ModernaTX, Inc

INDICATION: Prevention of COVID-19 in individuals 18 years of age and older

  • Administered via intramuscular injection as a series of two doses, one month apart

ADDRESSING UNMET NEED: Second vaccine to combat the pandemic

MECHANISM OF ACTION: Contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive “spike” protein; triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2  


  • Ongoing randomized, placebo-controlled U.S. study, n=28,207 participants without SARS CoV-2 infection
  • 94.1% effective in preventing COVID-19 disease; 11 cases in vaccine group vs. 185 in placebo with 30 severe cases
  • Data are not available to determine how long the vaccine will provide protection
  • No available evidence of prevention of person to person transmission
  • Most commonly reported side effects: Pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, swollen lymph nodes in the same arm as the injection, nausea and vomiting, and fever; mostly after second dose


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

FDA website

Translations of Fact Sheet

CDC information

Design-a-thon for COVID-19 At-Anywhere Diagnostic Tests

AIM: To increase speed, quality, comprehensiveness, and utility of SARS-CoV-2 diagnostic test data


Oracle: COVID-19 Immutable Test Results Submission and Visualization

Interpret-COVID: Consumer Dx Test App

Net Medical Xpress Solutions, Inc: Net Medical’s Telemed for COVID-19 Wireless Data 



FDA Food Safety tips for the holidays