BRUSSELS (AP) – Amid a dispute over planned shortcomings, the European Union is studying legal ways to ensure the delivery of all doses of COVID-19 vaccine it bought from AstraZeneca and other drug manufacturers, as regulators they should consider approving the company’s Anglo-Swedish vaccine for use in the EU from 27 countries.
The European Medicines Agency is expected to authorize the use of the AstraZeneca vaccine developed with Oxford University on Friday. It would be the third authorized to be used in the EU, after the BioNTech-Pfizer and Moderna vaccines.
However, Brussels officials have been fighting AstraZeneca after the pharmaceutical company said it would deliver smaller-than-expected supplies to EU member states. The bloc’s executive committee asked 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 now.
European authorities are under pressure after a slow start to the EU vaccination campaign in its first month, and AstraZeneca serum would add much-needed extra supplies.
In a reply to a letter he received from four European government leaders, EU Council President Charles Michel said the EU “should explore all options and make use of all legal means and measures of application within our reach “, if negotiations with pharmaceutical companies do not give satisfaction.
The EU disagrees with AstraZeneca over the expected delays in deliveries. AstraZeneca said last week that it planned to reduce initial deliveries to the EU, from 80 million doses planned for the first quarter of the year to 31 million doses. The company cited reduced yields from its manufacturing plants in Europe, but the EU suspects that doses produced in Europe have been directed elsewhere.
Michel said the EU could invoke an article in one of its treaties that allows members to take action “if serious difficulties arise in the supply of certain products”.
Michel wrote that the use of Article 122 “would give the EU and the Member States the legal means, through the adoption of appropriate urgent measures, to ensure the effective production and supply of vaccines for our population. I believe that such a solution would demonstrate the EU’s strength and reliability in protecting the health of its citizens above all other considerations. “
The European Commission also envisages new rules to strengthen control over vaccine exports to ensure that the doses it bought are delivered to block residents.
In Germany, the draft recommendation added a question about its breadth, although the country’s health minister stressed that no final decision will be made until after Friday’s EMA meeting.
The vaccination advisory committee of Germany, an independent group advising the government, called for the use of the AstraZeneca vaccine for the 18-64 age group based on currently available information. He said “there is currently not enough data to assess the effectiveness of vaccination from the age of 65.”
AstraZeneca said after the German draft was published on Thursday that “the latest analysis of clinical trial data for the AstraZeneca / Oxford COVID-19 vaccine supports efficacy in the age group over 65” . He added that he awaits the decision of the EMA.
The company noted earlier this week that British regulators supported its use in the older age group despite the lack of late-stage efficacy data. He noted data from previous phases published in the Lancet magazine in November “showing that older adults showed strong immune responses to the vaccine, with 100% of older adults generating specific antibodies to the surge after the second dose.” .
But questions remain about vaccine protection for the elderly. Only 12% of AstraZeneca research participants were over 55 and enrolled later, so there has not been 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 discussion about the lack of data on the issue since the autumn, but it was still unclear “to what extent specifically” this would affect the authorities’ decisions.
AstraZeneca said Thursday that the latest analyzes of clinical trial data “support efficacy in the age group over 65” and awaits the EMA’s decision.
The EU, which has 450 million people, has signed agreements for six different vaccines. In total, it has ordered up to 400 million doses of the AstraZeneca vaccine and sealed agreements with other companies for more than 2 billion shots.
The inspection that the European Commission requested of the production at the factory of the manufacturer Novasep 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 factory 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 should provide vaccines from its UK facilities if it cannot meet the commitments of EU factories. Kyriakides also made it clear that the EU would find out if some of the doses manufactured in the EU would be diverted to other places.
The CEO of the company, Pascal Soriot, has argued in an interview with the newspaper Die Welt this week that the UK government helped develop the vaccine and signed his contract three months before the EU reached its agreement. . He said the contract with the British authorities specifies that vaccines produced at UK sites must go first to the UK.
However, the Commission said it remains confident that AstraZeneca’s delay will not affect its plans to ensure that at least 80% of EU citizens over the age of 80 are 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.
More than 400,000 EU residents with COVID-19 have died since the beginning of the pandemic.
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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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