In a public letter Pfizer (PFE) CEO Albert Bourla wrote that the company hopes to have initial data from its Phase 3 clinical trail of a coronavirus vaccine by the end of October and that it will wait until the third week in November to file an emergency use authorization application with the U.S. Food & Drug Administration.
Bourla explained the the initial data on the effectiveness of the vaccine–the initial data likely to be ready by the end of this month–is only one part of the requirements for approving a vaccine. The other factors include safety and manufacturing quality data.
To assure safety, Pfizer and its partner BioNTech (BNTX) need to follow participants in the trial for at least 2 months. (The FDA recently increased its follow-up period from 1 month to 1. Non-emergency applications generally require 6 months of follow up).
The FDA repeated that point in an article in the New England Journal of Medicine today. “The FDA generally requires at least 6 months of safety follow-up,” the FDA’s authors wrote. “Given that some vaccines under evaluation for preventing Covid-19 are based on technologies not previously used in licensed vaccines, arguments could be made in favor of longer safety follow-up to support an EUA.”
The timeline from Pfizer is well ahead of that from competitor Moderna (MRNA), which said it will have its data by Thanksgiving Day.
The FDA has said that it takes several weeks to process an emergency use authorization (EUA). Which means one could be issued by the end of 2020.
Shares of Pfizer were up 3.83% at the close today, October 16. Pfizer is a member of my Dividend Portfolio. The shares are up 0.11% as of the close on October 16 from August 28, 2020 when I added them to the portfolio. They pay a 4.16% dividend.