The PHH-1V HIPRA vaccine: a new tool in the vaccination strategy against COVID-19

Abstract

Objectives. Vaccination against SARS-CoV-2 is essential to mitigate the personal, social and global impact of the coronavirus disease (COVID-19) as we move from a pandemic to an endemic phase. Vaccines are now required that offer broad, long-lasting immunological protection from infection in addition to protection from severe illness and hospitalisation. Here we present a review of the evidence base for a new COVID-19 vaccine, PHH-1V (Bimervax®; HIPRA HUMAN HEALTH S.L.U), and the results of an expert consensus. Materials and methods. The expert committee consisted of Spanish experts in medicine, family medicine, paediatrics, immunology, microbiology, nursing, and veterinary medicine. Consensus was achieved using a 4-phase process consisting of a face-to-face meeting during which the scientific evidence base was reviewed, an online questionnaire to elicit opinions on the value of PHH-1V, a second face-to-face update meeting to discuss the evolution of the epidemiological situation, vaccine programmes and the scientific evidence for PHH-1V and a final face-to-face meeting at which consensus was achieved. Results. The experts agreed that PHH-1V constitutes a valuable novel vaccine for the development of vaccination programmes aimed towards protecting the population from SARS-CoV-2 infection and disease. Consensus was based on evidence of broad-spectrum efficacy against established and emerging SARS-CoV-2 variants, a potent immunological response, and a good safety profile. The physicochemical properties of the PHH-1V formulation facilitate handling and storage appropriate for global uptake. Conclusions. The physicochemical properties, formulation, immunogenicity and low reactogenic profile of PHH-1V confirm the appropriateness of this new COVID-19 vaccine.

Humoral and cellular immune responses after 6 months of a heterologous SARS-CoV-2 booster with the protein-based PHH-1V vaccine in a phase IIb trial

“…PHH-1V has a good stability profile, high productivity yields and storage at refrigerator temperatures. Expert consensus claimed PHH-1V's storage characteristics and shelf life facilitate distribution in various logistics situations and reduce costs compared to vaccines that require lower temperatures [11].…”

Innovations and Challenges in the Development of COVID-19 Vaccines for a Safer Tomorrow

“…This approach guarantees all-encompassing protection against potential novel hazards [ 36 ]. As such, the European Medicines Agency (EMA) is assessing the Spanish Hipra vaccine for its capacity as a COVID-19 booster [ 37 ]. To enhance the immune response, the vaccine utilizes a recombinant protein, that mimics the RBD of the S protein in conjunction with an adjuvant.…”

Immunogenicity and safety of an Omicron XBB.1.16 adapted vaccine for COVID-19: Interim results from a randomized, controlled, non-inferiority clinical trial

“…[1][2][3] While current vaccines have shown effectiveness, their protection diminishes over time, particularly against emerging variants. [4][5][6] This highlights the crucial need to adapt vaccine compositions and develop updated strategies to sustain immunity. 7 Thus, with the emergence of Omicron XBB variants, regulatory and public health bodies such as the World Health Organization (WHO) Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC), the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA) recommended updates to specifically target viral lineages for primary or booster vaccinations.…”