Exclusive: Pfizer CEO Discusses Submitting the First COVID-19 Vaccine Clearance Request to the FDA

On Friday, Pfizer CEO and chairman Albert Bourla announced that the company has filed a request to the U.S. Food and Drug Administration (FDA) for emergency use authorization of its COVID-19 vaccine, making it the first to do so. In a discussion on TIME 100 Talks, Bourla says that if the FDA authorizes the vaccine, the company will be ready “within hours” from receiving the green light to start distributing the vaccine. Pfizer has been manufacturing doses even while safety and efficacy tests were ongoing, in order to avoid delays in shipping once authorized. According to Bourla, Pfizer is on “on track” to deliver the 50 million doses promised to the U.S. government by the end of the year, with 1.3 billion doses through next year. In an in-depth conversation about the journey the company has taken in developing its vaccine, Bourla admitted that, throughout the process, he wasn’t always sure that having a safe and effective vaccine ready for FDA review in less than a year was possible. “Conviction is a part of it, so I was always telling [our teams] that we will make it, and we will make it by October, and if not us, then who?” he says. “But I knew that it was an extremely risky suggestion, I knew it was going to be difficult, and the stars needed to be aligned all the way to the end.” Pfizer capitalized on a partnership begun in 2018 with German company BioNTech, which was founded by a husband-and-wife team of scientists w...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized COVID-19 Source Type: news