SOUTHBOROUGH, Mass.--(BUSINESS WIRE)--Veristat, a scientific-minded, global clinical research organization (CRO), today congratulated HIPRA for marketing authorization by the European Medicines Agency (EMA) and European Commission of BIMERVAX®, a bivalent adjuvanted vaccine based on the Beta and Alpha variants of SARS-CoV-2 and indicated as a booster dose for people over 16 years of age. BIMERVAX® is the first bivalent recombinant protein vaccine against the virus to be authorized in the European Union and the first human health vaccine to be designed and developed in Spain.
HIPRA worked tirelessly to support the development of a technologically agile platform, allowing for the inclusion of more than one variant in a single active substance, previously not achievable in the designs of other vaccines approved in the European Union. Veristat’s global teams collaborated closely with HIPRA to establish a comprehensive strategy to demonstrate the benefits of the next-generation COVID-19 vaccine in adult populations. HIPRA engaged Veristat across clinical studies, encompassing the planning and implementation of the pertinent scientific, operational, and biometrics aspects of the clinical trials.
“Clinical trial activity remains steady in new vaccine development, as COVID-19 continues to impart tremendous health and societal impact on our world,” stated Patrick Flanagan, Chief Executive Officer at Veristat. “Maintaining vaccine options for all populations, especially immunocompromised populations, remains vitally important. Congratulations to the entire HIPRA team for putting your tremendous talents and technologies to work in helping to safeguard society further from the often devastating consequences of COVID-19. You have set a new standard for what it means to be a true partner. Veristat is proud to have used our bold thinking and scientific expertise to support HIPRA in the clinical trials for BIMERVAX®.”
Around the globe, health authorities, governments, and biopharmaceutical companies continue their efforts to fast-track the development of therapies or platforms to prevent, diagnose, and treat widespread illness due to COVID-19 and its variants. Veristat’s expertise comes from planning or conducting more than 70 COVID-19 projects for a broad range of therapies, including anti-inflammatories, antivirals, antiseptics sprays, cannabinoids, advanced therapies, probiotics, monoclonal antibodies, and vaccines.
“We are thrilled with the results of the studies completed for BIMERVAX® and we are confident that it will play an important role in vaccination plans,” stated HIPRA. "We would extend our heartiest thank you to the entire Veristat team who has worked so diligently. HIPRA is gratified to know that the efforts and commitment of the teams have resulted in an approved vaccine to advance protection against the virus.”
Veristat, a scientific-minded global clinical research organization (CRO), enables sponsors to solve the unique and complex challenges associated with accelerating therapies through clinical development to regulatory approval and commercialization. With more than 28 years of experience in clinical trial planning and execution, Veristat is equipped to support any development program.
Veristat's focus on novel drug development has led to success when handling the unknowns that arise across complicated therapeutic areas, such as rare/ultra-rare disease, advanced therapies, oncology, and infectious disease trials. Every day, we apply this knowledge base to solve any program’s clinical, regulatory, statistical, data, or operational challenges, from the simplest to the most complex. Veristat has assembled an extraordinary team of experts worldwide who have mastered therapeutic development intricacies, enabling sponsors to succeed in extending and saving patients’ lives.