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COVID-19 Management

Safety and Efficacy Data of BNT162b2 COVID-19 Vaccine

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BACKGROUND AND PURPOSE: 

  • BNT162b2 is a lipid nanoparticle–formulated, nucleoside-modified RNA vaccine that encodes a prefusion stabilized, membrane-anchored SARS-CoV-2 full-length spike protein
    • The messenger RNA (mRNA) used in this vaccine includes the code used by SARS-CoV-2 to produce spike protein that helps the virus enter and infect cells
    • Following vaccination, the mRNA enters the vaccine recipient’s normal cells that will use the mRNA code to produce spike proteins that will generate an immune reaction
    • In the future, if the vaccine recipient is exposed to the SARS-CoV-2 virus, the antibodies generated by this immune system reaction will recognize and neutralize the invading virus
  • Polack et al. (NEJM, 2020) report on the safety and efficacy of the BNT162b2 (Pfizer-BioNTech) vaccine in preventing COVID-19

METHODS:

  • Ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial
  • Participants
    • ≥16 years old
  • Interventions
    • BNT162b2 vaccine candidate
      • 30 μg per dose
      • Two doses, 21 days apart
    • Placebo
  • Study design
    • 1:1 randomization
  • Primary outcome
    • Efficacy of the vaccine against laboratory-confirmed COVID-19
    • Safety

RESULTS:

  • 42,448 participants were randomized and received injections
    • BNT162b2: 21,720 participants
    • Placebo: 21,728 participants
  • BNT162b2 was 95% effective in preventing COVID-19
    • Placebo: 162 cases
    • BNT12b2: 8 cases (onset at least 7 days after the second dose)
    • (95% CI, 90.3 to 97.6)
  • Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by
    • Age | Sex | Race | BMI | Coexisting conditions
  • There were 10 cases of severe COVID-19 with onset after the first dose
    • Placebo: 9 cases
    • BNT162b2: 1 case
  • Side effects
    • Mild-to-moderate pain at the injection site
    • Fatigue
    • Headache
  • Fever (≥38°C): After second dose: 16% of younger vaccine recipients (16 to 55 years) | 11% of older recipients (>55 years)
    • Fever ≥38.9 to 40°C
      • After first dose: 0.2% of vaccine recipients | 0.1% of placebo
      • After second dose: 0.8% of vaccine recipients | 0.1% placebo
    • Fever >40.0°C
      • 2 participants each in the vaccine and placebo groups
  • Incidence of serious adverse events was low and similar for the vaccine and placebo groups

CONCLUSION:

  • Two doses of BNT162b2 spaced 21 days apart conferred 95% protection against COVID-19 in people aged 16 and over with a safety profile similar to other vaccines
  • This study does not address the following populations
    • Adolescents | Children | Pregnant women
  • Vaccine requires very cold temperatures for shipping and long-term storage
    • Standard refrigerators can be used for up to 5 days when ready for use
  • The authors state

The data presented in this report have significance beyond the performance of this vaccine candidate

The results demonstrate that Covid-19 can be prevented by immunization, provide proof of concept that RNA-based vaccines are a promising new approach for protecting humans against infectious diseases, and demonstrate the speed with which an RNA-based vaccine can be developed with a sufficient investment of resources

Learn More – Primary Sources:

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

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Related ObG Topics:

COVID-19 Guidance: Key Highlights for Healthcare Professionals
COVID-19 Testing: CDC Guidance on Virus and Antibody Testing
NIH COVID-19 Treatment Guidelines

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