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BioNTech must produce detailed records on adverse events linked to the COVID-19 vaccine it co-produced with Pfizer, a German appeals court ruled last week. The ruling upholds a lower court’s judgment against the company, in a lawsuit brought by an unnamed person injured by the vaccine.
German attorney Tobias Ulbrich, who represents the plaintiff, announced the ruling in a post on X last week and shared the first page of the decision. According to Ulbrich, the ruling by the Higher Regional Court of Oldenburg is “final and binding.”
The ruling upholds the March ruling of the Regional Court of Aurich, which required BioNTech to release 32 types of internal safety, toxicity and manufacturing records, including adverse event records.
The March ruling held that the Pfizer-BioNTech COVID-19 shot may have resulted in “harmful effects … beyond a level considered acceptable according to the findings of medical science,” and that vaccine-injured plaintiffs have the right to review these records under German pharmaceutical law.
According to Ulbrich, the plaintiff — born in 1975 — sustained several serious health complications after receiving the second dose of the Pfizer-BioNTech vaccine in August 2021.
The conditions included arrhythmia, migraines, neurological symptoms and Myalgic encephalomyelitis/chronic fatigue syndrome — a severe chronic illness that can result in significant physical disability.
Last week’s ruling also requires BioNTech to pay the plaintiff’s legal costs.
Harald Walach, Ph.D., founder and director of the Change Health Science Institute in Germany, called the ruling “good news for those who suffer side effects” from the COVID-19 shots. He said the ruling leaves BioNTech with no option other than to “make the list of side effects public.”
Walach, who is also a professorial research fellow at Kazimieras Simonavičius University in Lithuania, said he hopes the ruling will “shift the stonewalling on the part of the media and authorities toward more openness and transparency.”
Silvia Behrendt, Ph.D., founder and director of the Global Health Responsibility Agency, said the ruling indicates that “something is changing in Europe.” She called it “a very important victory for transparency and, potentially, for patients seeking to understand what happened to them after vaccination.”
According to Behrendt, the ruling requires BioNTech to respond to an “extensive” set of “highly technical questions.” She said it remains to be seen whether BioNTech will provide “specific, complete and scientifically verifiable information and the underlying evidence” or seek to conceal evidence and stonewall the process.
Other pharmaceutical experts suggest that it remains an open question whether the ruling will result in a significant release of records.
The ruling “may be significant from a procedural point of view, but will it help a victim to get an appropriate compensation?” asked German toxicologist Helmut Sterz. Previously a researcher for major pharmaceutical companies, Sterz said the records alone won’t help vaccine-injured plaintiffs, who will also have to prove causality.
“A recorded case of damage has no consequences regarding compensation as long as there is no medical expertise which proves causality between the shot and the damage,” Sterz said.
Ruling focuses on safety profile of two vaccine batches
According to Expose News, Ulbrich challenged regulators’ determination that the COVID-19 vaccine had a positive risk-benefit profile.
In an analysis of the ruling posted on X, German investigative reporter and commentator Zara Riffler wrote that the ruling focuses on the safety profile of two Pfizer-BioNTech COVID-19 vaccine batches, FE6975 and 1D020A, and their potential link to a range of conditions, including autoimmune disease, cardiac disorders, nervous system dysfunction and menstrual disorders.
The ruling requires BioNTech to release documents about the suppliers and the manufacturing technology used to produce the batches in question.
BioNTech is also required to provide information about specific lipid nanoparticles and spike protein used in the vaccine — and information about possible DNA contaminants in the shots.
Behrendt said the “most important question is what the underlying records actually show.”
“They could help establish what BioNTech knew, when it knew it, which scientific data were available, how potential risks were assessed, what quality and manufacturing information existed, how safety signals were evaluated and whether the methods and data relied upon were sufficient to support the regulatory conclusions,” Behrendt said.
But for Sterz, significant questions remain. He said that while the records “might reveal a criminal act of Pfizer-BioNTech by hiding a high number of side effects that should have been indicated,” it’s uncertain whether this will impact individual compensation by vaccine-injured claimants.
Behrendt said that while the ruling is significant, the German legal system “does not operate a system of binding precedent” similar to that of the U.S. However, the ruling “may have substantial persuasive and practical significance for comparable cases.”
Behrendt said that she has filed several freedom of information requests with the European Medicines Agency — the European Union’s pharmaceutical regulator — through her Transparency4Safety Initiative but has encountered “major resistance.”
Despite this resistance, Behrendt said that the initiative has released a report on residual DNA in the COVID-19 shots and is preparing follow-up reports on contaminants in the shots and the toxicological profile of the vaccines.
Yet, “important parts of the regulatory dossier remain redacted or undisclosed,” Behrendt said. “A regulator’s task is not merely to receive data supplied by a pharmaceutical company. Its role is to independently assess, challenge and supervise the evidence on which the authorisation and continued marketing of a medicinal product are based.”
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1 in 6 Germans reported COVID vaccine side effects
An October 2024 survey conducted in Germany found that 1 in 6 respondents reported experiencing side effects after receiving a COVID-19 vaccine.
Internal documents released by an anonymous whistleblower in July 2024 showed that the Robert Koch Institute (RKI), Germany’s equivalent to the Centers for Disease Control and Prevention, overlooked COVID-19 vaccine safety concerns.
RKI sought to skip Phase 3 trials of the Pfizer-BioNTech COVID-19 vaccine and to release the product “straight into broad application.”
Last year, Germany’s Federal Court of Justice ruled that federal or state authorities, not doctors and healthcare providers, are responsible for compensating people injured by COVID-19 shots.
In 2023, Germany’s then-Federal Minister of Health Karl Lauterbach acknowledged that COVID-19 vaccine adverse events are prevalent and that those suffering from severe vaccine injuries are being ignored.
Last month, Germany stopped recommending COVID-19 shots for healthy people.
Related articles in The Defender
- ‘Better Late than Not At All’: Germany Ends COVID Vaccine Recommendation for Healthy People
- ‘Stunning’: Only 1 in 7 Germans With Positive PCR Test Had COVID Infection
- Germany’s Top Court Rules Doctors Not Liable for COVID Vaccine Injuries
- Even When It Came to Children, German Government Ignored Own Scientists to Impose Strict COVID Vaccine, Mask Mandates
- 1 in 6 Germans Experienced COVID Vaccine Side Effects, Survey Finds
- German Health Minister Reverses Course on COVID Vaccine Injuries, Says Injured Being Ignored
