Washington, D.C.—Congressman Henry Cuellar (TX-28), along with Members of the Asian, Black, Hispanic, and Native American Congressional caucuses, participated in a meeting with Dr. Francis Collins and Dr. Anthony Fauci to discuss ways to increase the number of diverse participants at each of the COVID-19 clinical trial sites. 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.

“Hispanic populations have long been underrepresented in medical research despite being disproportionately affected by many of the studied disease, including the COVID-19,” said Congressman Cuellar. “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.” 

“As we continue to combat the COVID-19 pandemic, we know from history that we cannot get this wrong. I am committed to working with the National Institute of Health to ensure the future vaccine is affordable and accessible in all communities. I want to thank Dr. Fauci and Dr. Collins for taking the time to meet with us as well as working to ensure that Hispanic populations are represented in this vital work.”

Congressman Asks First Questions During Meeting with NIH

During the meeting, Congressman Cuellar asked Dr. Anthony Fauci and Dr. Collins the first two questions. Congressman Cuellar asked how Moderna is considering the possible effects of the vaccine of Hispanic populations, who have higher rates of diabetes, hypertension, and heart disease. The Congressman also asked how NIH will ensure an equitable distribution of the vaccine when it becomes readily available.

Pictured above is Congressman Cuellar asking Dr. Collins and Dr. Fauci first questions during meeting.

To watch Congressman Cuellar ask Dr. Facui and Dr. Collin the two questions, click here.

Moderna’s Clinical Trial Sites in South Texas 

The NIH knows that the vaccine’s effectiveness in at-risk populations can only be assured by a diverse participant pool in clinical trials. The NIH is seeking collaboration from Congressman Cuellar and other Members of Congress in encouraging local participation to ensure the volunteer pool is as diverse as possible. To see a map of the Moderna site coverage, click here.

The companies that will be conducting the COVID-19 vaccine trials in South Texas include:

• Laguna Clinical Research Associates in Laredo
•  Centex Studies, Inc. in McAllen
• Clinical Trials of Texas in San Antonio

Adults who are interested in joining this study can visit:  

• Coronavirus Prevention Network
• Clinical Trials

Participating in a COVID-19 Vaccine Trial will entail the following:

• Volunteers must provide informed consent to participate in the trial.
• Trial volunteers will receive two intramuscular injections approximately 28 days apart.
• Participants will be asked to provide a nasopharyngeal swab and a blood sample at an initial screening visit.
• 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

Federal Government Involvement with COVID-19 Vaccine

Congressman Cuellar helped direct nearly $10 billion to vaccine and treatment development by passing the Coronavirus Aid, Relief, and Economic Security (CARES) Act and other supplemental funding.

The federal government has taken several steps to facilitate the development of COVID-19 vaccines. In April 2020, the NIH announced the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership to help coordinate research strategies through collaborations with government agencies, academic, nonprofit organizations, and biopharmaceutical companies. In May 2020, the Administration announced the Operation Warp Speed initiative, a national program to accelerate the develop, manufacturing, and distribution of COVID-19 countermeasures, including vaccines.

To help accelerate the development of COVID-19 vaccines, Operation Warp Speed originally selected 14 vaccine candidates to receive government support with the goal of having three to five candidates launch large-scale randomized trials. The federal government is assuming financial risk by investing in manufacturing capacity while selected vaccine candidates are still in development, rather than scaling up after approval or authorization.

Companies Developing COVID-19 Vaccine

As of July 15, 2020, at least 140 COVID-19 vaccine candidates are in preclinical evaluation and at least 23 candidates are in clinical evaluation worldwide. Currently there are five companies involved with Operation Warp Speed with the goal of developing a COVID-19 vaccine for the U.S. by early 2021 including:

• AstraZeneca,
• Johnson & Johnson,

• Merck
• Moderna
• Pfizer

Moderna’s COVID-19 Vaccine

Moderna is a clinical stage biotechnology company based in Cambridge, Massachusetts, working on messenger RNA (mRNA) therapeutics and vaccines, including the first COVID-19 vaccine candidate to enter clinical trials in the United States. Through Operation Warp Speed, Moderna was awarded $483 million in April and another $53 million in May to accelerate development of and increase manufacturing capacity for the company’s vaccine candidate.

Phase 1 trials for Moderna’s COVID-19 vaccine candidate were announced on March 2020 and were conducted by NIH. The results of Moderna’s Phase 1 trials were published in the New England Journal of Medicine on July 14. The study enrolled 45 healthy volunteers ages 18 to 55, testing three dose levels of Moderna’s vaccine. The trial participants were split roughly 50-50 between men and women. The population was 89% white, 13% Hispanic, 4% Black, 2% Asian, and 2% Native American.

Moderna intends to begin a Phase 3 trial consisting of approximately 30,000 participants in July, in collaboration with NIH. Moderna expects to supply between 500 million and one billion doses of its vaccine per year, beginning in 2021.

The Vaccine Development Process

As the number of confirmed COVID-19 cases and deaths increase, there is a strong need for developing a COVID-19 vaccine to help stop the spread of COVID-19 and prevent future outbreaks. As of July 22, there are more than 3.8 million reported COVID-19 cases and 140,630 COVID-19 related deaths in the United Sates.  The National Institute of Allergy and Infectious Diseases (NIAID) and the biological company Moderna, Inc. initiated clinical trials in March 2020 for a potential vaccine in the United States at a hospital in Seattle.

Vaccines are developed to prevent diseases and generally work by introducing pathogens to the body to trigger an immune response to the disease. To be approved for use in the United States, the Food and Drug Administration (FDA) must determine that a vaccine is safe and effective, based on data from laboratory studies and clinical trials. In certain emergency situations, FDA may issue an emergency use authorization (EUA) for a vaccine before it is approved if several legal requirements are met, including a determination that a vaccine “may be effective” in preventing the disease and that its known and potential benefits outweigh known and potential risks.

Clinical trials intended to demonstrate a potential vaccine’s safety or effectiveness for purposes of FDA approval generally proceed in three successive phases. Currently Moderna’s COVID-19 vaccine is in phase three of clinical trials, which individuals in Laredo, the Rio Grande Valley, and San Antonio will participate in.

•  Phase I: small groups of people receive the trial vaccine.
•  Phase II: the clinical study is expanded, and vaccine is given to people who have characteristics (such as age and physical health) similar to those for whom the new vaccine is intended.
•  Phase III: the vaccine is given to thousands of people and tested for efficacy and safety.
•  Phase IV: many vaccines undergo a fourth state. Formal, ongoing studies after the vaccine is approved and licensed.

To see a graphic that explains how a new vaccine is developed, approved, and manufactured, click here.

Timeline of Vaccine Development

Before a new vaccine is ever given to people, extensive lab testing is done that can take several years. Once testing in people begins, it can take several more years before clinical studies are complete and the vaccine is licensed. The clinical vaccine development process typically takes ten to 15 years to complete. Studies have found that only six percent of vaccine candidates in pre-clinical development reach the market historically, and that approximately 33 percent of infectious-disease vaccines in clinical trials ultimately secure approval.