pfizer and biontech to submit emergency use authorization request today to the u.s. fda for covid-19 vaccine
pfizer and biontech to submit emergency use authorization request today to the u.s. fda for covid-19 vaccine
we look forward to the upcoming vaccines and related biological products advisory committee discussion and continue to work closely with the fda and regulatory authorities worldwide to secure authorization of our vaccine candidate as quickly as possible. filing for emergency use authorization in the u.s. is a critical step in making our vaccine candidate available to the global population as quickly as possible, said ugur sahin, m.d., ceo and co-founder of biontech.", "these forward-looking statements may include, but may not be limited to, statements concerning: biontechs efforts to combat covid-19; the collaboration between biontech and pfizer to develop a potential covid-19 vaccine; our expectations regarding the potential characteristics of bnt162b2 in our phase 2/3 trial and/or in commercial use based on data observations to date; the expected timepoint for additional readouts on efficacy data of bnt162b2 in our phase 2/3 trial; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the timing for submission of data for, or receipt of, any marketing approval or emergency use authorization; the timing for submission of manufacturing data to the fda; our contemplated shipping and storage plan, including our estimated product shelflife at various temperatures; and the ability of biontech to supply the quantities of bnt162 to support clinical development and, if approved, market demand, including our production estimates for 2020 and 2021.", 


































"from the start of the research program earlier this year, pfizer and biontech have successfully supplied and distributed their investigational vaccine to more than 150 clinical trial sites across the u.s., as well as europe, latin america, and south africa.", "this release contains forward-looking information about pfizers efforts to combat covid-19, the collaboration between biontech and pfizer to develop a potential covid-19 vaccine, the bnt162 mrna vaccine program and modrna candidate bnt162b2 (including qualitative assessments of available data, potential benefits, expectations for clinical trials, the submission of a request for emergency use authorization and other regulatory submissions, the anticipated timing of regulatory submissions, regulatory approval or authorization and anticipated manufacturing, distribution and supply), that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements."


































)