Children's Hospital Colorado

COVID-19 Pfizer and BioNTech Vaccine Trial Information

Our team of medical experts is now conducting a clinical research study evaluating the Pfizer and BioNTech COVID-19 investigational (study) vaccine to learn if it can produce an immune response against COVID-19, and if it is safe, in children 5 to 11 years old. 

Pfizer and BioNTech C4591007 is a Phase 1/2/3 study to evaluate the safety, tolerability and immunogenicity of a SARS-COV-2 RNA vaccine candidate against COVID-19 in healthy children.

About the COVID-19 vaccine trial

We invite you to consider referring potential study candidates to us. This study will enroll over 4,600 subjects worldwide.

  • Participants will receive 2 injections about 3 weeks apart.
  • Two thirds of the participants will receive the COVID-19 study vaccine, and one third will receive the placebo.
  • Initially, participants and their family will not know if they received the vaccine or placebo.
  • Participants and their family will learn if they received the placebo approximately 6 months after they received their second injection. If they received the placebo, they will be given the opportunity to receive the COVID-19 vaccine.
  • Over the course of the 2 years, there will be between 6 and 11 planned visits.

Who can participate in the vaccine trial

  • Children who are 5 to 11 years old
  • Children who have not been previously diagnosed with COVID-1

To learn more about inclusion and exclusion criteria, visit clinicaltrials.gov

How to refer your patients to this Pfizer and BioNTech vaccine trial

It is especially important that this vaccine trial includes children from the communities most significantly impacted by COVID-19. Involving people from all backgrounds will improve the development of this investigational vaccine for everyone.

Patients can learn more about this trial at the Pfizer and BioNTech COVID-19 Vaccine study website.