JACKSONVILLE, Fla. — Americans have heard a lot of different dates about when a possible COVID-19 vaccine will be ready. The dates ranged from before Election Day, according to the president, to next spring or summer according to the director of the Centers for Disease Control and Prevention.
"There has never been anything like this in terms of urgency of the studies," Dr. Michael Koren, medical director at the Jacksonville Center for Clinical Research, said. "We've never seen anything like this before."
Koren heads up two local COVID-19 vaccine trials on the First Coast -- Pfizer and Moderna's trials. The Jacksonville Center for Clinical Research is one of a few private sites across the country that was awarded COVID-19 vaccine trials. Researchers started phase three of the two trials in July.
The trials are placebo-controlled studies, meaning not everyone will get the active vaccine. According to Koren, a few months into both trials, so far, so good. The Pfizer study also expanded its enrollment from 30,000 people to 44,000, Koren said.
"The people that do it [vaccine research] are people like me and others that, we are data people. We are driven by the science," Koren said. "We are driven by patient safety. We’ve been doing this for a long time."
"We've seen different politicians come and go, and at the end of the day, we want our patients to have the best possible experience and hopefully we get a product to market that will make a difference for many lives," Koren said.
Koren said the speed of the studies is not politically motivated. President Donald Trump has pushed for a vaccine to be ready before Election Day.
"This is because they are prioritizing this problem, this illness for public health reasons. We just happen to be having an election, of course, but the truth is this is a major health care crisis, and we've had companies step up and give a lot of resources," Koren said.
Earlier this week, White House officials blocked the Food and Drug Administration's stricter guidelines for emergency approval of a COVID-19 vaccine. The new guidelines say companies should follow trial participants for at least two months after the last dose to rule out safety issues. This would most likely push vaccine authorization after Election Day.
“At the end of the day, the FDA is going to make its own decision. There’s a lot of political posturing and this administration likes to show that it gets things done fast, and it pushes people to do things, and people in the regulatory community like to be circumspect and take things at a pace to which ensures safety," Koren said.
The FDA posted the guidelines to its website, and the White House ultimately approved the guidelines Tuesday.
“I’m a scientist, so I take it with a grain of salt. I know how these things work and I have a lot of confidence in our system, that we won’t be compromised," he said.
"So, when people hear that the study has a result, it will be a very robust scientific-based result. I am very confident about that," Koren said.
As far as when Americans could see those results and vaccine production, Koren said he anticipates Pfizer's will be ready sometime in December, and Moderna early next year.