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What awaits AstraZeneca after the mass rejection of the vaccine?

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24 countries have suspended the use of the AstraZeneca vaccine due to side effects — a number of vaccinated people developed problems with blood clotting, several people died of thrombosis and pulmonary embolism. The expert of the pharmaceutical market believes that the company will avoid losses if the supply contract contains a clause on the removal of responsibility for possible side effects.

Sweden has suspended the use of the coronavirus vaccine produced by the Swedish-English AstraZeneca as a precautionary measure until the situation with side effects from the use of the drug is clarified. This is reported by the Swedish Health Agency.

The use of the drug will be banned until the investigation of possible side effects by the European Medicines Agency (EMA) is completed. During this investigation, it is planned to find out whether the cases of thrombosis in vaccinated people are associated with vaccination.

The Swedish agency noted that the AstraZeneca vaccine provides good protection against coronavirus, and the total number of administered doses is 17 million. In Sweden itself, no side effects have been reported from the drug.

Earlier, the authorities of Austria, Germany, France, and Italy, and 14 other EU countries decided to suspend vaccination with AstraZeneca as a precautionary measure. Outside of Europe, the use of the drug was suspended by Indonesia, the Democratic Republic of the Congo, Thailand, and South Africa.

The denials came after a Danish woman who had been vaccinated with the AstraZeneca vaccine died of thrombosis. Another Danish woman also developed thromboembolism. In addition, patients from other countries were found to have blood clotting disorders after vaccination.

The pharmaceutical company said that there is no evidence of a link between the formation of blood clots and vaccination. According to AstraZeneca, in the European Union and the UK, 15 cases of deep vein thrombosis and 22 cases of pulmonary embolism were detected among 17 million vaccinated people.

In 2020, AstraZeneca, together with the University of Oxford, developed the vector vaccine AZD1222. By November 2020, the company reported that the vaccine after the introduction of two doses shows the effectiveness of 70%, and immunity is developed within 14 days after the first injection.

However, immediately after the announcement of the results, it became clear that there were violations during the clinical trials. So, one group of volunteers was first given only half of the dose, and after a while, they were given the drug completely — while others were tested with one dose of the drug.

At the same time, the company actually combined two different studies in one report, and the promising one-and-a-half-dose scheme was tested only on 2,700 volunteers, which is clearly not enough for final conclusions about the effectiveness and safety of the vaccine.

In addition, then the experts drew attention to the fact that in this group, none of the vaccinated was older than 55 years, that is, the drug was not actually tested on the elderly. However, the Oxford scientists claimed in The Lancet that their vaccine worked particularly well on the older age group.

After that, AstraZeneca undertook to conduct additional research — at the same time, at that time, contracts for deliveries to some countries were already concluded, the DW publication wrote.

In the case of lawsuits from the purchasing states, AstraZeneca can avoid losses-it all depends on what was spelled out in the agreement for the supply and use of the vaccine, says a pharmaceutical market expert and development director at RNC Pharma.

“In the case of Pfizer, for example, the company is generally relieved of any responsibility for possible side effects, since the drug was developed in a very short time frame.

With AstraZeneca, I would not characterize the situation as a failure yet. It is quite working. If side effects are detected and there are suggestions that they may be related to the drug, then its circulation is simply suspended, “an expert explains in a conversation.

After that, investigations are launched: specialists find out what led to side effects: the drug itself or the production technology of a separate batch of the product, violations of the conditions of storage or transportation of the vaccine.

“Only after the reasons are established, it will be possible to talk about the consequences for the company and the health care system of European countries. In general, the situation is very unpleasant both for the company and for the countries where it was planned to use this product, “ expert says.

If it turns out that the problem is in the drug itself, then the company will have two options: complete refusal and suspension of production of the vaccine, or use it for a limited category of people.

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