UNCP Professor Practices What She Teaches, Joins COVID Clinical Trial

Dr. Maria Santisteban
Dr. Maria Santisteban

The COVID-19 pandemic has cost the lives of more than half a million Americans, millions more have become ill, some with long-lasting symptoms, and society has been turned on its heels. Despite it all, some Americans are either reluctant or outright opposed to receiving the new vaccines, approved for emergency use, that have been rolling out since December. But Dr. Maria Santisteban, a UNCP microbiologist is so convinced that the new vaccines are safe and effective, that she volunteered to participate in a COVID vaccination trial. 

After hearing of a new trial on December 28, Dr. Santisteban decided to do some background checking. The American company Novavax (headquartered in Maryland) was launching the trial, and it was recruiting participants from certain risk groups, including Hispanics. Dr. Santisteban, who is a native of Spain, decided to volunteer. She explained, “I teach microbiology, and I tell my students that vaccines make our lives better and they work, and it’s only through experimentation like these trials that we can find out if the work, so I volunteer.”

Dr. Santisteban further explained that as a microbiology professor she teaches her students how vaccines have transformed society, allowing people to live. Because of polio vaccines, polio has been eradicated almost globally. Smallpox has been eradicated. “We hear some people saying that they won’t take the vaccine because they fear to feel a bit unwell after it. Well, dying from COVID is much more uncomfortable. It is a horrible death. People can’t breathe. It is true that people report fatigue, headache and chills after the second shot of the Moderna and Pfizer vaccines, but that may just be a positive sign.” The Zoe Covid Symptom Study, which collected feedback from 280,000 people, found that women, younger people and people who have had COVID were more likely to report side effects after receiving COVID vaccinations. Those side effects are actually indicators that the immune system is working.

She said the new vaccines cannot give you COVID. “You will not be injected with anything that can give you COVID-19. These are subunit vaccines; you either get mRNA, DNA or protein from the SARS-CoV-2 virus, but you don’t get any complete viral particles that could give you COVID. Also, to those who may believe in conspiracy theories or ‘science fiction scenarios’ where their genetic material would be changed by the vaccine, I want to say that is a myth. It is simply not possible for the vaccine to change your genetic material. The RNA from the vaccine can’t get into the nucleus of the cells where the DNA is, and so it cannot affect it or interact with it in any way. Even if remotely this was a possibility, the RNA could not be converted into DNA; the vaccine does not come with the reverse transcriptase needed for that, and our cells simply do not have it. And even if those two impossible scenarios happened, the DNA made from the viral RNA would have to insert itself into the genome, which is, again, not possible without the right enzyme.  In summary, SARS-CoV-2 is not a retrovirus, the spike protein is not a complete virus, and the mRNA in the vaccine cannot change your genetic code.”

Some people are afraid of getting sick from the vaccines, but other people have already been tested with these vaccines. Indeed, clinical trials like the one in which Dr. Santisteban is participating, demonstrate vaccine safety and efficacy. She explained that she has volunteered for Novavax’ phase 3 trial (called PREVENT-19), which has been designed to test the safety and efficacy of the company’s vaccine candidate NVX-CoV2373, and earlier trials have tested the vaccine’s safety. The phase 3 trials include 30,000 participants in the United States and Mexico, 15,000 participants in the United Kingdom (UK), and 4400 participants in South Africa.

Novavax published interim data in late January 2021 that showed 89% vaccine efficacy on a phase 3 trial started last summer in the UK.  Among trial participants who contracted COVID, half of them had contracted the UK variant of the disease. A trial launched in South Africa showed a 60% efficacy, and among those participants who had contracted COVID, 93% had contracted the South African variant; Novavax enrolled participants in their trials who already had COVID. Dr. Santisteban pointed out that vaccines that have already been rolled out for emergency use, such as the Pfizer vaccine, have not undergone testing for efficacy against the new COVID variants. 

Dr. Santisteban chose to use a clinical trial site in Fayetteville, which is one of several sites in North Carolina that are also running trials for the Moderna and the Johnson & Johnson vaccines. Before her first appointment date, however, a member of her family tested positive for COVID, which delayed Dr. Santisteban’s initial appointment until January 18. Her initial visit included blood work and a questionnaire, and she was sent home with a kit by which she monitors her temperature daily and completes a questionnaire about symptoms. She has already received the required two shots, which were separated by three weeks, but she experienced no side effects, aside from a sore arm after the second shot.  She laughed and said, “maybe they just put saline in my arm.”  

Two-thirds of the Novavax trial participants received the vaccine and one-third received a placebo. She returned to the clinical trial site on day 35 and is scheduled to return after three months, six months, one year and after two years. Novavax plans to do a crossover injection study, if results look promising, whereby participants will receive two more shots. Participants who received the placebo initially will receive the vaccine and vice versa. The company may apply for emergency use authorization from the Food and Drug Administration (FDA) to roll out its COVID vaccine.

According to Dr. Santisteban, the Novavax vaccine is quite different from Pfizer, Moderna, Johnson & Johnson and AstraZeneca vaccines, which work by tricking cells in the human body into making viral protein. These vaccines are formulated in one of two ways. They contain either another virus that has been modified with the gene for making viral “spike” protein from SARS-CoV-2, or they contain mRNA molecules that enter human cells and cause them to produce the spike protein. It is this spike protein that causes the body to launch an immune response that protects against the COVID virus. The Novavax vaccine, however, uses nanoparticle technology, and the spike protein is first produced inside insect cells. Afterward, nanoparticles of spike protein are attached to a carrier substance, which is injected into people. The human body recognizes the protein as being foreign, and so the immune system makes antibodies to the virus. The Novavax vaccine also has an adjuvant that boosts the immune system. Unlike other COVID vaccines, the Novavax vaccine does not require freezing, but it does take longer to manufacture. 

Fortunately, if Dr. Santisteban received only placebo instead of COVID vaccines, she will be able to receive Novavax vaccine in the near future.  Indeed, when she discusses vaccinations and the COVID pandemic while in the college classroom, she can now add her personal testimony that new vaccines are grounded in solid science and that they undergo rigorous testing for safety and efficacy before they ever reach the general public. 

Dr. Santisteban offered this final insight.  “For the reasons we talked about, I would say to people, get the vaccine. If you don’t do it for yourself, do it for someone else.  A year ago today (March 30, 2020), during the first wave of the pandemic in Spain, when the ICUs were saturated and, in some cases, doctors were forced to triage, my sister’s father-in-law died, alone. One less person bound for the ICU (you) is one more bed/tank of oxygen for someone who can’t/didn’t get the vaccine.” 

COVID Vaccination information for North Carolinians

If you are not already registered to take COVID vaccinations, please visit North Carolina’s website to Find Your Spot to Take Your Shot

The UNC Pembroke campus will begin vaccinating students on campus beginning April 1st.  The University just released this information:

“In collaboration with the UNC System Office, NCDHHS and Optum Serve, beginning today, UNCP students can now receive the J&J/Janssen one-shot vaccine on campus. This opportunity is open to all faculty, staff and students, and appointments are still available! 

Appointments are required for vaccinations. You can register for an appointment now by calling 877.505.6723 or visiting myoptumserve.com/covid19.

All vaccine clinics will be held in the Auxiliary Gym…. available appointment times are listed at the registration link above.

Safe, effective vaccines, along with mask-wearing and social distancing, is our best protection against the spread of COVID and can help us return to normal as quickly as possible. We encourage you to learn more about the safety and efficacy of COVID vaccines and make an informed decision about which vaccine is right for you by reading more about the different vaccines available

Students, faculty and staff also have the option of getting their COVID vaccine at any off-campus provider. To find an alternate convenient vaccine location near you, visit myspot.nc.gov.“

Dr. Maria Santisteban mentors undergraduate researchers in molecular genetics research, investigating the role of histones in eukaryotic gene regulation. She teaches undergraduate courses in cell biology, genetics, genomics, and molecular biology, and she engages her students in Course-based Undergraduate Research Experiences (CUREs) by way of the Genomics Education Partnership.  She is the co-director of the NSF-funded COMPASS Scholarship Program, which prepares UNCP students to enter the STEM workforce and graduate programs.