BRUSSELS (AP) – As the European Union’s regulatory authority is preparing to consider eliminating the AstraZeneca COVID-19 vaccine for use on Thursday, a draft recommendation from a German committee of experts requested that it be offered only to age under 65 – adding vaccine to the spotlight.
And amid a heated dispute between the EU and the Anglo-Swedish company over its plans to deliver doses to the 27-nation bloc, the EU executive committee has called on the Belgian authorities to inspect a Belgian plant that is part of the production chain. European Vaccine Agency.
The European Medicines Agency is expected to phase out 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 the first month, and the AstraZeneca vaccine would add much-needed additional supplies.
However, Brussels and the drug manufacturer are holding back the expected delays in deliveries. 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 due to low efficiencies in its production plants in Europe, but the EU suspects doses produced in Europe was directed elsewhere.
The German draft recommendation also adds 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 European Commission has asked the Belgian government to inspect Novasep’s plant in Seneffe, Belgium because of dissatisfaction with AstraZeneca’s explanations for its inability to deliver all expected EU doses on time.
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.
A third round of talks between AstraZeneca and EU officials on Wednesday did not produce immediate results, but the Commission said it hoped 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 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.
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.
Soriot said that “once we have reached a sufficient number of vaccinations in the UK”, the company will be able to use the British sites to supply Europe as well.
Kyriakides also said the EU would find out if some of the doses made in the EU would be diverted elsewhere.
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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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