Research Highlights: BNT162b2 Vaccine Evaluation

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BNT162b2 mRNA COVID-19 Vaccine Safety Evaluation

  • Trials have shown that mRNA-based vaccines against the COVID-19 virus had a good safety profile.
  • However, some trials were subject to size and patient-diversity limitations.
  • The safety of the BNT162b2 mRNA vaccine with respect to a broad range of possible adverse events needs to be evaluated.
  • BNT162b2 is a lipid nanoparticle–formulated, nucleoside-modified RNA (modRNA) encoding the SARS-CoV-2 full-length spike, modified by two proline mutations to lock it in the prefusion conformation.[1]
  • BNT162b2 is a type of vaccine manufactured by Pfizer and BioNTech.[2]
  • Researchers used data from a health care organization in Israel to assess the safety of the vaccine.
  • Vaccinated individuals were matched to unvaccinated individuals according to sociodemographic and clinical variables.
  • The result shows that the vaccine was strongly associated with an increased risk of myocarditis (0.0027% probability), lymph node disease (0.0784% probability), appendicitis (0.0050% probability), and shingles (0.0158% probability).
  • The vaccine was associated with an excess risk of myocarditis with 2.7 events per 100,000 individuals.
  • However, SARS-CoV-2 infection was associated with a substantial elevated risk of myocarditis and other serious adverse events which include arrhythmia, pericarditis, pulmonary embolism, deep-vein thrombosis, intracranial hemorrhage, myocardial infarction, and thrombocytopenia.
  • COVID-19 infection was associated with substantial increased risk of myocarditis with 11 events per 100,000 individuals.

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Barda, N., Dagan, N., Ben-Shlomo, Y., Kepten, E., Waxman, J., Ohana, R., Hernán, M. A., Lipsitch, M., Kohane, I., Netzer, D., Reis, B. Y., & Balicer, R. D. (2021). Safety of the BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Setting. The New England journal of medicine, 10.1056/NEJMoa2110475. Advance online publication.