Tag: Vaccines

A Tale of Two Timelines

| Sam Sun |

In the midst of growing public and scientific concern regarding the integrity of clinical trials for COVID-19 vaccines, Moderna publicly released its 135-page clinical study protocol. Of biopharma companies with a COVID-19 vaccine candidate in phase 3 trials, Moderna is the first to publicly release its study protocol. The overall goal or primary endpoint of the Moderna’s phase 3 trial is to show that mRNA-1273 has a vaccine efficacy (VE) of 60% in preventing COVID-19. In biostatistics parlance, the VE is [1-HR], or 1 minus the hazard ratio. That is, the goal is to show that healthy participants who receive Moderna’s vaccine are 40% as likely to develop COVID-19, compared to participants that receive placebo. In the trial, a case of COVID-19 is defined as:

  • At least TWO of the systemic symptoms: fever (at least 100.4 degrees), chills, muscle aches, headache, sore throat, loss of taste or smell;
  • At least ONE of the respiratory symptoms: cough, shortness of breath, difficulty breathing, or pneumonia; AND, 
  • At least ONE nasopharyngeal, nasal, saliva, or respiratory test that’s positive for SARS-CoV-2
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