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- 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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Sources:
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
[1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7745181
[2] https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/Pfizer-BioNTech.html
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The Chromoscience uses AI-assisted tools to support the preparation and editing of science articles. Content is reviewed by the editor for clarity and consistency with the cited research before publication. Readers are encouraged to consult the original scientific publications for complete findings, methods, and limitations.
