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Pfizer CEO Albert Bourla described the day as “historic” shortly after the announcement that the pharmaceutical industry and BioNTech had submitted a request for the coronavirus vaccine to be licensed in the United States.
In a video message on Twitter, Albert Bourla referred to the 248 days it took to create the vaccine and thanked the volunteers who participated in the clinical trials. “We have operated with unusual speed in the clinical development program, from the conception of the idea to the submission of the application to the regulatory authorities, always focusing on safety. “So many things have made this happen: advancements in technology, amazing collaboration, thousands of courageous test volunteers around the world, and of course the same motivated partners at both companies.” Μπουρλά.
The message of A. Bourlas after the application for a license for the vaccine
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“It is a historic day, a historic day for science and for all of us. It took us only 248 days from the day we announced our plan to work with BioNTech to submit the application to the FDA. We worked with unprecedented speed on the program for clinical development, from idea conception to application submission to regulatory authorities, always with a focus on safety. So many things have happened to make this happen: advancements in technology, incredible collaboration, thousands of brave test volunteers around the world and, of course, the same motivated partners in both companies.
Today, we were able to submit a very robust data package, which we believe meets, and in many cases exceeds, high FDA standards. Our candidate vaccine has shown 95% efficacy against Covid-19, with no serious safety concerns so far.
Of course, the journey is not over yet. In addition to today’s submission (of the application) to the FDA, we have already started submitting applications to Australia, Canada, Europe, Japan and the UK and we intend to submit (applications) to other regulators around the world. We also look forward to the next discussion, in December, in the Advisory Committee of the United States Vaccines and Related Organic Products Advisory Committee (VRBPAC).
Finally, we will continue the work that is already underway to ensure that we can begin shipping the vaccine as soon as approval is given. Based on current forecasts, we expect to produce up to 50 million doses worldwide by 2020 and up to 1.3 billion doses by the end of 2021.
“I want to thank everyone who volunteered for the clinical trial, our university colleagues, and our colleagues and collaborators around the world who work around the clock to help ensure that science wins.”
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