Q&A with leader of new COVID-19 vaccine trials

February 02, 2021
Dr. Patrick Flume in discussion with a colleague
Dr. Patrick Flume in discussion with a colleague

Patrick Flume, M.D., an MUSC pulmonologist who co-led the AstraZeneca vaccine trial that recruited more than 650 people in Charleston answers questions about the Novavax and Johnson & Johnson/Janssen vaccine trials that just launched in January. Flume also co-directs the South Carolina Clinical & Translational Research Institute, the mission of which is to speed research breakthroughs, such as the COVID-19 vaccines, into the clinic.

The Novavax and Johnson & Johnson/Janssen trials will be recruiting 600 participants each in the Charleston area, and participants will be compensated. Flume would like to recruit clinical trial participants who reflect the diversity of the population.

“We need a broad mix of people to participate,” said Flume. “We need young and old, men and women, black and white, Hispanic and non-Hispanic.”

Such diversity helps to ensure that the vaccine, once released, will work in all of these groups.

“If we do a study in all young white people and the drug works, will it work in an older black person?” asked Flume. “Probably, but I would feel a lot more confident about that if we had these people in the study.”

To learn more about joining one of the COVID-19 clinical trials, visit the COVID-19 clinical trial website, contact the COVID Vaccines Research Team at covidvaccine@musc.edu or fill out a Vaccine Study Interest Form.

How do COVID-19 vaccines work, particularly those in clinical trials at MUSC?

The bottom line with vaccines is you're trying to give to the body the protein for which you want it to form an antibody. For the COVID-19 vaccines, that’s the spike protein on the coronavirus that it uses to bind to host cells. The authorized Pfizer and Moderna vaccines use messenger RNA, which provides a template for building the protein and gives it to the cells so that they can crank out the protein. The AstraZeneca and Johnson & Johnson/Janssen vaccines puts a protein message into a harmless viral vector that can harness the cell machinery to start cranking out the protein. The Novavax vaccine just gives the protein itself and ties it to a nanoparticle. So they're all different platforms trying to achieve the same goal: introduce the protein into the body so that antibodies can be formed and other parts of the immune system can be activated.

If the authorized Pfizer and Moderna vaccines are so effective, why do we need to continue to develop new vaccines? 

First and foremost, we need more vaccine. We just don’t currently have the volume of the drug we need to do broad-scale vaccination. To get people vaccinated across the nation and the world, we need more options, and we need options that don’t present the logistical challenges, such as the ultracold freezers, that the authorized vaccines do. If we were getting news right now that AstraZeneca hit, and Janssen and Novavax hit, and we were going to have a lot more vaccine available and it would be easier to administer, we'd be in much better shape.

Note: Johnson & Johnson reported efficacy findings after this interview was conducted.

What else can these trials teach us about the vaccines?

The more people who enroll and the more diverse the population, the more certain we can be that the vaccine will work for American men and women of every race and ethnicity. We will also ultimately need data on groups such as pregnant women and children so we can have a better understanding of how the virus affects these groups and whether or not it’s safe to vaccinate them. We may miss such crucial data if it is not collected in a formal, systematic manner, as it is in a study.

If I participate in the study, can I still get an authorized vaccine when I become eligible?

Half of those in the Janssen and two-thirds of those in the Novavax trial will receive the vaccine, and the rest will receive a harmless placebo that does not contain any vaccine. If trial participants become eligible for an authorized vaccine, there is a mechanism for telling them whether they received the vaccine or a placebo. Those who received a placebo could then obtain a vaccine but would remain in the study.

If I participate in the study, do I still need to wear a mask and follow social distancing guidelines?

Yes, definitely. Not everyone in the trial will receive the vaccines; some will receive a placebo. But all participants should continue wearing masks and taking other precautions to prevent transmission. When we do these vaccine studies, we are not testing people to see if they get infected, only if they develop symptoms. Vaccines can give you benefit by preventing infection or preventing serious consequences of infection, and either one is a win. We know the Pfizer and Moderna vaccines prevent serious disease – we are still gathering data to determine whether AstraZeneca, Johnson & Johnson/Janssen and Novavax vaccines do so. But we don’t yet know whether any of them prevent vaccinated people from getting the virus and passing it on.

When we started the AstraZeneca vaccine trial, we told people that this is not like the old Off commercials where the guy sprayed his arm with Off and stuck his arm in a container full of mosquitos. That is not what we are trying to do. We are not giving the vaccine and then telling people that they can go out there and mingle.

We’ll get to a point when we don’t need the masks and other precautions only when many more people have been vaccinated and the infection rate gets really low. When you see that positivity rate out there at 20-30%, we are a long way away from that. Until then, everyone needs to stay disciplined, including those enrolled in clinical trials.

About the Author

Kimberly McGhee

Keywords: COVID-19, Research