Rutgers has been selected as a clinical trial site for the global Pfizer-BioNTech research study to evaluate the efficacy of its COVID-19 vaccine in children ages 6 months to 11 years.
This is the third time Rutgers has served as a COVID-19 vaccine clinical trial site for pharmaceutical companies. Last fall, it conducted trials for Moderna and Johnson & Johnson.
The Pediatric Clinical Research Center at Rutgers Robert Wood Johnson Medical School in New Brunswick is one of the several clinical trial sites for Pfizer-BioNTech’s pediatric study. It is the only clinical trial site in New Jersey. Rutgers will enroll up to 100 children ages 5 to 12 and 50 children each from the age groups 2 to 5 years and 6 months to 2 years out of 4,644 children to be enrolled worldwide.
Participants who meet the eligibility requirements for the study will be randomly selected to receive two doses of the potential vaccine or a placebo. Participants will be unblinded six months after the second dose and the vaccine will be offered to those who received the placebo. Researchers will track whether those who were vaccinated have lower rates of infection with moderate to severe symptoms than those who were unvaccinated over two years.
“Children can get sick from COVID-19 and can spread the virus to others even if they are asymptomatic. While most children experience mild or no symptoms, some children can get severely ill and could have long-term effects,” said co-lead investigator Simon Li, an associate professor of pediatrics at Rutgers Robert Wood Johnson Medical School. “Maximizing COVID-19 vaccination in all age groups is important to stop the global progression of the disease. Vaccination will also help us feel safer about our children resuming school and daily activities.”
Pediatricians and parents who are interested in their children being considered for the vaccine clinical trial can click here.
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