CNS Healthcare Announces Local Enrollment for Late Stage Global Study of mRNA Vaccine Candidate Against COVID-19

Jul 28, 2020 at 12:06 pm by pj


 

  • Mike Dever, MD will lead the CNS Healthcare study program  
  • Potential participants can visit www.covidvaccinestudy.com to learn more about local enrollment criteria  

CNS Healthcare has announced plans to participate as a study site for, and begin enrolling participants into, the Phase 2/3 global study sponsored by Pfizer Inc. and BioNTech SE of an investigational vaccine, BNT162b2, against SARS-CoV-2, the virus causing the current global pandemic. CNS Healthcare study site is one of more than 120 clinical investigational sites around the world that will collectively enroll up to 30,000 participants.    

About the Phase 2/3 Study  

The Phase 2/3 study is an event driven trial that will continue enrollment on a rolling basis, enroll up to 30,000 participants at more than 120 clinical investigational sites around the world, in non-pregnant adults 18-85 years old.  

The Phase 2/3 trial is designed as a 1:1 investigational vaccine candidate to placebo, randomized, observer-blinded study to obtain safety, immune response, and efficacy data needed for regulatory review. The trial’s primary endpoints will be prevention of COVID-19 in those who have not been infected by SARS-CoV-2 prior to immunization, and prevention of COVID-19 regardless of whether participants have previously been infected by SARS-CoV-2.  Secondary endpoints include prevention of severe COVID-19 in those groups.   

People interested in participating in the study through the CNS Healthcare site can visit www.covid19research.us to find out more. 

Since 1996, CNS Healthcare has partnered to conduct world-class research that is providing for new and improved treatments which have resulted in the FDA approval of over 80 medications. With offices in Orlando, FL, Jacksonville, FL and Memphis, TN, they research diseases that affect both the physical and mental well-being of men, women and children, both now, and for generations to come.