AstraZeneca vaccine delay in EU linked to regulatory issues

AstraZeneca’s fight to increase the EU vaccine supply is partly due to the inability of one of the company’s main European manufacturing sites to deliver doses to the block six months after signing the contract supply.

The Dutch plant, run by subcontractor Halix, has yet to receive EU regulatory approval to supply the region, although it was named in the agreement signed between AstraZeneca and the European Commission in August.

EU officials said AstraZeneca had not yet provided sufficient data. The company said approval of the site remains “on track.”

The mystery of the Dutch plant highlights growing questions regarding both AstraZeneca’s handling of its contract with the EU and oversight of the bloc. AstraZeneca is far behind its planned vaccine deliveries to the EU, which has had a major effect on the vaccination rollout.

The EU had administered 10.4 doses of vaccine per 100 inhabitants on Friday, compared to 29.7 in the United States and 36.5 in the United Kingdom, according to data collected by the Financial Times. The United States and the United Kingdom entered into agreements with AstraZeneca before the European Commission.

EU officials said this week that AstraZeneca will reduce its target of delivering 40 million doses by the end of March by around 10 million doses. That target was already well below the initial supply schedule of at least 100m shots by the end of the month. Thierry Breton, EU industry commissioner, said on Thursday he did not believe AstraZeneca had done “everything possible” to meet its commitments – a reference to the wording of the August supply contract.

Concern is now growing that the Anglo-Swedish company may also fail to deliver the 180 million doses it originally promised the EU for the second quarter of the year, half of which are expected to come from outside the EU. block. The United States has so far refused to allow exports of any production from the US-based company, EU officials said. Supplying the EU from other countries in AstraZeneca’s global production network could also be difficult.

The Halix plant is one of two facilities – along with the Belgian plant in Seneffe – designated as the main sources of the so-called vaccine drug substance in AstraZeneca’s contract with the commission. Pascal Soriot, CEO of the company, explained in an interview with European newspapers in January that the vaccine drug substance is produced in Belgium and the Netherlands, then finished and packaged in vials at factories in Germany and Italy.

The Seneffe plant has struggled to achieve lower yields than expected, while the Halix plant in the Leiden Bio Science Park in the Netherlands has produced vaccines but is still not licensed to supply them in the EU.

Last week, Breton visited the Halix factory – which is expected to produce at least 5 million doses per month – as part of a tour of European vaccine manufacturing sites. Discussions about the plant’s regulatory approval by the European Medicines Agency to supply the EU market were ongoing, officials said.

When asked about the Halix situation, the committee said on Friday that the EMA was ready to expedite the authorization of new production facilities once it received an application and the necessary information from AstraZeneca. “It is, however, the responsibility of the company to request that the plants be covered by a marketing authorization and to submit all the data necessary for this purpose,” he said. “The commission encourages the company to do so.”

A spokesperson for AstraZeneca said: “Site approval with EMA remains on track with our original plans and we can confirm that it is part of our delivery plans.”

Halix did not respond to requests for comment.

EU diplomats are increasingly agitated over how many doses of vaccine Halix has actually made in the meantime and what AstraZeneca is doing with the product. Officials are counting on stocks of vaccine that will be released for use in the EU once the plant is cleared. In January, the bloc introduced new discretionary controls on vaccine exports to 31 high and middle-income countries, which Italy has already used to prevent shipment to Australia.

Brussels has already clashed with AstraZeneca and London over vaccine exports. EU officials have claimed the company has shipped vaccines produced in the EU to the UK. AstraZeneca has so far not sent doses the other way around, although two UK drug factories are mentioned in the EU supply contract as potential sources of vaccines.

The Halix situation also raises the question of whether the European Commission and EU member states have paid sufficient attention to tracking the delivery of the factory on time. Halix did not issue a press release announcing that he had been hired to produce vaccines until December, more than three months after his appointment to the AstraZeneca contract with the commission.

“While it is true that this facility does not produce for the EU, it is really confusing,” said an EU diplomat. “This would mean that three of the four factories listed in the original EU contract do not supply doses to the EU.”

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