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East TN researchers to conduct clinical study to test a COVID-flu combo shot

The clinical study pays participants $830 over the course of the research and is specifically looking for people 65 and up.

KNOXVILLE, Tenn. — A new study in East Tennessee is looking to test a vaccine that combines influenza and COVID-19 vaccines into one single shot. 

Dr. William Smith, founder and president of the Alliance for Multispecialty Research in Knoxville, is currently working on a new clinical study with the goal of testing the safety and antibody response from the combination shot. 

After starting phase one trials in November, Pfizer announced its combined mRNA-based flu and COVID shot had received a "fast track" designation from the U.S. Food and Drug Administration, which will expedite the development and review of the shot. Novavax and Moderna are also testing competing versions of a similar combo vaccine.  

The Knoxville study is specifically looking for people 65 and older who had the flu shot more than four months ago and who've had at least four COVID shots since the vaccine's initial rollout in 2021. 

Smith said participants will receive $830 dollars over the course of the study. For AMR, the challenge is finding enough people who meet all of the requirements.

"We need people that got their flu shot early in the year, and we need people that have already had multiple COVID vaccines," Smith said.

Smith has been a doctor for more than 30 years. He has taught at the cardiology department at the University of Tennessee in Knoxville.

This study will begin this Friday, and Dr. Smith said it could make life easier. The flu vaccine has long been recommended yearly, and doctors believe COVID might end up being a regularly spread virus like the flu. 

"For the foreseeable future, we're going to need COVID vaccinations on a repeat basis," Smith said. "The latest suggestion is annually."

The main question with this vaccine: Will a single yearly shot protect people -- particularly people who are more vulnerable to serious respiratory illness -- from COVID and the flu?

Smith said larger studies have already checked the efficacy of the flu and COVID vaccines. What they need to know is if the two can be delivered together with similar antibody responses seen in the individual shots.

"This study is not looking at efficacy, it's looking at antibody levels," Smith said. "It's to show that the antibody levels are comparable and that the side effect profile is equal to what we see when we give them independently."

Smith said the study will benefit the community as a whole should the combo vaccine receive federal approval. 

He said the convenience factor alone should play a role in increasing vaccination rates. FDA officials said moving to an annual schedule would also make it easier to promote vaccine campaigns.

"The more convenient we make vaccines for people, the higher the vaccination rate is," he said. 

People interested in participating in the study can learn more by visiting AMR's website at this link or by emailing knoxville@amrllc.com or calling them at (865) 305-DRUG during normal business hours.

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