Bellaire - Meyerland - West U Edition | May 2020

O N E S T E P A T A T I M E The National School of Tropical Medicine at Baylor College of Medicine and the Center for Vaccine Development at Texas Children’s Hospital follow dened steps to develop a vaccine. Making a vaccine

Researchers identify a microbe’s weakness, called the antigen. Antigen discovery Process development 2 1 The antigen is cloned, and processes are developed to create quantities for testing.

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The formulated vaccine is tested in animals to determine safety, dosage and eectiveness. Preclinical testing The immune response triggered by the vaccine is analyzed to determine its type and duration. Immunology testing The vaccine is tested under approved laboratory practices to identify potential toxicities. Toxicology testing

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Dr. Maria Elena Bottazzi works on developing a SARS vaccine— work she and a research team performed between 2011 and 2016. (Courtesy Baylor College of Medicine)

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The clinical-grade antigen is combined with substances that boost immune response. Vaccine formulation

Three phases of testing on volunteers identify unforeseen eects and actual eectiveness. Human clinical trials

SOURCE: TEXAS CHILDREN’S HOSPITALCOMMUNITY IMPACT NEWSPAPER

COVID-19 patients, as of April 27. The TMC estimates 80% to 90% of COVID-19 patients in the ICU require a ventilator. In addition to the front-line response, the TMC has also exed its scientic muscles, quickly ramping up research on a vaccine and treat- ment for the viral disease, while one engineering group with Rice Univer- sity has a potential solution for venti- lator shortages. Vaccines Finding a long-term vaccine against the virus that causes COVID-19 has remained a focus for research teams at the TMC, including both Baylor College of Medicine’s National School of Tropical Medicine and the Center for Vaccine Development at Texas Children’s Hospital. It is one of three Houston-area eorts and 96 total vac- cine candidates worldwide as of April 27, according to the Milken Institute, a California-based economic think tank. Co-led by Dr. Maria Elena Bottazzi and Dr. Peter Hotez, the research team is drawing from experience gained between 2011-16 in developing a vaccine for the coronavirus strain that causes SARS, or severe acute respiratory syndrome. That work has provided the team with time-saving, parallel and rapid-switch strategies as well as critical scientic informa- tion that may help accelerate the

development of a safe and eective COVID-19 vaccine. However, there is a risk for research teams using such methods to speed up development, Bottazzi said. “Because when you have time to look at the data and study it and inter- pret itwith time, you can look at things with a dierent set of eyes rather than trying to rush things,” Bottazzi said. “Again, we’re not doing business as usual, so a lot of things may be done with a little bit higher level of risk ... with as much scientic evidence that justies such a decision.” The COVID-19 vaccine being devel- oped by the research team is based on a fragment of a viral protein called the receptor binding domain, which is part of the spike protein the coronavi- rus uses to attach to and infect cells. Preclinical testing has been com- pleted for the SARS vaccine, and researchers are able to develop both vaccines in parallel, with a slightly adjusted time frame for COVID-19. “If all goes well, we estimate that we may have a COVID-19 vaccine can- didate ready for Phase 1 human clin- ical trials in a year from now, which is when we predict the safety trial for the SARS vaccine still will be run- ning,” Bottazzi said. Baylor College of Medicine is one of many institutions developing vac- cines both locally and worldwide. The Woodlands-based VGXI Inc., a plasmid DNA manufacturer,

announced April 6 it had completed the manufacturing process for its COVID-19 vaccine and had begun clinical trials for 40 volunteers, with results expected late summer. VGXI is working with Houston Methodist’s RNA therapeutics research program. Treatment Eorts out of the TMC are being made to nd treatment options for COVID-19 in two distinct ways: clini- cal trials for antiviral medication and experiments with blood plasma trans- fusions from COVID-19 survivors into critically ill patients. Baylor College of Medicine began enrolling participants in a treatment trial for adult patients with a COVID-19 diagnosis hospitalized at either Bay- lor St. Luke’s Medical Center or Harris Health System’s Ben Taub Hospital. The study will evaluate the safety and eectiveness of new therapeutic agents, the rst of which is the experi- mental antiviral drug remdesivir. The drug is a nucleotide analog designed to insert into the RNA of the virus and eectively kill it, according to the drug’s developer, Gilead Sci- ences Inc. The experimental treatment will initially be compared to a placebo, and researchers will monitor results to determine if the treatment is eec- tive and safe or if other treatments should be added. If a particular therapy shows positive results, the

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In late February, when conversa- tions about COVID-19 began in the morning huddles Molly Cook partic- ipated in with her emergency room unit at Houston Methodist Hospital, preparation for an increase in cases was the topic of discussion. “We’re anticipating this is going to happen, here’s what we have from the hospital, here’s how much [per- sonal protective equipment] we have, backup available, we’re going to look at processes this way,” Cook recalled from the conversations. When the outbreak began taking its toll on Houston, confusion and uncertainty from hospital sta began to take hold, especially on equipment shortages, Cook said. “The shortage is very real,” Cook said. “Anxiety, specically around a personal protective equipment short- age, is very real.” As of April 27, over 2,000 patients had been hospitalized for COVID-19 across nine counties in the Greater Houston area in hospitals across the Texas Medical Center’s member insti- tutions, according to TMC data span- ning St. Luke’s, Harris Health System, Houston Methodist, MD Anderson Cancer Center, Memorial Hermann and Texas Children’s Hospital. Of the medical center’s intensive care unit capacity of 1,462 beds, 900 were occupied, 259 of those by

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