The company took six days to parse the top-line data into the nitty-gritty details that the Food and Drug Administration wants to see.
While the overall results are important, the agency needs patient-level details on who developed COVID-19 and when it happened relative to the vaccination. And the FDA will want a breakdown of each and every adverse event reported. And there's manufacturing data. And the list goes on.
Given the work, submitting an application less than a week after having top-line data is actually quite an accomplishment.
Now, the FDA will take about three weeks to review the application for emergency use. Most of the work will be complete by Feb. 24, when the agency is scheduled to post its review of the clinical trial data ahead of the FDA advisory committee meeting on Feb. 26. The committee of outside experts will likely take a vote at the end of the meeting, but investors should keep in mind that it's ultimately just a recommendation. The FDA has the final say.
Interestingly, the advisory committee meetings reviewing the application for the vaccine from Moderna (MRNA 2.74%) and the one from Pfizer (PFE -5.12%) and BioNTech (BNTX -1.01%) were both on a Thursday, which allowed the FDA to complete its review on the following day. Feb. 26 is a Friday, suggesting the agency might need to work through the weekend to get the vaccine authorized as quickly as possible. Otherwise we might need to wait until Monday for the authorization.
Presumably Johnson & Johnson will be ready to ship its vaccine within a day or two of the FDA authorization, although it'll take awhile to manufacture and ship all 100 million doses that the company plans to supply in the first half of 2021.