New SARS-CoV-1 antibody available for vaccine researchers

A collaboration between PATH, Baylor College of Medicine, and the Medicines and Healthcare products Regulatory Agency (MHRA) has made a monoclonal antibody (mAb) specific for SARS-CoV-1 available to researchers globally. This mAb can support the development of vaccines for SARS-CoV-1 and its evolving variants, as well as future characterization of novel and multivalent coronavirus vaccines.

SARS-CoV-1, responsible for the 2003 SARS outbreak and a cousin of the SARS-CoV-2 virus that causes COVID-19, is a respiratory virus with a high mortality rate. There is currently no licensed vaccine to protect against the disease, despite its pandemic potential. In addition, there are limited SARS-CoV-1 specific antibodies available for vaccine development or therapeutic indications.

Through this collaboration, scientists from Baylor produced high-quality recombinant SARS-CoV-1 RBD proteins, vaccinated mice, and tested selected mAbs for their functionality. The use of various techniques to characterize the binding sites and pseudovirus neutralization helped establish a toolbox of mAbs with identified key epitopes within the RBD and discriminate vaccine antigens. Selected hybridoma cultures were shipped to PATH for further screening and down-selection, validation, scale-up production, and distribution. Manufacturers can potentially use the resulting mAb to quantify SARS-CoV-1 spike protein in complex vaccine formulations. These efforts were conducted by:

• Jeroen Pollet, Ph.D., associate professor in pediatric tropical medicine at Baylor;
• Wen-Hsiang Chen, Ph.D., associate professor in pediatric tropical medicine at Baylor;
• Uli Strych, Ph.D., associate professor in pediatric tropical medicine at Baylor and director for strategic initiatives and program development of the Texas Children's Center for Vaccine Development; and
• Maria Elena Bottazzi, Ph.D., senior associate dean of the National School of Tropical Medicine at Baylor and co-director of the Texas Children’s Center for Vaccine Development.

“Access to well-characterized reference antibodies is essential for evaluating the much-needed emerging pan-coronavirus vaccine candidates and ensuring consistent product development across laboratories," said Dr. Strych. "We are pleased that this collaboration has made this resource broadly available to support coronavirus vaccine research worldwide."

A full characterization report will be provided along with the antibody, detailing the specificity across different antigens and vaccine formats, based on data produced by Baylor and PATH.

To help ensure equitable access, the antibody generated is available for a small handling charge and the cost of shipping for use by vaccine researchers and manufacturers who are developing vaccines for use in countries with low- and middle-income economies. Providing these open resources is one component of PATH’s ongoing work with partners to advance the development of vaccines that are low-cost, broadly protective, and tailored for use in low-resource settings.

The SARS-CoV-1 antibody is available from MHRA via their online repository and distribution center. Visit www.nibsc.org or contact cidr@mhra.gov.uk.

“Making this antibody available to the global vaccine development and manufacturing community—at minimal cost for vaccines targeted toward low-resource economies—can help clear hurdles and accelerate efforts to bring a SARS-CoV-1 vaccine to market,” said Dr. Jessica White, PATH Senior Scientist, Vaccine Formulation. “Though the COVID-19 pandemic is over, coronaviruses have not gone away and this will be a helpful tool for future pandemic responses. PATH is proud to be part of this fruitful collaboration and to be supporting researchers in their work to expand coronavirus vaccine development.”

PATH, Baylor, and the MHRA previously collaborated to make SARS-CoV-2 antibodies specific to the Wuhan, Omicron, and Delta variants available to researchers.

Funding for SARS-CoV-1 antibody development was provided to PATH from the Coalition for Epidemic Preparedness Innovations.

About PATH

PATH is a global nonprofit dedicated to achieving health equity. With nearly 50 years of experience forging multisector partnerships, and with expertise in science, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales up innovative solutions to the world’s most pressing health challenges. For more information, visit www.path.org.

About Baylor College of Medicine

Baylor College of Medicine (www.bcm.edu) in Houston is recognized as a health sciences university and is known for excellence in education, research and patient care. Baylor is a top-ranked medical school and listed 23rd among all U.S. medical schools for National Institutes of Health funding. Located in the Texas Medical Center, Baylor has affiliations with seven teaching hospitals and jointly owns and operates Baylor St. Luke’s Medical Center, part of St. Luke’s Health. Currently, Baylor has more than 3,000 trainees in medical, graduate, nurse anesthesia, physician assistant, orthotics and prosthetics, genetic counseling and clinical psychology as well as residents and postdoctoral fellows.

About the MHRA

The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices, and blood components for transfusion in the UK. The MHRA is responsible for making sure these products meet set standards for safety, quality, and effectiveness. The MHRA is an Executive Agency of the Department of Health and Social Care. Learn more at www.gov.uk/mhra.

National Institute of Biological Standards and Control (NIBSC) standards, from the MHRA, are available globally to set the quality of biological medicines. The MHRA develops and produces over 90% of the World Health Organization International Standards in use around the world and supplies the healthcare sector with a variety of reagents which are used to develop, control, and calibrate biological assays. The MHRA also offers NIBSC contract and control services. www.nibsc.org.