On Monday, BioNTech (22UAy.DE) will defend itself against a German woman’s complaint alleging side effects from its COVID-19 vaccination, the first of potentially hundreds.
The woman, who is not revealing her name under German privacy law, is suing the German vaccine maker for at least 150,000 euro ($161,500) in damages for bodily harm and unspecified material damage, according to the Hamburg regional court and law firm Rogert & Ulbrich, which is representing her.
She alleges the immunization caused upper-body pain, swelling extremities, exhaustion, and sleeping disorders.
Monday’s hearing begins.
Tobias Ulbrich, a lawyer at Rogert & Ulbrich, told Reuters he planned to sue European Union regulators and German vaccine review organizations for deeming the BioNTech shot safe.
German medication and vaccine companies are only liable for side effects if “medical science” establishes that their products cause disproportionate harm relative to their advantages or if the label information is inaccurate.
After careful study, BioNTech, which owns the German marketing authorization for the shot it created with Pfizer <PFE.N>, determined the case was without merit.
“The positive benefit-risk profile of Comirnaty remains positive and the safety profile has been well characterised,” the biotech business said of the vaccine’s brand name.
Over 64 million Germans had received the shot, along with 1.5 billion worldwide.
According to the EMA, BioNTech’s Comirnaty, the most popular Western drug, is safe.
In a media briefing last week, the EMA underlined the benefits of all COVID shots it approved, including BioNTech’s, saying vaccines saved almost 20 million lives worldwide in the first year of the epidemic.
Comirnaty, immunization may cause myocarditis and pericarditis in young boys.
Post-approval side effects are infrequent. The rapid development of COVID vaccinations during the pandemic may have prevented the detection of rare side effects.
EMA stated the fast-track evaluation did not impact safety monitoring.
By May, the EMA had received over 1.7 million spontaneous side-effect reports or 0.2 per 100 delivered doses.
The European Economic Area (EEA)—the 27 EU member states plus Iceland, Liechtenstein, and Norway—has administered about 768 million vaccination doses.
The most prevalent transient adverse effects are headache, fever, weariness, and muscle soreness.
After vaccination, the EMA analyzes adverse events and sickness for frequencies above non-vaccinated rates.
LIABILITY
If the plaintiff wins, the legal fees and compensation are unclear.
Sources say some of the EU’s bulk purchase agreements with vaccine makers, including BioNTech-Pfizer, contained complete or partial liability releases for legal fees and potential compensation, which might force EU governments to pay some of the costs.
Unlike many other nations, Germany has a no-fault compensation program for vaccine-injured people, although participation does not prevent someone from suing for damages.
Regulatory-approved COVID vaccination makers in the US are immune from liability.
Rogert & Ulbrich claims to have filed 250 COVID-19 vaccine injury cases for clients.
Caesar-Preller, another law company, says it represents 100 cases, and both firms say they cover practically all German cases.
Italy has several comparable examples.
