JACKSONVILLE, Fla. – Clinical research centers across the US, including the Jacksonville Center for Clinical Research, are being impacted by the Department of Health and Human Services’ announcement to cancel contracts and withdraw funding for vaccines being developed to combat viruses like COVID-19 and the flu.
HHS Secretary Robert F. Kennedy said in a statement Tuesday that $500 million worth of vaccine development projects using mRNA technology will no longer receive federal funding, which will cause mRNA vaccine research to halt, or force pharmaceutical companies to use their own money to pay research clinics to continue conducting human trials of mRNA vaccines.
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mRNA stands for messenger ribonucleic acid. As a vaccine, the messenger ribonucleic acid instructs cells in the human body to produce pieces of a virus protein, which then triggers an immune response to a virus.
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During the first Trump administration, particularly during the height of the global COVID-19 pandemic, President Trump signed off on what became known as “Operation Warp Speed.” The operation was a collaboration between the US government and privately owned pharmaceutical companies to quickly create and distribute a vaccine to protect people from COVID-19.
This was at a time during the pandemic when hospitals were inundated with COVID-19 patients in critical condition and a rising COVID-19 death toll.
At the time, Johnson & Johnson, Moderna, and Pfizer were the three main pharmaceutical companies that had quickly developed a vaccine that had undergone human trials. Moderna and Pfizer were using mRNA technology, while Johnson & Johnson was using a traditional method of creating a vaccine.
Eventually, the mRNA vaccine proved to be more effective against COVID-19, and the Johnson & Johnson vaccine was eventually canceled in the US due to health risks, such as a rare but serious type of blood clotting.
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Fast forward to Wednesday, when the HHSA announced that it was canceling mRNA vaccine contracts and pulling funding from mRNA vaccine research.
The announcement came as a big surprise to Dr. Michael Koren, who is the director of the Jacksonville Center for Clinical Research. For several years, JCCR has helped pharmaceutical companies like Moderna and Pfizer test mRNA vaccines and even non-mRNA vaccines against viruses that attack the human respiratory system.
Wednesday morning, after the HHSA announcement, JCCR received an email from Vaxart, a pharmaceutical company that was relying on JCCR to conduct human trials on an oral COVID-19 vaccine that does not use mRNA technology.
“They were saying we should stop the study, and I thought this did not make any sense. This is not a study for mRNA. This is a study for a new platform that is being compared to mRNA to hopefully show that the new platform is better than mRNA,” said Dr. Koren.
Dr. Koren explained to News4JAX why he believes the sudden stoppage is unethical, citing a variety of reasons.
“First, there is a concept we have in medicine called respect for persons,” he said. “When we take a situation like this with 200 people who signed up, and were told what was going to happen during the study, then we suddenly tell them we’re stopping it, but not for a good reason...the reason that has been stated is to move on from mRNA, when the study was already about moving from mRNA.”
A second ethical problem, according to Dr. Koren, is the way research is structured. For vaccine research to be scientifically valid and ethical, it requires a certain number of patients.
“To suddenly change that number of patients means you’re probably not going to get the conclusion, one way or another, either good or bad, that you thought you were going to get.”
In other words, now that the study has come to a sudden halt, we may never know if the oral non-mRNA COVID-19 vaccine is better than the mRNA vaccine that’s injected into muscle tissue.
“There’s nothing wrong with saying we want to find something better than mRNA, but it doesn’t justify shutting down a study that already has thousands of people in it,” Dr. Koren said.
A third ethical problem, according to Dr. Koren, comes on the business side of things.
JCCR has business contracts with various pharmaceutical companies that have contracts with the federal government. HHSA announced it was canceling contracts linked to mRNA research.
From a local standpoint, this could impact research employment at JCCR.
“There are probably a couple of dozen people who have been working on this project, and their jobs could be in jeopardy. As far as the patients who signed up for the project, I don’t know what to say to them because we don’t have enough details right now of how this is going to move forward, so it’s a big problem, “said Dr. Koren.
Dr. Koren admits politics is playing a role in the announcement made by HHS, and it’s no secret that the department’s secretary has spoken out about his lack of trust in mRNA technology.
“We need to keep science, science. We need to keep medicine as medicine and not get into politics, and again, how do you do that? You do studies like we do here. If you think one technology is not as good as the other, compare them. Do a study. Make it objective,” said Dr. Koren.
The HHS announcement comes on the heels of a recent CDC report that showed COVID-19 cases on the rise in 27 states; however, officials note that positive cases and emergency room visits for COVID-19 remain low.
Medical experts believe the rise in positive cases is due to increased summer travel, indoor gatherings as a result of hot outdoor temperatures, and people who are choosing to either not get vaccinated or not receive a COVID-19 booster.
