A medical facility in New Orleans that was among the 120 sites around the world participating in the Pfizer COVID-19 vaccine trial is now gearing up for distribution.
Director of Infection Control and Prevention at Ochsner, Kathy Baumgarten told Reuters on Thursday (November 26) she feels very confident in the process of handling the vaccine and knows they can hit the ground running as soon as the first doses arrive.
“I think it gives us a comfort level that we know what to do and how to do it, and we’ve done it before. So because we have done it successfully with the trial and we’ve also figured out the process, because it is a process, I mean the vaccines distribute it on dry ice, there’s a tracker on it to make sure that it’s handled, the temperature is appropriate. And we’ve had experience with doing all of this,” Baumgarten said.
Ochsner had about 230 people from across Louisiana enrolled in the trial. All participants randomly received either the vaccine or placebo, two shots of the same; 50% received the vaccine and 50% the placebo.
Dr. Victoria Smith, who practices family medicine in Jefferson participated in the clinical trial. The Ochsner-Pfizer partnership was a double-blinded study, meaning neither the volunteers nor the researchers know who received the vaccine or just a placebo. Even Dr. Smith doesn’t yet know which shot she got. The data of who got what, Baumgarten explained, will be revealed as soon as the FDA gives the green light and those who only got the placebo will be among the first ones to be offered the immunization shots.
Both Pfizer and U.S. Health Secretary Alex Azar have said the FDA could authorize the vaccine in mid-December.
Seeing first hand the impact the experimental COVID-19 had in the volunteers, Baumgarten could anticipate a few side-effects from receiving the COVID jab. “The company has not yet told us all of the details, but we do know there are some fatigue and maybe a little bit of headaches and fevers after the vaccine, but that’s good because that means you’re mounting a response. And certainly having no side effects is better than getting it or spreading covid. We don’t know if the vaccine will prevent spread, but we do know it prevents disease,” she said.
Pfizer applied to U.S. health regulators on November 20th for emergency use authorization (EUA) of its COVID-19 vaccine, the first such application in a major step toward providing protection against the new coronavirus after the company and German partner BioNTech reported final trial results that showed the vaccine was 95% effective in preventing COVID-19 with no major safety concerns.
The companies expect the FDA to grant the EUA by mid-December and said they will begin shipping doses almost immediately. Pfizer has said it expects to have 50 million vaccine doses ready this year, enough to protect 25 million people.
The final trial data showed the vaccine provided a similar level of protection across different ages and ethnicities – an encouraging result as the disease disproportionately hurts the elderly and minorities.
Of the 170 volunteers who contracted COVID-19 in Pfizer’s trial involving over 43,000 people, 162 had received only a placebo, meaning the vaccine was 95% effective, far higher than originally expected. The U.S. FDA had set minimum bar for efficacy of 50%.
Moderna is expected to be the next company to seek a U.S. emergency use nod for a COVID-19 vaccine. An initial analysis of data from its late-stage trial showed the vaccine was 94.5% effective. Final results and safety data are expected in the coming days or weeks.
“We want to be sure that everybody gets it, otherwise it won’t be helpful, otherwise we can’t get back to some degree of what we were like before. I don’t know that we’ll ever be, sort of the same as we were before, but to get to some degree of normalcy again, to be able to have or people at Thanksgiving or more people at Christmas. It’s important that everybody that can gets this vaccine,” Baumgarten concluded.
Both the Pfizer/BioNTech and Moderna vaccines work using a new technology to trigger an immune response known as synthetic messenger RNA that can be produced at scale much more quickly than traditional vaccines.
(Production: Catherine Koppel and Temis Tormo)