FDA Delays Review of Pfizer Vaccine for kids under 5

The FDA said it wants to see more data from Pfizer before proceeding.



The Food and Drug Administration (FDA) has delayed its review of Pfizer and BioNTech's COVID-19 vaccine for children under the age of 5, allowing the drugmakers to collect more data from an ongoing clinical trial. Pfizer and the FDA said on Friday afternoon that they will delay filing for approval of their shot in infants and young children until they have more data on the efficacy of a third dose. As a result, the FDA has postponed a highly anticipated advisory committee meeting scheduled for this week and will likely not decide on clearance of the shot until later on. Adults, teenagers, and children 5 years and older are eligible for COVID-19 vaccinations, but the 19 million Americans who are under 5 are left without an option.


While kids are less likely than adults to experience COVID-19’s most serious outcomes, children under 5 still accounted for 2% of COVID-19 hospitalizations reported last week ending 5th February, according to data from the Centers for Disease Control and Prevention. Through a clinical trial process known as "immunobridging", Pfizer and BioNTech have begun testing their vaccine in younger people. After demonstrating that their vaccine can prevent COVID-19 in adults, they've been doing research to see if vaccination might elicit a similar immune response in adolescents and young children. Immunobridging, on the other hand, is intended to be a faster and more convenient means to expand use than waiting for massive clinical trials that can more conclusively determine whether participants get sick.