JEFFERSON CITY, Mo. — The Missouri-developed COVID-19 vaccine from Pfizer is expected to receive federal approval by the end of the year.
“The company expects to see an emergency-use approval from the FDA and could then start distributing the vaccine by the end of the year because we — Pfizer and [our collaborator] BioNTech — have already started to make it,” Dr. Christine Smith, head of Pfizer’s Chesterfield site, said.
The template for the vaccine will be developed at the Chesterfield location, which is also set to conduct testing on the final drug product, according to Smith.
Smith said more than 43,000 subjects around the world were enrolled for the tests, and 39,000 had already received the second dose since the company began its third phase of testing in July. She said the vaccine candidate had been highly effective so far.
“As I stated at this podium in May, to beat this pandemic it would take science, creativity, and the resolute will of passionate researchers around the world, including right here in the state of Missouri,” Smith said. “The vaccine candidate we’re developing with our collaborator was found to be more than 90 percent effective in preventing COVID-19 in participants having no evidence of prior SARS-COV2 infections.”
Smith said the analysis was performed by an external data-monitoring committee.
The company has more data to collect before submitting the compound for emergency-use authorization with the FDA, including information on manufacturing and side effects, but testing hasn’t presented safety concerns so far, according to Smith. Pfizer also agreed to hold off on submitting the vaccine candidate until 164 positive COVID-19 cases were confirmed in the trial.
Smith said more than 2,000 employees at the Chesterfield facility had worked on developing the vaccine. She said many of the individuals enrolled in the trials were Missourians as well.
“This is very encouraging news, and we are proud that Pfizer in Chesterfield is leading the way on this critical global development,” Gov. Mike Parson said. “Missouri has been considered a leader in this area, and that will only continue when a vaccine becomes available.”
Parson said Missouri was “fully prepared” for distribution when a vaccine is approved.
Missouri submitted its vaccine distribution plan to the CDC last month. The state planned to take a phased approach to distribution, allocating the vaccine to health care workers, those considered to be high risk, and schools and critical businesses before providing it to the general public, based on guidelines provided by the CDC.
Department of Health and Senior Services (DHSS) Director Dr. Randall Williams confirmed the state had finalized plans for distribution centers for the vaccine.