Pfizer labs in Chesterfield, Missouri are ready to mass-produce a new COVID-19 vaccine as soon as the FDA approves its success rate and safety data. Pfizer and BioNtech have teamed up to develop a successful mRNA-based vaccine and have reached a 90 percent success rate in its studies so far.
At a press conference with Missouri Gov. Mike Parson Thursday, Vice President of Biotherapeutics Pharmaceutical Science Christine Smith, the site manager for the Chesterfield facility said there is more work to do. Their industry-leading study continues until they get to 164 confirmed cases of the vaccine’s success. The company must provide safety data for the FDA 60 days after giving a second injection to test subjects.
Smith said the safety step is critical for the candidate vaccine.
“We’ve not seen any serious safety concerns, I cannot underscore the importance of knowing more about the safety profile of our candidate. We’ll know more about these results in the coming weeks before we submit the file for emergency use authorization. And we are preparing the necessary manufacturing data to submit to the FDA to demonstrate the safety and quality of the vaccine product produced,” she said.
With approval, she says they can start distributing the vaccine by the end of the year, “because we — Pfizer and BioNtech — have already started to make it.”
Missourians would get the vaccine from the Chesterfield facility, which would reduce travel and handling of shipments that must be stored at minus 94 degrees Fahrenheit. Read related story.
Smith thanked the 43-thousand participants who enrolled across the world, including “many Missourians.”
“We are one step closer, science is winning,” she said.