From CNBC.com…
Parents of children under 5 will have to wait until at least April to get their kids vaccinated against Covid-19, after the Food and Drug Administration and Pfizer this week abruptly delayed plans to get the shots authorized on a fast-track basis.
The FDA had originally planned to authorize the first two doses of what will ultimately be a three-dose vaccine as soon as this month. However, Dr. Peter Marks, head of the FDA’s vaccine division, said updated data submitted by Pfizer and BioNTech did not support the plan to get the first two doses out early. Marks acknowledged that the decision was abrupt, but said the FDA was following the science.
“The data that we saw made us realize that we needed to see data from a third dose in the ongoing trial in order to make a determination that we could proceed with doing an authorization,” Marks told reporters during a call Friday, without providing specifics on the data.
