Covid vaccination: EMA: "AstraZeneca is a safe and effective vaccine"

Covid vaccination: EMA: “AstraZeneca is a safe and effective vaccine”

EMA is in favor of continuing to use AstraZeneca, but the Covid vaccine and vaccine responses will continue to be closely monitored.

6:54 p.m., March 18, 2021

EMA decision on AstraZeneca
EMA decision on AstraZeneca © AFP / Johan Nilsson

The European Medicines Agency EMA announced their recommendation regarding AstraZeneca’s Covid vaccination on Thursday. And it reads as follows: “We have come to the clear scientific knowledge that this is a safe and effective vaccine,” said Emer Cooke (EMA director). The EMA therefore recommends continuing to use the vaccine.

This re-evaluation and the new safety report of the British-Swedish vaccine had become necessary after unexpected possible side effects such as blood clots occurred close to the vaccination – we have reported about it here. The benefits of the vaccine would clearly outweigh the disadvantages, Cooke said. AstraZeneca has an effectiveness of at least 70 percent.

Several EU countries temporarily suspended immunizations with the AstraZeneca vaccine this week after isolated thromboses and embolisms in vaccinated people. The vaccine developed by the British-Swedish pharmaceutical company together with the University of Oxford has already been administered millions of times in Great Britain. There – and in previous clinical studies with tens of thousands of test persons – no abnormalities regarding thrombosis were found.

Warning in the “instruction leaflet”

But it will be an extra one Warning in the drug description in relation to rare blood clots (sinus vein thrombosis) in cerebral veins included in the possible side effects. In connection with these “rare cases”, the data situation is not yet sufficient to say with certainty whether a connection with AstraZeneca can be ruled out.

It is “inevitable” that such vaccination campaigns will also experience rare side effects. So far have been seven million people in the EU with the AstraZeneca vaccine been vaccinated and eleven million people in the UK. “We have carefully evaluated all available data and will continue to closely monitor vaccination reactions and side effects.”

Kurz and Anschober see Austria’s path confirmed

Minister of Health Rudolf Anschober saw an initial reaction confirming the Austrian approach: “It is important that the EMA has made a clear decision today: the continuation of the vaccinations with the vaccine from AstraZeneca and the corresponding adjustments to the technical information for the vaccine are the basic message. For me it is a common European one The procedure is particularly important. “

Chancellor Sebastian Kurz said on the sidelines of his visit to Berlin: The EMA has once again confirmed that all vaccines that have been approved by the EMA should be used, and this also confirms the path that the Austrian experts have already taken. ”

What does the EMA recommendation mean?

So what does this decision mean for the general population? The basic safety of the vaccine has been confirmed by the EMA, the serious blood clotting disorders occur very rarely, and there are millions of people who have been vaccinated. Nevertheless, vaccination reactions are to be expected at AstraZeneca, as with the other Covid vaccinations. If symptoms such as headache, fever or body aches last longer than 48 hours or recur after a few symptom-free days, a doctor should be consulted.

Accumulation in the EU

The fact that these rare cases occurred mainly in EU countries, but not in this number in Great Britain, could be due to the fact that different population groups were vaccinated. In the EU it was mainly younger groups, in Great Britain it was mostly older, over 65-year-olds. Blood clotting disorders were more likely to occur in younger sections of the population than in older ones, said Peter Arlett (EMA).

Austria has ordered 5.9 million cans

AstraZeneca plays an important role in the European vaccination strategy, but in that of Austria. The federal government has ordered 5.9 million cans from AstraZeneca. Austria has only ordered more from Biontech / Pfizer (11.1 million cans / as of March 15). So far, 369,000 doses of the British-Swedish vaccine have been delivered to Austria.

“The benefit of the vaccination is greater than the risk,” said the President of the Medical Association Thomas Szekeres on the Thursday before the EMA’s decision. In Austria, too, there are some cases of thrombosis among people who have been vaccinated, but “an accumulation cannot be determined,” emphasized the doctor. In Germany, however, there have been several cases of sinus vein thrombosis in connection with AstraZeneca vaccinations. “That should be investigated,” says Szekeres. And further: “We can only get out of the pandemic through vaccination.” The AstraZeneca vaccination offers almost 100 percent protection against serious illness three weeks after the first dose.

Chancellor said something similar Sebastian Kurz on Wednesday evening in the time in picture 2: “In Europe, more than 1000 people die of Corona every day. The virus is the danger, not the vaccine. “

WHO meets again on Friday

The World health organization wants to take the floor again on AstraZeneca on Friday, said a spokesman. Most recently, the WHO had also recommended that vaccinations with AstraZeneca continue, as the benefits of the vaccine would outweigh the risks. The reviews of the Vaccine Safety Advisory Board were still ongoing.

WHO Europe Director Hans Kluge said Thursday, “So far we don’t know whether some or all of the health problems were caused by the vaccination or by other, random factors,” he said. “At any rate, we now know that the benefits of the AstraZeneca vaccine far outweigh the risks.”

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