Astrazeneca plc’s saga of its COVID-19 vaccine continued this week with the European Commission (EC) deciding to begin legal action against the Cambridge, U.K.-based company, claiming it has failed to deliver doses in line with its contract.
“Our priority is to ensure COVID-19 vaccine deliveries take place to protect the health of [the EU]. This is why [the] EU Commission has decided jointly with all member states to bring legal proceedings against Astrazeneca,” Commissioner Stella Kyriakides tweeted April 26.
Astrazeneca said the litigation is without merit, adding that it has fully complied with its advance purchase agreement with the EC. “Following an unprecedented year of scientific discovery, very complex negotiations, and manufacturing challenges, our company is about to deliver almost [50 million] doses to European countries by the end of April, in line with our forecast,” the company said, as it vowed to defend itself in court.
The EC’s decision comes on the heels of several countries, including EU member states, pausing use of the Astrazeneca vaccine while regulators investigated reports of rare blood clots with thrombocytopenia associated with the adenovirus vector vaccine. Some EU states dropped the vaccine entirely. Last week, the EMA supported the continued use of the vaccine in adults.
According to the EC, Astrazeneca’s supply problems began even before the vaccine was authorized for use in the EU. Back in January when the vaccine was in the final stages of the EMA’s approval process, Astrazeneca informed the EC and EU member states that it would have fewer doses in the coming weeks than agreed upon. Citing manufacturing problems at its Belgian plant and invoking the “best reasonable efforts” provision in its EU purchase agreement, the company said it would have to limit its shipments to the EU to 31 million doses in the first quarter. However, its U.K. shipments were unaffected.
“This new schedule is not acceptable to the European Union,” Kyriakides said at the time.
“The European Union has pre-financed the development of the vaccine and the production and wants to see the return,” Kyriakides continued, adding that she had written to Astrazeneca demanding to know how many doses had been produced by the company and to whom they were delivered.
Kyriakides said the EC’s steering committee and member states had discussed the issue with the company but weren’t satisfied with the answers they received. Because of the concerns, the EC imposed an export transparency measure in January requiring member states to authorize the export of COVID-19 vaccines from companies with EU advanced purchase agreements.
Meanwhile, in the U.S. where Astrazeneca has yet to submit a request for emergency use authorization for its vaccine, the Biden administration this week said it expects to have 60 million doses of the vaccine within the next two months that it can share with other countries, including India, which is grappling with a surge of COVID-19. About 10 million doses could be available as soon as the FDA clears them for release. As the doses become available, plans will be finalized as to where they’ll be sent, a senior administration official said April 26 at a White House media briefing.
The administration also has committed to diverting the U.S. order for raw materials for the production of the Astrazeneca vaccine to the Serum Institute of India. “Because of the scope of the current situation in India and the . . . state of our own production here at home, this was the most effective and rapid step we could take at this stage to provide support at scale” to India, the official explained.