Vaccine factory inspected amid EU dispute with AstraZeneca

January 28, 2021

BRUSSELS (AP) — Belgian health authorities said Thursday they have inspected a pharmaceutical factory to determine whether expected delays in the deliveries of AstraZeneca’s coronavirus vaccine are actually due to production issues amid a heated public dispute between the European Union and the Anglo-Swedish drugmaker.

The European Commission asked the Belgian government to inspect the factory in Belgium due to dissatisfaction with AstraZeneca’s explanations for its inability to deliver all the EU's expected doses on time. EU officials are under tremendous political pressures because the vaccine rollout in the 27-nation bloc has gone much more slowly than the ones in Israel and the U.K..

Chemical manufacturer Novasep's factory in the town of Seneffe is part of the European production chain for the Oxford-AstraZeneca coronavirus vaccine. AstraZeneca said last week that it planned to cut initial deliveries in the EU from the scheduled 80 million doses scheduled to to 31 million doses because of reduced yields from its manufacturing plants in Europe. The EU said it would receive even fewer, just one-quarter of the doses that its member nations were supposed to get during January, February and March.

However, the bloc's executive commission said it remains confident that the AstraZeneca delay will not affect its plans to ensure that at least 80% of EU citizens over age 80 are vaccinated by March. Stefan de Keersmaecker, the Commission’s health policy spokesman, said that target is based on the availability of doses manufactured by Pfizer-BioNTech and Moderna.

“It is an ambitious target, but we believe it is a realistic one," he said. The EU, which has 450 million people, has signed deals for six different vaccines, but so far regulators have only authorized the use of two - one made by Pfizer and another by Moderna. The European Medicines Agency is scheduled to consider the AstraZeneca vaccine on Friday.

In total, the EU has ordered up to 400 million doses of the AstraZeneca vaccine and sealed deals with other companies for more than 2 billion shots. A third round of talks between AstraZeneca and EU officials did not produce immediate results on Wednesday, but the commission still hopes the dispute can be resolved.

“What we have been discussing with AstraZeneca is how they can deliver to us as quickly as possible the doses which we believe are required in order to vaccinate the population," European Commission spokesperson Eric Mamer said. “We believe it is in the interest of European citizens."

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 four AstraZeneca sites included in the contract sealed by the commission and the company to produce vaccines for the EU market.

France Dammel, a spokesperson for Belgium's health minister, said experts from the federal medicine agency inspected the Novasep site. They will now work with Dutch, Italian and Spanish experts before delivering a report in the coming days.

“Manufacturing the COVID-19 vaccine is a pioneering process in terms of scale, complexity and quantity,” Novasep said in a statement to The Associated Press. “We have worked closely with AstraZeneca and conducted regular and coordinated reviews of the production processes to ensure the active drug substance was delivered on time and met the highest standards for quality and stability.”

Stella Kyriakides, the European Commissioner for health and food safety, said AstraZeneca should provide vaccines from its U.K. facilities if it it is unable to meet commitments from factories in the EU. She also made clear the EU would find out if some of the doses manufactured in the EU were diverted elsewhere.

“No company should be under any illusion that we don't have the means to understand what is happening," Kyriakides said. “We do have a knowledge of the production of the doses, where they were produced, and if they have bee sent anywhere, where this is."

Sylvain Plazy contributed to this story.