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A Massachusetts-based biotech company is rolling out their next phase of development of a COVID-19 vaccine in south Texas.
Congressman Henry Cuellar (TX-28), announced the clinical trials from the company Moderna which is part of this phased plan to vaccinate thousands of people and test them for efficacy and safety.
Moderna announced their vaccine trial sites for the COVID-19 vaccine in many locations across the United States, including Laredo, the Rio Grande Valley and San Antonio.
Congressman Cuellar said in a Monday virtual press conference that the inclusion of testing sites in south Texas was to provide diversity in clinical trials.
“Hispanic populations have long been underrepresented in medical research despite being disproportionately affected by many of the studied diseases, including the COVID-19,” Cuellar said. “For this reason, I am working hard with the National Institute of Health and the National Institute of Allergy and Infectious Diseases to create a diverse study population of the COVID-19 vaccine to ensure all Americans benefit from the eventual treatments. The inclusion of Laredo, the Rio Grande Valley, and San Antonio in this vaccine trial will help to guarantee that treatments work for all communities in America.” The clinical trial locations include Laguna Clinical Research Associates in Laredo, Centex Studies, Inc. in McAllen and Clinical Trials of Texas in San Antonio.
Cuellar’s announcement occurred after he participated in a meeting with National Institute of Health Director Dr. Francis Collins and Dr. Anthony Fauci, a leading member of the White House Coronavirus Task Force, to discuss ways to increase the number of diverse participants at each of the COVID-19 clinical trial sites.
“One of the things we’ve said as members of congress is we understand the minority communities have been really hit by COVID-19,” Cuellar said, referencing to numerous reports and studies from the Centers for Disease Control and Prevention showing that the COVID-19 infection and death rates are higher among minorities than white people.
“We don’t want a study on just white people, we have to make sure this study is representative of the community,” Cuellar said. “Keep in mind in the Hispanic community, there are high rates of hypertension, diabetes, and other diseases. Dr. Fauci said this is why all those conditions are taken in consideration when picking this site as a clinical trial.”
Cuellar added that due to the Families First Coronavirus Response Act, any future COVID-19 vaccine must be made available to all U.S. consumers at no cost.
According to a news release, the clinical trials entail volunteers who must provide informed consent to participate in the trial to receive two intramuscular injections approximately 28 days apart.
Participants will also be asked to provide a nasal swab and a blood sample at an initial screening visit and additional blood samples will be asked at specified time points after each vaccination and over the two years following the second vaccination.
Scientists will examine blood samples in the laboratory to detect and quantify immune responses to SARS-CoV-2.
Moderna is one of five organizations developing a COVID-19 vaccine as part of the Operation Warp Speed initiative, a national program to accelerate the development, manufacturing, and distribution of COVID-19 countermeasures, including vaccines.
Through Operation Warp Speed, Moderna was awarded more than $500 million to develop a vaccine.
Phase 1 trials for Moderna’s COVID-19 vaccine began last March and were published July 14. The study enrolled 45 volunteers whose ages ranged from 18 to 55, split between men and women with 89 percent of volunteers identifying as white.
Phase 2 of the clinical trial expanded the study by giving the vaccine to people who have characteristics (such as age and physical health) similar to those for whom the new vaccine is intended according to Moderna.
Phase 3 began in July in south Texas with the intent to vaccinate thousands of people and test them.
Operation Warp Speed hopes to have a vaccine developed for the U.S. and distribute up to 1 billion doses per year by early 2021