Proteins in saliva could aid in COVID-19 detection and predict severe illness

Reprinted with permission from the American Physiological Society.

Researchers have identified a family of proteins that is significantly elevated in the saliva of patients hospitalized with COVID-19. The proteins, known as ephrin ligands, could potentially serve as a biomarker to help doctors identify patients who are at risk for serious illness.

“Ephrins are detectable in saliva samples and could serve as adjunct markers to monitor COVID-19 disease progression,” said study author Erika Egal, DVM, PhD, a postdoctoral fellow in the laboratory of Patrice Mimche, PhD, in the Department of Pathology at University of Utah Health in Salt Lake City. “We can collect saliva without harm or discomfort for most patients, which can reveal patient responses to COVID-19 and potentially guide care.”

Egal presented the findings at the American Physiological Society annual meeting during the Experimental Biology (EB) 2022 meeting, held in Philadelphia April 2–5.

For the study, researchers analyzed saliva samples collected from patients admitted to the University of Utah Hospital emergency department with respiratory symptoms. Sixty-seven of the patients tested positive for COVID-19 while 64 patients did not. They found that the presence of ephrin ligands in saliva was strongly associated with the diagnosis of severe COVID-19.

Researchers said the study findings could help shed light on the biological processes involved in severe reactions to COVID-19 infection. Previous studies suggest ephrins play a role in injury and inflammation. The scientists say more research is needed to determine whether ephrin concentrations are linked with a higher likelihood of hospitalization, critical illness or death. In addition, as new viral variants emerge, it can be difficult to tell whether existing COVID-19 tests are able to accurately detect infections involving new variants. Looking for ephrins in saliva could offer a simple, non-invasive way to provide corroborating evidence when there is inconsistency between test results and the clinical picture, Egal said.

“Saliva is packed with information beyond detecting the COVID-19 infection itself,” said Mimche. “We demonstrate that immune cells, cytokines and soluble proteins can be reliably measured from saliva samples. Our findings provide a starting point for investigations looking into causal pathways between infection and bad medical outcomes.”

The research was overseen by Mimche in collaboration with Theodore Liou, MD and My N. Helms, PhD, from the Department of Internal Medicine at University of Utah Health, as part of a multidisciplinary project to better understand the biology of SARS-CoV-2 and how it causes serious COVID-19 infections.

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About Experimental Biology 2022

Experimental Biology (EB) is the annual meeting of five scientific societies bringing together thousands of scientists and 25 guest societies in one interdisciplinary community. With a mission to share the newest research findings shaping clinical advances, EB offers an unparalleled opportunity to tap into the latest research in anatomy, biochemistry, molecular biology, investigative pathology, pharmacology and physiology. The Experimental Biology 2022 meeting will be held April 2–5 at the Pennsylvania Convention Center in Philadelphia. www.experimentalbiology.org #expbio

About the American Physiological Society (APS)

Physiology is a broad area of scientific inquiry that focuses on how molecules, cells, tissues and organs function in health and disease. The American Physiological Society connects a global, multidisciplinary community of more than 10,000 biomedical scientists and educators as part of its mission to advance scientific discovery, understand life and improve health. The Society drives collaboration and spotlights scientific discoveries through its 16 scholarly journals and programming that support researchers and educators in their work. http://www.physiology.org

Convalescent plasma could lower hospitalization risk for newly infected COVID-19 patients

Early treatment of newly diagnosed COVID-19 patients with plasma extracted from individuals who have recovered from the disease reduces the need for hospitalization by more than 50%, according to a new nationwide clinical trial.

The researchers, including scientists at University of Utah Health, say the study provides solid evidence that the use of plasma from convalescent patients—containing high levels of antibodies against SARS-CoV-2, the virus that causes COVID-19—should be part of the treatment arsenal for the disease and other emerging viral threats to global health.

The study, led by scientists at Johns Hopkins University School of Medicine in Baltimore, appears in the April 6, 2022 issue of the New England Journal of Medicine.

During the outpatient study, conducted between June 2020 and October 2021, the researchers randomly treated 1,181 patients with either plasma containing SARS-CoV-2 antibodies taken from individuals who had recovered from the disease or a placebo plasma that contained no SARS-CoV-2 antibodies. Patients were aged 18 or older and had tested positive for SARS-CoV-2 in the previous eight days.

Emily Spivak, associate professor of medicine in the Division of Infectious Diseases at U of U Health

Of the 592 patients who received convalescent plasma, only 17 (2.9%) required hospitalization within 28 days of transfusion. In contrast, 37 of 589 patients (6.3%) who were given the placebo plasma were hospitalized within a month. Overall, the findings translated into a 54% reduction in the relative risk of hospitalization for those who received convalescent plasma.

The researchers conclude that convalescent plasma is a viable early treatment for COVID-19 that has the advantages of being low-cost and widely available, particularly in countries with little or no access to vaccines and other treatments such as monoclonal antibodies. Since each person who recovers from a variant of COVID-19 produces antibodies that subdue that specific virus, convalescent plasma treatment can potentially keep new strains of SARS-CoV-2 in check.

“In theory, if you collect plasma from donors who have recovered from omicron or another new variant, they will likely have plenty of antibodies for that variant,” says Emily Spivak, a co-author of the study and an associate professor of medicine in the Division of Infectious Diseases at U of U Health. “As a result, convalescent plasma is theoretically more adaptable and may deal with new variants faster than other treatments currently available.”

The study, “Randomized Controlled Trial of Early Outpatient COVID-19 Treatment with High-Titer Convalescent Plasma,” appears in the April 6, 2022, issue of the New England Journal of Medicine. It was supported by the U.S. Department of Defense’s (DOD) Joint  Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO- CBRND), in collaboration with the Defense Health Agency (DHA). Additional support was provided by Bloomberg Philanthropies, State of Maryland, the National Institutes of Health (NIH) National Institute of Allergy and Infectious Diseases (NIAID), NIH National Center for Advancing Translational Sciences (NCATS), Division of Intramural Research NIAID NIH, Mental Wellness Foundation, Moriah Fund, Octapharma, HealthNetwork Foundation and the Shear Family Foundation.

University of Utah Health provides leading-edge and compassionate care for a referral area that encompasses 10% of the U.S., including Idaho, Wyoming, Montana and much of Nevada. A hub for health sciences research and education in the region, U of U Health touts a $428 million research enterprise and trains the majority of Utah’s physicians, including more than 1,460 health care providers each year at its Colleges of Health, Nursing and Pharmacy and Schools of Dentistry and Medicine. With more than 20,000 employees, the system includes 11 community clinics and five hospitals. For 11 straight years, U of U Health has ranked among the top 10 U.S. academic medical centers in the rigorous Vizient Quality and Accountability Study.

Can salivary glands infected with COVID-19 increase risk for relapse or reinfection?

University of Utah Health scientists are leading an effort to determine if salivary glands infected with the virus that causes COVID-19 could diminish a person’s long-term immunity to the disease after being immunized or after recovering from the illness.

The investigation, supported by a two-year grant from the National Institutes of Health, will explore whether salivary glands that have SARS-CoV-2 can lessen the body’s ability to make antibodies that would protect it against reinfection by the virus.

A graphic drawing of a person with inflamed salivary glands injected with viruses.

A person with viral inflammation of the salivary glands. Vector illustration of sialolithiasis. Photo credit: Getty Images

Viruses like SARS-CoV-2 are commonly found in salivary glands. How SARS-CoV-2 gets there, though, is still a mystery. Typically, viruses can enter the salivary glands through the moist inner lining of the oral cavity, called mucosa, or travel there via the bloodstream, says Melodie Weller, Ph.D., an assistant professor of dentistry who is leading the new study.

Like some other parts of the body, the salivary glands have what is known as “immune privilege,” meaning that even though they are infected, the immune system may not effectively clear pathogens within the glands. As a result, the salivary glands can be a lingering repository for viruses such as SARS-CoV-2 and other viruses.

Proteins that we are exposed to in our digestive tract can trigger what is called “oral tolerance.” As a result, our immune system won’t produce antibodies to these proteins, such as those in the foods that we eat, Weller says. However, because viruses contain proteins, they too may be overlooked by the immune system in the gastrointestinal tract.

“If viral proteins are released into the saliva––and we swallow a lot of saliva every day––then they may have the capacity to decrease our ability to make antibodies,” Weller says. “That can have an impact on how long immunity will last. So, the better we can understand the role of SARS-CoV-2 in the salivary glands, the better we’ll understand how reinfection and breakthrough infections after immunization are occurring during this pandemic.”

The researchers suspect that SARS-CoV-2 released from the salivary glands may inhibit the production of antibodies—and, as a result, increase the risk of relapse or reinfection. They also could limit the long-term effectiveness of vaccines.

Weller and colleagues are testing this hypothesis in mice, expressing SARS-CoV-2 viral proteins in the salivary glands. They plan to vaccinate these animals to see how they respond.

“If they’re getting viral protein exposure in the gut through swallowing saliva, then we will likely see a decrease in immunity or a decrease in the duration of the immune response,” Weller says.

mRNA vaccines slash risk of COVID-19 infection by 91 percent

People who receive mRNA COVID-19 vaccines are up to 91 percent less likely to develop the disease than those who are unvaccinated, according to a new nationwide study of eight sites, including Salt Lake City. For those few vaccinated people who do still get an infection, or “breakthrough” cases, the study suggests that vaccines reduce the severity of COVID-19 symptoms and shorten its duration.

Researchers say these results are among the first to show that mRNA vaccination benefits even those individuals who experience breakthrough infections.

“One of the unique things about this study is that it measured the secondary benefits of the vaccine,” says Sarang Yoon, D.O., a study co-author, assistant professor at the University of Utah Rocky Mountain Center for Occupational and Environmental Health (RMCOEH), and principal investigator of the RECOVER (Research on the Epidemiology of SARS-CoV-2 in Essential Response Personnel) study in Utah.

The study, published online in the New England Journal of Medicine, builds on preliminary data released by the Centers for Disease Control and Prevention (CDC)in March.

The study was designed to measure the risks and rates of infection among those on the front lines of the pandemic.

“We gave these vaccines to some of the highest risk groups in this country—doctors, nurses, and first responders,” Yoon says. “These are the people who are getting exposure to the virus day in and day out, and the vaccine protected them against getting the disease. Those who unfortunately got COVID-19 despite being vaccinated were still better off than those who didn’t.”

Sarang Yoon, D.O., assistant professor at the University of Utah Rocky Mountain Center for Occupational and Environmental Health.

The study found that mRNA COVID-19 vaccines were:

  • 91% effective in reducing risk for infection once participants were “fully” vaccinated, two weeks after the second dose.
  • 81% effective in reducing risk for infection after “partial” vaccination, two weeks after the first dose but before the second dose was given.

The HEROES-RECOVER network recruited 3,975 participants at eight sites. In addition to Salt Lake City, sites included Miami, Florida; Temple, Texas; Portland, Oregon; Duluth, Minnesota; and Phoenix and Tucson, as well as other areas in Arizona. Participants submitted samples for COVID-19 testing on a weekly basis for 17 weeks between Dec. 13, 2020 and April 10, 2021. Participants also reported weekly whether they had COVID-19-like symptoms, including fever, shortness of breath, and loss of taste and smell.

Only 204 (5%) of the participants eventually tested positive for SARS-CoV-2, the virus that causes COVID-19. Of these, 156 were unvaccinated, 32 had an indeterminate vaccine status, and 16 were fully or partially vaccinated. The fully or partially vaccinated participants who developed breakthrough had milder symptoms than those who were unvaccinated:

  • Presence of fever was reduced 58% percent among those vaccinated with a breakthrough infection.
  • Days spent sick in bed were reduced by 60% among those who developed a breakthrough infection.
  • Detection of the virus was reduced by 70% percent among those with breakthrough infections, from 8.9 days to 2.7 days.
  • The three people who were hospitalized were not immunized, meaning that no one who developed a breakthrough infection was hospitalized.

These findings also suggest that fully or partially vaccinated individuals who get COVID-19 might be less likely to spread the virus to others. The researchers found that infected study participants who had been fully or partially vaccinated when infected had 40% less detectable virus in the nose and did so for six fewer days compared to those who were unvaccinated.

Overall, the researchers conclude the study’s findings support the CDC’s recommendation to get fully vaccinated as soon as possible.

“I hope these findings reassure the public that mRNA COVID-19 vaccines are safe and protect us from this severe disease,” Yoon says.

The RECOVER study is ongoing, and results from future phases will help determine how long COVID-19 vaccines protect against infection and the real-world effectiveness of newer vaccines. A new study will test the same questions in children 12 and older who are now eligible to receive the COVID-19 vaccination. The research will also investigate how well COVID-19 vaccines protect against new variants now circulating in the U.S., including the highly transmissible Delta variant of SARS-CoV-2.

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The study, “Prevention and Attenuation of Covid-19 with the BNT162b2 and mRNA-1273 Vaccines,” appears in the New England Journal of Medicine.

In addition to Dr. Yoon, Kurt Hegmann, M.D., director of RMCOEH, Matthew Thiese, Ph.D., associate professor, and Andrew Phillips, M.D., assistant professor of RMCOEH, were co-investigators on the Utah portion of the study.

COVID-19 vaccine effectiveness dips, but remains potent deterrent

COVID-19 vaccines remain effective, but their potency has diminished in recent months, according to a nationwide study at eight sites, including Salt Lake City, Utah.

Scientists calculated vaccine effectiveness to be 80% in a large group of fully vaccinated frontline workers between December 2020 and August 2021, compared to 91% in earlier surveys. The estimates were based on COVID-19 RT-PCR testing and did not measure whether there were changes in efficacy in protecting against severe disease, including hospitalization and death.

The authors say one reason for the change could be waning immunity, a decrease in the strength over time of the body’s vaccine-activated defenses against the virus. The difference may also reflect the fact that the vaccines are not as effective against the highly contagious Delta variant of the SARS-CoV-2 virus, which since June 2021, has become the most common cause of COVID-19 in the U.S.

“The vaccines are still helping save lives and keep people from getting sick despite a slight diminishing return over many months,” explains Matthew Thiese, Ph.D., associate professor at the University of Utah Rocky Mountain Center for Occupational and Environmental Health (RMCOEH). “These data, combined with other data, demonstrate that vaccinated people are much less likely to get COVID-19 and are much less likely to be hospitalized.” Thiese is co-investigator and RMCOEH assistant professor Sarang Yoon, D.O., is primary investigator of the HEROES-RECOVER (Research on the Epidemiology of SARS-CoV-2 in Essential Response Personnel) study site in Utah.

The study published on August 24 in the Morbidity Mortality Weekly Report (MMWR) from the Centers for Disease Control and Prevention (CDC). Additional study sites in the HEROES-RECOVER network are Phoenix, Tucson, and other areas in Arizona; Miami, Florida; Portland, Oregon; Duluth, Minnesota; and Temple, Texas.

The network followed 4,136 health care personnel, first responders, and essential workers who had not previously had COVID-19. Study participants submitted samples for RT-PCR testing on a weekly basis and 2,976 participants were fully vaccinated within the study period, receiving either the Pfizer-BioNtech (65%), Moderna (33%), or Johnson & Johnson (2%) vaccines. Test results from these groups between December 14, 2020, to August 14, 2021, show that:

  • Among unvaccinated study participants, 194 infections occurred in 181,357 person-days (combined total of number of days of testing for this group).
  • Among fully vaccinated participants, 34 infections occurred in 454,832 person-days.

During that time period, the vaccines were 80% effective for all fully vaccinated study participants, but preliminary data indicate that vaccines may wane in intensity over time with lower effectiveness after five or more months following full vaccination. In addition, the vaccines appeared to be less effective during the last 43 days of the study period when Delta became the predominant virus variant. However, because sample sizes were small, these results were not statistically significant. These trends will be investigated further in future studies.

“These data show that the vaccine is still quite effective against the different strains of COVID-19, including the Delta variant,” Thiese says. “The protection people get from the vaccine is keeping people from getting COVID-19 at a ratio of 14 to 1. As these data continue to come in, they are going to help chart recommendations for masking, social distancing, and booster shots.”

Test to play and to stay

When COVID-19 cases began to rise dramatically in Utah in November 2020, schools faced a difficult choice. They could maintain normal activities, giving students valuable in-person instruction and social interaction but risking spread of COVID-19. Or they could send students home, keeping them safe from disease but putting their education, emotional health and social well-being at risk.

With a goal of preserving the best of both worlds, Utah Department of Health (UDOH) implemented two COVID-19 testing programs in collaboration with local health departments and Utah schools. These programs helped students participate in extracurricular activities and stay in school while likely reducing spread of the virus.

“For most students, being able to attend school in-person and participate in extracurricular activities is best for their learning as well as their social and emotional well-being,” says Adam Hersh, senior author on the study, professor of pediatrics at University of Utah Health, and Utah HERO investigator. Hersh collaborated with UDOH to study these testing programs. “When combined with other prevention strategies, most importantly masking, these testing strategies helped keep our schools safe and open.”

Testing allowed for the completion of 95% of more than 11,000 high school extracurricular competition events and saved an estimated 109,752 in-person instruction days for students. The results were published in the Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report (MMWR).

“Before the school year started, our school communities advocated for safe in-person education and participation in extracurricular activities,” says Kendra Babitz, COVID-19 State Testing Coordinator, UDOH. “Their dedication to maintaining optimal environments for learning and growth made these programs a success and kept kids in school.”

One COVID-19 testing program, “Test to Play”, was implemented in 66% (127 of 193) of Utah’s public high schools. In order to participate in extracurricular activities such as sports, students took part in mandatory, rapid antigen testing every 14 days.

“Test to Stay” was presented as an option when schools had outbreaks. Of the 28 high schools that reported outbreaks, 13 elected to conduct school-wide Test to Stay events. Students who tested positive were required to isolate for 10 days while students who tested negative could continue in-person learning.

Between November 30, 2020, and March 20, 2021, schools reported 165,078 tests. Among the 59,552 students tested, 1,886 (3.2%) had a positive result.

The study authors say that by identifying these positive cases, the testing programs likely helped reduce the spread of COVID-19 in schools and the community by enabling the students who tested positive to isolate while their close contacts could quarantine.

“Utah’s high school testing programs could not have been successful without the willingness, flexibility, and innovation of school staff,” said Commander William A. Lanier, lead author of the study and U.S. Public Health Service officer who was assigned to the UDOH to help with COVID-19 testing. “Their hard work helped preserve extracurricular and in-person learning opportunities for Utah students during a very challenging time.”

New partnership to develop a new ultra-fast test for COVID-19 antibodies

Find the original release online: https://pivotcenter.utah.edu/press-release/university-of-utah-arup-and-techcyte-develop-nanospot-ai-a-new-ultra-fast-test-for-covid-19-antibodies/

The University of Utah, ARUP Laboratories, and Techcyte Inc. announced today that they have formed a partnership to develop NanoSpot.AI, a less than five-minute, easy-to-administer SARS-CoV-2 antibody test. NanoSpot.AI is estimated to be significantly less expensive to manufacture than other SARS-CoV-2 antibody tests, so it has the potential to be considerably more affordable than currently available tests, making it possible to extend the test to every corner of the world.

The patent-pending NanoSpot.AI is performed on a spot of blood obtained through a finger prick. Individuals then receive their test results on their mobile phones. The test could be used around the globe to help prioritize who should receive SARS-CoV-2 vaccinations, or to easily and quickly detect whether individuals have some immunity against COVID-19 for travel or immigration purposes. Clinical studies validating NanoSpot.AI are currently underway.

A close up of two people's hands. One person is wearing white rubber gloves pricking an ungloved finger. The testing card is on the table.

The NanoSpot.AI rapid COVID-19 antibody test is performed on blood collected through a finger prick using a microcollection tube. Droplets of blood are then placed on three spots on a ready-to-use, synthetic, embossed card. One of the spots displays the test result, while the other two spots are positive and negative controls for the test.

“Other antibody tests are available and are very good, but it takes time to get test results back and they’re relatively expensive,” said Hans Haecker, MD, PhD, who codeveloped NanoSpot.AI with Vanessa Redecke, MD, PhD. Both are professors in the U Pathology Department Division of Microbiology and Immunology. “Based on what we know so far, we believe NanoSpot.AI checks all the boxes,” Haecker said. “Because it is simple, fast, and very affordable, it can be done anywhere without specialized equipment, creating the potential for us to have an impact on human health around the world.”

The partners in NanoSpot.AI created a video that explains the science behind the assay, demonstrates how the test is administered, and provides details about the AI used to analyze and confirm test results.

“As a national reference laboratory, ARUP has a wide view of laboratory diagnostics,” said Mark Astill, ARUP director of Research and Development. “The expertise and experience we bring enabled what may be the first instance of combining seemingly disparate elements to produce a rapid, economical, QR-code-curated, consistent, point-of-care result.”

All NanoSpot.AI test components are provided in a self-contained kit. The person administering the test places droplets of blood in three small spots on a ready-to-use card. One of the spots displays the test result while the other two confirm the test was properly run. Antibodies against SARS-CoV-2 are quickly apparent because the blood spot begins to separate within seconds when the test result is positive.

To ensure accurate results, the person administering the test uses a mobile phone to take a photograph of the card, which is then transmitted to Techcyte for analysis using the company’s AI-based image analysis tool. Techcyte, a U startup company, is a developer of artificial intelligence (AI)-based image analysis solutions for the diagnostics industry.

A white index-sized card with the nanospot website on the top. The center has three open circles that you smear blood on. The sides have a QRT code.

When blood spots collected for the NanoSpot.AI rapid COVID-19 antibody test are mixed with a predispensed, dried reagent on the test card, the blood spot on the circle displaying the test result shows agglutination that indicates SARS-CoV-2 antibodies are present.

Techcyte CEO Ben Cahoon said the company modified its digital diagnostics platform to work with images captured by mobile phones rather than microscopes for NanoSpot.AI.

“Our platform breaks each blood spot into thousands of features that the AI uses to statistically determine which specimens are positive for SARS-CoV-2 antibodies,” Cahoon said.

Haecker said the assay can be easily adapted to test for antibodies to SARS-CoV-2 variants as new mutations emerge. The test can be viewed as a platform because it and the AI can be developed to test for antibodies against other viruses.

“This has been an extremely effective partnership and collaboration between the U, ARUP and Techcyte, demonstrating how university technology can be fast-tracked by collaborating with the right partners,” said Aaron Duffy, technology manager at the U’s Partners for Innovation, Ventures, Outreach & Technology (PIVOT) Center. PIVOT Center, which manages the U’s innovations and drives them to market, is now seeking partners to launch Nanospot.AI.

For more information, contact Duffy at PIVOT Center (aaron.duffy@utah.edu); Astill at ARUP (astillme@aruplab.com); or Cahoon at Techcyte (ben.cahoon@techcyte.com).

About PIVOT Center 
The Partners for Innovation, Ventures, Outreach & Technology (PIVOT) Center leads the University of Utah’s centralized and integrated strategy and operation for technology commercialization, corporate engagement, and economic development. In doing so, PIVOT Center serves as a hub for the U to foster partnerships between industry, university, and government entities. The center formalizes the U’s commitment to broaden its impact on Utah’s economy by enhancing local and global collaborations to catalyze innovation. The center’s mission is to generate economic returns for the university and the state of Utah, expand the university’s reputation for innovation, and positively impact society. The University of Utah was recently ranked second among large research universities for “innovation productivity impact.” 

About ARUP Laboratories
Founded in 1984, ARUP Laboratories is a leading national reference laboratory and a wholly-owned nonprofit enterprise of the University of Utah and its Department of Pathology. ARUP offers more than 3,000 tests and test combinations, ranging from routine screening tests to esoteric molecular and genetic assays. ARUP serves clients across the United States, including many of the nation’s top university teaching hospitals and children’s hospitals, as well as multihospital groups, major commercial laboratories, group purchasing organizations, military and other government facilities, and major clinics. In addition, ARUP is a worldwide leader in innovative laboratory research and development, led by the efforts of the ARUP Institute for Clinical and Experimental Pathology®. ARUP is ISO 15189 CAP accredited.

About Techcyte
Headquartered in Orem, Utah, Techcyte Inc. is the world leader in AI-based digital diagnostics for liquids and cells. Techcyte’s use of deep machine learning to perform automated analysis of both cellphone and microscopy images is revolutionizing human, animal and environmental diagnostics.

COVID-19 vaccines as effective in real-world settings as in clinical trials

mRNA COVID-19 vaccines offer substantial protection from infection by the novel coronavirus, SARS-CoV-2, in the “real-world”, concludes a large study carried out at six regions across the U.S. including Salt Lake City, Utah. The performance of the vaccines was consistent with their performance in closely controlled clinical trials that led to their approval for emergency use.

The results are particularly noteworthy considering that participants in the study were amongst those at highest-risk for being exposed to the virus, the researchers say. These included health care workers, first responders and essential workers who routinely come in close contact with the public as a routine part of their job.

“There are usually differences in how well interventions perform in clinical trials as compared to real-world settings,” explains Sarang Yoon, assistant professor at the University of Utah Rocky Mountain Center for Occupational and Environmental Health (RMCOEH) and principal investigator of the RECOVER (Research on the Epidemiology of SARS-CoV-2 in Essential Response Personnel) study in Utah. In this case, the results support a large body of evidence, from clinical trials and other research, showing that COVID-19 vaccines are very safe and effective.

“This research is showing how well these vaccines work,” says Yoon.

Headshot of Sarang Yang.

Sarang Yoon, assistant professor at the University of Utah Rocky Mountain Center for Occupational and Environmental Health and principal investigator of the RECOVER (Research on the Epidemiology of SARS-CoV-2 in Essential Response Personnel) study in Utah.

The study published on March 29 in the Morbidity Mortality Weekly Report (MMWR) from the Centers for Disease Control and Prevention. Kurt Hegmann, director of RMCOEH, Matthew Thiese, associate professor and Andrew Phillips, assistant professor of RMCOEH were co-investigators on the Utah study. Additional study sites that are part of the HEROES-RECOVER network are Phoenix and Tucson, Arizona; Portland, Oregon; Duluth, Minnesota; and Temple, Texas.

The study showed the mRNA COVID-19 vaccines were:

  • 90% effective at reducing risk for infection once participants were “fully” vaccinated, two weeks after the second dose.
  • 80% effective at reducing risk for infection after “partial” vaccination, two weeks after the first dose (before the second dose was given).

Among those fully vaccinated, there were only 3 infections among 2,479 workers and no severe COVID-19 infections or deaths in people who were vaccinated. This is much lower when compared to the period when participants were not immunized, 161 infections were identified.

The authors note that even though the vaccines were highly effective after one dose, it is not known how long that immunity lasts. The CDC recommends two doses of the Pfizer-BioNTech and Moderna vaccines.

3,950 study participants submitted samples for COVID-19 tests on a weekly basis for 13 weeks between December 14, 2020 to March 13, 2021. During that time, 2,479 participants have been fully vaccinated, receiving two doses of either the Pfizer-BioNTech or Moderna mRNA COVID-19 vaccine. In addition to submitting samples for COVID-19 test, participants reported weekly whether they had COVID-like symptoms including fever, shortness of breath and loss of taste or smell.

Study participants were:

  • Health care workers (e.g. physicians, nurses, medical assistants),
  • First responders (e.g. firefighters, police officers, staff at correctional facilities), and
  • Frontline and essential workers (e.g. teachers, hospitality, retail, restaurants, airlines).

Results from COVID-19 tests and surveys also showed that among those who tested positive for SARS-CoV-2, 87.3% had COVID-19 symptoms and 10.7% were asymptomatic.

“We are incredibly grateful to our participants for their time and dedication to the study.” says Yoon. “With their help, we will be able to better understand COVID-19 vaccine efficacy and COVID-19 illness.”

The RECOVER study is ongoing and results from future phases will help determine how long COVID-19 vaccines protect against infection and the real-world effectiveness of newer vaccines.

The research will also investigate how well COVID-19 vaccines protect against new variants of the SARS-CoV-2 virus that are highly transmissible and are now circulating in the U.S.

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The research publishes as, “Interim Estimates of Vaccine Effectiveness of BNT162b2 and mRNA-1273 COVID-19 Vaccines in Preventing SARS-CoV-2 Infection among Healthcare Personnel, First Responders, and Other Essential and Frontline Workers – Six U.S. Region, December 2020-March 2021.”

U OF U Health research plays major role in new CDC guidelines

Research from University of Utah’s Health and Economic Recovery Outreach (HERO) Project contributed to the Centers for Disease Control and Prevention’s (CDC) revised physical distancing guidelines that reduces the space between students in classrooms from six feet to three feet.

Utah HERO partnered with Granite School District within Salt Lake County to investigate how COVID-19 spreads in elementary schools. The study found low levels of COVID-19 transmission when students and staff wore masks and followed other prevention measures, even when students were unable to be spaced six feet apart and when community infection rates were high.

The study took place in 20 elementary schools in the Granite School District and one independent school in Salt Lake City. To determine whether a positive case was acquired in school or out of school, researchers gathered detailed histories about the positive patient, and tested their initial contacts and household members. Overall, researchers found five secondary cases that were likely due to school exposure for a rate of 7 per 1,000 contacts.

“In four or five of these cases, there were obvious breakdowns in prevention strategies, including poor mask use,” says Adam Hersh, lead study investigator and professor in the Division of Pediatric Infectious Diseases at U of U Health. “This helped us understand why transmission happened in these instances.” Researchers also found in most positive cases, transmission was more likely among members of their households than between two masked students.

Although the study looked at the risk of infection from COVID-19 in one school district, researchers say the information can be related to classrooms in any part of the country if masking and other prevention measures are in place. “In-person schooling can be done safely with multi-layer, strictly enforced prevention measures,” says Andy Pavia, chief of the Division of Pediatric Infectious Diseases at U of U Health. “It enforces and reinforces the Governor’s recommendation that we should continue masking throughout all schools in Utah and provides reassurance that we know how to keep schools safe.”

The study did not look at COVID-19 transmission out of the classroom. “When masks are on, three feet of distance between students seems to be safe,” says Hersh. “However, in circumstances where masks are off, such as lunch, it’s really important to ensure there is more spacing than three feet.” At the time of the study, extracurricular school activities were limited. Researchers say COVID-19 transmission may look very different when students are playing sports and doing other activities where the environment is not as controlled.

The study validates that COVID-19 prevention measures are working and that in-person learning can be done safely under these conditions. “We hope this provides reassurance for our school communities throughout the state and for other communities throughout the county, many of which are struggling with decisions around school opening and school operations,” says Hersh.

Statement from the CDC Morbidity and Mortality Weekly Report (MMWR):

The study from Utah published in the MMWR presented findings supportive of CDC’s revised guidance allowing for three feet of distance between children in school settings. The Utah study, one of many across the nation, affirmed CDC’s recommendation that schools should return to in-person learning and that doing so can be accomplished safely for the protection of students, teachers and communities.  

“Based on available science, like the joint publication today by CDC and University of Utah, schools remain a safe place for America’s students and teachers when following CDC’s guidance,” said Victoria Chu, MD, MPH and author of MMWR article published today. “CDC remains committed to ensuring America’s children can return to in-person schooling for their well-being and development.”

University of Utah embarks on ambitious COVID-19 testing effort

The David Eccles School of Business at the University of Utah and University of Utah Health announce the start of Utah HERO (Health & Economic Recovery Outreach), a massive undertaking that will begin with the testing of 10,000 Utahns across four counties. The data gathered will inform decision-makers in the state as they work to help keep residents safe and get people back to work.

As part of Utah HERO, households in Utah, Davis, Salt Lake and Summit counties will be randomly selected for participation in the study. Random sampling is a way to accurately determine how much COVID-19 has spread in Utah without testing every person in the state.

Utah HERO team members will tag these households with a flyer or door hanger explaining the project. Field teams will then follow up with an in-person visit to gather information about those living in the residence and provide instruction on how to get tested. All those living in the residence who are 12 years and older will be asked to visit a testing site where they will receive two tests: PCR (swab test to detect the presence of coronavirus) and serology (blood draw to detect antibodies). Antibodies to the coronavirus indicate probable past infection.

“A survey of this magnitude would normally take months to organize, but we’ve been able to move things forward in a couple of weeks thanks to all of our collaborators,” said Stephen Alder, director of field operations for Utah HERO and professor in the Department of Family and Preventative Medicine. “The University of Utah is committed to serving the state during this difficult time and we hope this information will help our leaders make informed public health and business decisions.”

High levels of voluntary participation will enhance the accuracy of the study and will improve the ability to interpret results of COVID-19 testing. Testing is completely confidential and no information on immigration status will be collected.

U of U Health’s Wellness Bus and Huntsman Cancer Institute’s Cancer Screening bus—both of which have been redeployed to perform COVID-19 testing—will be set up in designated neighborhoods to serve as Utah HERO test sites. Testing will also take place at existing U of U Health evaluation tents, as well as pop-up locations at various church parking lots. Testing will be performed at ARUP Laboratories, which does all COVID-19 testing for U of U Health along with other clients in Utah and nationwide.

Utah HERO data will be used to more accurately establish the rate of infection in Utah and rates of infection in various age groups and job categories. The data are important because they will indicate where COVID-19 has spread, which occupations and other groups are most impacted and how many undetected infections are occurring. Undetected infections can occur because people have mild symptoms or no symptoms, or because of differences in testing. This can inform the safest way to relax public health restrictions and get Utah back to work.

“Utah HERO represents the critical balance between protecting public health and moving the economy forward,” said Taylor Randall, dean of the David Eccles School of Business. “This information will help us better understand how COVID-19 has spread through our community and inform business leaders on the best, data-driven ways to get people back into the workforce safely.”

The Governor’s Office of Management and Budget contracted with the U to design and implement Utah HERO. “This study is important because it is the first initiative to gain an understanding of statewide COVID-19 prevalence in Utah,” said Angela Dunn, state epidemiologist for the Utah Department of Health. “This random sampling allows us to see a representative picture of the extent to which COVID-19 has spread in our community. This will enable us to make informed decisions about how to best move forward,” she said.

Other Utah HERO collaborators include:

  • ARUP
  • Utah Department of Health
  • Salt Lake County Health Department
  • Summit County Health Department
  • Davis County Health Department
  • Utah County Health Department

Staffing for Utah HERO field teams is made possible by Hope Corps, a nonprofit organization that connects students to opportunities to serve in the state of Utah and help support the economy.

Here are a few additional details about Utah HERO:

  • The project will begin sampling small numbers of households then scale up over a period of weeks.
  • Survey participants do not pay for testing and do not need to show proof of insurance.
  • Survey participants do not need to show ID or proof of residency.
  • Those reporting symptoms will be instructed on safe practices to prevent the spread of COVID-19.
  • Those with positive test results will be notified and given instructions on how to quarantine and prevent the spread of the disease within households.
  • The Church of Jesus Christ of Latter-day Saints has generously provided parking lot space for additional testing sites.

For more information visit eccles.link/utahhero