BIOS601 Resources: COVID Vaccine Trials

FDA Guidance

• Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry

Ongoing Trials

• NYTimes Coronavirus Vaccine Tracker
   
• Will covid-19 vaccines save lives? Current trials aren't designed to tell us Commentary on 7 Ongoing Trials
   

Protocols (5)

• BioNTech/Pfizer   Nov2020
  
  
• AstraZeneca/Oxford   USA trial     UK trial
  
  
• Moderna
  
  
• Janssen (Johnson & Johnson)     Update on sample size
  
  
• Novavax
  
  
• Sinovac (PROFISCOV Study Protocol, Instituto Butantan, Brazil)
  
  

Announcements/Publications

• BioNTech / Pfizer [Interim]     The Guardian     BBC     CBC     CNN     CNBC     NPR     NYTimes
  
  BioNTech / Pfizer [Final]     NEJM   Editorial
  
  
• Oxford/AstraZeneca: Safety&Immunogenicity     Efficacy     The Guardian     BBC     CBC     CNN     CNBC     NPR     NYTimes     Blog     Scrutiny     Stephen Senn     Others
  
  The Lancet
  
  
• Moderna      The Guardian     BBC     CBC     CNN     CNBC     NPR     NYTimes     The Guardian (Nov 30 update)    NEJM
  
  
• Russia/SputnikV     The Lancet
  
  
• Cuba/SOBERANA 02     medRxiv preprint
  
  

FDA Hearing on Pfizer/BioNTech application

• BBC story,   Meeting   and some of the material including this briefing document. See graph on page 30 .

FDA Hearing on Moderna application

• LINK

Other

• Salk Polio Vaccine Trial
   
• Analyze Once, Analyze Often
   
• When it comes to COVID-19 vaccines, how good will be good enough? [Oct 28]
   
• ' I just want to see the evidence ': Scientists want more data to confirm Pfizer vaccine is 90 per cent effective[Nov 10]
  
   
• For EPI607, August 2020: Statistical Analyses in the Time of COVID-19
  
   
• The History of Vaccines - : a collection of materials