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Status: 03/18/2021 8:22 pm
The AstraZeneca vaccine should be used again in Germany from Friday. Federal Health Minister Spahn said that the federal government, the states and the responsible Paul Ehrlich Institute had agreed to this.
In response to the recommendation of the European Medicines Agency (EMA), AstraZeneca in Germany approves the further use of the corona vaccine. However, with caveats. So said the federal Minister of Health, Jens Spahn. The federal government, the states and the responsible Paul Ehrlich Institute (PEI) agreed to this after deliberations. Vaccinations with the preparation should be resumed on Friday.
“The EMA analysis confirms our approach,” Spahn said. “It was correct to suspend vaccines as a precautionary measure until the conspicuous accumulation of cases of this very rare type of thrombosis is analyzed.” Doctors should be informed of the risks so that they can inform their patients. In a state vaccination campaign, there is a duty of care towards those who wish to vaccinate. “Citizens can trust that they will be informed in a transparent way.” After vaccines were suspended on Monday, it is now important to make up for the four days lost, the minister said. Now it is about “that we continue to vaccinate quickly”.
“Very rare event”
The president of the Paul Ehrlich Institute responsible for vaccines, Klaus Cichutek, said an audit found that the benefits of continuous vaccines against AstraZeneca outweigh the risks. Those who want to be vaccinated should be aware of the risks in the warnings, in particular the specific symptoms that could indicate a thrombosis. These could include shortness of breath, chest pain, or pinpoint bleeding under the skin, which can occur four to 16 days after vaccination, that is, after the immediate reaction to the vaccination has subsided.
This is a “very rare event,” Cichutek said. In Germany there were 13 cases of sinus vein thrombosis, twelve in women under 55 years of age, two of which were fatal. There was a case with a man, also with a fatal outcome.
The EMA considers the vaccine to be “safe and effective”
After reports of severe blood clots in some vaccinated people, Germany and several other European countries had suspended vaccinations with the British-Swedish manufacturer’s vaccine for the time being. On Thursday, after a review, the EMA declared the vaccine “safe and effective” and found there was no evidence of an increased risk of blood clots from the drug.
The authority also referred to individual cases in which rare “but serious” bleeding disorders had occurred after vaccination with AstraZeneca. A connection to vaccination could not “finally” be ruled out. The vaccine product information will now be adapted accordingly.
WHO also joins AstraZeneca
EMA experts had previously verified the case data together with the vaccine manufacturer, blood disease experts and health authorities. EMA chief Emer Cooke emphasized that clinical studies have shown the agent to be at least 60 percent effective. Evidence in the “real world” suggested that the effectiveness could be even higher.
AstraZeneca itself, citing its vaccination data, announced that there was no evidence of an increased risk of blood clots. The World Health Organization (WHO) said Wednesday it would continue to recommend the vaccine for now. “WHO believes that the benefits outweigh the risks,” he said. The safety of the vaccine will be further checked.