Updated evaluation: EMA maintains the AstraZeneca vaccine



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Status: 03/18/2021 5:28 pm

The European Medicines Agency (EMA) continues to recommend the AstraZeneca vaccine. The vaccine is “safe and effective.” However, a warning of possible blood clots will be included in the package insert.

The AstraZeneca corona vaccine is safe from the point of view of the European Medicines Agency (EMA). The agency said it still believed the benefits of the vaccine outweigh the risks. “Vaccination is safe and effective,” said EMA chief Emer Cooke.

There is no evidence that the vaccine has an overall increased risk of blood clots. At the same time, a connection to certain cases could not be definitively ruled out. Therefore, the examinations and studies would continue.

Michael Grytz, ARD Brussels, on the results of the EMA press conference

tagesschau24 5:00 pm, March 18, 2021

Side effects warning

An authority committee advocates creating “greater awareness” of the risks. Therefore, the EMA recommends that a description of these cases be included in the vaccine package insert so that healthcare workers and patients are aware of the cases of thrombosis.

EMA experts had previously verified the case data together with the vaccine manufacturer, blood disease experts and health authorities. 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.

Delayed vaccination campaigns

After reports of severe blood clots in some vaccinated people, Germany and more than a dozen other European countries had suspended vaccination with the vaccine for the time being. As a result, vaccination campaigns in the federal states were delayed.

In Germany, vaccines were suspended on Monday. There are now 13 reported cases of such vaccine-related blood clots nationwide, the Federal Ministry of Health announced.

Also WHO to use

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.

The EMA’s decision will also determine how mass corona vaccinations will continue in Germany. According to its own statements, the federal government considers the experts’ recommendation binding. Shortly after the EMA’s decision, the Spanish government also announced that a committee would meet to evaluate a possible resumption of vaccines against AstraZeneca.

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