On Monday, BioNTech was supposed to appear in court to defend itself against a lawsuit filed by a German lady demanding damages for purported adverse effects of its COVID-19 vaccination, the first of potentially hundreds of cases in the country. According to the regional court in Hamburg that is hearing the case and the law firm Rogert & Ulbrich that is representing her, the woman is suing the German vaccine maker for at least 150,000 euro ($161,500) in damages for bodily harm as well as compensation for unspecified material damage, exercising her right under German privacy law not to have her name made public.
The complainant says that the vaccine caused her upper-body pain, swelling limbs, exhaustion, and a sleeping disturbance. The first hearing is scheduled for Monday. Tobias Ulbrich, a lawyer at Rogert & Ulbrich, told Reuters that he planned to challenge in court the European Union regulators’ and German vaccine review organizations’ determination that the BioNTech shot has a favorable risk-benefit profile.
According to German pharmaceutical law, drug or vaccine, manufacturers are only liable for side-effect damages if “medical science” demonstrates that their medicines cause disproportionate harm relative to their advantages or if label information is incorrect.
After careful study, BioNTech, which owns the marketing authorization in Germany for the shot it created with Pfizer, stated that the case was without merit. “The positive benefit-risk profile of Comirnaty remains positive, and the safety profile has been well characterised,” the biotech firm stated, referring to the brand name of the vaccine. It was noted that around 1.5 billion people have received the shot worldwide, including more than 64 million in Germany.
According to the European Medicines Agency (EMA), BioNTech’s Comirnaty, the most widely used in the Western world, is safe to use
According to the European Medicines Agency (EMA), BioNTech’s Comirnaty, the most widely used in the Western world, is safe to use. In a press conference last week, the EMA reaffirmed the efficacy of all COVID injections it had approved, including BioNTech’s, stating that vaccines saved lives in the first year of the epidemic.
It has been said that there is a very tiny risk of myocarditis and pericarditis, two forms of heart inflammation, following Comirnaty vaccination, primarily in young boys. Unexpected adverse effects are uncommon once a medicine has received regulatory approval. Because of the unusual rapidity with which COVID vaccinations were created during the pandemic, any uncommon adverse effects may not have been recognized as easily as they would have been in longer trials.
The EMA has stated that safety monitoring was not jeopardized during the expedited examination. By May, the EMA had received about 1.7 million spontaneous reports of possible side effects, which equates to around 0.2 for every 100 delivered doses.
In the European Economic Area (EEA), which includes the 27 EU member states as well as Iceland, Liechtenstein, and Norway, about 768 million vaccination doses have been provided. Headache, fever, weariness, and muscle soreness are the most prevalent transient adverse effects.
The EMA also analyses adverse events or sicknesses following vaccination, looking for rates that exceed typical rates in the non-vaccinated population. If the plaintiff wins the case, it is unclear who will pay the legal fees and compensation. According to sources, some of the EU’s bulk purchase agreements with vaccine manufacturers, including BioNTech-Pfizer, included complete or partial liability waivers for both legal fees and potential compensation, potentially forcing EU governments to shoulder some of the costs.
Manufacturers of COVID vaccinations that gain regulatory approval in the United States are immune from responsibility
Germany, like many other countries, has a public sector financial support plan known as a no-fault compensation program for persons who suffer irreversible harm from vaccines, although participation in the program does not exclude someone from claiming damages individually. Manufacturers of COVID vaccinations that gain regulatory approval in the United States are immune from responsibility.
According to Rogert & Ulbrich, it has filed over 250 cases for people seeking compensation for purported side effects of COVID-19 vaccines. Another law company, Caesar-Preller, claims to be representing 100 cases, with both firms claiming to cover nearly all cases in Germany. In Italy, a few similar cases have been filed.
