Two years after the initial COVID-19 vaccine push swept across the globe, Pfizer’s COVID-19 vaccine partner BioNTech is heading to court in its home country of Germany to defend itself against allegations that its shot caused injuries.
This lawsuit comes from a German healthcare worker who seeks at least 150,000 euros ($161,500) in damages for alleged bodily harm, plus compensation for unspecified material damage, Reuters reports. The woman claims she suffered from upper-body pain, swollen extremities, fatigue and a sleeping disorder as a result of taking the Comirnaty vaccine.
The plaintiff’s attorneys at the firm Rogert & Ulbrich will challenge the vaccine’s positive risk-benefit profile as assessed by European Union regulators and vaccine assessment agencies, according to the news service. Under German drug laws, drugmakers are only liable for side-effect damages if “medical science” can prove their meds have an incorrect label or cause disproportionate harm relative to their benefits, Reuters reports.
The public hearing in Hamburg, Germany, was due to begin on June 12 but has been postponed after the plaintiff’s attorney filed a motion against the judge due to impartiality, according to a BioNTech spokesperson.
BioNTech reviews each liability case through a “dedicated team” of medical experts and would “meet any justified claims,” a company spokesperson said in an emailed statement. The vaccine maker stands by Comirnaty’s risk-benefit profile and noted that more than 1.5 billion people worldwide, 64 million in Germany alone, have received the shot.
“We have carefully assessed the health impairments described by the plaintiff based on all provided information and have concluded that the lawsuit is without merit,” the spokesperson said.
The European Medicines Agency tracked almost 1.7 million reports of suspected vaccine side effects as of this May, which comes out to about 0.2 reports for every 100 vaccine doses given. So far, almost 768 million doses have been doled out in Europe.
In the U.S., former Department of Health and Human Services Secretary Alex Azar invoked the Public Readiness and Emergency Preparedness Act in relation to the COVID-19 pandemic in 2020.
The declaration gave COVID-19 vaccine makers and administrators immunity from legal liability for losses deriving from injuries, with the exception of death or serious injury arising from “willful misconduct." The declaration lasts through December 2024.