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COVID-19 Vaccine Tested at Texas Biomed Gains FDA Emergency Use Authorization

Novavax expands global options for prevention of disease and severe outcomes

SAN ANTONIO (July 28, 2022) – The Food and Drug Administration has authorized the Novavax COVID-19 Vaccine, Adjuvanted for those 18 and older. Extensive preclinical testing done at Texas Biomedical Research Institute supported development of this protein-based vaccine.

The emergency use authorization significantly expands the COVID-19 vaccine options available to U.S. residents.

“We continue celebrating science as the hero of this ongoing pandemic, and this is something we have been working on with Novavax since the beginning,” says Texas Biomed President/CEO  Larry Schlesinger, MD. “This means that yet another vaccine is now available as an option that meets very high safety and efficacy standards.”

Dr. Ricardo Carrion, Jr.
Dr. Ricardo Carrion, Jr.

Ricardo Carrion, Jr., PhD, a professor of Disease Intervention and Prevention, and his team at Texas Biomed collaborated with Novavax and published findings last year demonstrating vaccine efficacy in the journal Cell Reports Medicine.

“This vaccine uses more traditional technology compared to the mRNA vaccines we have been using against COVID-19 – such as the Pfizer-BioNTech and Moderna vaccines,” Dr. Carrion says. “It’s protein-based and there’s hope that it will appeal better to those who may have been hesitant regarding mRNA technology. It is clear that vaccines continue to be critical in preventing severe disease and remain important weapons in the ongoing pandemic.”

Although mRNA vaccines have been newly available to the public to combat the ongoing pandemic, they have been studied for decades and have been deemed safe and effective under the same regulatory standards for other vaccines in the United States.

The Novavax shot differs in that –  instead of injecting the genetic recipe for the spike protein into cells, which then the body’s own cells can use to make the spike protein, as mRNA vaccines do – it actually injects the spike protein itself, inducing an immune response. This is similar to the way widely used vaccines for tetanus or diphtheria toxoid vaccines work, for example.

FDA provided emergency use authorization for Novavax’s two-dose vaccine series to those 18 and older. It does not cover the use of the Novavax vaccine as a booster shot, which the agency will evaluate separately.

Maximum Containment Contract Research (MCCR) group at Texas Biomed
The Maximum Containment Contract Research (MCCR) group at Texas Biomed, led by Dr. Ricardo Carrion, Jr. (front row, far right), conducted preclinical trials for Novavax’s COVID-19 vaccine.

Dr. Carrion said the vaccine is an important tool to continue fighting the virus.

“What we’re seeing is incredible ingenuity continue to come together at a critical time in the fight against COVID-19,” he says. “We are proud to have provided support that ultimately helped widen the options for those seeking vaccination.”

Novavax COVID-19 vaccine
The Novavax COVID-19 vaccine is protein-based, offering another style of vaccine to help protect people from the coronavirus.

Experiments done at Texas Biomed provided early insight into the strength of immune response – known as immunogenicity – and protective efficacy of the Novavax vaccine. Continued work is important as variants continue to emerge and the landscape continues to change.

Dr. Gale Smith, Senior Vice President of Discovery and Chief Scientist at Novavax, praised Texas Biomed for its work throughout the development process:

“From the beginning of the pandemic and now by meeting future challenges in the face of an ever-changing threat, the team at Texas Biomed has been incredibly supportive, working with us to better understand the safety and potential of our protein-based vaccine. Novavax cannot thank everyone there enough!”

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ABOUT TEXAS BIOMED

Texas Biomed is one of the world’s leading independent biomedical research institutions dedicated to eradicating infection and advancing health worldwide through innovative biomedical research. Texas Biomed partners with researchers and institutions around the world to develop vaccines and therapeutics against viral pathogens causing AIDS, hepatitis, hemorrhagic fever, tuberculosis and parasitic diseases responsible for malaria and schistosomiasis disease. The Institute has programs in host-pathogen interaction, disease intervention and prevention, and population health to understand the links between infectious diseases and other diseases such as aging, cardiovascular disease, diabetes and obesity. For more information on Texas Biomed, go to www.TxBiomed.org.