Tag: Vaccines

Projections for “The COVID-19 Vaccines Timeline”

| Sam Sun |

Vaccines against COVID-19 could be available as early as the end of this year, and Russia has already granted full regulatory approval to its vaccine candidate. inDemic.org tracks the clinical development, regulatory milestones, and manufacturing capacity associated with each of the most promising vaccines to show not only when vaccines could be approved but also when they could be rolled out for at-risk populations (e.g. healthcare workers) and the general public. Comments or questions regarding the Vaccines Timeline can be sent anytime to director@indemic.org.

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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