BRUSSELS (AP) – As the European Union’s drug regulator prepares to consider eliminating AstraZeneca’s COVID-19 vaccine, a draft recommendation from a German committee of experts called for it to be offered only to those under 65 for now, which adds to the vaccine hotspots.
And amid a heated dispute between the EU and the Anglo-Swedish company over its plans to deliver doses to the 27-country bloc, the EU executive committee called on the Belgian authorities to inspect a factory in Belgium that forms part of the European vaccine production chain.
The European Medicines Agency is expected to remove the AstraZeneca vaccine for use in the EU on Friday. It would be the third approved in the EU, after the BioNTech-Pfizer and Moderna vaccines.
European authorities are under pressure after a slow start to the EU vaccination campaign in its first month, and the AstraZeneca vaccine would add much-needed extra supplies.
However, Brussels and the drug manufacturer are in danger of expected delays in deliveries. AstraZeneca said last week that it planned to reduce initial deliveries to the EU from 80 million doses scheduled for the first quarter of the year to 31 million doses due to reduced yields at its manufacturing plants in Europe, but the EU suspects that doses occurring in Europe have been directed elsewhere.
And the draft German recommendation adds a question mark over its breadth, though 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 European Commission asked the Belgian government to inspect the factory of the manufacturer Novasep in Seneffe, Belgium, due to dissatisfaction with AstraZeneca’s explanations about its inability to deliver all expected EU doses on time.
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.
A third round of talks on Wednesday between AstraZeneca and EU officials did not produce immediate results, but the Commission said it was waiting for a resolution.
More than 400,000 EU residents with COVID-19 have died since the beginning of the pandemic.
According to the EU, the Belgian factory is one of the 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.
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.
Soriot said that “after we have gotten enough vaccines in the UK,” the company will be able to use British sites to supply Europe as well.
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.
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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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