The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) began the rolling review procedure for the protein-based COVID-19 Vaccine HIPRA (PHH-1V) against SARS-CoV-2 on 28 March 2022. The vaccine is produced by the Spanish manufacturer HIPRA. The vaccine is intended for booster vaccination of individuals who have completed primary immunisation with mRNA and/or vector vaccines. In a rolling review process, the data needed for a complete application for marketing authorisation can be submitted and evaluated as it becomes available. HIPRA is a biotechnologically produced protein vaccine that contains spike protein components of the Alpha and Beta virus variants of the SARS-CoV-2 coronavirus. The vaccine also contains an adjuvant.
The CHMP's decision to launch the assessment procedure was based on preliminary results from non-clinical studies and from clinical trials with adults. In the clinical trials, the immune response to the vaccine (measured by the amount of antibodies against SARS-CoV-2) was compared with antibody formation after vaccination with the mRNA vaccine Comirnaty. Preliminary results suggest that the immune response following vaccination with COVID-19 Vaccine HIPRA may be effective against SARS-CoV-2, including against virus variants such as Omicron. COVID-19 Vaccine HIPRA is intended for booster vaccination in individuals who have completed primary immunisation with an mRNA and/or a vector vaccine against COVID-19.
The CHMP will evaluate the data as soon as it is available to determine whether the benefits outweigh the risks. The Committee will continue the ongoing review until sufficient data is available for a formal application for authorisation.
The protein-based vaccine is based on a genetically engineered fusion protein that contains components of the receptor-binding domain (RBD) of the spike protein of SARS-CoV-2 virus variants B.1.1.7 (Alpha) and B.1.351 (Beta). HIPRA also contains an adjuvant, a substance that enhances the immune response to the vaccine. After vaccination, the immune system recognises the protein particles as foreign and forms natural defences, antibodies and T cells. If the vaccinated person is later exposed to SARS-CoV-2, the immune system recognises the spike protein and fights the virus.
COVID-19 Vaccine HIPRA is intended for use as a booster vaccine in individuals who have received a complete primary immunisation course with an mRNA and/or a vector-based COVID-19 vaccine.
Updated: 29.03.2022
