Former Pfizer toxicologist’s new book raises fresh questions over COVID-19 vaccine safety

A new book by Dr. Helmut Sterz, a veteran pharmaceutical toxicologist and former Pfizer executive, has reignited debate over how quickly COVID-19 vaccines were developed, the extent of preclinical safety testing they underwent, and whether regulators and public-health authorities adequately scrutinised the products before they were rolled out globally.

Titled The Vaccine Mafia: Pfizer’s Former Chief Toxicologist Proves How Toxic Substances Were Unlawfully Sold to Us as a Solution for COVID-19, the 208-page book was published on August 25, 2026, by Skyhorse Publishing under the Children’s Health Defense Books imprint.

According to the publisher’s biography, he spent decades in the industry, including senior positions at Boehringer Mannheim, Servier and Roche, before Pfizer appointed him in 2001 to head its European toxicology centres in France and England.

His professional background gives the book particular significance, although his conclusions remain contested and should be distinguished from the findings of independent regulators and mainstream public-health agencies.

The central allegation

At the heart of Sterz’s argument is the claim that the unprecedented speed of the COVID-19 vaccine programme came at the expense of established toxicological and safety procedures.

READ ALSO; How CDC, others colluded to conceal side effects of COVID-vaccines—report

The book focuses particularly on Pfizer/BioNTech’s mRNA vaccine and argues that emergency authorisation procedures permitted manufacturers and regulators to depart from established approaches to preclinical testing, including aspects of reproductive, genotoxicity and carcinogenicity assessment.

Sterz contends that these departures were not merely technical adjustments made during a public-health emergency but represented serious failures in the way potential risks were assessed before mass vaccination.

The publisher describes his work as an examination of alleged failures by pharmaceutical companies, regulators, politicians and international institutions to observe established scientific and ethical standards during the pandemic.

It further says Sterz argues that evidence of adverse effects was ignored or concealed and that the global vaccination campaign was shaped by political and economic interests.

What happened during the original approval process?

The Pfizer-BioNTech vaccine was developed and authorised at a pace unprecedented for a vaccine programme of its scale. In December 2020, the U.S. Food and Drug Administration considered Pfizer’s request for Emergency Use Authorization through its Vaccines and Related Biological Products Advisory Committee before issuing the EUA on December 11.

The more difficult question raised by Sterz is different: whether the safety programme was sufficiently comprehensive for a novel mRNA technology being administered to hundreds of millions of people, and whether some conventional long-term toxicological investigations were shortened, deferred or omitted because of the emergency.

There is also evidence that COVID-19 vaccines have been associated with some serious adverse events, although health authorities characterise them as rare.

The U.S. Centers for Disease Control and Prevention acknowledges a causal association between mRNA COVID-19 vaccines and myocarditis and pericarditis, particularly among adolescent and young adult males and most often after the second dose.

The World Health Organization likewise acknowledged very rare cases of myocarditis and pericarditis following mRNA vaccination and said available evidence supported a relationship, while maintaining that the benefits of vaccination outweighed the risks for eligible populations.

READ ALSO; FDA cut child COVID vaccine death count from 10 to 7, newly released records show

Other adverse events have also been monitored. CDC records identify anaphylaxis and myocarditis/pericarditis among serious adverse events associated with COVID-19 vaccines, while Guillain-Barré syndrome and other potential safety signals have been investigated.

Traditional vaccine development can take many years, partly because researchers need sufficient time to identify uncommon or delayed adverse effects. COVID-19 vaccines were instead developed, tested, authorised and distributed within an extraordinary timeframe because governments treated the pandemic as an emergency.

His criticism therefore goes beyond whether the vaccines produced immediate side effects. He questions whether regulators could have adequately evaluated potential long-term consequences before billions of doses were administered.

Sterz portrays the pandemic vaccination campaign as part of a broader system involving pharmaceutical companies, regulators, politicians and international organisations.

The publisher says he alleges that misleading public messaging was politically motivated and calls for legal accountability, compensation for people claiming vaccine injuries and a comprehensive reassessment of pandemic policies.