Clinical Trials – Vaccine Safety

Page last updated 08 December 2022

Key Points

Key Points are meant to be a scientific, factual summary of the available information that relates solely to the Pfizer-BioNTech COVID-19 Vaccine, as supported by referenced publications within this section. Conclusions should not be drawn from the inclusion or absence of information.

Pfizer-BioNTech Vaccine-related Safety Key Points References
Most Common Adverse Drug Reactions (ADRs)
  • The safety and reactogenicity of a primary series (2 doses) of BNT162b2 were evaluated in clinical trials in children, adolescents, and adults.
    • The most frequently reported ADRs were:

       

      Ages 5–11 years1 Ages 12–15 years2 Age ≥ 16 years3

      Pain at injection site:

      • 71–74%

      Pain at injection site:

      • 79–86%

      Pain at injection site:

      • 66–83%

      Fatigue:

      • 34–39%

      Fatigue:

      • 60–66%

      Fatigue:

      • 34–59%

      Headache:

      • 22–28%

      Headache:

      • 55–65%

      Muscle pain:

      • 14–37%

    • Follow-up through 6 months post vaccination in age ≥ 16 years demonstrated a comparable safety profile to the pivotal study3,4
  • The safety and reactogenicity of a 3rd dose (1st booster) of BNT162b2 were evaluated in clinical trials in participants ≥ 16 years5, and these were consistent with findings of the previously listed clinical trials.1–6 Lymphadenopathy was observed at higher frequency in patients receiving a booster dose compared to 2 doses.3,5
  • Special populations:
    • A sub-analysis in participants with past or active neoplasms, ages ≥ 16 years showed similar safety profile as the overall trial population. The most common AEs in this population were pain at injection site, fatigue, and pyrexia.6
 (1) Walter; (2) Frenck; (3) Polack; (4) Thomas NEJM 2021; (5) Moreira; (6) Thomas Vaccine 2022
ADRs identified during Post-marketing surveillance7-12
  • Cardiac: myo/pericarditis*
  • Gastrointestinal: diarrhea, vomiting
  • Immune: severe allergic reactions, including anaphylaxis; other hypersensitivity reactions (rash, pruritus, urticaria, angioedema)
  • Musculoskeletal and connective tissue: pain in extremity (arm)
  • Nervous system: syncope
 (7) EUA Fact Sheet For Vaccination Providers (≥12 Years), BIVALENT (Original and Omicron BA .4/BA .5 ),DO NOT DILUTE, Gray Cap (8) EUA Fact Sheet For Vaccination Providers (5-11 years), BIVALENT (Original and Omicron BA .4/BA .5) , DILUTE BEFORE USE, Orange Cap (9) Full prescribing information (≥12 years) , DO NOT DILUTE BEFORE USE, Gray Cap (10) EUA Fact Sheet for Vaccination providers (≥12 years), DO NOT DILUTE, Gray Cap. (11) EUA Fact Sheet For Vaccination Providers (5-11 years), DILUTE BEFORE USE, Orange Cap (12) EUA Fact Sheet for Vaccination Providers (6 months- 4 years), DILUTE BEFORE USE, Maroon Cap
General considerations
  • The safety profile of BNT162b2 was favorable in clinical trials in children, adolescents, and adults.1-6
  • Rates of serious ADRs and study withdrawal due to serious ADRs was extremely low (< 1%) and similar to placebo across studies.1-6
  • The most common ADRs were reported at slightly higher rates in ages 12–15 compared to 5–11 and ≥ 16 years.1-6
  • Participants > 55 years of age reported lower rates of pain at injection site, fatigue, and muscle pain when compared to ages 16–55.3
 (1) Walter; (2) Frenck; (3) Polack; (4) Thomas NEJM 2021; (5) Moreira; (6) Thomas Vaccine 2022

*Please refer to the Vaccine-related Myo/pericarditis Key Point Summary