BNT162b2 mRNA COVID-19 Vaccine Safety Evaluation
August 29, 2021
- 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.
- BNT162b2 is a type of vaccine manufactured by Pfizer and BioNTech.
- 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.
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. https://doi.org/10.1056/NEJMoa2110475