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- EMA starts rolling review of COVID-19 Vaccine HIPRA (PHH-1V)
Source:European Medicines Agency said:EMA’s human medicines committee (CHMP) has started a rolling review of COVID-19 Vaccine HIPRA (also known as PHH-1V). This protein-based vaccine is being developed by HIPRA Human Health S.L.U. as a booster vaccine for adults who have already been fully vaccinated with a different COVID-19 vaccine.
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How is the vaccine expected to work?
COVID-19 Vaccine HIPRA works by preparing the body to defend itself against COVID-19. It contains two versions of part of the spike protein (the receptor binding domain) which have been produced in the laboratory: one version corresponds to part of the spike protein of the alpha variant and the other corresponds to that of the beta variant. The spike protein is found on the surface of SARS-CoV-2 (the virus that causes COVID-19) and is used by the virus to enter the body’s cells. The vaccine also contains an ‘adjuvant’, a substance to help strengthen the immune responses to the vaccine.
https://www.ema.europa.eu/en/news/ema-starts-rolling-review-covid-19-vaccine-hipra-phh-1v
See also:
https://clinicaltrials.gov/ct2/show/NCT05246137
Source:Managing Director Human Health HIPRA said:The vaccine developed by HIPRA is the first (and so far, the only one) bivalent (Alpha and Beta) recombinant protein vaccine developed to fight against variants, and it is now at the final steps of Phase III clinical studies in Europe and about to start the Rolling Review in front of the European Medicines Agency (EMA). [As of March 14, 2022, four vaccine candidates are under EMA rolling review: Sinovac, Sanofi, Valneva and Russia’s Gamaleya Research Institute]
Our shot is designed to serve as a booster. Our new and exclusively dedicated facilities were inspected in January 2022 and are already GMP certificated. The company feels ready and is already manufacturing the antigen for the vaccine in order to deliver the product as early as mid-June when we expect to receive conditional marketing authorisation.
https://pharmaboardroom.com/interviews/carles-fabrega-managing-director-human-health-hipra/