The FDA’s 242-page manual titled Communicating Risks and Benefits: An Evidence-Based User’s Guide explains that the “number needed to treat” (NNT) is one of the three most important statistics for describing the risk and benefits of any drug or vaccine. Toby Rogers, Ph.D., explains that the CDC and the FDA violated their own standards and the fundamental norms of science by not revealing the NNT when reviewing the Emergency Use Authorizations (EUA) and Biologics License Application from Pfizer-BioNTech when reviewing its COVID-19 vaccine for use in children ages 5 to 11.
Dr. Rogers explains that the pharmaceutical industry hates talking about NNT. They hate talking about NNT even more when it comes to COVID-19 vaccines because the NNT is so high that the COVID-19 vaccines could not pass any honest risk-benefit analysis.
The NNT can be reported for any number of variables, such as deaths, ICU admissions, hospitalizations, etc. Taking death as an example, the death NNT for 5 to 11 year-olds from COVID-19 would tell the researchers and the public how many children need to be vaccinated to prevent a single death from COVID-19.
The lower the risk from the disease, the higher the NNT. Children ages 5 to 11 are at extremely low risk of hospitalization, ICU admission, or death from COVID-19. Indeed, there were no hospitalizations, ICU admissions, or deaths in either the vaccine group or the control group in the Pfizer-BioNTech trials involving 5 to 11 year-olds. Dr. Rogers explains:
[The NNT] is calculated by dividing 1 by the Absolute Risk Reduction. But there was no risk reduction in hospitalizations, ICU admissions, nor death for 5 to 11 year olds. So if one remembers grade school math, 1/0 is “undefined” since one cannot divide by zero.
This means one could vaccinate every child age 5 to 11 in the U.S. and not prevent a single hospitalization, ICU admission, or death from coronavirus — according to Pfizer’s own clinical trial data as submitted to the FDA.
It appears Pfizer was not even trying to conduct a responsible clinical trial of its mRNA shot in kids ages 5 to 11. Pfizer submitted an EUA application to the FDA showing no health benefit in children ages 5 to 11 and the FDA’s Vaccines and Related Biologics Products Advisory Committee approved it anyway, 17 – 0 with 1 abstention.
Dr. Rogers assumed a very generous 80% efficacy in preventing hospitalizations and deaths of 5 to 11-year-olds. He extrapolated that efficacy rate from the FDA claim that Pfizer-BioNTech has an 80% efficacy rate for COVID-associated hospitalizations for ages 20+ years old. The FDA used that 80% figure to estimate the efficacy rate for the Pfizer-BioNTech COVID-19 vaccine for 5 to 11-year-olds. Using the FDA’s very optimistic benefit of the Pfizer-BioNTech COVID-19 vaccine, Dr. Rogers calculated the death NNT for children 5 to 11 years old.
Dr. Rogers used the optimistically reported efficacy of 80% from the FDA and applied that figure to the reported fatalities for COVID-19 for 5 to 11-year-olds and calculated the death NNT for the Pfizer-BioNTech COVID-19 vaccine was 630,775. That means that the vaccine must be given to 630,775 children to save one child.
But that astronomical death NNT does not tell the whole story. We must compare that death NNT to the death risk from the vaccine. Dr. Rogers used the nearest age group vaccine risk data (12 to 15-year-olds) available and applied that data to the 5 to 11-year-olds. This is known as immuno-bridging of data. The VAERS data under-reports adverse events by a factor of 100. But Dr. Rogers multiplied the reported death numbers by a more conservative 41 times. By doing that, he determined that there were 5,248 deaths in the 12-15-year-old age group from the COVID-19 vaccines. Dr. Rogers compared the death rate to the death NNT and concluded:
Simply put, the Biden administration plan would kill 5,248 children via Pfizer mRNA shots in order to save 45 children from dying of coronavirus.
For every one child saved by the shot, another 117 would be killed by the shot.
The Pfizer mRNA shot fails any honest risk-benefit analysis in children ages 5 to 11.
The Biden Administration, the FDA, and the CDC claim they “follow the science” and yet they violate their own standards and scientific norms in order to exaggerate the benefits and hide the harms from vaccines.
The FDA refused to calculate an [NNT], not because it forgot, but because agency officials knew the number and corresponding side effects are so high it would destroy the case for mRNA vaccines in children this age.