Continuing our role as a leader in vaccine development, the University of Rochester Medical Center and its referring providers will participate in phase 2 and phase 3 trials in collaboration with Moderna Inc., testing the vaccine on 600-700 healthy children.
URMC—along with other select academic medical centers—plans to test the vaccine in 600-700 healthy children aged 6 months to 12 years. The trials will include two doses of vaccine and will begin in Spring 2021.
The trials will be critical for selecting the appropriate dose and proving the vaccine is safe and generates an immune response in children. These data are necessary because children's immune systems may respond differently to the virus than adults, according to Jennifer Nayak, M.D., associate professor in the Department of Pediatrics and the Division of Infectious Diseases and Microbiology and Immunology.
"Preliminary data show that children have different disease manifestation with COVID, so it's important to test the vaccine specifically in children to make sure it's safe and works," she said.
Current research shows that children under the age of 10 may be less likely to transmit the COVID virus than adults, but there is evidence that children above the age of 10 can spread the disease as easily as adults. Although the virus tends to cause less severe illness in children, the risk of severe disease in some children and the risk of spreading it to household members, grandparents, teachers, and other children necessitates the development of a pediatric vaccine, according to the American Academy of Pediatrics.
While the CDC and AAP have not recommended that a pediatric vaccine should be required for a full return to school, this vaccine will still facilitate the easing of restrictions in both school and recreational environments for children, which have been significantly disrupted by the pandemic. As a result, pediatric vaccine trials should be a priority, according to Mary Caserta, M.D., professor in the Department of Pediatrics, Division of Infectious Diseases.
"A pediatric vaccine will help provide parents with a level of comfort in getting kids fully back to normal life, including school and activities. It's ok to start trials with adults first, but we shouldn't have a long delay to pediatric trials, especially since there could eventually be less infections in the community, which will make the vaccine in children harder and longer to study."
As part of the rollout of these vaccine trials, URMC and its participating providers are implementing screening protocols where volunteers can sign-up to be pre-screened.
"It is a unique protocol where families interested in new vaccines would be pre-screened."
Both Nayak and Caserta will be monitoring the progress of the study. Strong results from the adult vaccine trials suggest the possibility for a high rate of success, according to Caserta.
Parents who are interested in volunteering their children for vaccine trials are encouraged to visit the website www.bringrocback.com and click on the 'get started' link.