HIPRA SARS-CoV-2(Laboratorios HIPRA)

The Medicines and Healthcare products Regulatory Agency (MRHA) has authorised HIPRA Human Health’s COVID-19 vaccine, Bimervax, after it met the regulator’s required safety, quality and effectiveness standards. HIPRA, a biotech company that provides vaccines and diagnostic services, developed Bimervax, which combines part of the SARS-CoV-2 virus spike protein with an additional ingredient designed to trigger a stronger immune response, known as an adjuvant. The new COVID-19 vaccine will be given as a booster injection to eligible individuals aged 16 years and over. The regulator’s decision was based on data from a study of 765 adults who received primary vaccination with two doses of the Comirnaty COVID-19 vaccine and then a booster dose of either Bimervax or Comirnaty. Bimervax showed a strong immune response, and common side effects were mild and self-resolved within a few days of vaccination. The MRHA’s authorisation comes less than a month after HIPRA said it would be initiating a clinical trial to evaluate the safety and immune response of Bimervax when co-administered with the seasonal influenza vaccine. The study, which will involve 300 adults aged 65 or older who were first vaccinated against COVID-19 with an mRNA vaccine, has been authorised by the Spanish Agency for Medicines and Health Products and will last two months. Bimervax is now the ninth COVID-19 vaccine to be authorised by the MRHA. The MRHA authorised SK Chemicals’s SKYCovion earlier this year for use as a primary vaccination in those aged 18 and over, making it the eighth COVID-19 vaccine to be approved by the regulator. Its decision was based on data from two clinical trials of approximately 3,100 individuals between the ages of 18 and 84. SKYCovion demonstrated a strong immune response, with only mild common side effects that resolved on their own soon after vaccination.

Veristat Delivered a Full Range of Clinical Trial Services Culminating in Marketing Authorization of HIPRA’s SARS-CoV-2 Vaccine and Celebrates this Significant Accomplishment for Patients 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.” About Veristat 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. View source version on businesswire.com: Contacts Lauren L. Brennan, Vice President of Marketing, Veristat media@veristat.com Source: Veristat View this news release online at: