Quantifying Pfizer mRNA vaccine safety/efficacy or harm/benefit - part I
Pfizer and the FDA didn't do it, so I decided to take a crack at it.
Abstract
Pfizer, with the support of the FDA, tested its synthetic COVID-19 mRNA vaccine product (BNT162b2) for primary clinical efficacy against COVID-19 in a study population of roughly 40,000 people, with half of participants randomized to receive BNT162b2 and half of them randomized to receive placebo. In addition to clinical efficacy data, Pfizer collected clinical safety data. Based on about 2 months of safety and efficacy data collection, in December 2020 the FDA declared BNT162b2 to be safe and effective and granted Pfizer emergency use authorization for BNT162b2. Unfortunately, the FDA’s analysis was inadequate as they failed to calculate and analyze key outcome measures having to do with absolute efficacy and safety and failed to provide a quantitative and meaningful estimate of the ratio of BNT162b2 harm to benefit. The publicly available FDA/Pfizer analysis also failed to demonstrate efficacy mechanism of action and failed to expound known and potential mechanisms of harm. Here, it is argued that according to the data made available at the time, BNT162b2 was more likely to harm than benefit patients as it pertains to short-term COVID-19 and COVID-19 like side effects. In particular, it is determined that BNT162b2 will benefit one person or eliminate one case of COVID-19 for roughly every nintey people who complete a two dose course but will harm one person or produce COVID-19 like side effects for every three people who receive the same two dose injection sequence. The results suggest that EUA was not justified. Future work will focus on analyzing safety and efficacy clinical outcomes related to severe COVID-19, unknown risks and benefits, and mechanistic considerations.
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