Pfizer, BioNTech COVID-19 Vaccine Planned for Late November FDA Submission


Pfizer anticipates to have completed FDA-mandated safety data a month from now. An EUA application should shortly follow.

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) appearing less associated with adverse events, according to findings from a non-peer reviewed paper. A phase 3 trial was expanded from 30,000 to 44,000 participants last month, with the inclusion then of adolescent participants and those living with other viral diseases.

In late August—prior to the FDA guidance update—Pfizer stated they were on track to seek regulatory review as early as October, and could potentially provide up to 100 million doses before the end of the year, and approximately 1.3 billion doses by the end of 2021.

Bourla wrote in his open letter Friday morning that the company may know whether BNT-162 is efficacious in COVID-19 prevention by the end of October. They first must accumulate a specific rate of COVID-19 cases in vaccine-administered trial participants to compare against control patients.

“As Pfizer is blinded to who received the vaccine versus the placebo, a committee of independent scientists will review the complete data and they will inform us if the vaccine is effective or not based on predetermined criteria at key interim analysis points throughout the trial,” he explained.

The company intendeds to continue running the trial through its final analysis point regardless of the efficacy outcomes observed in the data likely used for EUA application.

In an interview with sister publication HCPLive®, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Disease (NIAID), said his institution is involved with Pfizer and BioNTech on pursuing long-term follow-up safety analysis for the candidate.

“Our challenge is going to be to reach out to the public, particularly the vulnerable people who should be vaccinated, and get them enrolled in a clinical trial,” Fauci said, “because we really need what I call comparable representatives of the diversity in the population.”

Bourla stressed that a conclusive readout of phase 3 efficacy data will be made available for public consumption as soon as is deemed practical—regardless if the data were positive or negative.

“Our purpose is to discover breakthroughs that change patients’ lives,” he concluded. “I cannot think of a breakthrough that would be more meaningful to a greater number of people than an effective and safe COVID-19 vaccine.”

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