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good morning we'd like to welcome you all to our virtual press conference today to discuss the fda's emergency youth authorization of the pfizer biontech covid19 vaccine first we always hear from fda commissioner dr stephen hahn and dr peter marks the director of the fda's center for biologics evaluation and research following their remarks we will open up for questions and with that let's turn the press conference over to dr han good morning and welcome to this food and drug administration press conference i am pleased to announce that late yesterday the fda authorized for emergency use the pfizer bioentic covid19 vaccine this is the first cova-19 vaccine to be authorized in the united states the fda is respected worldwide and is considered the gold standard regulator of medical products we applied our high standards of review in reviewing this product so that americans can have trust and confidence that the vaccine meets fda's rigorous standards for safety and effectiveness and with this authorization we know that our federal partners are already moving to distribute the first doses of the vaccine throughout the country the fda's authorization for this vaccine is a significant milestone in battling a devastating pandemic that has affected so many families in the u.s and around the world our action comes as that we are near the end what has been truly a year unlike any other in modern times while this year has been marked by tragedy sadness and sacrifice it is also a year that has generated unparalleled scientific achievement that will resonate for many future generations scientific processes for medical product development including vaccines traditionally take years what we have seen this year is a historic partnership among the private sector academic researchers and the federal government to find efficiencies in our scientific processes as well as the dedication of time and energy toward a common goal which has led to the rapid development of truly innovative medical products but let me be clear efficiency does not mean any cutting of corners medical products are still undergoing rigorous study in clinical trials important safety checks remain in place the fda's review teams continue as they have always done to comb through the data submitted by companies regarding their medical products what's different during coven 19 is that developers researchers and regulators have found new and hopefully lasting ways to be dynamic and efficient at the fda we have been applying a variety of resources and tools in our search for solutions and to support the nation's medical needs which has led to this achievement we found ways to cut the red tape and reduce regulatory burden on medical product sponsors when possible one important tool we have used during this pandemic including for this vaccine action is the emergency use authorization or eua created by congress specifically to provide us with the means to respond rapidly during a public health emergency for an eua to be issued the fda's career scientists...