Pharmaceutical company BioNTech SE of Mainz, Germany is facing a lawsuit filed by a German health care worker who was injured by the company’s Comirnaty COVID-19 messenger RNA (mRNA) shot, which it developed in collaboration with Pfizer, Inc. of the United States. The plaintiff said she suffered pain in her upper body, extreme swelling, fatigue and a sleeping disorder after receiving the shot.1
According to the regional court in Hamburg, Germany and the law firm Rogert & Ulbrich representing the health care worker, the plaintiff (who does not want to be named) is suing the German biologics manufacturer for at least €150,000 ($161,500) in damages for bodily harm and compensation for unspecified material damage.1
It is estimated that more than 64 million people in Germany and more than 1.5 billion people across the world have received Comirnaty.2
Plaintiff’s Attorneys To Challenge Comirnaty’s Positive Risk-Benefit Clamed by German Drug Regulators
Tobias Ulbrich, an attorney with Rogert & Ulbrich said that they would challenge the Comirnaty shot’s positive risk-benefit profile as assessed by European Union (E.U.) regulators and vaccine assessment agencies in Germany. Under German drug laws, drug makers are only liable for adverse effect damages if evidence from medical science can prove their drugs/biologics have an incorrect label or cause more harm relative to the benefits.3
BioNTech said it has investigated the case and stated:
The positive benefit-risk profile of Comirnaty remains positive and the safety profile has been well-characterized.4
Continuous monitoring of the vaccine’s safety profile and after more than 2.6bn doses of [the COVID-19 vaccine] administered worldwide has to date not identified potential side effects other than those already listed in the respective product information.”5
The company added that the plaintiff’s lawyers have not provided evidence of a “causal relationship between the adverse events and the vaccine” and deemed the case a coincidental one describing the lawsuit as “without merit.”6
European Medical Agency Reported 1.7 Million Adverse Effects From COVID-19 Vaccines Shots
The European Medical Agency (EMA) reported that by May 2023 there were nearly 768 million vaccine doses administered in E.U. and European Economic Area (E.E.A.) countries. It is reported that there were about 1.7 million reports of suspected side effects, which translate into 0.2 reports for every 100 doses administered. In addition, there were about 12,000 reports of fatalities in the E.U. and E.E.A. following COVID vaccination, which translates into approximately 0.001 reported fatal outcomes for every 100 doses administered.7
There are questions about who will incur the legal costs and compensation if the plaintiff wins the case. It is believed that some of the E.U.’s bulk purchase agreements with vaccine makers, including Pfizer/BioNTech, contained full or partial liability waivers for both legal costs and potential compensation, which could force E.U. governments to cover some of the costs.
Germany also has a public sector vaccine injury compensation program for people who suffer permanent vaccine injuries known as a no-fault compensation program; however, participation in the program does not prevent someone seeking additional compensation separately.8
About 250 Lawsuits Filed in Germany Against COVID Vaccine Makers
Rogert & Ulbrich said that it filed about 250 cases for clients seeking damages for adverse effects from COVID-19 vaccines. Ulbrich said:
We have a federal minister who for quite some time has dubbed vaccination as free of side effects.9
In our case, civil claims are always against the manufacturer. And ultimately it is then the manufacturer who can again demand exemption from liability, i.e. repayment by the federal government. So from a purely economic point of view, we have the Federal Republic of Germany as an opponent and only on paper, the vaccine manufacturer.10
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1 Burger L, Weiss P. BioNTech faces first German lawsuit over alleged COVID vaccine side effects. Reuters June 12, 2023.
2 Deutsche Welle. Germany: BioNTech COVID vaccine to face damages trial. June 12, 2023.
3 Becker Z. COVID-19 vaccine injury claim in Germany. Fierce Pharma June 12, 2023.
4 Deutsche Welle. Germany: BioNTech COVID vaccine to face damages trial. June 12, 2023.
5 Pitel L. BioNTech faces hundreds of German compensation claims for Covid-19 jab. Financial Times June 11, 2023.
7 European Medical Agency. Safety of COVID-19 vaccines.
8 Burger L, Weiss P. BioNTech faces first German lawsuit over alleged COVID vaccine side effects. Reuters June 12, 2023.
9 Pieper O. Post-vac syndrome — the forgotten COVID victims. Deutsche Welle Mar. 21, 2023.