Pfizer, BioNTech COVID-19 Vaccine May Be Ready for FDA Submission by Late November

Study results for Pfizer’s investigational coronavirus disease 2019 (COVID-19) vaccine could be ready by the end of November to support filing for US Emergency Use Authorization (EUA).¹ BNT162, which is being developed by Pfizer in partnership with BioNTech, is a mRNA-based vaccine.

In an open letter published on Friday, Pfizer Chairman and Chief Executive Officer Albert Bourla wrote that the efficacy and safety data for the company’s vaccine candidate, BNT-162, could be submitted to the FDA for EUA by late November, assuming positive data from clinical trials. Completion of safety data is expected by mid-November at the earliest.¹ Pfizer initially indicated that the company was on track to seek regulatory review for BNT162b2 as early as October 2020.²

For EUA consideration in the US for a potential COVID-19 vaccine, the FDA is requiring that companies provide 2 months of safety data on half of the trial participants following the final dose of the vaccine. “Based on our current trial enrollment and dosing pace, we estimate we will reach this milestone in the third week of November,” Bourla wrote.¹

According to Bourla, the company may know whether or not BNT162 is effective in COVID-19 prevention by the end of October. For this to happen, they must accumulate a certain number of COVID-19 cases in the trial in order to compare the efficacy of the vaccine in unvaccinated individuals with those received a placebo.¹

Related: HHS Permits Pharmacists to Order and Administer COVID-19 Vaccines​

“Since we must wait for a certain number of cases to occur, this data may come earlier or later based on changes in the infection rates,” Bourla wrote. Bourla also noted that a committee of independent scientists will review the complete data and determine whether the vaccine is effective based on predetermined criteria at key interim analysis points throughout the trial.¹

Pfizer will continue running the trial through its final analysis point even if it is declared effective at an earlier stage.¹

“The timelines above reflect our best estimates of when these important milestones could be achieved,” Bourla wrote in the letter.¹

References:

1. An Open Letter From Pfizer Chairman and CEO Albert Bourla. Statement Pfizer; October 16, 2020. Accessed October 16, 2020. https://www.pfizer.com/news/hot-topics/an_open_letter_from_pfizer_chairman_and_ceo_albert_bourla​
2. Pfizer and BioNTech Share Positive Early Data on Lead MRNA Vaccine Candidate BNT162B2 Against COVID-19. Press release. Pfizer; August 20, 2020. Accessed October 16, 2020. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-share-positive-early-data-lead-mrna​