EU clashes with AstraZeneca over Covid-19 vaccine deficit

Before a meeting between the company and EU officials on Wednesday night, the bloc’s health commissioner, Stella Kyriakides, said the EU contract with AstraZeneca requires the pharmaceutical company to supply the bloc using UK factories, if those on the continent can’t.

“We are in a pandemic. We lose people every day, ”Kyriakides told reporters. “Pharmaceutical companies and vaccine developers have moral, social and contractual responsibilities that need to be respected.”

The deficit in AstraZeneca leaves the EU with few options to close a large gap in its vaccination plans in the coming months. The company told European authorities last week that at worst AstraZeneca may be able to supply only about 30 million of about 80 million doses that EU countries had predicted for February and March, a decline of around 60% of the company’s previous estimates.

On Wednesday night, AstraZeneca’s chief executive, Pascal Soriot, attended the meeting by videoconference with the EU and officials from member states. After the meeting, Ms. Kyriakides said she welcomed the “constructive tone” shown, but regretted “the continued lack of clarity in the delivery schedule” for vaccines until March.

Vaccine developers spent nearly a year setting up production, aligning suppliers and contracting third-party manufacturers to start producing at least hundreds of millions of doses a year. It would take months for other companies to increase their production to make up for the slack left by AstraZeneca, say pharmaceutical industry executives.

The tensions arising from vaccine nationalism are testing the ability of pharmaceutical companies to work across borders. The UK’s recent departure from the EU redefined its commercial relationship with the bloc, sowing the seeds for the confrontation with AstraZeneca.

AstraZeneca claims to have established vaccine production and supply chains to serve specific countries and regions. Two factories in the UK are producing most of the vaccine’s active substance for the UK, while a factory in the Netherlands and one in Belgium are producing for the continent, the company says.

Soriot said in an interview on Tuesday with the Italian newspaper La Repubblica that his contract with the EU only requires the company to do its best to deliver the doses.

“The reason we said this is because Europe at the time wanted to be supplied at about the same time as the United Kingdom, although the contract was signed three months later,” said Soriot. “So we said, ‘OK, let’s do our best, let’s try, but we can’t contractually commit because we’re three months behind the UK'”

The UK approved the AstraZeneca vaccine on 30 December, while the EU drug regulator is expected to approve it in the coming days.

Ms. Kyriakides has denied the company’s claim that it is only obliged to make every effort to deliver on planned deliveries. She asked AstraZeneca to publish the contract, which she said included advance purchase agreements forcing the company to build the capacity to produce the vaccine as soon as possible, so that a stock of doses was ready as soon as it was authorized.

Ms. Kyriakides said that the company’s two factories in the UK have the same supply pre-delivery obligations to the EU as its two factories on the continent. And she said that AstraZeneca cannot prioritize the UK market just because the UK first signed the agreement with AstraZeneca.

“We reject the logic of first come, first served. This may work in the neighborhood butcher shop, but not in contracts and not in our advance purchase agreements, ”she said.

Other drug makers have signaled that they will not be able to rapidly increase production to make up for any shortages in the supply of rival vaccines.

BioNTech SE from Germany,

that developed the first Covid-19 vaccine to receive regulatory approval in the West in partnership with Pfizer Inc.,

he said he is working hard to expand his production capacity in Europe and fulfill existing commitments more quickly. However, a BioNTech spokesman said that companies are unlikely to fill any supply gap caused by other companies that do not meet the deadline.

Pfizer-BioNTech’s contract with the EU stipulates that 300 million doses are to be delivered to the pack by the end of this year, but companies are working to deliver them faster, said a BioNTech spokeswoman. The EU has proposed to buy an additional 300 million doses, with deliveries starting in the second quarter of this year.

BioNTech has organized a manufacturing alliance for several European companies. This week, he attracted French pharmaceutical giant Sanofi SA

fill vials with the vaccine and pack them, the final stage of the production process. The facility will produce 125 million finished doses this year, Sanofi said, but production will not begin until July.

A potential bottleneck in BioNTech’s supply chain is the vaccine’s active substance, messenger RNA, or mRNA, a molecule of genetic material that delivers immunity-related information directly to human cells. In Europe, it is manufactured only at BioNTech’s headquarters in Mainz, Germany.

At the end of February, a new BioNTech plant that will also manufacture mRNA is expected to start operating in Marburg, Germany, with a capacity to produce 750 million doses per year. But that extra capacity will be used to deliver existing orders. The companies have pledged to deliver two billion doses globally this year.

Modern Inc.

it hired Swiss manufacturer Lonza Group to help produce the active substance in its vaccine. At its facilities in the alpine city of Visp, Lonza built three production lines in less than 11 months, with the capacity to produce 300 million doses per year for markets outside the USA. The EU has ordered up to 160 million doses of the vaccine.

Significantly increasing production would also require new investments that would take another seven to eight months, said a person familiar with the matter.

Write to Laurence Norman at [email protected], Matthew Dalton at [email protected] and Bojan Pancevski at [email protected]