BRUSSELS (AP) – Belgian health authorities said on Thursday they have inspected a pharmaceutical factory to determine whether expected delays in the delivery of AstraZeneca’s coronavirus vaccine are actually due to manufacturing issues amid a heated public dispute between the European Union and the Anglo-Swedish drug manufacturer.
The European Commission asked the Belgian government to inspect the factory in Belgium due to dissatisfaction with AstraZeneca’s explanation for the inability to deliver all expected doses from the EU on time. EU officials are under immense political pressure because vaccine roll-out in the 27-country bloc has been much slower than those in Israel and the UK.
Chemical manufacturer Novasep’s plant in the city of Seneffe is part of the European production chain for the Oxford-AstraZeneca coronavirus vaccine.
AstraZeneca said last week that it planned to reduce initial deliveries in the EU from the planned 80 million doses to 31 million doses due to reduced yields from its factories in Europe. The EU said it would get even less, just a quarter of the doses Member States would receive in January, February and March.
However, the bloc’s executive committee said it is 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. Stefan de Keersmaecker, the Commission spokesman on health policy, 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.
The EU, of 450 million people, has agreements for six different vaccines, but so far regulators have only approved the use of two: one from Pfizer and one from Moderna. The European Medicines Agency will consider the AstraZeneca vaccine on Friday.
In total, the EU has ordered up to 400 million doses of the AstraZeneca vaccine and has signed agreements with other companies for more than 2 billion injections.
A third round of talks between AstraZeneca and EU officials did not yield immediate results on Wednesday, but the committee still hopes the dispute can be resolved.
“What we discussed with AstraZeneca is how they can provide us with the doses we believe are needed to vaccinate the population as quickly as possible,” said European Commission spokesman Eric Mamer. “We believe it is in the interest of European citizens.”
Since the start of the pandemic, more than 400,000 residents of the EU have died with COVID-19.
According to the EU, the Belgian plant is one of the four AstraZeneca sites included in the contract concluded by the commission and the company for the production of vaccines for the EU market.
France Dammel, a spokesman for the Belgian health minister, said experts from the federal drug agency inspected the Novasep site. They are now working with Dutch, Italian and Spanish experts before releasing a report in the coming days.
“The production of the COVID-19 vaccine is a groundbreaking process in terms of scale, complexity and quantity,” Novasep said in a statement to The Associated Press. “We worked closely with AstraZeneca and conducted regular and coordinated reviews of the manufacturing processes to ensure the active substance was delivered on time and met the highest standards of quality and stability.”
Stella Kyriakides, the European Commissioner for Health and Food Safety, said AstraZeneca must deliver vaccines from its UK facilities if it is unable to meet commitments from factories in the EU. She also made it clear that the EU would find out if some of the doses produced in the EU would be diverted elsewhere.
“No company should be under the illusion that we don’t have the resources to understand what is happening,” said Kyriakides. “We have knowledge of how the doses were produced, where they were produced and whether they were sent somewhere where this is.”
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Sylvain Plazy contributed to this story.
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