BALTIMORE, MD (WJMN) – On Monday, Pfizer announced vaccine data showed its shots could be 90% effective at preventing COVID-19. Behind the team studying the vaccine is Kirsten E. Lyke, MD, a Professor of Medicine at the University of Maryland School of Medicine and the Center for Vaccine Development and Global Health.
Lyke said she is the principal investigator of all the initial Pfizer studies which began on May 4th. Her background working with Malaria and other tropical diseases has served her throughout the process.
“It was actually extraordinarily useful because through my tropical disease work, I ran the first Ebola vaccine with (NIH) National Institutes of Health, and the first Zika vaccine,” Lyke explained. “So we had experience as a go-to site for academics and we’re right down the road from NIH. We’ve been able to get a few trials off the ground in the matter of a month or so but this was taking it to the next level.”
Having experience was one part of the equation, the next was timing.
“We knew things were moving quickly because usually we have 12 to 18 months to ramp up to begin a study. Pfizer contacted us in mid-April and requested that we participate. So we had slightly more than two weeks to get the whole study off the ground, begin recruiting and start,” added Lyke.
She described a typical timeline where it would take a year to get documents together and approvals for a study. To complete phase one would have easily been 24 to 30 months, but this wasn’t a typical study.
“With this trial, it’s really a phase one on steroids,” said Lyke. “We had originally had no idea it was an adaptive design. We were told it could be 250, all the way up to 800 people so we were told to start and we’ll just whittle away at it as we go along. If there’s a vaccine we don’t want to pursue, we’ll drop it. If there’s another one we want to add, we’ll add it. If there’s a different dose we want to add, we’ll do that. So we started with 4 vaccines at 3 doses. So 12 different groups. We added a fifth vaccine with 3 different groups. Along the way we dropped several of them.”
Phase one, two, and three were completed in six months.
She added, “It’s been long days, 24/7. It’s exciting because I love when we’re able to eliminate a lot of the administrative. My favorite trials are adaptive designs. So you have the flexibility to just drop stuff that’s not going to work and move on with things that are going to work. And we learned day by day.”
This weeks announcement was a welcome surprise for Lyke and her team.
“It was really like the frosting on the cake this week. We’ve been working so hard, and just to get such positive results super gratifying. Our team is just extremely thrilled and tired, but happy that it appears to be working.” Lyke went on to say, “We couldn’t have imagined in our wildest dreams. We were hoping to get 50 or 60%. The threshold the FDA set was 50%. So we were nervously awaiting results to see if we surpassed 50%. No one expected 90, or greater than 90. Again, I have to temper this with it’s short term results. We don’t know long term and we’re only 6 months into this. and all these volunteers are going to be followed for two years. So we’ll have additional peeks at the data as we go along.”
We asked about possible side effects of the vaccine. Lyke said if there were to be any, it would be early on. The volunteers involved in the study will be monitored for effects over the next two years.
How does the vaccine work?
“It’s the first of it’s kind that’s ever reached this stage of its study,” said Lyke. “It’s a messenger RNA vaccine. You can think of it as the equivalent of a short bit of computer code that’s basically telling our cells to make a protein. You can program this to make any protein in the world you want. In this case we’re telling it to make very specific full length spike proteins. The spike protein is the little spiky knob on the Coronavirus. It’s probably where a lot of the immune response occurs. So we’re telling our own cells to make this spike protein, then our cells make the protein and express it. Then it makes our bodies think it’s seeing this random protein so they mount an immune response. That’s how the immune response works, so it’s very natural. Then the RNA will disintegrate in a matter of days so there’s no residual RNA that gets incorporated into your cells. So it’s kind of a vanishing vaccine that’s there temporarily and just disappears.”
How soon after getting the vaccine could it take effect?
“Our results looked at all COVID infections that occurred more than 7 days after the second vaccination,” said Lyke. “So all we can say is everyone got the second vaccination and were more than 7 days out from that when they got their infection and that’s when the analysis was done.
How long will the vaccine last?
“We don’t know how long that immune response is going to last, so how long the vaccine protects is just a matter of time. We’re in real time here, we’re not holding back data. We got the data on Sunday and the press release was Monday. As soon as we know, the public knows,” added Lyke.
What happens when I get the vaccine?
“Be prepared to have a little soreness, a little bit of a fever. I can guarantee you it’s not going to last more than 30 to 36 hours. I can predict when I vaccinate you when it’s going to end. If you know what’s coming, it’s not going to be a surprise and it’s not scary. It’s your immune response that’s kicking in and you should look at that as a positive,” said Lyke.
Who is being tested?
Lyke said 42% of the population of the trial is vulnerable populations and ethnicities that are at high risk for COVID. She said they want people to feel safe that we’re looking at the right populations that represent them. The group also includes HIV populations, cancer patients, people with high-risk, front-line workers.
Lyke said there are two next steps. The second step is to collect all the safety data for the two months following the second dose. That data is still being collected and they are still in that time period for many of the volunteers. That will go as a safety package to the FDA. The package will include databases which are cleaned up and tightened, double-checked, quality control, and submitted as a package. The third step will be their next interim analysis. It will be done when they hit
another critical number of threshold Coronavirus infections in the study population.
Lyke said production of the proposed vaccine is already underway, with an estimated 50 million doses ready by December. If all goes well in the safety package and the study results remain positive, it’ll go to the FDA who will have to review it. She does not know how long that process will take. She believes the vaccine would go under scrutiny for an emergency use authorization (EUA) rather than full licensure because of the threat of the pandemic.
A Michigan Connection
Dr. Lyke grew up just outside of Marquette in Harvey. She said, “I got a great education. At the time, we didn’t have any AP classes or honors classes, but I was very well prepared. I think people coming from the Midwest are hardworking in general and don’t tend to complain very much. They just kind of tackle whatever’s thrown at you. Maybe that carried forward. I don’t think I was particularly brighter than anyone but I do think I worked a little bit harder. If I have to credit anything for my success it’s my work ethic developed as part of growing up in the U.P.”
Dr. Lyke still has family in the area, that she hasn’t been able to see in person. “I don’t think we’re going to be able to come home for the holidays because it looks bad and we shouldn’t be traveling between states.” Lyke went on to say, “That will be a first for me not to come back to the U.P. for Christmas.”
Our conversation ended with a message to the youth of the U.P., to believe it what is possible.
“You are not limited in anyway. The U.P. sends out people all over the world and are doing amazing things. There are many people in my field. I can name about three physicians from the Marquette area that I regularly interact with. Coming out of the area, you can go anywhere you want. For me, I very intentionally decided to go to college on the East Coast because it was scary and because I had no experience, and because I knew it would open doors to things I had never been exposed to before. I would say, don’t feel like you have to stay close to home. This is your chance to try something new. If you can make it work, travel to a new state, and get some new experiences, it’s always nice to now you can always come back to the U.P.”