At the start of 2020, the scientific community was faced with an unimaginable task: to develop, test, and deploy effective COVID-19 vaccines at lightning speed without compromising patient safety.

Despite the multitude of challenges, Pfizer and BioNTech’s BNT162b2 mRNA product received regulatory approval just 266 days after the World Health Organization’s pandemic declaration – and as of May 2021, 154 million doses had been administered in the USA alone.

This was achieved with the help of applying an agile Risk-Based Quality Management (RBQM) approach to the pivotal clinical trial.

Download the case study to learn how Pfizer overcame the hurdles presented during the pandemic, such as the inability to perform on-site monitoring visits and ensuring the integrity of the data generated from over 43,000 patients, to get them over the COVID-19 vaccination approval finish line first.