On November 30, Texas Attorney General Ken Paxton initiated legal action against pharmaceutical giant Pfizer, accusing the company of deliberately misrepresenting the efficacy of its COVID-19 vaccine.
The lawsuit, filed in Lubbock County, Texas, alleges that Pfizer misled the public by promoting the results of a clinical trial that supposedly demonstrated the vaccine's effectiveness.
In a statement, Mr. Paxton, a Republican, emphasized the pursuit of justice for the people of Texas, many of whom, he claimed, were compelled to take a vaccine under what he referred to as “tyrannical vaccine mandates.”
According to him, these individuals were deceived by the alleged misinformation spread by Pfizer. The attorney general declared, “The facts are clear. Pfizer did not tell the truth about their COVID-19 vaccines.”
Pfizer and its partner BioNTech had previously asserted that their vaccine was 95 percent effective against COVID-19 infection, based on the trial results. However, the lawsuit contends that Pfizer misrepresented the efficacy by emphasizing relative risk reduction and relying on just two months of clinical trial data.
The lawsuit specifically argues that Pfizer excluded COVID-19 cases in vaccinated individuals that occurred within seven days after the second dose, creating a misleading impression of the vaccine's effectiveness. Additionally, the suit claims that Pfizer was aware of the lack of evidence regarding the vaccine's ability to prevent transmission, even though the company allegedly ran advertisements suggesting otherwise.
The FDA's preferred efficacy metric, absolute risk reduction, was purportedly not adequately disclosed by Pfizer in its public statements. The lawsuit highlights that the FDA recommends presenting both relative and absolute risks to provide a comprehensive understanding of a product's effectiveness.
The legal action also accuses Pfizer CEO Dr. Albert Bourla of making misleading statements, including claims that the vaccine would contribute to ending the pandemic and assertions about the robustness of protection after six months, despite insufficient trial data at that time.
The lawsuit against Pfizer is part of an investigation initiated by Attorney General Paxton in May, examining whether COVID-19 vaccine manufacturers, including Moderna and Johnson & Johnson, misled the public or manipulated trial data. Paxton emphasized the need to hold companies accountable if they took advantage of consumers during the challenging pandemic period or compromised safety for profit.
As of the time of reporting, Pfizer officials had not responded to requests for comments on the lawsuit. Neither the FDA nor the U.S. Department of Justice provided comments on the legal action.