German biotech company BioNTech is set to appear in court on Monday to defend a lawsuit filed by a woman who claims the company’s new coronavirus vaccine caused harmful side effects.
The trial at the Hamburg District Court will be the first to deal with such allegations regarding the novel coronavirus vaccine. Hundreds of damages lawsuits have been filed or are being prepared across the country, according to law firm statistics.
According to BioNTech, more than 64 million people in Germany and about 1.5 billion people worldwide were vaccinated with the company’s Komilnati vaccine, the most commonly used vaccine in the West, during the coronavirus pandemic.
The European Medicines Agency (EMA) has approved it as safe.
Under German pharmaceutical law, drug and vaccine manufacturers are only liable for damages if it is scientifically proven that their products cause disproportionate harm to their interests, or if label information is incorrect. lose.
The court said a ruling on the case was unlikely on Monday.
What are plaintiffs alleging?
The woman, whose name has not been released under German privacy law, said the vaccine caused symptoms including upper body pain, swollen extremities, fatigue and trouble sleeping.
She is suing BioNTech for at least €150,000 ($161,500) for bodily harm and unspecified property damage, according to the court.
Her lawyer, Tobias Ulbrich, told Reuters that she would challenge assessments by EU and German health regulators that the communati’s jabs had a positive risk-benefit effect. Told.
What are BioNTech and EMA saying?
BioNTech said it had carefully considered the matter and concluded that the lawsuit was without merit.
“Comilnati’s positive benefit and risk profile remains favorable, with a well-characterized safety profile,” the report said.
The EMA last week reaffirmed the benefits of all approved COVID-19 vaccines, including Komilnati. The vaccine is estimated to have saved nearly 20 million lives worldwide in the first year of the coronavirus pandemic alone, he said.
The researchers found a very small risk of developing two types of heart inflammation (myocarditis and pericarditis) after community vaccination, mainly in young men.
According to the EMA, about 1.7 million spontaneous reports of suspected side effects had been registered by May, equivalent to about 0.2 per 100 doses. Many vaccinations against illnesses cause adverse side effects, but these are usually temporary and limited to headache, fever, fatigue, and muscle aches.
The EMA monitors post-vaccination adverse events and illnesses and also monitors whether adverse events and illnesses occur more frequently in vaccinated people than in non-vaccinated people. .
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