IMPORTANT UPDATES

Children’s and Emory have participated in trials that have led to the authorization of COVID-19 vaccinations for more children.

Evan Anderson, MD, Pediatric Infectious Disease Physician at Children’s and Professor with the Emory Department of Pediatrics, has from the beginning advocated for COVID-19 vaccine trials in children. He is serving as Principal Investigator of the Moderna and Pfizer-BioNTech trials for children at the Emory-Children’s Center (ECC), which has enrolled more than 250 children. Data from these studies has contributed to the FDA’s decision to grant emergency use authorization for vaccinations in children as young as age 5 (Pfizer-BioNTech) and young adults as young as age 18 (Moderna). Already, more than 2.8 million children have been vaccinated in the U.S.

According to Dr. Anderson, the work of his team has helped “make it possible for children to receive the same type of immune protection now provided to adults.” The Pfizer and Moderna trials continue to produce critical data, and Dr. Anderson and his team have also participated in Johnson & Johnson and Novavax studies.

Vaccines are proving to be effective at preventing COVID-19. But research at Children’s and Emory is also making an impact on the lives of those who contract the virus.

Drug discovery expert and Professor of Pediatrics at Emory, Raymond F. Schinazi, PhD, DSc, has served as lead virologist for a major COVID-19 treatment discovery. Baricitinib – an anti-inflammatory drug and JAK inhibitor originally developed for treating rheumatoid arthritis – has now been tested in several clinical trials in adults with severe COVID-19. The results have been encouraging, as patients who received baricitinib were 46% less likely to die from the virus, and the drug has been authorized for solo use for hospitalized patients needing supplemental oxygen, ventilation or life support.

Clinical trials for its application in Atlanta were led by Vincent Marconi, MD, Professor of Medicine and Global Health at Emory. He and Dr. Schinazi have previous experience studying a similar drug for HIV patients, working with Christina Gavegnano, PhD, Assistant Professor in the Department of Pathology and Laboratory Medicine at Emory.

As new COVID-19 variants emerge, researchers at Children’s and Emory’s are hard at work determining if – and how – they will respond to the vaccines already developed.

A report published in the New England Journal of Medicine by Mehul Suthar, PhD, Assistant Professor of Pediatrics at Emory, indicates antibodies induced by mRNA vaccines are less effective in neutralizing the Delta and Kappa variants of COVID-19. Using lab assays with live SARS-CoV-2 virus, Dr. Suthar and his team found that vaccine-induced antibodies are 2.9 times less able to neutralize Delta and 6.8 times less able to neutralize Kappa. However, they reported the antibodies will be strong enough in many people and protective immunity is “most likely retained” against Delta and Kappa.

For the study, the research team obtained blood samples from 24 people who had recovered from COVID-19 in 2020, 15 people who had received the mRNA-1273 Moderna vaccine and 10 people who had received the Pfizer–BioNTech vaccine.

One wouldn’t think that research into children with traumatic brain injury (TBI) would be useful in studying COVID-19. But an unexpected discovery was made in the Children’s and Emory pediatric neurotrauma lab, led by Andrew Reisner, MD, Medical Director of Neurotrauma and Pediatric Neurosurgeon for Children’s.

The team discovered a molecular indicator, or biomarker, for COVID-19 and MIS-C severity while studying the same marker in children with TBI. The lab noticed similarities between the inflammatory responses of TBI and the virus and analyzed whether the plasma osteopontin biomarker could also identify those children with COVID-19. And, indeed, it could as levels of the biomarker were correlated with clinical data and were significantly elevated in children with moderate and severe COVID-19 and MIS-C compared to mild or asymptomatic children.

Findings were published in the peer-reviewed journal, Experimental Biology and Medicine, with collaboration from Neuropsychologist Laura Blackwell, PhD, and Stacy Heilman, PhD, Iqbal Sayeed with the Pediatric Neurotrauma Lab, and Children’s Infectious Disease Physicians Evan Anderson, MD, Andi Shane, MD, and Christina Rostad, MD. While larger follow-up trials are needed to determine the specificity and predictability of this marker for widespread clinical use, it is stable, easily accessible through a blood test, and can be quickly and affordably measured at the point of care. Plasma osteopontin therefore has the potential to scale up and inform the prognosis of anyone with COVID-19.

Participating in the National Institute of Health’s (NIH) Rapid Acceleration of Diagnostics (RADx) program is one of the most significant COVID-19 contributions undertaken by our investigators to date.

The research was initially funded by a $31 million grant, the largest singular NIH award in the history of research at Children’s or Emory, and additional NIH grants, which catapulted the entire research program to No. 1 in NIH funding for pediatric departments in 2020.*

Led by Wilbur Lam, MD, PhD, the RADx program in Atlanta has contributed to the FDA, NIH and White House recommending and fast-tracking COVID-19 diagnostic tests, making them readily available in stores nationwide since soon after the pandemic began. As one of only five RADx sites in the nation and the only pediatric site, Atlanta is now also evaluating new variants of the virus, developing a pediatric self-administering protocol, and continuing to assess tests with a new focus on scaling at-home diagnostics to market. Dr. Lam and his RADx team encapsulate the unique opportunity available in Atlanta with a laboratory at Georgia Tech, tenured professorship at Emory and patients at Children’s.

“The synergy between the three institutions allows me and my team to do what we do,” said Dr. Lam, who sees patients at Children’s while serving as a professor at Emory University and the Georgia Institute of Technology, where his lab is located.

Timeline of some RADx Atlanta highlights from the year:

  • January: Children’s appointment-only RADx collection site reaches 10,000 specimens.
  • February: The first at-home, non-prescription, over-the-counter, self-administered COVID-19 diagnostic evaluated by RADx Atlanta is made available to the public nine months after the study launched.
  • May: Dr. Lam is selected as the 2021 Health Care Heroes Award recipient in the Health Care Innovator/Researcher category from the Atlanta Business Chronicle. He commented: “We answered the challenge for the country, and today you can go to retail outlets and buy tests.”
  • August: At-home tests with a 90% accuracy rate for positive cases recommended to the FDA by RADx Atlanta are in high demand as the Delta variant spreads.
  • October: The Atlanta RADx site is chosen to continue participating in diagnostic evaluations. The NIH invests $70 million to boost the supply of at-home tests by accelerating test developers’ progress through the regulatory authorization process.
  • November: The RADx Atlanta team has enrolled 5,000 children into the research protocol, making it one of our largest pediatric clinical studies to date.

“In my journey as a researcher and clinician, I have met very few people who understand the intersection of engineering and medicine the way Wilbur does,” said Doug Graham, MD, PhD, Chief of Aflac Cancer and Blood Disorders Center. “It’s in his DNA.”

*According to rankings from the Blue Ridge Institute for Medical Research published Feb. 11, 2021.

The earlier autism can be detected in children, the sooner they can begin treatment.

And autism researcher Gordon Ramsay, PhD, Director of the Spoken Communication Laboratory at Marcus Autism Center at Children’s, is exploring novel ways to make early detection happen through the use of wearable sensors on babies.

Voice recorders track the sounds that babies make in their first three years of life to help his team determine if certain vocalizations may be an early indicator of autism spectrum disorder. The recorder is light and portable, weighs only two ounces and is tucked into the baby’s clothing. Parents turn on the recorder when the baby wakes up in the morning, put it inside the pocket of the onesie, and leave it running all day.

To date, the team has tracked vocalizations from 450 babies, capturing 6,000 days and more than 60,000 hours of their early speech. Using this method, the team discovered boys produce significantly more protophones, the precursors to speech, including vowel-like sounds, squeals and growls, than girls, and this difference was even more pronounced in infants at high risk for autism. Thus, their findings, published in Current Biology, may lead to a vocal biomarker for autism in the early stages of development, hopefully encouraging parents to seek treatment sooner.

Also, the study is an exemplary model of how to acquire data from a distance, which enabled the research to proceed during the pandemic. Dr. Ramsay and his team send out and receive the recorders using standard mail service, and all data was collected in a pandemic-friendly, remote manner.