Posted by Michael Wonder on 26 Jul 2021
FDA asks Pfizer, Moderna to test their vaccines in more children to help rule out safety issues
26 July 2021 - Federal regulators have requested that vaccine companies expand their trials to test coronavirus shots in several thousand school-aged children before seeking authorisation — a move intended to assess whether a rare inflammation of the heart muscle that has been seen in young adults shortly after vaccination is more common in younger age groups.
The changes to on-going paediatric trials run by Moderna and Pfizer and its German partner BioNTech could delay the availability of the vaccines to children between the ages of 5 and 11 beyond the hoped-for timeline of early fall, although it is unclear by how much. As the country faces a surge fuelled largely by cases in unvaccinated people and the school year approaches, paediatricians and families have impatiently awaited shots of protection.
