On June 17, the state of Kansas filed a lawsuit against Pfizer Inc., accusing the pharmaceutical giant of making misleading statements about the safety and efficacy of its Covid-19 vaccine. The lawsuit, led by Kansas Attorney General Kris Kobach, was filed in Kansas District Court in Thomas County and alleges that Pfizer violated the state’s consumer-protection law by misrepresenting its vaccine.
Allegations of Safety Misrepresentation
The lawsuit highlights several key instances in which Pfizer allegedly misled the public. The safety profile of the vaccine has been lied about, implies Kobach, saying,
Pfizer said its COVID-19 vaccine was safe even though it knew its COVID-19 vaccine was connected to serious adverse events, including myocarditis and pericarditis, failed pregnancies, and deaths.
One notable claim from Pfizer, made in its press release on April 1, 2021, asserted that there were “no serious safety concerns through up to six months following the second dose” of their vaccine. In August, September, and November of 2021, when the vaccination campaign was in full swing all over the world, Pfizer and its CEO, Albert Bourla, reiterated the claim that vaccines were “safe and effective.”
However, documents made public through legal proceedings revealed that Pfizer’s proprietary adverse events database [pdf] had recorded 158,893 adverse events globally between December 1, 2020 and February 28, 2021.
That database, focusing on post-authorization safety analysis, contained more than 1,200 types of so-called adverse events of special interests (AESI), which is a type of adverse event that is identified as being of particular concern, normally identified before the drug is cleared for authorization or approval. Pfizer’s list of AESIs includes numerous cardiovascular, neurologic, and reproductive issues in vaccine recipients. Moreover, Pfizer’s recorded as many as 1,223 deaths among vaccine recipients, “although Pfizer did not make causality findings.”
Kobach noted that while Pfizer did not identify “the magnitude of underreporting” in that database, the underreporting was “likely significant.”
“Pfizer’s representations that its COVID-19 vaccine did not have any safety concerns were inconsistent with the adverse events data it possessed. Pfizer concealed, suppressed, or omitted material facts it possessed showing significant safety concerns associated with Pfizer’s COVID-19 vaccine,” says the attorney general.
Vaccines in Pregnancy
Another important point made by the suit is that Pfizer likely misrepresented the safety of its vaccine to pregnant women and their babies. While expectant mothers were excluded from the clinical trials, Pfizer and its partner, BioNTech, tested the jabs on pregnant rats.
While the conclusion of the study was positive and said that the administration of the vaccine was merely associated with non-adverse effects, a deeper look into the details of the study reveals a more concerning picture. Fetuses of the pregnant rats inoculated with the Pfizer shot developed severe malformations. Additionally, these rats had higher rates of failed pregnancies, with more than double the embryo implantation failure rate compared to the control group.
Despite these findings, Pfizer did not publicly disclose the study’s results. While other animal-study findings related to its vaccine were published and promoted, the details of the rat fertility study remained hidden until they were released in November 2022 through a Freedom of Information Act (FOIA) lawsuit.
By February 28, 2021, Pfizer had reports of 458 pregnant women exposed to its vaccine, with more than half (54 percent) reporting adverse events. Notably, more than 10 percent of these women experienced miscarriages shortly after vaccination. Furthermore, six cases of premature deliveries were reported, with several resulting in infant deaths.
Pfizer sought to conduct further studies on pregnant women, according to the February 18, 2021, announcement. While it failed to attract as many participants as it looked for, the trials were completed on July 15, 2022. The results were never published.
Cardiac Safety Claims
Vaccine-caused cardiac issues, such as myocarditis and pericarditis, were also misrepresented by Pfizer, according to the lawsuit. As an example of such misrepresentation, Kobach quotes Bourla, who said on January 18, 2023 that Pfizer had not seen “single [safety] signals [on strokes and myocarditis] … although we have distributed billions of doses.”
However, says Kobach, authorities in both the United States and foreign countries have detected such signals early on. For instance, “by June 2021, [U.S.] military doctors found an association between the COVID-19 vaccine and myocarditis in at least 23 military patients who had no known cardiac issues until 12 to 96 hours following a mRNA COVID-19 vaccination, after which they developed myocarditis.” When the Department of Defense analyzed its health system data for 2021, it discovered that individuals who had recently been vaccinated experienced rates of myocarditis and pericarditis that were 2.6 and 2.0 times higher, respectively, compared to those who had never been vaccinated.
In addition to that, as early as March 2021, Israel’s Ministry of Health contacted the U.S. Centers for Disease Control and Prevention (CDC) about a “large number of myocarditis and pericarditis cases in young individuals soon after Pfizer COVID-19 vaccine.”
In June 2021, the U.S. Food and Drug Administration (FDA) added a warning to the vaccine’s label regarding myocarditis and pericarditis. These side effects are described by the CDC as “rare” and easily treated.
Efficacy Claims
The lawsuit also addresses claims about the vaccine’s effectiveness. Pfizer’s April 2021 press release claimed 91.3 percent protection against Covid-19 up to six months post-second dose. However, subsequent documents showed that effectiveness was recorded at 83.7 percent at four months, with indications of further waning by six months. Pfizer did acknowledge this decline in a preprint paper released on July 28, 2021, but omitted this information in public communications, focusing instead on positive findings from another study.
The lawsuit contends that Pfizer’s omission of the waning effectiveness allowed the company to continue profiting from vaccinations in Kansas, potentially misleading individuals who might have reconsidered their choices had they known about the declining efficacy.
According to the announcement of the lawsuit, other states might join Kansas, “depending on Pfizer’s reaction.”
The lawsuit mentions a Multistate Working Group comprised of 33 states plus the District of Columbia, whose attorneys general could participate in suing Pfizer.
Pfizer’s Response
Pfizer responded to the lawsuit, expressing confidence in the merits of their case. In a statement provided for media outlets, the company said, “We are proud to have developed the COVID-19 vaccine in record time in the midst of a global pandemic and saved countless lives. The representations made by Pfizer about its COVID-19 vaccine have been accurate and science-based. The company believes that the state’s case has no merit and will respond to the suit in due course.”
