BRUSSELS (PA) – Amid disputes over expected deficiencies, the European Union is looking for legal ways to ensure delivery of all doses of COVID-19 vaccine it has bought from AstraZeneca and other drug manufacturers, as regulators should consider approving the Anglo-Swedish company’s vaccine agreement for use in the EU-27.
The European Medicines Agency is expected on Friday to authorize the use of the AstraZeneca vaccine developed in conjunction with Oxford University. It would be the third authorized for use in the EU, after the BioNTech-Pfizer and Moderna vaccines.
However, officials in Brussels quarreled with AstraZeneca after the pharmaceutical company said it would deliver supplies less than expected to EU member states. The bloc’s executive committee has asked the Belgian authorities to inspect a Belgian plant that is part of the AstraZeneca vaccine production chain.
Adding 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 the age of 65.
European authorities are under pressure after a slow start to the EU vaccination campaign in the first month, and the AstraZeneca serum would add much-needed additional 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 use all legal means and enforcement measures to at our disposal ”, if negotiations with pharmaceutical companies yield satisfaction.
The EU is at odds with AstraZeneca over expected delivery delays. AstraZeneca said last week that it intends to reduce initial deliveries in the EU from 80 million doses scheduled for the first quarter of the year to 31 million doses. The company cited low production from its production plants in Europe, but the EU suspects that doses produced in Europe have been diverted elsewhere.
Michel said the EU could invoke an article in one of its treaties that allows members to take action “if there are severe difficulties in supplying certain products”.
Michel wrote that the use of Article 122 “will provide the EU and the Member States with the legal means, by taking appropriate urgent measures, to ensure the efficient production and supply of the vaccine to our population. I believe that 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 intends to adopt new rules to strengthen control over vaccine exports to ensure that the doses it has purchased are delivered to the block’s residents.
In Germany, the draft recommendation added a question mark over how widely it could be used – although the country’s health minister stressed that a final decision would not be made until after Friday’s EMA meeting.
The German Vaccination Advisory Committee, an independent government advising group, has requested the use of the AstraZeneca vaccine for the 18-64 age group based on currently available information. He said that “there are currently not enough data to assess the effectiveness of vaccination at age 65.”
AstraZeneca said after the launch of the German project 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”. He added that he is awaiting 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 efficiency data at a later stage. This indicated data from the previous phase published in the Lancet in November, which shows that older adults had strong immune responses to the vaccine, with 100% of older adults generating peak-specific antibodies after the second dose.
But questions remain about how well the vaccine protects the elderly. Only 12% of AstraZeneca participants were over 55 years old and enrolled later, so there was not enough time to see if they became ill at a lower 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 not yet clear “how concrete” it would ultimately affect the authorities’ decisions.
AstraZeneca said on Thursday that the latest analyzes of clinical trial data “support efficacy in the age group over 65” and await 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 AstraZeneca vaccine and entered into transactions with other companies for more than 2 billion photos.
The inspection requested by the European Commission for production at the Novasep plant in Seneffe, Belgium, has been carried out and the data collected will be analyzed in the coming days, the Belgian authorities said.
The EU said the Belgian plant is one of four AstraZeneca sites included in the contract between 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 supply vaccines from its UK units if it is unable to meet commitments from EU factories. Kyriakides also said the EU would find out if some of the doses made in the EU would be diverted elsewhere.
The company’s CEO, Pascal Soriot, said this week in an interview with Die Welt that the British government had contributed to the development of the vaccine and signed its contract three months before the EU reached its agreement. He said the contract with the British authorities specifies that vaccines produced on British sites must first go to the UK.
However, the Commission said it remains confident that the delay in AstraZeneca will not affect its plans to ensure that at least 80% of EU citizens over the age of 80 are vaccinated by 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 target, but we think it’s a realistic one,” 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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