In a recent roundtable discussion on COVID-19 vaccines and public health messaging, researchers presented their findings on biases and manipulation in the clinical data of Pfizer and Moderna COVID-19 vaccines. According to the researchers, these issues have led to an overestimation of vaccine efficacy and an underestimation of vaccine adverse events.
One key problem highlighted by the researchers is the unclear definition of vaccinated and unvaccinated individuals in the clinical trials. They found varying definitions of fully vaccinated and unvaccinated, with a tendency to ignore COVID infections in partially vaccinated individuals. This lack of clarity could lead to misleading results.
Another concern raised by the researchers is the evaluation of vaccine effects from a later date, rather than from the day the vaccines are administered. This approach inflates the perceived efficacy and safety of the vaccines. In fact, the researchers suggest that it could make an ineffective vaccine appear to have up to 48 percent efficacy. This finding is based on a paper authored by Professor Peter Doshi from the University of Maryland and others.
The researchers also point out that the timing of COVID cases in vaccinated individuals is counted weeks after vaccination, rather than immediately after. For example, in Pfizer's clinical trials, a person is considered vaccinated and their COVID cases are counted a week after they receive the second dose. This delay in counting cases could further contribute to an inflated perception of vaccine effectiveness.
Additionally, the researchers found that real-life factors during vaccine rollouts, such as older people being more likely to get vaccinated early on, could reduce the perceived vaccine efficacy. They argue that as COVID cases were peaking and people were building natural immunity to the virus, the subsequent decline in cases coincided with increased vaccination rates, creating a false perception of high efficacy.
The mRNA vaccines have been promoted as having saved millions of lives. However, the researchers caution that these statements may not reflect what actually happened in real life. They are currently partaking in a study to review whether the mRNA vaccines have indeed saved millions of lives.
Furthermore, the researchers have identified several problems with the studies that claim COVID-19 vaccines reduce severe disease, hospitalizations, and deaths. One of the major issues is the lack of a consistent definition of what counts as a vaccinated person.
The Pfizer clinical trials also acknowledged a significant number of suspected but unconfirmed COVID-19 cases, split almost evenly between the treatment and placebo groups. If all of these suspected cases were indeed COVID-19 cases, it would significantly impact the estimated vaccine efficacy.
Another concern raised by the researchers is the underreporting of adverse events. Adverse events that occur soon after vaccination may not be attributed to the vaccine if several weeks have passed since vaccination. This leads to an underestimation of adverse event rates. Additionally, adverse event reporting relies heavily on unsolicited reporting by vaccine participants, making it difficult to track serious adverse events, especially if they result in death.
The researchers also highlight the issue of “unblinding” the placebo group by later giving them the COVID-19 vaccines. This makes it impossible to compare the placebo and vaccine groups for potential long-term safety signals.
Overall, the researchers' findings raise important concerns about biases and manipulation in the clinical data of Pfizer and Moderna COVID-19 vaccines. These issues have the potential to impact the perception of vaccine efficacy and the understanding of vaccine safety. It is crucial for further research and transparency to address these concerns and ensure accurate assessment of COVID-19 vaccines.
