Pharm-Olam, a global, midsized CRO offering full-service clinical development solutions for infectious diseases, vaccines, rare diseases, and oncology, is now enrolling UK volunteers into a pivotal Phase III COVID-19 vaccine study. 

The Phase III "Cov-Compare" trial (VLA2001-301) will compare Valneva's SARS-CoV-2 vaccine candidate, VLA2001, against AstraZeneca's conditionally approved vaccine, Vaxzevria [1], in a comparative immunogenicity trial. There will be roughly 4,000 participants. 

Pharm-Olam is the full-service provider for this study. It has a strong history of drug development related to medical countermeasures. Pharm-Olam holds memberships in the Medical CBRN Defense Consortium and has augmented the infectious disease prevention and therapeutic efforts of several governmental entities, including BARDA, the Centers for Disease Control and Prevention, National Institutes of Health, and the Department of Defense. 

Kelly Garner, Senior Project Manager said: "It is an incredible opportunity and privilege to have a leading role with Pharm-Olam, supporting Valneva with their VLA2001 COVID-19 vaccine candidate, of which the UK Government have secured 100 million doses. We have been able to successfully achieve the study milestones for Phase 1/2 and 3 of the VLA2001 program. It gives me a great sense of pride to be successfully contributing towards overcoming the global pandemic on behalf of Pharm-Olam, in strong collaboration with Valneva."

Maria-Cruz Morillo, Director, Project Management said: "In my role of oversight of the Valneva program, I am proud to be part of a team working together to meet extremely tight timelines with a high level of quality and commitment to deliver quality results."

Dr. Robert J. Davie, Chief Executive Officer said: "Pharm-Olam is delighted to partner with Valneva in their on-going clinical development programme for the tremendously important SARS-CoV-2 vaccine candidate, VLA2001. Our Clinical Team, together with our investigative sites throughout the UK, are fully committed to the delivery of the Cov-Compare trial and we look forward to having played our part in overcoming COVID-19 and the challenges it has caused around the world."

[1] Approved by MHRA under reg. 174 and by the European Commission as conditional approval

ABOUT PHARM-OLAM LLC

Pharm-Olam is a global clinical research organization that delivers right-sized trial services to pharmaceutical, biotechnology, government, and public health organizations around the world. They specialize in small molecule therapies and biologics in infectious disease, and vaccines oncology-hematology, rare disease, allergy, autoimmune, infectious disease, and vaccines. Founded in 1994, with operations in 60 countries, this CRO goes the distance to create a healthier world through agile, innovative, and customized CRO solutions for Phase I-IV research.

ABOUT VALNEVA

Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. The Company has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.