Upstate Medical University one of four sites worldwide to enroll young children in Pfizer covid vaccine trial
Upstate Medical University will be one of the first sites in the world to enroll children under 5 years of age in the Pfizer Covid-19 vaccine trial when the study begins April 5.
Joseph Domachowske, MD, professor of Pediatrics and of Microbiology and Immunology at Upstate, is the principal investigator.
“We know that infection with the coronavirus SARS-CoV-2 occurs across all age groups. When children become infected, some certainly progress to severe illness, while many others develop mild disease or have no symptoms at all. While infected, children can transmit infection to their friends, family members, and close contacts at school,” said Domachowske.
Domachowske, an expert in pediatric infectious diseases who has spent 30 years caring for children at Upstate, understands the significance of this vaccination effort as the world tries to recover from the grips of the Covid-19 pandemic. While the virus has disproportionately impacted adults, children have become infected and some have had serious complications.
“Children who have been infected are at risk for developing multisystem inflammatory syndrome in children, known as MIS-C, even if their initial illness was mild or asymptomatic. We need safe and effective vaccines for children to keep them healthy, to prevent MIS-C, and to reduce potential transmission to others,” said Domachowske.
Domachowske says in order to protect children, stop the spread of Covid-19 and optimize community or “herd” immunity, experts must prevent childhood infections through safe vaccination protocols.
Upstate’s Pfizer study for kids will roll out in phases over the next few months. Phase 1 will open in April and establish optimal dosage of the vaccine for this younger set of participants. Phase 1 is expected to be completed by the end of May. Phase 2/3 is the full enrollment and efficacy phase of the blinded placebo-controlled trial, and is expected to begin by June.
To be eligible for the study, children between 6 months and 11 years of age must be in good health and be able to make a two-year commitment to the study. Volunteers will be required to provide blood samples for up to two years after receiving the vaccine/placebo. Participants might be seen up to 10 times during the two-year study period. The two-year time frame for the study is important to assess the safety and long-term immune response.
Study visits will take place in Upstate’s Pediatric Infectious Diseases outpatient clinic located on the fifth floor of the Physicians Office Building, Irving Avenue.
A leader in Covid-19 response since the beginning of the pandemic, Upstate has excelled in caring for covid patients, utilized technology to connect families when visitation was not possible, developed the number-one ranked FDA-approved spit test for covid detection, and has emerged as key participants in worldwide clinical trials for covid vaccine research.
For media inquiries, email Kathleen Froio at FroioK@Upstate.edu.