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On Monday took place the first visit by officials of the Belgian Federal Agency for Medicines to a plant in the Belgian province of Hena. Samples and documents were taken from the factory, and more inspections are expected at the AstraZeneca factory in the coming days.
The European Commission requested the study in response to questions about AstraZeneca’s explanation of why the European Union would receive fewer vaccines than promised. The British and Swedish company claims that it will only be able to deliver 25% of the goods to the European Union. promised 100 million doses, expected by the end of March. The company attributes the problems to a production failure at a plant in Belgium owned by the French scientific company Novasep. The European Medicines Agency is expected to approve the vaccine on Friday.
AstraZeneca assures the British authorities that it will be able to produce two million doses a week for the UK and 100 million doses will be fulfilled. The vaccine was approved by the British Medicines Authority in December.
The European Commission has questioned the company’s explanation of the vaccine shortage for the European Union and wants to know whether vaccines for the Union have sometimes been diverted to the UK in recent weeks.
The formal investigation was also supported by AstraZeneca’s claims that it did not intend to make up the shortfall in the European Union by redistributing vaccine doses produced in Oxford and Staffordshire.
It is recommended to vaccinate only people under 65 years of age
The German Vaccination Commission (STIKO) recommended on Thursday that AstraZeneca be vaccinated against COVID-19 only in people under 65, due to insufficient data on its effectiveness in the elderly.
According to the commission, the vaccine, developed in collaboration with the University of Oxford, should only be used in people “aged 18 to 65,” based on available data.
“There is currently not enough data to evaluate the effectiveness of the vaccine in people 65 and older,” he added.
Except for this restriction, this vaccine is considered suitable for use, according to STIKO.
The AstraZeneca vaccine is not yet approved for widespread use in the European Union (EU), but is expected to be approved by the European Medicines Agency (EMA) on Friday.
STIKO did not provide detailed data on clinical trials of the vaccine in the elderly, but two well-known German media outlets earlier this week reported that the vaccine was less than 10% effective in people over 65.
The business daily The Handelsblatt reported on Monday, citing unidentified sources, that Berlin estimated the vaccine’s effectiveness in people over 65 at just 8 percent.
AstraZeneca and the German Ministry of Health strongly rejected these reports.
“The false statement does not become true just because it is repeated,” a spokesman for the German Health Ministry said on Wednesday, adding that it was well known that AstraZeneca had fewer older people than other manufacturers.
“However, the fact that the efficiency is only 8% is incomprehensible and, in our opinion, wrong,” the spokesperson said.
Among other things, AstraZeneca is currently embroiled in a dispute with the EU over the company’s claim that it will deliver only a quarter of the vaccine doses it promised by the first quarter of 2021.
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