Separate research projects at Texas Children’s Hospital and Baylor College of Medicine seek to control COVID-19 by creating a new vaccine and by testing different vaccines and treatments developed by others.
In late December 2021, Texas Children’s and Baylor announced that their jointly developed vaccine technology, Corbevax™, had received Emergency Use Authorization for use in India.
In two Phase III clinical trials with more than 3,000 participants in India, Corbevax™ was found to be effective in preventing symptomatic infections. It was safe and well tolerated.
A team of researchers at Texas Children’s Center for Vaccine Development — co-directed by Peter Hotez, MD, PhD, Dean of the National School of Tropical Medicine at Baylor; and Maria Elena Bottazzi, PhD, Associate Dean of the school — developed the Corbevax™ technology. Both Dr. Hotez and Dr. Bottazzi are Professors of Pediatrics and Molecular Virology & Microbiology at Baylor.
Toward halting the pandemic
“This is the first COVID-19 vaccine specifically designed for production and use in low- and middle-income countries,” Dr. Hotez said. “It is an important first step in vaccinating the world and halting the pandemic.”
By reducing the vast numbers of unvaccinated people in developing countries, the vaccine is expected to contribute toward limiting the emergence of future COVID-19 variants.
The work is so important that Dr. Hotez and Dr. Bottazzi both received Nobel Peace Prize nominations.
Peter Hotez, MD, PhD, and Maria Elena Bottazzi, PhD, lead the research team that developed a COVID-19 vaccine for production and use in low- and middle-income countries. By April 2022, the vaccine reached 20 million children in India.Low cost, familiar technology
Patent-free and fully explained in multiple scientific publications, Corbevax™ can be produced for less than $2 per dose. It is highly stable and requires only simple refrigeration. Unlike vaccines using the newer mRNA technology, Corbevax™ production uses a traditional protein-based technology with proven safety records. This technology has been used widely in many countries to make other vaccines.
“Because of the fact that it uses the same technology as the hepatitis B vaccine, which has been given to kids safely for decades, we think this will be one of the best safety profile vaccines and ideally suited for global health,” Dr. Hotez said.
Biological E Limited (BioE), a vaccine and pharmaceutical company in India, licensed the COVID-19 vaccine technology that led to Corbevax™ from BCM Ventures, Baylor’s commercialization team. By February 2022, the vaccine received additional authorization in India for those between the ages of 12 and 17 and was endorsed for pregnant women.
The Baylor-Texas Children’s team also collaborates with other vaccine companies to develop their COVID-19 vaccine technology and build production capabilities including: BioFarma in Indonesia, Incepta in Bangladesh and ImmunityBio in the U.S., which in turn has partnered with Botswana.
“Texas Children’s has collaborated with the government of Botswana for years,” Dr. Bottazzi said. “It fits well not only to produce our vaccine there, but also to continue helping to build a stronger medical and scientific infrastructure.”
Clinical trials continue to test other COVID-19 vaccines and treatments for children in the United States and other countries. In spite of vaccine hesitancy among some people in the U.S., parents have been eager to enroll their children in clinical trials at Texas Children’s.
“I’ve been doing vaccine research for over 20 years, and I can recall the only other time when there was such enthusiasm for children to be in a clinical trial at Texas Children’s and Baylor during the influenza pandemic in 2009. Now with the threat of COVID-19, from the moment we began the study, we have had a lot of parents who want to have their children enrolled,” said Flor Muñoz, MD, MSc, Associate Professor of Pediatrics-Infectious Disease and Molecular Virology & Microbiology at Baylor. She is principal investigator for the Texas Children’s site.
More than 300 children are participating in Texas Children’s clinical trial, which is one of about 100 sites worldwide for the Pfizer-BioNTech vaccine study. In April 2021, trial researchers began testing children from 6 months to 11 years old in the Phase I study searching for the optimal dose for their age — which is the dose that produces enough antibodies to protect them from COVID-19 with minimal reactions such as fever, irritability, muscle aches or fatigue.
Their findings led to Emergency Use Authorization of the Pfizer vaccine for children 5 to 11 years of age in November 2021.
“All the study participants in the 5- to 11-year-old age group now are fully vaccinated, and continue in the study, so we can follow them for safety and to ensure the vaccine continues to work over time,” Dr. Muñoz said.
Ongoing trials will evaluate the vaccine in children younger than 5 and determine whether 5- to 11-year-old children should receive boosters.
Vaccine for immunocompromised children
Dr. Muñoz is principal investigator at the Texas Children’s site for another national Pfizer vaccine trial for immunocompromised children from 6 months to 17 years of age. Most of the participants at Texas Children’s are solid organ transplant recipients. Other conditions requiring medications that weaken the immune system include bone marrow transplantation, and systemic inflammatory or auto-immune conditions such as lupus, juvenile arthritis and inflammatory bowel disease.
“Because of their weaker immune systems, these patients are less able to fight infections and are more at risk of COVID-19 than other children. This study is evaluating a three-dose series of the COVID-19 vaccine because we know these patients will need additional doses to develop an adequate response and protection,” Dr. Muñoz said.
Effects of maternal immunization
Funded by the National Institutes of Health, a study called MOMI-VAX is evaluating the immune response to different COVID-19 vaccines given to women who are pregnant or have recently delivered a baby. Dr. Muñoz, who is principal investigator for this national project, initially proposed the research protocol.
COVID-19 during pregnancy puts women at greater risk for hospitalization, admission to the intensive care unit, use of mechanical ventilation and death. It also may cause complications for the infant, such as preterm birth.
Patients at Texas Children’s Pavilion for Women who received the Pfizer, Moderna or Johnson & Johnson vaccine while pregnant are eligible to participate. The study researchers will follow these mothers and babies through the first year after delivery to gather and analyze specific information for each vaccine, including:
Treatment studies
The antiviral Remdesivir is the first drug approved by the FDA for treatment of COVID-19 in hospitalized patients 12 and older. Dr. Muñoz is principal investigator for the Texas Children’s site testing Remdesivir in children younger than 12, including newborns. The study is sponsored by Gilead, the drug’s manufacturer. Results of the study will help support the licensure of this antiviral treatment in young children.
As that study concludes, Dr. Muñoz hopes to begin a clinical trial for a monoclonal antibody that has shown activity against the COVID-19 Omicron variant.
“The monoclonal antibody already is authorized under Emergency Use for children 12 and older, but not for those who are younger. I’m going to try to bring a clinical trial to Texas Children’s so that we can offer it, especially for high-risk children with immune compromise or cancer,” Dr. Muñoz said.
As clinical studies of antivirals, vaccines and other therapeutic options for pediatric patients become available, Dr. Muñoz and her team will continue to work to bring such trials to Texas Children’s Hospital and give children and their families the option to receive preventive vaccines and treatments against COVID-19.
Texas Children’s well-established Center for Vaccine Development, and the large population of children and mothers receiving care in the Texas Children’s network, make it an ideal location for derailing COVID-19.