU leaders have expressed outrage over the slowdown, though Pfizer has insisted that delivery is expected to start increasing again from the week of 15 February. Pfizer also sent the company a formal warning on Monday.

However, the impact of AstraZeneca is worse in its scope and consequences. Many EU countries chose not to order their full pro rata allocation of BioNTech / Pfizer and Moderna mRNA vaccines because it was too difficult to use and expensive, but rather opted for the UK vaccine, which is cheaper and logistically easier to handle.

For most of the global vaccination battle, Oxford / AstraZeneca is considered the forerunner, and was one of the first to launch clinical trials, promising to sell the vaccine at cost, and promising EU capitals a lot easier. serum to use compared to mRNA jabs.

But AstraZeneca is now looking worse, and new questions have been raised about the efficacy of the vaccine in people over 65 years of age.

According to the person familiar with the ministry, the German Ministry of Health has decided to suspend the administration of the AstraZeneca vaccine to the elderly until there is evidence of its effectiveness among the 65-year-olds. This means that Germany will be forced to rely more on the scarce BioNTech / Pfizer vaccine to protect its most vulnerable population.

The company nevertheless backed down in a statement on Monday night, saying such allegations were “completely wrong” and pointed out that their use in such populations was supported by the British authorities. A spokesman cited Phase 2 data published in The Lancet magazine, which shows that older adults generate ‘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 received a huge down payment in return. There is also much greater indemnity protection granted to its competitors, which means that governments will help pay part of the legal costs should problems arise with the vaccine.

Kyriakides said on Monday that the EU has 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 said it would now deliver 60 percent fewer doses to the block during the first quarter than initially projected, and there were initial reports of various production problems. One EU official said that a bad amount of vaccines had to be thrown away and that the company was struggling to obtain enough raw materials for mass production.

But after an initial meeting Friday with company officials and another one that lasted most of Monday afternoon, Kyriakides, who was apparently furious, issued a statement saying the company could not adequately explain why she supply would not fall short.

“The European Union wants to know exactly what doses have been produced by AstraZeneca and where exactly so far and whether or to whom it has been delivered,” Kyriakides said, adding: “The company’s responses so far have not been satisfactory.”

Matthew Karnitschnig, Jakob Hanke Vela and Carlo Martuscelli contribution made.

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