Jacksonville clinical research center begins trials on another COVID-19 vaccine

‘So far, we’re not having any adverse reactions to report of any significance, which is good news,’ researcher says

JACKSONVILLE, Fla. – While the Pfizer and Moderna COVID-19 vaccines continue to be administered across the United States under an emergency authorization status, the Jacksonville Center for Clinical Research has just begun clinical trials for the Novavax vaccine.

Novavax is another drug manufacturer to come out with a COVID-19 vaccine after Pfizer and Moderna that does not require injecting a person with the live virus.

COVID-19 vaccine researcher Dr. Micheal Koren explained how the Novavax vaccine works.

“It injects a small amount of the spike protein, pure spike protein, with something called an adjuvant that presents that protein to the immune system, so the immune system knows what to do with really a small amount of spike protein put into someone’s system,” Koren said.

In other words, the spike protein is what’s required for the virus to penetrate human cells. Under a microscope, the spike protein is the protruding tentacle-like object seen extending from the virus.

“So the concept here is that instead of showing the whole virus to people, which can cause all kinds of complications, just a critical part of the virus is presented to the immune system so that your immune system is prepared to fight if you ever get confronted with the virus,” Koren said.

The Pfizer and Moderna vaccines are different from the Novavax vaccine because they give the human body a genetic code to produce the spike protein, which triggers the immune system to fight the virus.

Another difference between the first two vaccines and the third is storage. The Novavax vaccine must be stored in a freezer, but not anywhere near the extreme frigid temperatures required for the Moderna and Pfizer vaccines.

Koren said the vaccine game changer is manufacturing capacity. There is already a lot of stress on Pfizer and Moderna to manufacture enough doses of their vaccines, but if Novavax gets government approval for an emergency use only status like Pfizer and Moderno, Novavax could pick up the slack in vaccine production.

But right now, the Novavax vaccine is still in clinical trial status. As of Wednesday morning, nearly 100 people in Northeast Florida have enrolled in the clinical trials at the Jacksonville Center for Clinical Research

“So far, we’re not having any adverse reactions to report of any significance which is good news,” Koren said.

Gagan Gupta is one of the trial participants who allowed News4Jax to monitor and video record the process he went through. First, he received specific instructions about monitoring his health. Then he was required to perform a COVID-19 nasal swab test. After that, he had to take a blood test. His COVID-19 and blood tests came out fine. The next step was receiving the shot.

“Hopefully I don’t get the placebo and have immunization. The reason I decided to take part in this is because just like everyone else, I’m ready for this whole thing to be over,” Gupta said.

It’s unknown if he received the actual vaccine or was only given a placebo.

Koren said if trial participants are presented an opportunity to receive the Pfizer or Moderna vaccine, they will have to first consult with the clinical research center. During the consultation, they will be notified of whether they were given a placebo or the actual Novavax vaccine. Koren said this is a safety measure because as it stands right now, researchers are not sure if a person could experience adverse immune reactions after receiving two different types of COVID-19 vaccinations. So, as a precaution, if a trial participant did receive the actual Novavax vaccine, consultation at the research center will determine if receiving the Moderna or Pfizer vaccine is safe or even necessary.

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