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New Jersey’s Rutgers University will enroll as many as 200 children between the ages of 6 months and 11 years to take part in a COVID-19 vaccine trial for Pfizer and its German partner BioNTech.
The college announced Thursday it has been selected as a clinical trial site for Pfizer-BioNTech’s global research study “to evaluate the efficacy” of the companies’ two-dose COVID-19 vaccine in children.
The Pediatric Clinical Research Center at Rutgers Robert Wood Johnson Medical School in New Brunswick is one of several clinical trial sites for the pediatric study and the only trial site in the Garden State.
Rutgers said it will enroll up to 100 children ages 5 to 12, 50 children ages 2 to 5 and 50 kids ages 6 months to 2 years in the trial.
In total, 4,644 children are slated to take part in the program worldwide, according to the university.
Trial participants will be randomly selected to receive two doses of Pfizer’s coronavirus vaccine or a placebo.
Six months after the second dose, participants will be “unblinded” and “the vaccine will be offered to those who received the placebo,” the school said.
Rutgers said it will enroll up to 100 children ages 5 to 12, 50 children ages 2 to 5 and 50 kids ages 6 months to 2 years in the vaccine trial. Richard Harbus“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,” co-lead investigator Simon Li, an associate professor of pediatrics at Rutgers Robert Wood Johnson Medical School, said in a statement.
Li added, “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.”
The Pediatric Clinical Research Center at Rutgers Robert Wood Johnson Medical School in New Brunswick will be the only trial site in New Jersey to vaccinate children with the COVID-19 vaccine. Richard HarbusRutgers has served as a COVID-19 vaccine clinical trial site for pharmaceutical companies twice before. Last fall, it conducted trials for both Moderna and Johnson & Johnson’s vaccines.
Meanwhile, Pfizer-BioNtech announced Friday that they’ve applied for full regulatory approval from the Food and Drug Administration for their COVID-19 vaccine for people 16 and older in the US.
The companies are the first coronavirus vaccine makers in the country to apply for full approval.
In addition, the partners have applied to the FDA to expand the current emergency authorization for their vaccine to people ages 12 to 15.
