The U.S. Food and Drug Administration’s risk-benefit assessment in connection with Pfizer’s application for emergency use of its COVID vaccine for children 5 to 11 describes only relative risks in an older population. It ignores absolute risk and also the standard calculation for measuring a drug’s effectiveness — Number Needed To Vaccinated (NNTV).
The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) routinely violate their own standards and the fundamental norms of science when reviewing Emergency Use Authorizations (EUA) and Biologics License Applications from pharmaceutical companies that wish to introduce a new vaccine.
The FDA publishes a 242-page book called Communicating Risk and Benefits: An Evidence-Based User’s Guide. The guide states that absolute risk, relative risk and number needed to treat (NNT) are all necessary for proper decision-making.
Yet the recent FDA risk-benefit assessment in connection with the Pfizer EUA application for children 5 to 11 described only relative risks in an older population and ignored absolute risk and NNT altogether.
Similarly, the CDC’s “Guidance for Health Economics Studies Presented to the Advisory Committee on Immunization Practices (ACIP)” describes 21 items every health economics study in connection with vaccines must do. In four separate places, the CDC guidance document mentions the importance of coming up with a number needed to vaccinate (NNTV).
The FDA and CDC work hand-in-hand to review vaccine safety. Yet the FDA’s risk-benefit analysis violated at least half of the 21 CDC standards and never once estimated an NNTV.
Because the FDA failed to provide an NNTV, I will attempt to provide it here.
First a little background and context. The NNT in order to prevent a single case, hospitalization, ICU admission or death is a standard way to measure the effectiveness of any drug. It’s an important tool because it enables policymakers to evaluate tradeoffs between a new drug, a different existing drug, or doing nothing.
In vaccine research, the equivalent term is number needed to vaccinate (NNTV), sometimes also written as NNV) in order to prevent a single case, hospitalization, ICU admission or death (those are four different NNTVs that one could calculate).
The pharmaceutical industry hates talking about NNTV, and they hate talking about NNTV even more when it comes to COVID-19 vaccines because the NNTV is so high that this vaccine could not pass any honest risk-benefit analysis.