EU Protests AstraZeneca Vaccine Delays – Could Block UK-Bound Exports Medicines & Vaccines 28/01/2021 • Madeleine Hoecklin Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) The Oxford/AstraZeneca vaccine is 2 months behind schedule due to an issue in manufacturing. AstraZeneca has joined Pfizer in announcing delays in deliveries of COVID-19 vaccines to countries in Europe, leading furious EU officials to plan for a system of tighter monitoring of vaccine exports. The British-Swedish pharma company that developed its COVID-19 vaccine with researchers at Oxford University, informed the European Commission on Friday that there would be a 60% shortfall in vaccine deliveries this quarter due to a manufacturing issue at a production plant in Belgium. The company is reportedly two months behind schedule with regard to vaccines destined for European countries. Since vaccine deals with the United States and the United Kingdom were signed earlier on, and are based around manufacturing sites in those countries, the company has had a headstart in resolving “glitches” in those supply chains, pharma officials said. But the Commission had its doubts over this given explanation. Following an EU-requested investigation into AstraZeneca’s Belgian-based production facility on Wednesday, the European Commission has said it would establish a new mechanism that grants national regulators the power to refuse exports of vaccines. The mechanism – the criteria for which is expected to be published on Friday – could throw the security of the UK’s 40m-dose deal with Pfizer/BioNTech. The investigation, a spokesperson for the Belgian health ministry said, was to “make sure that the delivery delay is indeed due to a production problem on the Belgian site”. AstraZeneca ‘Scaling Up’ Doses, As EU Leaders Question Pharma Company Pascal Soriot, CEO of AstraZeneca “We are scaling up to hundreds of millions, billions of doses of vaccines at a very high speed. A year ago we didn’t have a vaccine. When you do that, you have glitches, you have scale-up problems. Therefore, the yield varies,” said Pascal Soriot, CEO of AstraZeneca, in an interview with la Repubblica, an Italian newspaper, on Tuesday. News of the delays was met with frustration by EU officials and leaders, who were expecting to receive 80 million doses by the end of March. “This new schedule is not acceptable to the European Union,” said Stella Kyriakides, European Commissioner for Health and Food Safety, in a statement released on Monday. “The European Union wants to know exactly which doses have been produced by AstraZeneca and where exactly so far, and if, or to whom, they have been delivered.” Stella Kyriakides, European Commissioner for Health and Food Safety, at a press briefing on Wednesday. Soriot disputed suggestions that the company sold the doses elsewhere for a higher price, claiming that “there is a lot of silly talk going on right now about all sorts of things,” and the response from the European Commission and EU member states is because “there are a lot of emotions running in this process right now.” “The suggestion [that] we sell to other countries to make more money is not right because we make no profit everywhere…That’s the agreement we have with Oxford University,” said Soriot. “Governments are under pressure. Everybody is getting kind of…aggravated or emotional about those things. But I understand because the Commission is managing the process for the whole of Europe,” he added. In late August, the EU made an upfront payment of €336 million to the company to secure 300 million doses of the vaccine. EU officials have disputed AstraZeneca’s explanation of production issues, claiming there are no excuses for the delay. “The flimsy justification that there are difficulties in the EU supply chain but not anywhere else does not hold water, as it is of course no problem to get the vaccine from the UK to the continent,” said Peter Liese, an EU parliamentarian from Germany’s Christian Democratic Union. Currently AstraZeneca is producing 17 million doses per month. That number will reach 100 million doses from February onwards, according to Soriot, meaning 1.2 billion doses per year. And Europe will receive 17% of the global production in February for a population that represents 5% of the world’s population. The Oxford/AstraZeneca vaccine is in the final stages of the approval process with the European Medicines Agency (EMA) and is expected to receive the recommendation for market authorization on Friday. After being approved, the company plans to deliver three million doses immediately. Meetings between EU officials and AstraZeneca have done little to resolve the issue, with Kyriakides announcing on Twitter: “Discussions with @AstraZeneca today resulted in dissatisfaction with the lack of clarity and insufficient explanations. EU Member States are united: vaccine developers have societal and contractual responsibilities they need to uphold.” With our Member States, we have requested from AZ a detailed planning of vaccine deliveries and when distribution will take place to Member States. Another meeting will be convened on Wednesday to discuss the matter further. — Stella Kyriakides (@SKyriakidesEU) January 25, 2021 The EU Steering Board, the body that oversees vaccine deals, plans to meet with AstraZeneca again on Wednesday at 6:30pm CET and hopes to “resolve this in a spirit of collaboration and responsibility,” according to Kyriakides. The Italian government plans to take legal action against Pfizer and AstraZeneca over their delays in deliveries, according to an announcement made by Foreign Minister Luigi Di Maio on Sunday. “This is a European contract that Pfizer and AstraZeneca are not respecting and so for this reason we will take legal action,” Di Maio said on RAI state television. “We are activating all channels so that the EU Commission does all it can to make these gentlemen respect their contracts.” According to Soriot, however, the vaccine deal signed with the EU was not a contractual commitment but a best effort, so there is no feasible basis for legal action. EU to Establish a Vaccine Export Transparency Mechanism The Oxford/AstraZeneca vaccine is also considered one with global potential – due to its ability to be stored at refrigerator temperatures. Amidst some countries’ suspicions that countries outside Europe are receiving priority for vaccines produced at the Belgium plant, the European Commission announced plans to establish an export transparency mechanism for vaccines to ensure clarity on transactions and to protect its investments in the R&D that led to development of vaccines like AstraZeneca’s. AstraZeneca is also a major supplier of the WHO COVAX global distribution initiative – which has pledged to begin distributing vaccine doses to the 92 lowest-income countries in the world within the next two months. Although most of the COVAX supplies were reportedly to be produced by India’s Serum Institute or in the Republic of Korea, the exact supply lines remain unclear. “Europe invested billions to help develop the world’s first COVID-19 vaccines…And now, the companies must deliver,” said Ursula von der Leyen, President of the European Commission, at the World Economic Forum on Tuesday. “They must honor their obligations. This is why we will set up a vaccine export transparency mechanism. Europe is determined to contribute to this global common good. But it also means business.” Ursula von der Leyen, President of the European Commission, speaking at the World Economic Forum on Tuesday. “In the future, all companies producing vaccines against COVID-19 in the EU will have to provide early notification whenever they want to export vaccines to third countries,” said Commissioner Kyriakides. The aim of the proposed system will be to monitor, but not block, exports, officials said. And humanitarian deliveries would be anyway exempt from this oversight mechanism. EMA Yet To Issue Final Approval – Insufficient Data on Vaccine in Older People Meanwhile, the EMA has yet to issue its final regulatory approval for the two-dose Oxford/AstraZeneca vaccine, and is reportedly considering limiting the age range to people under the age of 65 – due to a lack of data on effectiveness in older people. Unlike mRNA counterparts produced by Moderna and Pfizer, the AstraZeneca/Oxford vaccine uses a disabled, modified version of a chimpanzee adenovirus that can enter human cells but cannot replicate or cause the disease, as a vector to deliver a fragment of SARS-CoV2 spike protein, stimulating COVID-19 immunity. According to data shared by the company, only 10% of participants in the vaccine clinical trials were over the age of 65 because it was first waiting for sufficient safety data in the 18 to 55 age group before vaccinating older individuals. “We don’t have a huge number of older people who have been vaccinated,” said Soriot. “But we have strong data showing very strong antibody production against the virus in the elderly, similar to what we see in younger people.” The results of an ongoing, larger Phase 3 clinical trial with 30,000 participants being conducted in the United States are expected to provide insight into the protection the vaccine provides to older individuals and ethnic minorities populations – groups that were not very well represented in previous trials. In addition, scientists are exploring whether a half-dose of the first vaccine would reliably yield a higher efficacy rating of 90% that was seen in initial trials. The other regime, involving two full doses was only 62% effective, according to the results released by the company in late November and reviewed by an independent Data and Safety Monitoring Board. That still meets key global benchmarks for efficacy, but is significantly lower than the 94-95% efficacy results for the Moderna and Pfizer mRNA vaccines. The AstraZeneca vaccine has, however, already been authorized in the UK, is already being used in British vaccination campaigns, including for people over 70 years old. Image Credits: AstraZeneca, AstraZeneca, Twitter, Twitter. Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) Combat the infodemic in health information and support health policy reporting from the global South. 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