Dr. Maggie Powers, Infectious Disease Research Scientist, University of Cincinnati Health is one of the lead members of the team conducting the MODERNA COVID Vaccine trial at U.C. Health. She spoke with Loveland Beacon about the 95% efficacy rate in the early phases of the trial in a story published in November 2020. Since then, the Moderna two-dose vaccine received an Emergency Use Authorization (EUA) along with the Pfizer two-dose vaccine and later the Johnson & Johnson single dose; all three of which are being administered throughout the United States and other areas around the Globe. It began as a nationwide trial involving 90 health systems with approximately 30,000 enrolled participants. With the issuance of the EUA, millions of vaccinations have been administered moving the trial into Phase 4. Dr. Powers took time out recently to talk with Loveland Beacon and answer questions regarding the continued trial, data gathering, and analysis of the Moderna vaccine.
The general public continues to express questions about the safety, benefits, side effects, term of effectiveness, need for a booster or annual vaccination, and ultimate impact on their health and well-being beyond simply protection against infection by, or spreading of the coronavirus itself. Many millions of eligible Americans have already received at least one, if not both doses of the vaccine. Some who are eligible still have not received the shot; either by choice or some other circumstance preventing them from receiving the vaccine. Rumors have been flying about the potential long-term effects, both good and bad. Dr. Powers is directly involved in the study and analysis of data gathered through the enrolled clinical trial participants with the U.C. Health group, but does not refer to herself as an expert for all of the Moderna trials or the vaccine being administered to those 16 and older around the nation as a result of the issuance of the EUA order.
“Clinical trials have four phases. We often talk about that phase three, but there is a fourth phase to clinical research,” said Dr. Powers. “That is after something has been used; either authorized or approved. Remember, we still don’t have FDA approval on any of the vaccines. They have been released to the public under the Emergency Use Authorization.”
Discussion of Phase 4 of a trial comes when the product – in this case vaccine – is out among the broader population. Collection of data continues with numerous resources available to the research scientists for continuing to monitor vaccine safety since the EUA was issued.
“They’ve actually expanded with the COVID vaccines there are now even more resources available,” Dr. Powers explained. “This is something that has been ongoing for all vaccines development; to have this continued safety analysis.”
Modern technology plays a role in even more resources being available. Powers pointed out there are “apps available” and numerous other reporting mechanisms available. That’s how clinical trials continue beyond the Phase 3 planned study.
“Not only are the Phase 1, 2 and 3 trials ongoing in that we are collecting data from those patients (enrolled participants), but we are also collecting data from the public who have received these vaccines and report side effects or anything that may have occurred,” said Dr. Powers.
In short, YES infectious disease research scientists like Dr. Powers continue to collect data to determine the safety and efficacy of the Moderna vaccine and others. This data is being gathered and analyzed through numerous and expanded resources making the information available to medical researchers studying the effects of the vaccine on those vaccinated.
One of the most frequently asked questions is about the endurance of the vaccine. The durability was a huge unknown at the outset of the clinical trial. Analysis of clinical trial participants who had their second dose more than six months ago has shed some light on how long the vaccine remains effective.
“We look at the presence of antibodies through six months following that second dose,” Dr. Powers said. “Based on their report, it showed there are antibodies present. We still don’t necessarily have an exact understanding of the protection or what the titers are – that’s the antibody level.”
As a result of the clinical studies of those patients who received a second dose of the vaccine six months ago, Moderna published a commentary in New England Journal of Medicine reporting the presence of antibodies in those patients. The presence of antibodies at that point is an encouraging sign pointing to the durability of the vaccine for Dr. Powers. Learning more about how long the antibodies are present will ultimately reveal answers to the question of need for booster, or if the vaccine may become more flu-like with recommendation for an annual shot.
“It is all data driven,” she said. “All that we’ve established the role antibodies play. We also know there are other means of immune protection against viral infections that may be independent of antibodies. It’s good news, but it is not the whole picture.”
The expressed concern is the continuing evolution of the pandemic. We have all heard of the concern about variants as the coronavirus mutates or evolves. Dr. Powers, researchers, and the rest of the medical community have seen variants and have been left to wonder what impact they will have on herd immunity. While not directly involved, she is aware of Moderna studies looking into impact and possibility of booster shots.
“I am aware Moderna has announced doing some booster studies,” said Dr. Powers.
She believes it is being done in the earlier phase enrollment as a modification. These are likely non-clinical tests being done in the lab with variants to look at potential protection. Also they are looking at what kind of protection, what antibodies would be produced if they boost the immune response with a variant. Powers says that falls more in line with an influenza vaccine you would get each year due to the different virus circulating – in this case potentially a coronavirus variant.
“It is different than what we would consider a booster using the same vaccine just because our immune system has waned,” Dr. Powers explained. “So, using the word booster, but also incorporating the idea of a variant within it.”
One thing is very clear talking with Dr. Maggie Powers, Research Scientist, Infectious Disease Division of University of Cincinnati College of Medicine, science comes first. She points to the importance of investing in scientific research which allows important research for future medicine.
“Having public health funding allows us to do things like study viruses, sequence them and do analyses which help us learn about that piece of information,” said Dr. Powers. “Then it guides patient care decisions.”
The patient care decision strikes at the very heart of the issue: to get the vaccine, or not to get the vaccine. Dr. Powers is first to tell you she is NOT a medical doctor, not your physician, and not the one to tell us absolutely whether we should or should not get the vaccination. She does have a good answer for anyone trying to make the right decision for their health and the health of others around them.
“I think it is all about talking to a trusted health care professional,” she said. “If there is not one in your circle that has the information about vaccines, look for resources that reflect that mission toward scientific integrity.”
Dr. Powers suggested two sources she would recommend as trustworthy resources for anyone looking for vaccine information. The University of Cincinnati, College of Medicine, U.C. Health has released numerous messages from many of her colleagues and clinicians talking about this information. As an alternative choice, aside from your own trusted physician, the Center for Disease Control (CDC) national data can be trusted to help determine a recommendation that fits your specific health care situation. Why trust the science of these coronavirus vaccines, or any vaccine?
“We’ve established research institutions; scientists with no vested interest in anything but gathering good quality data,” Dr. Powers said. “That is their main mission – to move research forward. That’s who is working on this, reporting data and involved in the analysis. It is that level of scientific integrity combined with compassion. Everyone involved in these studies is working toward the greater good. That’s’ what clinical research is built on. I think there has been even increased emphasis on trust and transparency within research.”
CLICK HERE to see the Moderna Commentary in the New England Journal of Medicine
CLICK HERE for more on the vaccines from U.C. Health
CLICK HERE to for more from the CDC