BRUSSELS (AP) – Amid a dispute over expected shortages, the European Union is looking for legal ways to ensure the supply of all COVID-19 vaccine doses it has purchased from AstraZeneca and other drug manufacturers as regulators will consider pushing the Anglo -Swedish industrial vaccine for use in the EU of 27 countries.
The European Medicines Agency is expected to approve the use of the vaccine AstraZeneca developed in collaboration with Oxford University on Friday. It would be the third approved for use in the EU, after the BioNTech-Pfizer and Moderna vaccines.
However, officials in Brussels have argued with AstraZeneca after the pharmaceutical company said it would make smaller-than-expected deliveries to EU member states. The bloc’s executive committee asked the Belgian authorities to inspect a factory in Belgium that is part of AstraZeneca’s vaccine production chain.
In addition to the uncertainty, a draft recommendation from a German committee of experts called for the Oxford-AstraZeneca vaccine to be offered only to people under 65 for the time being.
European authorities are under pressure after a slow start to the EU’s vaccination campaign in the first month, and AstraZeneca’s serum would add much-needed extra supplies.
In response to a letter he received from four European heads of government, EU Council President Charles Michel said that the EU should “explore all options and make use of all legal and enforcement measures available to us,” as negotiations with pharmaceutical companies that do not give satisfaction.
The EU is at odds with AstraZeneca over expected delivery delays. AstraZeneca said last week that it plans to cut first deliveries in the EU from the planned 80 million doses for the first quarter of the year to 31 million doses. The company cited reduced yields from its factories in Europe, but the EU suspects doses produced in Europe are directed elsewhere.
Michel said the EU could rely on an article of one of its treaties that allows members to take action “if there are serious problems with the supply of a particular product.”
Michel wrote that the use of Article 122 “would give the EU and Member States the legal means, by taking appropriate urgent measures, to ensure effective production and delivery of vaccines for our population. I think this solution would demonstrate the EU’s strength and reliability in protecting the health of its citizens above all other considerations. “
The European Commission also plans to draft new rules to strengthen controls on vaccine exports to ensure that the purchased doses are delivered to the residents of the block.
In Germany, the draft recommendation added a question mark over how widely it could be used – though the country’s health minister stressed that a final decision will not be made until after Friday’s EMA meeting.
The German Vaccine Advisory Commission, an independent panel that advises the government, called for the use of the AstraZeneca vaccine for the 18-64 age group based on currently available information. It said that “there is currently not enough data to assess the effectiveness of vaccination over the age of 65.”
AstraZeneca said after publishing the German draft on Thursday that “the latest analyzes of clinical trial data for the AstraZeneca / Oxford COVID-19 vaccine support efficacy in the age group over 65 years old.” It added that it is pending the EMA’s decision.
The company noted earlier this week that UK regulators supported its use in the older age group, despite a lack of data on its effectiveness at a late stage. It pointed to earlier stage data published in November in the journal Lancet “showing that older adults showed strong immune responses to the vaccine, with 100% of older adults generating spike-specific antibodies after the second dose.”
But there are still questions about how well the vaccine protects older people. Only 12% of the AstraZeneca study participants were over 55 and enrolled later, so there was not enough time to see if they get sick at a slower rate than those who did not receive the vaccine.
German Health Minister Jens Spahn said there had been a debate since the fall about a lack of data on this topic, but it was not yet clear “how concrete” this would ultimately affect the authorities’ decisions.
AstraZeneca said Thursday that the latest analyzes of clinical trial data “support efficacy in the age group over 65” and is awaiting the EMA’s decision.
The EU, of 450 million people, has agreements for six different vaccines. In total, it has ordered up to 400 million doses of the AstraZeneca vaccine and entered into agreements with other companies for more than 2 billion injections.
The inspection requested by the European Commission for production at manufacturer Novasep’s factory in Seneffe, Belgium, has been carried out and the data collected will be analyzed in the coming days, according to the Belgian authorities.
The EU said the Belgian plant is one of four AstraZeneca sites included in the contract signed by the Commission and the company to produce vaccines for the EU market.
Stella Kyriakides, the European Commissioner for Health and Food Safety, said AstraZeneca must deliver vaccines from its UK facilities if it is unable to meet commitments from factories in the EU. Kyriakides also made it clear that the EU would find out if some of the doses manufactured in the EU would be diverted elsewhere.
The company’s CEO, Pascal Soriot, argued in an interview with Die Welt newspaper this week that the British government helped develop the vaccine and signed the contract three months before the EU reached an agreement. He said the contract with the UK authorities states that vaccines produced on UK sites must first go to the UK.
However, the Commission said it is confident that AstraZeneca’s delay will not affect its plans to ensure that at least 80% of EU citizens over 80 have been vaccinated in March. Health policy spokesman Stefan de Keersmaecker said the goal is based on the availability of doses manufactured by Pfizer-BioNTech and Moderna.
“It’s an ambitious goal, but we think it’s realistic,” he said.
Since the start of the pandemic, more than 400,000 residents of the EU have died with COVID-19.
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Moulson reported from Berlin. Danica Kirka in London and Sylvain Plazy in Brussels contributed to this story.
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