SYRACUSE, N.Y. — Upstate Medical University will be one of the first sites in the world to enroll children under five years of age in the Pfizer COVID-19 vaccine trial when the study begins April 5.
Dr. Joseph Domachowske, professor of pediatrics and of microbiology and immunology at Upstate Medical, is the principal investigator.
“We know that infection with the coronavirus SARS-CoV-2 occurs across all age groups,” said Domachowske. “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.”
Domachowske — an expert in pediatric infectious diseases who has spent 30 years caring for children at Upstate — says the virus has “disproportionately” impacted adults, but children have also 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,” he said.
To protect children, stop the spread of COVID-19, and promote herd immunity, experts “must prevent” childhood infections through safe vaccination protocols, he added.
The Pfizer vaccine is currently approved for use in those age 16 and older. The company announced Wednesday that its study of the vaccine in adolescents age 12-15 found it to be 100 percent effective. The company is also conducting studies of the vaccine in kids age 11 and under, including the study at Upstate Medical University.
Getting involved
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.
The medical school expects to complete the first phase by the end of May. Phases two and three will involve 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, Upstate said.
Study visits will take place in Upstate’s Pediatric Infectious Diseases outpatient clinic located on the fifth floor of the Physicians Office Building on Irving Avenue.
For more information on the trial or to sign up, people are asked to call the dedicated study phone line round-the-clock at (315) 706-5636, or email Jodi Halczyn at halczynj@upstate.edu or Diana Dick at dickd@upstate.edu.