The University of Rochester Medical Center (URMC) and its referring providers will participate in a SARS-COV-2 phase 2/3 vaccine trial in collaboration with Moderna, Inc., and Pfizer/BioNTech SE.
URMC – along with other select academic medical centers – plans to test the vaccine on 200-300 volunteers among healthy children aged 6 months to 11 years of age. The trials for Pfizer will begin enrollment for ages 5-11 on June 7, with Moderna trials expected to start in August.
The trials will be critical for demonstrating that the vaccine is safe and generates an immune response in young children. These data are necessary because children’s immune systems may respond differently to the virus than adults and adolescents, 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 young children to make sure it’s safe and works,” she said.
Although COVID-19 tends to cause less severe illness in children, there have been several thousand children hospitalized from the virus, including children in the Rochester community. In addition, children who are infected with the virus risk spreading it to household members, grandparents, teachers, and other children, necessitating 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 great that we have an authorized vaccine for children age 12-15 years and are moving quickly on starting trials for kids under 12," said Caserta.
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,” Caserta added.
In terms of success of the trials, both Nayak and Caserta will be monitoring the progress of the study. Strong results from the vaccine trials for children age 12-15 suggest the possibility for a high rate of success.
Parents who are interested in volunteering their children for vaccine trials are encouraged to visit the www.bringrocback.com website and click on the ‘get started’ link.