In a sudden turnabout, Pfizer and BioNTech today announced they were delaying the application process for an emergency use authorization (EUA) for their vaccine for children ages 6 months to 4 years old, and gathering more information on two and three doses of the vaccine.The announcement comes just days before the Food and Drug Administration (FDA) was set to consider the application, and a day after the Centers for Disease Control and Prevention (CDC) had told pediatric vaccine providers to ready themselves for a Feb 21 delivery date of the mRNA vaccine."As part of its rolling submission, the company recently notified the agency of additional findings from its ongoing clinical trial," the FDA said in a statement. "Based on the agency's preliminary assessment, and to allow more time to evaluate additional data, we believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization.”In December, Pfizer released data on two 3-microgram doses of the Pfizer-BioNTech vaccine in children 6 months to 4 years.
In children 2 years and older, the reduced doses did not elicit a significant immune response, and the company suggested a third dose may be needed.Today in a statement Pfizer said an ongoing study of a third dose of vaccine administered 2 months after the primary series is "advancing at a rapid pace," and the companies will wait for the three-dose data, which they expect to have by early April, before applying for the EUA.The FDA meeting scheduled for Feb 15 has been delayed until further notice.Data: Protection drops 4 months after third doseToday in Morbidity and Mortality Weekly Report, scientists present new research showing