Texas Attorney General Ken Paxton on Nov. 30 sued Pfizer, alleging the company misrepresented how efficacious its COVID-19 vaccine was.
Pfizer misrepresented the results of a clinical trial run on its COVID-19 vaccine, according to the suit, which was filed in Lubbock County court.
“We are pursuing justice for the people of Texas, many of whom were coerced by tyrannical vaccine mandates to take a defective product sold by lies,” Mr. Paxton, a Republican, said in a statement. “The facts are clear. Pfizer did not tell the truth about their COVID-19 vaccines.”
Pfizer did not immediately respond to a request for comment.
Pfizer and its partner BioNTech touted their vaccine as 95 percent effective against COVID-19 infection in press releases and other statements, based on the trial.
The trial was aimed at determining how many participants contracted COVID-19 with symptoms after receiving a vaccine, not COVID-19 overall.
Tens of millions of Americans subsequently received the shot.
The efficacy estimate was a relative risk reduction for vaccinated individuals when compared to unvaccinated participants.
Of vaccinated participants who had no evidence of prior infection, 0.04 percent tested positive for COVID-19. Of unvaccinated participants without prior infection, 0.9 percent had a COVID-19 case. That meant there was a 95 percent relative risk reduction.
Absolute risk reduction, another way of measuring, is determined by subtracting the post-treatment risk of 0.04 percent from the baseline risk rate of 0.9 percent, which reaches a different efficacy estimate.
Pfizer misrepresented the efficacy by promoting the relative risk reduction number and relying on just two months of clinical trial data, according to the new suit.
“Of 17,000 placebo recipients, only 162 acquired COVID-19 during this two-month period. Based on those numbers, vaccination status had a negligible impact on whether a trial participant contracted COVID-19,” it stated. “The risk of acquiring COVID-19 was so small in the first instance during this short window that Pfizer’s vaccine only fractionally improved a person’s risk of infection. And a vaccine recipient’s absolute risk reduction—the federal Food & Drug Administration’s (FDA) preferred efficacy metric—showed that the vaccine was merely 0.85% effective.”
The FDA has said in guidance documents that relative risk estimates made reduction “seem large” and that “treatments are viewed more favorably than when the same information is presented using an absolute risk format.” It says drug manufacturers should provide absolute risks in addition to relative risks.
Pfizer also misled the public by excluding COVID-19 cases in the vaccinated if they happened before seven days had elapsed following a second shot, Mr. Paxton said.
Pfizer was also aware of the lack of evidence its vaccine protected against transmission, according to the suit, but repeatedly made statements and ran advertisements advertising it as a way to protect people and their loved ones. The FDA, for instance, repeatedly said there was not enough evidence to say the vaccine shielded against transmission.
“Additional evaluations … will be needed to assess the effect of the vaccine in preventing virus shedding and transmission,” the FDA said in one document.
Federal laws like the Food, Drug, and Cosmetic Act bar misbranding products regulated by the FDA. Misbranding occurs if advertising or labeling for the product is misleading, including when advertising “fails to reveal facts material in the light of representations.”
In many of Pfizer’s statements, the company did not explain the difference between absolute and relative risk reduction.
Dr. Albert Bourla, Pfizer’s CEO, also made misleading statements, the suit alleges, such as claiming—after the trial results were released—that the vaccine would “help bring an end to” the pandemic. He also claimed in February 2021 that the protection from the vaccines was “robust” after six months, despite trial data not being collected yet after six months.
“Pfizer’s misleading statements created the false impression that 95% of vaccine recipients would never obtain COVID-19, full stop,” the suit states.
Later in 2021, data from Pfizer, Israel, and elsewhere showed the vaccine protection started waning within months, leading to the clearance and promotion of boosters and, ultimately, new formulations.
The FDA and the U.S. Department of Justice did not respond to requests for comment on the new suit.
The suit stems from an investigation Mr. Paxton announced in May into whether Pfizer, Moderna, and Johnson & Johnson misled the public on their COVID-19 vaccines, including possibly manipulating vaccine trial data.
“This pandemic was a deeply challenging time for Americans,” Mr. Paxton said at the time. “If any company illegally took advantage of consumers during this period or compromised people’s safety to increase their profits, they will be held responsible.”
The suit also accuses Pfizer of working to censor people who questioned the company’s narrative about the vaccine, including journalist Alex Berenson, who repeatedly pointed out facts about the waning vaccine efficacy. It points in part to Dr. Scott Gottlieb, a Pfizer board member and former FDA commissioner, who urged Twitter to take action against Mr. Berenson.
Mr. Berenson was banned from Twitter but reinstated after suing the company. He has since sued Dr. Gottlieb and others for alleged violations of federal law.
From The Epoch Times
