One of the first physician/investigators to distribute the Novavax vaccine in the recently launched Phase 3 clinical trial was showcased via Utah’s KUTV recently as the Novavax clinical trial commences in Utah now via Velocity Clinical Research. Dr. Jeffrey Adelglass heads Research Your Health in Plano Texas and was interviewed recently by the media out of the Intermountain West’s capital. With Moderna and Pfizer/BioNTech mRNA-based vaccines approved on an emergency basis, why is it important to continue the vaccine studies going? Well, for a number of reasons. First and foremost, those previous vaccines are only approved on an emergency basis. They are not fully approved by the U.S. Food and Drug Administration (FDA) and a number of competitive investigational options is a good thing in such a pandemic as COVID-19. Novavax introduces a different kind of vaccine than the existing two recently cleared for emergency use. While the other vaccines introduced into the human body the genetic code to trigger protein production in response, the Novavax vaccine actually delivers the spike protein directly into the body. Dr. Adelglass explains the Novavax vaccine is “…bioengineered and that makes a big difference. There’s no mRNA or DNA from the exact virus.” Moreover, unlike the mRNA-based vaccines that require extremely cold temperatures. the Novavax vaccine only needs normal refrigeration which can make a big difference especially in rural areas or in developing nations. In the meantime, Utah’s Bob Tackleberry signed up as a participant in the Novavax vaccine via the Velocity Clinical Research trial site organization, now in the state viathe acquisiton of Advanced Clinical Research. Mr. Tackleberry, a ride-share driver and retail worker, forcefully summarized why he will participate in the study: “I felt that there was a personal and moral responsibility to make a difference and everything.”
COVID-19 in Utah
The beautiful state of Utah, home to the corporate headquarters of TrialSite News LLC and about 3.2 million people, hasn’t been spared by COVID-19, especially in this second wave with a total of 281,654 cases reported across the state along with 1,294 deaths. In the first report in 2021, a total of 5,042 cases were reported. With a rolling seven-day average of positive cases now at 2,506, this equates to approximately 27.4% of those tested. Local media reports although the Holiday surge has been the worse of the pandemic thus far, the number of infections appears to be easing but risks are still extraordinarily high.
Intermountain Healthcare, the regions largest healthcare provider, thus far has vaccinated about 20,000 health system caregivers and medical staff members; their vaccine inventory (Pfizer) remains at about 11,000.
The capacity crisis eased a bit as total as compared to mid-December which equaled a crisis condition as 99.4% of hospital beds were taken (534 out of 537 beds). Although there is now slight capacity, the conditions are still quite dangerous.
JPEO-CBRND-funded Study Comes to Utah
The Novavax study, backed by heavy federal defense-based hitters—the Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in collaboration with the Office of the Assistant Secretary of Defense for Health Affairs (OASD(HA)) and the Defense Health Agency—in total has received about $1.6 billion in total in association with the U.S. federal government’s Operation Warp Speed. Recently, TrialSite reported that prominent DoD medical centers were added to the Phase 3 clinical trial. Now the study is led by the Advanced Clinical Research team, a network of research centers located around the Western United States. For more on Advanced Clinical Research, see their website.
What is the Vaccine Candidate?
Called NVK-CoV-2373, this vaccine candidate represents a more traditional vaccine type, similar to the type targeting influenza. A protein-based vaccine candidate engineered from the generic sequence of SARS-CoV-2, the virus that causes COVID-19 disease, the product was developed using the sponsor’s recombinant nanoparticle technology to generate antigen from the coronavirus spike (S) protein adjuvanted with the sponsor’s patented saponin-based Matrix-M to enhance the immune response and stimulate high levels of neutralizing antibodies. The investigational product contains purified protein antigen and doesn’t replicate nor cause COVID-19.
Profiled recently by KUTV’s Kelly Vaughen, Dr. Jeffrey Adelglass, CEO and Medical Director of Plano, Texas-based Research Your Health, also participates in this pivotal Phase 3 clinical trial. Dr. Adelglass is on the record that this potential vaccine has a number of positive attributes making it a real contender in the competitive race of top vaccines for consideration. The Phase 3 clinical trial (NCT04611802) involves 30,000 participants so time will tell based on the data.
Lead Research/investigator in Utah