The factory has been producing doses already, but it requires the approval of the European Medicines Agency before the vaccines can be distributed throughout the bloc.
AstraZeneca has asked the EU’s drug regulator to certify a Dutch plant producing doses of the Oxford/AstraZeneca coronavirus vaccine, according to Health Commissioner Stella Kyriakides.
The comments were reported by Reuters on Wednesday night, and confirmed by a Commission spokesperson Thursday.
The factory operated by Halix has been producing doses already, but it requires the approval of the European Medicines Agency before the vaccines can be distributed throughout the bloc.
The EMA is working quickly with the aim of completing the authorization procedure this week — and if that happens, “we hope to see deliveries from this production site already this month,” the health commissioner said.
The regulator’s nod will likely be key if the company wants to deliver on its already much lowered target of 30 million doses by the end of the first quarter of the year. EU countries have received far less at this point. According to the vaccine tracker of the European Centre for Disease Prevention and Control, at least 17 million doses have been delivered.
On Wednesday news broke that Italian police conducted an inspection of a vaccine-filling plant in Italy over the weekend, finding 29 million doses of the Oxford/AstraZeneca vaccine. An EU official said that the active ingredient for a large portion of the doses probably comes from AstraZeneca’s Halix plant in the Netherlands.
Following the news, AstraZeneca said that 16 million of those doses are meant for Europe, awaiting quality control sign-off, while the rest are for the COVAX vaccine sharing pool.
The drugmaker was not immediately available for comment Thursday on the Halix plant.
Source: POLITICO https://www.politico.eu/article/astrazeneca-asks-for-certification-of-halix-vaccine-plant-in-netherlands/?utm_source=RSS_Feed&utm_medium=RSS&utm_campaign=RSS_Syndication