AstraZeneca recognizes rare adverse effect in Covid vaccine

AstraZeneca acknowledged for the first time before the Court that its vaccine against Covid-19 could cause a “rare side effect”. According to the British newspaper The Telegraphthe pharmaceutical company is the target of a collective action in which 51 families are asking for compensation of up to £100 million (around R$650 million).

In documents attached to the process, AstraZeneca said that the vaccine “may, in very rare cases, cause thrombosis syndrome with thrombocytopenia”. Called TTS, the condition is characterized by the formation of blood clots and can cause blockage of veins and arteries.

In a letter sent in May 2023 to lawyers for one of the claimants, AstraZeneca said that “does not accept” that the vaccine causes TTS “at the level generic”, but recognizes that the condition may, in “rare cases”, being one of the adverse effects of the immunizer.

“The causal mechanism is not known”, declared the pharmacist. “Furthermore, TTS can also occur in the absence of the AZ vaccine. [da AstraZeneca] (or any vaccine). Causation in any individual case will be a matter for expert evidence”, he added.

AstraZeneca’s Covid vaccine was developed in partnership with the University of Oxford.

In a statement sent to the publication, AstraZeneca said that its highest priority is patient safety. “Regulatory authorities have clear and strict standards to ensure the safe use of all medicines, including vaccines”, he stated.

“From the body of clinical trial evidence and real-world data, the AstraZeneca/Oxford vaccine has continually been shown to have an acceptable safety profile and regulators around the world have consistently stated that the benefits of vaccination outweigh the risks of potential side effects extremely rare”, he added.

In Brazil, the vaccine was produced by Fiocruz (Fundação Oswaldo Cruz). The Ministry of Health said, in a note issued in April 2023, that “that all vaccines offered to the population are safe, effective and approved” by Anvisa (National Health Surveillance Agency) and the WHO (World Health Organization).

“The vaccine manufactured by the company AstraZeneca/Oxford, developed at the beginning of the pandemic, and produced by the Oswaldo Cruz Foundation (Fiocruz), was extremely important for controlling cases and reducing deaths from Covid-19 in the country and around the world, saving thousands of people. lives. Since December 2022, this vaccine is recommended for people aged 40 and over, according to the most recent scientific evidence”, said the ministry.

“The current Covid-19 scenario in the country, with a reduction in serious cases and deaths from the disease, is the result of the vaccinated population. Adverse effects, inherent to any medication or immunizer, are rare and occur, on average, one for every 100,000 doses applied, presenting a significantly lower risk than complications caused by Covid-19 infection.”, the statement reads.

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