HAMBURG, Germany: In the first of potentially hundreds of lawsuits in the country, this week BioNTech will defend itself in a German court against a lawsuit from a woman seeking damages for alleged side effects after receiving the company’s COVID-19 vaccine.
According to a regional court in Hamburg, which is hearing the case, and law firm Rogert & Ulbrich, which is representing the anonymous woman, the German vaccine maker is being sued for some $161,500 in damages for bodily harm, including upper-body pain, swollen extremities, fatigue and sleeping disorder, as well as compensation for unspecified material damages.
In an interview with Reuters, Tobias Ulbrich, lawyer at Rogert & Ulbrich, said he is seeking to challenge in court the conclusion of European Union regulators and German vaccine assessment bodies that the BioNTech vaccine has a positive risk-benefit profile.
BioNTech, which co-developed its vaccine with Pfizer and holds the marketing rights in Germany for the shot, said that following careful consideration, it concluded that the case was without merit.
Referring to the vaccine’s brand name, the company said, “The positive benefit-risk profile of Comirnaty remains positive and the safety profile has been well characterized.”
Some 1.5 billion people received the vaccine across the world, including more than 64 million in Germany, it added.
BioNTech’s Comirnaty, the most commonly administered COVID-19 vaccine in the Western world, is safe to use, said the European Medicines Agency, in a media briefing last week.
There is a very small risk of myocarditis and pericarditis, two types of heart inflammation, following vaccination with Comirnaty, mainly in young males, but the presence of side-effects after a drug receives regulatory approval are rare.
The most common temporary side-effects are headache, fever, fatigue and muscle pain.
Rogert & Ulbrich said it has filed some 250 cases for clients seeking damages for the alleged side-effects of COVID-19 vaccines, and another law firm, Caesar-Preller, said it is representing 100 cases.
Several similar cases have been filed in Italy.