BRUSSELS (AP) – While the European Union’s drug regulator was preparing to consider releasing AstraZeneca’s COVID-19 vaccine for use, a draft recommendation by a German expert committee on Thursday asked to offer it only to minors 65 years old – contributing to the vaccine’s prominence.
And in the midst of a fierce dispute between the EU and the Anglo-Swedish company over its plans to deliver the doses to the 27-country bloc, the EU executive committee asked the Belgian authorities to inspect a factory in Belgium that is part of the supply chain. European vaccine production.
The European Medicines Agency is expected to release 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’s vaccination campaign in its first month, and the AstraZeneca vaccine would add much-needed extra supplies.
However, Brussels and the drugmaker are at odds over expected delivery delays. AstraZeneca said last week that it planned to cut initial deliveries in the EU from the 80 million doses scheduled for the first quarter of the year to 31 million doses because of reduced output from its factories in Europe, but the EU suspects that doses produced in Europe they were directed to another place.
And the German draft recommendation adds a question mark on the extent of its use – although the country’s health minister has emphasized that the final decision will not be taken before the EMA meeting on Friday.
Germany’s vaccination advisory committee, an independent panel advising the government, has asked for the use of the AstraZeneca vaccine for the 18- to 64-year-old age group based on currently available information. He said that “there is currently insufficient data to assess the effectiveness of vaccination from age 65”.
AstraZeneca said after the German draft was released on Thursday that “the latest analysis of clinical trial data for the AstraZeneca / Oxford COVID-19 vaccine supports effectiveness in the age group over 65.” He added that he is awaiting 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 data on the effectiveness of the final stage. He pointed to earlier stage data published in Lancet in November “demonstrating that older adults showed strong immune responses to the vaccine, with 100% of older adults generating specific antibodies to spike after the second dose.”
But doubts remain about how well the vaccine protects the elderly. Only 12% of AstraZeneca’s survey participants were over 55 and were enrolled later, so there was not enough time to see if they fell ill at a lower rate than those who did not get the vaccine.
German Health Minister Jens Spahn said there had been a discussion about the lack of data on the issue since the fall, but it was still unclear “how concretely” it would affect the authorities’ decisions.
AstraZeneca said Thursday that the latest analysis of clinical trial data “supports effectiveness in the age group over 65” and awaits the decision of the EMA.
The EU, which has 450 million inhabitants, has signed agreements for six different vaccines. In total, he ordered up to 400 million doses of the AstraZeneca vaccine and closed deals with other companies for more than 2 billion vaccines.
The European Commission has asked the Belgian government to inspect the manufacturer’s factory Novasep in Seneffe, Belgium, due to dissatisfaction with AstraZeneca’s explanations of 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 80 are vaccinated by March. Health policy spokesman Stefan de Keersmaecker said the target is based on the availability of doses manufactured by Pfizer-BioNTech and Moderna.
“It is an ambitious goal, but we believe it is realistic,” he said.
A third round of negotiations on Wednesday between AstraZeneca and EU officials did not produce immediate results, but the Commission said it expected a resolution.
More than 400,000 EU residents with COVID-19 have died since the pandemic began.
According to the EU, the Belgian factory is one of the four AstraZeneca facilities included in the contract sealed by the Commission and the company for the production of vaccines for the EU market.
Stella Kyriakides, the European commissioner for health and food safety, said that AstraZeneca should supply vaccines from its UK facilities if it is unable to fulfill its EU plant commitments.
The company’s CEO, Pascal Soriot, argued in an interview with the newspaper Die Welt this week that the UK government helped develop the vaccine and signed its contract three months before the EU reached an agreement. He said the contract with the British authorities specifies that vaccines produced in UK units must go to the UK first.
Soriot said that “after we have reached enough vaccinations in the UK”, the company will be able to use British websites to supply Europe as well.
Kyriakides also made it clear that the EU would find out if some of the doses made in the EU were 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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