“It is with great pride -and joy and even a little relief- but I can say that our request for emergency use authorization for our covid-19 vaccine is now in the FDA’s hands. This is a historic day for science, and for all of us,” Bourla said.
Reminding that It took just 248 days to get from the day they announced their plans to collaborate with BioNTech to their FDA submission date, Bourla added: “We have operated extraordinary speed in our clinical development program from concept to regulatory filing, while always maintaining our focus on safety.“
“Many things went into making this happen: Advances in technology tremendous collaboration thousands of courageous trial volunteers around the world. And, of course, the purpose-driven colleagues at both companies. Today, we were able to submit a very robust data set that we believe meets -in many cases exceeds- the FDA's high standards. Our vaccine candidate has demonstrated efficacy of 95% against covid-19 with no serious safety concerns observed to date.”
Underlining that the journey is not yet complete, he went on to say: “In addition to today's submissions to the FDA, we have already initiated rolling submissions in Australia, Canada, Europe, Japan and the UK, and we plan to submit immediately to other regulatory authorities around the world.”
“We also look forward to the upcoming feedback discussion in December in the US,” he noted.
He concluded his remarks as follow: “Lastly, we will continue the work already underway to make sure we can begin shipping the vaccine immediately after the authorization or approval. Based on current projections, we expected to produce globally up to 50 million doses in 2020- and have to 1.3 billion doses by the end of 2021. I want to thank everyone, everyone who volunteer to participate in the clinical trial, our academic collaborators and investigators at the study sites, and our colleagues and collaborators around the world who have been working day and night to help ensure that science will win.” (ILKHA)