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.
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.
Mny Americans subsequently received the shot.
The efficacy estimate was estimating a relative risk reduction for vaccinated individuals when compared to unvaccinated participants.
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Of vaccinated participants who had no evidence of prior infection, 0.04 percent of 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."
This is a breaking story that will be updated.