Pfizer, BioNTech COVID-19 vaccine planned for late November FDA submission

The first coronavirus 2019 (COVID-19) vaccine to be considered for emergency approval may be a month away. Pfizer chief executive officer Albert Bourla wrote in an open letter Friday morning that efficacy and safety data for vaccine candidate BNT-162, from his company and partner BioNTech, will be submitted to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) following the third week of November. The significance of the timeline, Bourla explained, is to comply with recent FDA COVID-19 vaccine development guidance, which state developers should provide safety data from at least half its trial patients taken 2 months following the final vaccine dose. “Based on our current trial enrollment and dosing pace, we estimate we will reach this milestone in the third week of November,” he wrote. The mRNA-based vaccine has been assessed in international phase 1/2 trials at 3 different doses, with the 2 lower doses (10 and 30 mcg)...