Vaccine Safety Parameters and Adverse Events

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Moderna mRNA-1273

In clinical trial data published at this time, no serious adverse events have been recorded. Most adverse events reported by patients were mild to moderate in nature. Side effects occurred in over half the patients and included:

  • Fatigue

  • Chills

  • Headache

  • Myalgia (muscle pain)

  • Injection site pain/redness/swelling

 Arthralgia (joint pain) was also reported in many patients. Fever was not present in the first dose but in the second dose of vaccine, with one patient receiving a high dose (that will not be used in the public) having a severe fever  of 103.28F (39.6C). It should be noted that one patient was unable to complete the study due to a side effect of transient urticaria, which presents as red swelling of the skin.

Pfizer BNT162b2

Available data from clinical trials indicate fair tolerability of the vaccine. In terms of local reactions, the majority of adverse reactions were mild to moderate in intensity with 1 case of severe intensity. Systemic adverse events include:

  • Fever

  • Fatigue

  • Headache

  • Chills

  • Diarrhea

  • Myalgia (muscle pain)

  • Arthralgia (joint pain)

The main local reaction reported by patients was injection site pain4.

Novavax NVX-CoV2373

 During the clinical trials, there were instances of ADEs, which should be monitored. The most common symptoms include:

  • Mild to severe headache

  • Fatigue, malaise

  • Myalgia (muscle pain)

  • Redness and tenderness around the injection site

  • Arthralgia (joint pain)

  • Nausea/vomiting

 Some laboratory abnormalities found in the trial included reduced hemoglobin, elevated alanine aminotransferase (ALT), elevated aspartate aminotransferase (AST), elevated bilirubin, and elevated urea. However, despite the presence of abnormal laboratory results, extensive blood work will likely not need to be monitored in the majority of patients. Unless patients show abnormal side effects such as urine discoloration or presence of jaundice, it may be cost ineffective to monitor all patients' lab values post-vaccine administration.

 NVX-CoV2373 was well-tolerated and has a reassuring safety profile. Tthere were no reported ADEs after 7 days following second vaccine dosage on Day 21. Although after dose 2, there was a higher immune reaction report with symptoms only lasting 2 days and were considered low risk1. Lastly, during the phase 3 clinical trials, the vaccine will be studied alongside other vaccines, such as the seasonal influenza vaccination.

Johnson & Johnson Ad.26.COV2.S

Some reported adverse events for the Johnson & Johnson vaccine include injection site pain and tenderness associated with erythema and swelling following injection. Other side effects include:

  • Fever

  • Fatigue

  • Headache

  • Myalgia (muscle pain)

 The majority of these side effects lasted no longer than a few days.

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Prepared in collaboration with graduate students from Keck Graduate Institute (Claremont, CA): Kaljit Atwal, Paola Montes, Joseph Nguyen, Alice Wen

References

  1. Keech, C., E., Robertson, A., Cho, I., & Albert, G. (2020). Phase 1–2 Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine. The New England Journal of Medicine.

  2. (n.d.). Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. from https://www.jnj.com/johnson-johnson-posts-interim-results-from-phase-1-2a-clinical-trial-of-its-janssen-covid-19-vaccine-candidate

  3. Anderson, E., & Al., E. (2020, November 24). Safety and Immunogenicity of SARS-CoV-2 mRNA-1273 Vaccine in Older Adults: NEJM, from https://www.nejm.org/doi/full/10.1056/NEJMoa2028436?query=featured_home.

  4. Sahin, U., Muik, A., Derhovanessian, E., Vogler, I., Kranz, L., Vormehr, M., . . . Türeci, Ö. (2020, September 30). COVID-19 vaccine BNT162b1 elicits human antibody and T H 1 T cell responses. Retrieved from https://www.nature.com/articles/s41586-020-2814-7.