A German court has forced the pharmaceutical company to reveal information about patients suffering from thrombosis after administering AstraZeneca’s Vaxzevria vaccine.

On May 7, the marketing authorization for Vaxzevria, the vaccine against COVID-19 from the AstraZeneca laboratory, was withdrawn at the request of the marketing-authorization holder. The request was underway since March 5.

In April, the Higher Regional Court in Bamberg (Germany) asked the pharmaceutical company to provide data on the damage caused by the COVID-19 vaccine in cases of thrombosis between December 27, 2020 and February 19, 2024.

The Court thus responded to the complaint of a 33-year-old woman who had suffered intestinal thrombosis after receiving the “Vaxzevria” vaccine. As a result of this complication, the woman fell into a coma and, to this day, she suffers aftereffects.

The plaintiff now claims compensation of at least 250,000 euros, 17,200 euros for loss of income and 600,000 euros for future damages.

The Bavarian Center for Social and Family Affairs has received a total of 2,712 complaints for damage after vaccination. So far, 2,000 applications have been processed and damages have been recognized in 140 cases.

The plaintiff’s lawyer states that “it could take years before a final verdict is reached, but it will still be worth it.”

A class action lawsuit

On the other hand, a class action lawsuit has been filed against AstraZeneca in the English Supreme Court with fifty-one cases of people with side effects derived from its COVID-19 vaccine. They are seeking compensation of £100 million.

In response to this situation, the pharmaceutical company AstraZeneca has admitted in a document presented to the High Court of the United Kingdom that the vaccine ““can, in very rare cases, cause TTS”. TTS stands for Thrombosis with Thrombocytopenia Syndrome.

However, the company denies that the reported cases are a direct consequence of the administration of its vaccine developed with the University of Oxford.

As we already published in the Bioethics Observatory, until 2021 there were 18 million people vaccinated against COVID-19 in the United Kingdom and 25 million people in the European Union. Within this group, 30 cases of thrombosis were detected in the UK and 87 cases of thrombosis in the EU.

That is, evaluating both results, the incidence of venous thrombosis due to the AstraZeneca vaccine is 0.00006%, compared to the incidence of venous thrombosis in people infected with COVID-19, which fluctuates between 14 to 17%.

Bioethical assessment

Pharmacotherapeutic control is essential in monitoring the effectiveness and safety of drugs authorized by the responsible agencies.

From a bioethical perspective, the necessary procedures must be implemented to ensure the following related aspects:

– The information provided by the manufacturing laboratory must be truthful, complete, agile and accessible. In this way, possible side effects that may appear can be quickly analyzed to prevent their spread to a larger population.

– Effective warning systems should be implemented that can record these possible effects and transfer them both to the specialists involved and to the competent regulatory bodies.

– Under no circumstances should advertising information be offered that overvalues ​​the effectiveness of the drug or hides or minimizes its risks.

– Patients who access pharmacological treatments, especially if they are new, must receive sufficient information in an intelligible manner to be able to make an autonomous decision based on the available scientific evidence regarding their acceptance or refusal of the treatment.

– Under no circumstances should advertising information be offered that overvalues ​​the effectiveness of the drug or hides or minimizes its risks.

– Patients who access pharmacological treatments must receive sufficient information, intelligible to be able to make an autonomous decision, and based on the available scientific evidence, to be able to accept or refuse the treatment.

On the other hand, the appearance of side effects associated with pharmacological treatments is a common occurrence, which does not always justify their withdrawal or restriction. The appropriate assessment of the risk/benefit ratio is what, ultimately, should influence the decision on whether to maintain or eliminate their use.

In the case of the COVID-19 pandemic, the administration of the vaccine to the general population has been justified, although there was evidence of its relationship with thromboembolic accidents, due to its benefits in preventing serious complications associated with the disease.

The recent news about its withdrawal, requested by the manufacturing laboratory, seems to respond to a cautious position until more evidence is available on the prevalence of this side effect that can be serious (thromboembolism).

The global data offered by COVID-19 vaccination campaigns demonstrates their effectiveness in reducing both mortality and serious complications associated with the disease.

The new epidemiological situation, with a decrease in its incidence, may mean making modifications to vaccination strategies. In order to correctly consider them, it is necessary to evaluate both the side effects and the real efficacy associated with the available vaccines.

Accurate, transparent, agile and complete information is an essential requirement to ensure the health of the population and its real capacity to make free decisions.

Julio Tudela and Paloma Aznar

Bioethics Observatory -Institute of Life Sciences

Catholic University of Valencia

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