The United States is awaiting further trial data before approval, and Germany announced on Thursday that it would recommend that the vaccine be used only on adults under 65 years of age.
The European Medicines Agency said on Friday that although it is not yet known how well the vaccine will work for the elderly, “protection is expected, given that an immune response is seen in this age group and based on experience with other vaccines.”
The UK and India have also approved it for all adults.
Europe’s regulatory decision comes in a furious battle between the EU and the British-Swedish company. AstraZeneca has said that its vaccine deliveries to the EU would be missing by as much as 60 percent in the quarter, following problems at a manufacturing site in Belgium. The EU has responded with threats of legal action and export controls while demanding to visit the website in question.
European governments are under pressure as they face a major coronavirus outbreak, which is increasingly being driven by the more contagious variant of the virus first identified in the UK.
The EU had tried to secure its efforts by pre-ordering several vaccines – some say, not enough. It has approved two others at this time: offers from Pfizer-BioNTech and from Moderna.
However, limited supply has meant that, although strict locking requirements still apply in many countries, vaccination campaigns have stopped in some regions. Less than 2% of the EU’s 450 million inhabitants have been shot – and many in that group have only received the first of two doses.
In a press conference on Friday, the German Minister of Health Jens Spahn said that Germany is facing “some hard weeks” with vaccine shortages.
“We are living with the biggest crisis since World War II,” he said, but added a note of optimism. “This crisis is a challenge for each of us, for science, for politics, for society. Many people suffer from the current situation and yes, many are also frustrated, frustrated because the vaccine is very scarce. ”
AstraZeneca’s CEO Pascal Soriot has said that the company is not legally obliged to deliver the expected amount to Europe and only undertook to make its ‘best attempt’ in the contract.
But Brussels wants the company to share the supply from British production facilities, publishes its contract with the pharmaceutical company on Friday to argue that it was obliged to. The agreement states that the company should make efforts to manufacture EU vaccines in locations within the European Union and the United Kingdom and can use other facilities if it accelerates supply.
To date, AstraZeneca’s deliveries to the UK have not been disrupted.
“There is clearly an obligation for the company. There is no shadow of a doubt about that, “said an EU official, informing journalists of the agreement under the basic rules of anonymity.
The EU’s contract with AstraZeneca is for 300 million doses, with the possibility of 100 million more. The vaccine was expected to make up the bulk of EU deliveries during the first quarter of the year.
The bloc has bought 160 million doses of Moderna, enough to vaccinate 80 million people. Brussels has recently increased its original order with Pfizer and BioNTech to enable the purchase of up to 600 million doses.
The European Medicines Agency has given a conditional approval for the sale of its vaccines, rather the faster emergency from the UK. Its officials say it means a deeper look at the data.
According to a breakdown of the experimental data published by the German Vaccination Committee, one of the 341 people over the age of 65 who received the AstraZeneca vaccination was infected with coronavirus. Only one person infected in the control group of 319 people over the age of 65 did not receive the vaccine.
Due to the “small number” of participants over the age of 65, “no statement can be made about the effect and safety of older people”, it is said.
AstraZeneca has said that they believe the vaccine is effective in the elderly, as everyone involved in the study showed antibodies after the second dose.
Given the limitations of its use in Germany, Berlin has said it will use the 3 million doses of AstraZeneca it expects to receive next month to inoculate younger people into high-priority groups, such as medical workers.
Brussels released further details on its new export controls on Friday, which they say are designed to improve “transparency” over where vaccines produced in the European Union are exported. Europe is particularly annoyed by investments in both Pfizer and AstraZeneca vaccines, and officials insist they see a “fair” return.
Pfizer and BioNTech said earlier this month that deliveries during the first three months of the year would be disrupted as they expand capacity at a plant in Belgium. Israel, which paid a higher price for its Pfizer vaccines than the European Union but also agreed to provide the company with medical information, has not had similar delays despite the fact that their vaccines were produced in Belgium.
“Our goal right now is for all European countries to receive vaccines at the same time in proportion to their population. Transparency is necessary, not that there is a vaccine war, “Didier Reynders, the EU’s top justice official, told Belgium’s RTBF broadcaster on Friday. “Maybe Britain wants to start a vaccine war, but we, we have created vaccines for European countries and our partners.”
The rules will mean that pharmaceutical companies must fill in a customs form stating the amount they want to export, which will be reviewed by the customs authorities of the country of production.
Some analysts have expressed concern that the controls could affect developing countries, which are opting for the cheaper and more easily distributed AstraZeneca vaccine. It is currently unclear how much the reduction in returns at AstraZeneca’s plant in Belgium will affect countries such as Brazil and Indonesia, which have also ordered.
There were some indications that the dispute between Europe and AstraZeneca over deliveries could subside on Friday, as Spahn said a new offer from the company to deliver extra doses despite production issues “creates confidence.”
However, Reuters reported that some EU officials are still dissatisfied with the figure, which does not correspond to the promised offer.
“What I think is important to see,” says Spahn, is “the way out of this century’s pandemic has begun.”
He pointed out that the fact that three vaccines are available in Europe just one year after the outbreak began is a “unique success story in medicine.”
Michael Birnbaum reported from Riga, Latvia. Luisa Beck in Berlin contributed to this report.
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