Infectious Disease News Briefs: January 25, 2024

COVID-19 Vaccine Receives WHO Approval

The World Health Organization has approved the Biological E's CORBEVAX, a traditional, recombinant protein-based COVID-19 vaccine under the Emergency Use Listing (EUL). The vaccine is developed and commercialized by Biological E Limited, an established global vaccine supplier based in Hyderabad, India, and over 100 million doses of CORBEVAX have been administered to people in India so far.¹

According to the announcement, the Texas Children's Hospital Center for Vaccine Development and BCM Ventures, Baylor College of Medicine's integrated commercialization arm, licensed the recombinant Pichia pastoris yeast strain that expresses the RBD protein of SARS-CoV-2 to Biological E Limited in 2020. Biological E subsequently developed large scale manufacturing technology for production of the RBD protein complying with Good Manufacturing Practices (GMP) as well as testing and characterization suitable for use as vaccine antigen. The RBD protein was then used as an antigen and formulated with optimized adjuvants (Alum and CpG1018) to develop a COVID-19 candidate vaccine.

"Achieving approval under WHO's EUL procedure represents an important step toward our goal of helping development of low-cost vaccines for the world's most vulnerable populations," said Peter Hotez, MD, PhD, codirector of the Center for Vaccine Development at Texas Children's Hospital and Dean of the National School of Tropical Medicine at Baylor College of Medicine. "Countries around the world will rely on the WHO's EUL to CORBEVAX and Biological E's established manufacturing and supply capacity to provide safe, effective inoculation against COVID-19."

Public Health Organization Awards $1.29 Million to Address HAIs and AMR

Healthcare-associated infections (HAIs) and antimicrobial resistance continue to be public health challenges. This week a national public health organization announced funding to go towards these 2 problems.

The National Association of County and City Health Officials (NACCHO), with the support of the CDC’s Division of Healthcare Quality Promotion, has announced the awards for $1.29 million in funding to go towards the organization’s Building Up Infection Prevention and Control in Local Departments in Healthcare-Associated Infections and Antimicrobial Resistance (BUILD HAIAR) project. These funds will support the 17 selected local health departments to leverage the CDC (Interim) Local Health Department Strategy for HAI/AR. The purpose of this strategy is to strengthen capacity to improve healthcare infection prevention and response efforts, including those for COVID-19 and other healthcare-associated infections (HAIs), as well as those infections caused by antimicrobial resistance (AR) pathogens.²

The selected local health departments will conduct infection control assessments, strengthen antimicrobial stewardship efforts, and build strategic approaches to HAI/AR, including addressing health equity. They will also coordinate with stakeholders at the local and state levels to advance these efforts.²

The 17 selected local health department participants are:

• Central District Health Department, NE ($80,000)
• Columbus Public Health, OH ($70,000)
• County of Peoria Health Department, IL ($60,000)
• County of San Diego Public Health, CA ($80,000)
• Dent County Health Center, MO ($80,000)
• Florida Department of Health in Polk County, FL ($80,000)
• Lubbock Public Health, TX ($80,000)
• Monongalia County Health Department, WV ($80,000)
• San Antonio Metropolitan Health District, TX ($80,000)
• Alexandria Health Department, VA ($60,000)
• Cincinnati Health Department, OH ($79,336.29)
• DuPage County Health Department, IL ($80,000)
• Farmington Valley Health District, CT ($80,000)
• Hennepin County Public Health, MN ($72,040.42)
• Long Beach Department of Health and Human Services, CA ($80,000)
• Stark County Health District, OH ($80,000)
• West Hartford-Bloomfield Health District, CT ($70,000)

Collaboration to Advance HIV Vaccine Candidate Towards Phase I Trial

This week, multiple organizations announced a collaboration to develop an HIV vaccine. Specifically, the ReiThera Srl, the Ragon Institute of Mass General, MIT, and Harvard, and IAVI are planning to develop a novel HIV vaccine candidate that will be composed of ReiThera’s GRAd vector and HIV T-cell epitopes identified by the Ragon Institute. This project will be funded by the Bill & Melinda Gates Foundation.³

Each partner will be responsible for a different aspect of the program:

• ReiThera will perform vector engineering and generation, process development, and good manufacturing practice(GMP) manufacture and release for the clinical use of GRAd-HIV vaccine.
• The Ragon Institute will lead GRAd-HIV preclinical development.
• IAVI will be the sponsor and execute a Phase I clinical trial to evaluate the safety and immunogenicity of the GRAd-HIV vaccine candidate.

ReiThera’s vaccine platform uses a novel proprietary replication-defective Gorilla adenoviral (GRAd) vector, belonging to species C adenoviruses that are considered among the most potent vaccine carriers for the induction of CD8 T-cell responses to the encoded antigens and having a low seroprevalence in humans.

“IAVI’s Product Development Center [PDC] is so pleased to be able to partner with ReiThera and the Ragon Institute to advance the clinical testing of the GRAd-HIV vaccine candidate through a phase 1 clinical trial,” Sangeetha Sagar, IAVI’s vice president of Product Development, said in a statement. “The PDC’s purpose is to advance promising biomedical innovations across the global health field by supporting clinical testing and product development, and we are excited to have the opportunity to support this new approach to HIV vaccine development.”

References

1.CORBEVAX, a COVID-19 Vaccine Developed by BIO E-India Based on the RBD Protein Antigen Technology From Texas Children’s Hospital Center for Vaccine Development, Receives World Health Organization Emergency Use Listing Approval. PRNewswire. January 22, 2024. Accessed January 25, 2024. https://www.prnewswire.com/news-releases/corbevax-a-covid19-vaccine-developed-by-bio-e-india-based-on-the-rbd-protein-antigen-technology-from-texas-childrens-hospital-center-for-vaccine-development-receives-world-health-organization-emergency-use-listing-approval-302040935.html

2. NACCHO Awards $1.29 Million to Address Healthcare-Associated Infections and Antimicrobial Resistance Prevention and Response. NACCHO press release. January 25, 2024. Accessed January 25, 2024. https://www.naccho.org/blog/articles/naccho-awards-1-29-million-to-address-healthcare-associated-infections-and-antimicrobial-resistance-prevention-and-response

3. ReiThera Srl, the Ragon Institute and IAVI announce collaboration to advance highly networked T-cell HIV vaccine candidate towards Phase I clinical evaluation. IAVI press release. January 22, 2024. Accessed January 25, 2024.
https://www.iavi.org/press-release/reithera-srl-the-ragon-institute-and-iavi-announce-collaboration-to-advance-highly-networked-t-cell-hiv-vaccine-candidate-towards-phase-i-clinical-evaluation/