“It gives us hope.” – Dr. Maggie Powers-Fletcher, PhD, member of U.C. & U.C. Health Moderna vaccine study team
By Chuck Gibson
LOVELAND, OH (November 23, 2020) – First we heard Pfizer announce a 90% efficacy rate on their COVID-19 vaccine trial, then last week Moderna announced a 95% efficacy rate on their COVID-19 vaccine trial. Now, just today, Astra-Zeneca announced a 90% efficacy rate on their COVID-19 vaccine trial. Where are they/we . . . really?
The University of Cincinnati and U.C. Health have been conducting a trial on the Moderna vaccine here in Cincinnati. Carl Fichtenbaum, MD and Margaret (Maggie) Powers-Fletcher M.D. are co-investigator (CI) for the trial here. Let’s start with some data from that trial here in Cincinnati:
The first dose was administered on August 25, with the final participant enrolled on October 23. Dr. Powers, says they screened 188 participants. An injection was given to 185 participants; three did not receive any injection.
The University of Cincinnati reports the study actually surpassed 40% enrollment of diverse populations with nearly half of the participants being non-white. Here is the breakdown:
Male – 60 %, Female – 40%
51.74 % White, 25% Black or African American, 20.35% Hispanic, 1.74% More than one race and 1.16% Asian.
Dr. Maggie Powers-Fletcher is a PhD scientist with U.C. & U.C. Health working directly as an investigator in the trial study being conducted here in Cincinnati. She said she prefers to be called Maggie, rather than the use of the more formal “Dr.” in front of her name. She spent close to an hour last Friday talking with me about the Moderna study and answering questions we both hope will bring some clarity to exactly where we are in the quest for a vaccine solution to the COVID-19 pandemic.
During the week prior to our conversation, Pfizer and Moderna made the announcements of their high efficacy rates in analysis of the COVID-19 vaccine trials. Both reported 95% efficacy rates from in-term analysis – first data they saw. In-term analysis of data is pretty standard with clinical trials according to Powers. It is preliminary.
“Not all the data is in yet,” said Powers. “What they saw is encouraging. They found the vaccine seems to be quite effective with this efficacy at about 95%, just under, which is incredibly encouraging.”
To help clarify what that means, Powers explained there are specific details for a clinical vaccine trial like this. Expectations are defined for what the researchers should expect to see. They also set parameters for what they need to see to determine success, or not. They are thinking about how the vaccine performs in real life. One group of participants received a placebo. In this case a saline injection which should have no effect. The other group received an injection of the actual vaccine. Both went out to be “maybe naturally exposed”. The trial team is looking to see how the vaccine does versus the placebo in protecting against infection.
“In particular, we’re looking at protecting against COVID-19 disease following a second dose,” Powers explained. The protocols for the Moderna vaccine study call for each participant to receive a second dose. In the data released, individuals had to have received the second dose. The study just closed – enrolled final participants at the end of October – some participants still have not received their second injection. The procedure calls for 28 days between the first and second dose. The data released is called in-term analysis because there is a lot more data to be collected.
“I think it is incredibly exciting,” exclaimed Powers. “I think the important message is; regardless of findings, the work is incredibly important.”
Powers acknowledged positive results are great, but ineffective results do not diminish the work of all scientists. They are learning. We are learning. They go into these clinical trials as investigators, as participants understanding there are no promises it will come out with positive results. Theirs is a need to learn.
“In that sense, any data is helpful information,” Powers said. “You go in with that mentality. There are trials with only 50% efficacy for other vaccines. To have this close to 95% efficacy is very positive.”
The study here in Cincinnati is part of the national Moderna vaccine study with 30,000 participants. The study does not end here. This is a two year study. What happens next, or is happening now? Participants will have a series of visits. Those who have only received the first dose are waiting the necessary 28 days and then will receive a second dose. There are telephone calls, follow up calls, collection of specimens and monitoring for any signs of COVID symptom. They’ll be trying to learn answers to questions like how long the vaccine will last.
“We don’t know,” said Powers. “That is a question of this study. The word you’ll hear is ‘durability’. How durable is the immune response these vaccines will elicit?”
It’s part of the reason for a lengthy – two-year – study says Powers. They seek to gain information. It may be possible this will be like influenza vaccine needed annually. She explained frequently seen shifts in the strain of the virus or slight changes require updated immune response. The idea may be the same. There may be a need to boost injection.
“We need to watch for that,” Powers said. “That data is not available yet. We need more data, participants willing to keep giving us that information.”
The trial calls for two doses. When approved, will two doses be required? Powers says they have to collect the data and analyze the data first. For now, it’s wait and see. In the meantime, it seems to some we are getting mixed messages about the availability of the vaccine.
“Yes, product is being produced so as soon as it is given approval, product will be available,” she said.
Concerns have been raised about the accelerated process. Powers explained there is no cause for concern. The accelerated process is not taking short cuts or skipping steps. Acceleration is allowed by investing resources with no guarantee to recoup costs.
In this case manufacturers are investing in high volume production already so product is ready as soon as there is a green light to go.
“Normally, that does not happen,” Powers said. “Normally, you wait for approval before investing resources. The government is taking a chance.”
With media bombarding us with announcements and speculation on the vaccines from Pfizer, now Astra-Zeneca, and the Moderna vaccine being studied right here, Powers has found the messaging and communication interesting. That is not what she cites as the most important aspect of what is happening though.
“The most critical thought here is: to find a solution to beat this pandemic, we are going to need multiple weapons in our arsenal,” explained Powers. “A lot of vaccines, possibly different types of vaccines, different methods of distribution. It’s a win-win if we can all show this is effective. It is pretty amazing these have shown to be so effective. It just gives us two options.
It could have looked a lot different. There could have been differences in efficacy rates. That would have raised questions about how to determine which vaccine to use or when to use it. Powers believes it is “fabulous” to now have what appears to be multiple options.
“It shows science can move forward, come up with solutions,” she said. “I think that’s really the story here.”
There’s more to the story than that. The Moderna vaccine study is focused on whether or not it will protect against getting COVID-19 disease. Powers explained the distinction between protecting against disease versus infection. The difference is COVID disease is with symptoms while someone could be infected, but asymptomatic, and not even know they are infected. They’re looking at how the vaccine protects against those with symptoms or severe disease requiring medical intervention or hospitalization. Powers finds it most compelling to see the fortitude of people continuing the fight.
“Whatever their fight looks like,” she said. “People coming together, I find admirable. There aren’t a lot of experiences where so many people band together to be part of the solution. It’s an honor to be part of that and help lead it. It’s incredible. I wish we could experience that kind of sentiment without it having to be a deadly pandemic. I wish we didn’t have this scientific discovery process under such terrible pressure.”
Many people remain hesitant to receive the vaccination once it is approved. Powers is not one of them. Not surprisingly, she is a self-described strong proponent of vaccinations. She recently took her four year old daughter to watch as she received her annual flu vaccination. Afterward they talked about it before taking her daughter to get hers.
“It’s an amazing way, just thinking about science, it’s something we can do to protect ourselves,” Powers said. “Yes absolutely. Good science and good data tells us we’ve got a way we can keep ourselves and others healthy. I’m definitely going to be in line! We should talk, question and learn from one another.”
So, where are we now? With all this good news, what is the final message from Dr. Maggie Powers? There is still more to be learned and she can’t say for sure when the vaccine will get the green go approval. She’s heard the same things we have and would only go so far to say 6 months may not be unrealistic.
“This is something to give hope,” said Powers. “We’re on the right track. It is in sight. Preliminary data has confirmed hope. We’ve learned so much. We’re more prepared, more ready for the next time. This is good news. It gives us hope!”
More about U.C. Health at: https://www.uchealth.com/