Makary criticized the data submitted by Pfizer and Moderna to receive the green-light, saying it was lacking: Pfizer's trial included under 1,000 children and didn't show any efficacy against infection, he reports.
Moderna reported just a four percent reduction in infection in their trial of around 6,000 children.
'A more honest announcement would have been: 'We approved the vax for babies & toddlers based on very little data. While we believe its safe in this population, the study sample size was too low to make a [conclusion] about safety. Note that studies were done in kids w/o natural immunity,'' Makary told DailyMail.com about the decision in June.
'The public has no idea how bad this data really is. It would not pass muster for any other authorization,' an FDA official said.
