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November 2, 2022

An mRNA COVID-19 Vaccine

Safety of an mRNA COVID-19 Vaccine

The questions below are based on the following article: https://www.nejm.org/doi/full/10.1056/NEJMoa2110475 Barda N et al. Safety of the BNT162b2 COVID-19 vaccine in a nationwide setting. New England Journal of Medicine Sept 2021, 385:1078-1090; DOI: 10.1056/NEJMoa2110475

Using data in the article (feel free to also incorporate other reliable sources if you wish, ensuring they are properly cited), discuss the causal question of “Does the BNT162b2 COVID-19 vaccine (plain English: that’s the Pfizer one) vaccine cause adverse health outcomes?” using the following paradigms:

1. All nine of Hill’s criteria + the criterion of alternative explanations (use Mini Lecture 1 as an example)

2. Causal pies (Mini Lecture 2). If the outcome is “adverse health outcomes” is the Pfizer vaccine an a) necessary, b) sufficient, or c) component cause? Justify your answer, knowing that more than one of these options may be true.

3. Counterfactuals (Mini Lecture 2). How would you design a study to test the causal effects of the Pfizer vaccine?

4. Based on your answers to 1-3 above, what grade in the USTFPF classification (Gordis chapter, and a slide in Mini Lecture 2) would you assign to the evidence supporting widespread use of the Pfizer vaccine?

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