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Vaccines

COVID-19 Vaccine Efficacy and Safety in Participants With a History of Cancer

Strategic Insights

— 1 min read

A subgroup analysis of a global phase 3 randomized clinical trial has found that the BNT162b2 mRNA COVID-19 vaccine was safe and efficacious against infection, hospitalization, and death in individuals with a history of cancer. The study, conducted by researchers at Pfizer, included 46,429 participants aged 12 years and older who were randomized at 152 sites in 6 countries between July 2020 and January 2021. Among the participants, 3,813 had a history of neoplasm, with the most common malignancies being breast, prostate, and melanoma. The vaccine efficacy was 94.4% (95% CI: 85.2, 98.5) after up to 6 months' follow-up post-dose 2, which is comparable to the vaccine efficacy of 91.1% in the overall trial population.

Key Takeaways:

  • The BNT162b2 mRNA COVID-19 vaccine was safe and efficacious against infection, hospitalization, and death in individuals with a history of cancer.
  • The vaccine efficacy was 94.4% (95% CI: 85.2, 98.5) after up to 6 months' follow-up post-dose 2, which is comparable to the vaccine efficacy of 91.1% in the overall trial population.
  • The most common adverse events were reactogenicity events, including injection-site pain, fatigue, and pyrexia.
  • Three BNT162b2 recipients and one placebo recipient withdrew from the study due to vaccine-related adverse events.
  • No vaccine-related deaths were reported in the study.

Statistics:

  • 46,429 participants aged 12 years and older were randomized at 152 sites in 6 countries between July 2020 and January 2021.
  • 3,813 participants had a history of neoplasm, including breast, prostate, and melanoma.
  • The vaccine efficacy was 94.4% (95% CI: 85.2, 98.5) after up to 6 months' follow-up post-dose 2.
  • AEs were reported at incidence rates of 95.4 (BNT162b2) and 48.3 (placebo) per 100 person-years.

Sources:

  • Pfizer's research on the efficacy and safety of the BNT162b2 mRNA COVID-19 vaccine in participants with a history of cancer (Efficacy and Safety of the Bnt162b2 Mrna Covid-19 Vaccine In Participants With a History of Cancer: Subgroup Analysis of a Global Phase 3 Randomized Clinical Trial) published in Vaccine, 2022;40(10):1483-1492.
  • NewsRx, "Investigators from Pfizer Report New Data on COVID-19 (Efficacy and Safety of the Bnt162b2 Mrna Covid-19 Vaccine In Participants With a History of Cancer: Subgroup Analysis of a Global Phase 3 Randomized Clinical Trial)", Medical Letter on the CDC & FDA, April 10, 2022, p 374.

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