Katheryn Stephenson, MD, MPH discusses the timeline for COVID-19 vaccine clinical trials

CBS This Morning – October 26, 2020

Kathryn Stephenson, MD, MPH (Center for Virology & Vaccine Research, BIDMC) discusses the timeline for COVID-19 vaccine clinical trials and addresses the general public’s concerns over potential side effects.

Two major clinical trials for coronavirus vaccines are resuming in the United States, after being paused over safety concerns. Estimates show the earliest time for an approved vaccine could be the end of November.

But a recent STAT-Harris poll showed a sharp decrease in the number of Americans who would get a vaccine right away.

CBS News senior medical correspondent Dr. Tara Narula spoke with a wide-ranging group about their thoughts on a vaccine.

Asked to rank their confidence level in a vaccine on a scale of 1 to 10, California resident Seana-Marie Sesma said 6; fellow Californian Adam Davis said 7.5; Lissi Marshall, a neuroscience college student from Philadelphia, said 7 or 8; Michigan resident Alyssa Kogut, who is diabetic, said 8; and Chad St. Clair, who is from California, said 1 or 2. 

St. Clair is adamant he will not get the vaccine, while Kogut said she definitely will. Marshall said she trusts the science but will wait a few months to get a vaccine. Sesma is still unsure due to concerns about potential side effects, and Davis is hesitant but open to it.

“If somehow, after however many months the participants of the preliminary vaccine research start to come out with any side effects … that would definitely change my mind,” Marshall told Narula. 

“I feel that, though the FDA has done the majority of good things, they have also taken products off the market that they approved at one point,” Sesma said. 

“We just don’t know enough about the vaccine yet. I’m young, I’m healthy. I exercise. And I’m low risk,” St. Clair said.

Sesma agreed with him. “We don’t know much about the vaccine or the long-term — short-term or long-term effects,” she said. 

Davis agreed he is concerned about potential risks or side effects. But Kogut said it was the “opposite” for her. 

“I know this virus, and I know what it can do to you,” she said. “I have diabetes, and my daughter has asthma. She’s only 7. So I would definitely take it to protect me and my kids.”

St. Clair said he is “on the other side.”

“I don’t want to panic. I know a lot of people who have had it and have recovered nicely, as well as our leader of our country,” he said. 

“For me, if I see people actually taking it and working, I’d be more inclined to do it,” Davis said.

Dr. Kathryn Stephenson, director of the Clinical Trials Unit of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, participated in the early development of the Johnson & Johnson COVID-19 vaccine candidate, and is an investigator in trials of other COVID-19 vaccine candidates.

Asked how she reassures people who are being asked to take a novel vaccine, Stephenson said, “Well, the first thing I would say is, that it’s very unusual for a vaccine to have a long-term side effect. Most of the side effects associated with vaccines have to do with upfront. So something like an allergic reaction.”

“And that’s true for all vaccines,” Stephenson added. 

On whether or not political pressure has played a role or could play a role in a vaccine being prematurely approved, Kogut said she doesn’t think President Trump “has any control over making the vaccine or rushing the vaccine.”

Davis, however, said, “I think it has a little bit to do with it. Especially with what’s going on. And you can tell where there is some pushing on both sides.”

“I would agree,” Marshall said. “I feel like, unfortunately, this year, a scary pandemic has been politicized more than it would have been, probably, if it weren’t an election year.”  

“I think the politics side is giving sometimes a lot of false hope that it’s going to happen faster than it really is. So I think that it’s creating confusion,” Sesma said.

Responding to the shortened timeline for the COVID-19 vaccine, Stephenson explained that some of the normal delays in vaccine research were removed. 

“Typically an academic vaccine researcher would have to apply for a lot of grants and start begging for money to do more research,” she said. 

“But now, this was like everybody knew that this was something we had to do, and there was a lot of funding,” she continued. “Then, how do you make a partnership with a pharmaceutical company? … Usually that takes a year, at least, to negotiate some sort of collaboration. That was instant.”

These were delays that could be removed without compromising the research, Stephenson said.

St. Clair asked Stephenson about the vaccine’s effectiveness. “We know about the flu vaccine, and is that 100% effective? And then is the coronavirus going to be 100% effective?” he asked.

“You may have a vaccine that’s maybe 60-70% effective — prevents a lot of deaths, not every one, but significantly slows down transmission of the virus, which benefits everyone,” Stephenson said. “So if you have 100% of people take the vaccine, and it’s only 50% effective, you’re going to do a lot better than if the vaccine is 100% effective but only a few people take it.”