Pfizer-BioNTech COVID-19 Vaccine


INDICATION & DOSING : For active immunization to prevent COVID-19 in individuals 16 years of age and older

  • Administered as a series of two doses, three weeks apart

DESCRIPTION: Contains SARS-CoV-2 virus’s mRNA that instructs cells to make virus’s distinctive “spike” protein; does not cause disease, but triggers the immune system to produce immune response against SARS-CoV-2    


  • Ongoing randomized, placebo-controlled international study, vaccine vs placebo
  • Analysis of 36,523 participants, majority from US, did not have evidence of SARS-CoV-2 infection through seven days after the second dose
  • 95% effective in preventing COVID-19 disease; 8 cases (1 severe) with vaccine vs 162 (3 severe) in placebo
  • Data not available to conclusively determine duration of protection or prevention of person-to-person transmission


  • Most commonly reported side effects: Pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, and fever; more people experienced side effects after the second dose  
  • Mandatory FDA reporting of all vaccine administration errors, serious adverse events, cases of Multisystem Inflammatory Syndrome (MIS), and cases of COVID-19 that result in hospitalization or death

REG PATHWAY: Emergency Use Authorization

  • Pharmacovigilance plan to monitor and complete longer-term safety follow-up for enrolled patients
  • Continue clinical trials to obtain additional safety and effectiveness information and pursue approval (licensure)