Roughly 42% of the trial’s global participants had racially and ethnically diverse backgrounds, Pfizer and BioNTech said, adding that there haven’t been any serious safety concerns reported yet.
The companies said they planned to submit for emergency use authorization to the U.S. Food and Drug Administration soon after they have two months of data, which is currently on track for the third week of November.
Based on current projections, Pfizer and BioNTech expect to produce up to 50 million vaccine doses in 2020, and up to 1.3 billion doses in 2021. The vaccine requires two doses per person. Though the companies didn’t take any money from the federal government for research and development for the drug, they reached a nearly $2 billion agreement in July to supply 100 million doses to the U.S. government as part of the Trump administration’s Operation Warp Speed. That money is helping with manufacturing and distribution.
Plans to deliver hundreds of millions of coronavirus vaccines around the world raise questions about logistics and distribution in part because of the need to store and transport them in supercooled containers.
Pfizer’s vaccine requires a storage temperature of minus 94 degrees Fahrenheit. By comparison, Moderna has said its vaccine must be stored at minus 4 degrees Fahrenheit.
The company reportedly plans to load suitcase-sized boxes from distribution sites in Kalamazoo, Michigan, and Puurs, Belgium, onto as many as two dozen trucks per day, allowing for the daily transit of roughly 7.6 million doses to nearby airports.
The companies said they plan to submit data from the full phase three trial, which began on July 27, for scientific peer-review publication.