A University of Nebraska Medical Center infectious disease specialist, José Romero, M.D., has been appointed to the United States Food and Drug Administration’s Vaccines & Related Biological Products Advisory Committee. Dr. Romero, whose appointment began Oct. 31, will serve in the role for three years.
The 13-member committee, which is responsible for evaluating new vaccines and biologicals, reviews the safety and effectiveness information then votes for approval. The committee works under the auspices of the FDA’s Center for Biologics Evaluation and Research, which regulates vaccine products.
Products licensed and regulated by the FDA such as vaccines, undergo a rigorous review of laboratory and clinical data to ensure product safety, effectiveness, purity and potency. Vaccines already on the market also may be required to undergo additional studies for further evaluation of safety, effectiveness, or possible side effects.
“It’s quite an honor to be selected,” said Dr. Romero, who is a UNMC professor of pediatrics and director of section of pediatric infectious diseases. “I’ve been scrutinized and my qualifications evaluated very carefully. The committee contributes to the health of the nation. It’s an important task, one that continues to ensure the safety of vaccines. This also falls under the public health aspect of my career.”
Current members of the committee include experts from Johns Hopkins University, Columbia University, Emory University and Baylor University.
Dr. Romero is well-versed in vaccine and pharmaceutical research. At UNMC, he led multi-center pediatric clinical trials for numerous vaccines, including FluMist, which ultimately was FDA approved for use in children age 2 and up. He also did research with pediatric vaccines for hepatitis A, chickenpox and measles, mumps and rubella.
He has presented many papers and made presentations nationally and internationally, and has published hundreds of articles and book chapters.
“Dr. Romero has been a leader in studying vaccines and in helping communities raise their immunization rates,” said Bruce Buehler, M.D., chairman of the UNMC Department of Pediatrics. “His passion for all children and their health is why he has been appointed to this prestigious board.”
Dr. Romero is board-certified in pediatrics and pediatric infectious diseases. He holds numerous memberships in national and local professional organizations, including the American Academy of Pediatrics, American Board of Pediatrics, the American Society for Microbiology and the Association for Minority Academic Physicians. He is a lifetime member of the Society for the Advancement of Chicanos and Native Americans in Science.
Dr. Romero has received numerous academic awards, including induction into the Alpha Omega Alpha National Honor Society 2003; Best Doctors in America Award 2001-2005; the Dr. Stephen A. Chartrand Memorial Award for Outstanding Faculty Creighton-Nebraska Universities Joint Pediatric Residency Program 2002; Outstanding Faculty Teaching Award, Departments of Pediatrics Joint Residency Program, Nebraska/Creighton Universities Health Foundation 1995.
He is medical advisor to the Douglas County Health Department, as well as medical consultant to the Tuberculosis Control Program of the Nebraska Department of Health and Human Services System.
UNMC is the only public health science center in the state. Its educational programs are responsible for training more health professionals practicing in Nebraska than any other institution. Through their commitment to education, research, patient care and outreach, UNMC and its hospital partner, The Nebraska Medical Center, have established themselves as one of the country’s leading centers in cancer, transplantation biology, bioterrorism preparedness, neurodegenerative diseases, cardiovascular diseases, genetics, biomedical technology and ophthalmology. UNMC’s research funding from external sources now exceeds $80 million annually and has resulted in the creation of more than 2,400 highly skilled jobs in the state. UNMC’s physician practice group, UNMC Physicians, includes 513 physicians in 50 specialties and subspecialties who practice primarily in The Nebraska Medical Center. For more information, go to UNMC’s Web site at www.unmc.edu.