Flying Blind by Design: How BioNTech Shed Liability While Germany's Safety Monitoring Failed

No monitoring, no data, no consequences — but the vaccines were of course “safe and effective.”

It is one of the biggest scandals in Germany’s postwar history — and hardly anyone is talking about it. BioNTech, the Mainz-based company celebrated as the hero of the pandemic, positioned itself legally so that it is formally not even a vaccine manufacturer. And the authority responsible for monitoring vaccine safety — the Paul Ehrlich Institute (PEI) — failed to evaluate the legally mandated data for years.

The result: millions of people were vaccinated with a product whose safety was never verified using German healthcare data. And no one is responsible.

BioNTech: Billions in Revenue, Liability Passed On

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The facts are known, but their implications are rarely stated plainly:

• BioNTech develops the mRNA active ingredient (BNT162b2)
• Pfizer is the official marketing authorization holder with the EMA
• BioNTech Manufacturing GmbH produces — a subsidiary, not an independent pharmaceutical entrepreneur in the classical sense

This construct has consequences. The EU contracts with Pfizer/BioNTech (Section I.12) state that the vaccines are administered “under the sole responsibility of the participating member states.” Liability? With the states. With the doctors. With the citizens. Not with the manufacturers.

Between 2021 and 2023, BioNTech generated over 35 billion euros in revenue from the COVID vaccine. Liability for adverse effects: offloaded.

§13 Para. 5 IfSG: The Law Nobody Enforced

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In November 2020, Germany’s Infection Protection Act was amended. §13 Paragraph 5 obligated the Associations of Statutory Health Insurance Physicians (KVs) to transmit healthcare data to the PEI — for the purpose of vaccine safety surveillance (pharmacovigilance).

This data — diagnostic codes (ICD-10), billing data, temporal correlations between vaccination and diagnoses — represents the gold standard for detecting vaccine adverse effects in real-world healthcare. Not self-reports via an app, not voluntary physician reports — but hard, systematic billing data from everyday medical practice.

What happened: Nothing.

• July 21, 2021: The PEI internally informs the Federal Ministry of Health (BMG) that it “cannot sufficiently assess” the safety of COVID vaccines with available German data
• 2021-2023: The KVs transmit no diagnostic data for pharmacovigilance purposes to the PEI
• 2024: The federal government acknowledges in response to a parliamentary inquiry that data transmission “has not yet” taken place
• 2026: To this day, no complete evaluation

Tom Lausen, data analyst and author of “Die Intensiv-Mafia” (The ICU Mafia), independently obtained, processed, and published the KBV billing data on the platform CORIH. Not the PEI. Not the KBV. Not the BMG. A single citizen.

The Logic of Failure

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What Lausen reveals can be summarized in one sentence:

“If the monitoring never takes place, no one can seriously claim that vaccine safety was ever verified.”

This is not an opinion. It is logic.

The authorities had three tasks:

1. Collect data — legally mandated, never implemented
2. Evaluate data — never happened
3. Publish results — no data = no results

And yet these same authorities proclaimed:

• “The vaccines are safe and effective”
• “The benefit-risk assessment is positive”
• “There are no indications of serious adverse effects beyond the known scope”

On what basis? Not on the basis of German healthcare data — which was never evaluated.

SafeVac: The App That Ignored Warning Signals

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Parallel to the unimplemented §13 monitoring, the PEI operated the SafeVac app — a voluntary reporting tool for vaccine reactions. Here too, the record is devastating:

• Hundreds of thousands of reports collected
• Alarming signals in the raw data
• No systematic evaluation published
• The app was quietly discontinued in 2023

Even their own safety monitoring instrument was not properly utilized. They collected data — and then did nothing with it.

The Liability Chain: Who Is Responsible?

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The interplay of irresponsibility is unprecedented:

At the end of the chain stands the citizen. Who relied on their government’s assurance that the vaccine was safe. An assurance without a data foundation.

Lauterbach and “Free of Side Effects”

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It becomes particularly explosive in the context of public communication. Karl Lauterbach, initially as SPD health policy spokesperson and later as Federal Minister of Health, declared in August 2021:

“The vaccinations are more or less free of side effects.”

This statement was made at a time when the PEI had already informed the BMG that it could not assess safety using German data. Either Lauterbach didn’t know this — in which case he was incompetent. Or he knew — in which case he deliberately deceived the public.

In 2023, Lauterbach backtracked and spoke of “relevant side effects” that he had “never concealed.” The recordings of his earlier statements still exist.

The Core of the Problem

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This state failure is systemic:

1. Laws without implementation: §13 Para. 5 IfSG has existed since November 2020. Over five years later, the mandated data transmission has not been fully implemented. A law backed by “substantial fines” — but no one is penalized.

2. Oversight without data: The PEI was supposed to monitor but had no data. Yet it gave the green light for everything — boosters, vaccination of children, vaccine mandate debates.

3. Communication without foundation: Politicians and authorities claimed safety without having the legally required evidence for it.

4. Liability without accountability: BioNTech points to Pfizer. Pfizer points to the EU. The EU points to member states. Member states point to doctors. And the doctors say: we relied on the authorities.

Conclusion

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The revelations by Tom Lausen and the investigations by NIUS paint a picture that is devastating in its totality: a state that passed a law to protect its citizens — and then failed to enforce it. Authorities that promised safety without having the data. And a company that earned billions while extricating itself from any responsibility.

“Flying blind” is not an exaggeration. It is the precise description of a pandemic policy that, on the central question of vaccine safety, operated on the principle of “don’t look = no problem.”

Six years after the start of the pandemic, the citizens of this country are still waiting for an honest reckoning. They will probably have to keep waiting.

Sources:

1. NIUS: The Non-Vaccine-Manufacturers of BioNTech — and Germany’s State Failure — Mar 14, 2026
2. FragDenStaat: Tom Lausen — Request on Data Flows per §13 Para. 5 IfSG
3. German Bundestag: Statement by Tom Lausen
4. German Bundestag: Evaluation of Data per Infection Protection Act
5. AfD Parliamentary Group: Implementation of §13 Para. 5 Sentence 1 IfSG — Mar 21, 2024
6. European Parliament: Parliamentary Question — Liability Indemnifications in EU Vaccine Contracts
7. Apotheke Adhoc: COVID-19 Vaccines — No Liability for Manufacturers
8. Pharmazeutische Zeitung: BioNTech/Pfizer Vaccine Approved in the EU
9. Transition News: As Long as the PEI Has Not Evaluated the KBV Data…
10. Rhineland-Palatinate State Parliament: Statement on §13 Para. 5 IfSG