BRUSSELS (AP) – As the European Union’s Drug Regulator is prepared to clear AstraZeneca’s COVID-19 vaccine for use, a draft recommendation from a German expert committee on Thursday called for it to be just under 65 for now. yearlings – what the spotlight on the vaccine.
And amid a heated dispute between the EU and the Anglo-Swedish company over its plans to deliver doses to the bloc of 27 countries, the EU executive commission has asked the Belgian authorities to inspect a factory in Belgium that part of the European vaccine production chain.
The European Medicines Agency is expected to clear the AstraZeneca vaccine for use in the EU on Friday. It is the third to be approved in the EU, after the BioNTech-Pfizer and Moderna vaccinations.
European authorities are under pressure after a sluggish start to the EU vaccination campaign in the first month, and the AstraZeneca vaccine will add much-needed extra supplies.
However, Brussels and the drugmaker are at odds over expected delays in delivery. AstraZeneca said last week that it plans to reduce initial deliveries in the EU from the scheduled doses of 80 million for the first quarter of the year to 31 million doses due to the reduced yields of its manufacturing plants in Europe, but the EU suspects doses directed elsewhere in Europe.
And the German draft recommendation adds a question mark over how widely it can be used – although the country’s health minister stresses that a final decision will only be taken after Friday’s EMA meeting.
Germany’s vaccination advisory committee, an independent panel advising the government, has asked to use AstraZeneca’s vaccine for the 18-64 age group based on the available information. It is said that “there are currently insufficient data to determine vaccination effectiveness from age 65.”
AstraZeneca said after Thursday’s announcement of the German draft that “the latest clinical trial analyzes for the AstraZeneca / Oxford COVID-19 vaccine support efficacy in the age group of over 65 years.” It added that it was awaiting the EMA’s decision.
The company noted earlier this week that UK regulators support its use in the older age group despite the lack of effectiveness data in the late stages. It pointed to earlier data published in the November issue of the journal Lancet “showing that older adults show strong immune responses to the vaccine, while 100% of older adults generate a specific antibody after the second dose.”
But there are still questions about how well the vaccine protects older people. Only 12% of AstraZeneca research participants were older than 55 and they were enrolled later, so there was not enough time to see if they got sick at a lower dose than those who did not get the vaccine.
German health minister Jens Spahn said there had been a lack of data on the subject 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 that it is awaiting the EMA’s decision.
The EU, which has 450 million people, has negotiated for six different vaccines. In total, it has ordered up to 400 million doses of the AstraZeneca vaccine and closed deals with other companies for more than 2 billion shots.
The European Commission has asked the Belgian government to inspect Novasep’s plant in Seneffe, Belgium, over dissatisfaction with AstraZeneca’s statements about its inability to deliver all of the EU’s expected doses on time.
However, the Commission said it was confident that the delay in AstraZeneca would not affect its plans to ensure that at least 80% of EU citizens over the age of 80 were vaccinated by March. Health policy spokesman Stefan de Keersmaecker said the target was based on the availability of doses manufactured by Pfizer-BioNTech and Moderna.
“It’s an ambitious target, but we believe it’s a realistic goal,” he said.
A third round of talks on Wednesday between AstraZeneca and EU officials yielded no immediate results, but the Commission said it was hopeful of a resolution.
More than 400,000 EU citizens with COVID-19 have died since the start of the pandemic.
According to the EU, the Belgian factory is one of four AstraZeneca sites included in the contract concluded by the Commission and the company to manufacture vaccines for the EU market.
Stella Kyriakides, the European Commissioner for Health and Food Safety, said AstraZeneca should supply vaccines from its UK facilities if it is unable to meet the obligations of factories in the EU.
The company’s CEO Pascal Soriot said in an interview with the newspaper Die Welt this week that the British government had helped develop the vaccine and signed his contract three months before the EU reached its agreement. He said the contract with the UK authorities stipulated that vaccines produced on UK websites should first go to the UK.
Soriot said that “after we have achieved a sufficient number of vaccinations in the UK”, the company will be able to use the UK websites to supply Europe as well.
Kyriakides has also made it clear that the EU will find out whether some of the doses produced in the EU will be diverted elsewhere.
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Moulson from Berlin reported. Danica Kirka in London and Sylvain Plazy in Brussels contributed to this story.
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