The European Medicines Agency (EMA) has started reviewing the evidence for a new COVID-19 vaccine, 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 an mRNA or an adenovirus COVID-19 vaccine, or both.
Preliminary results from laboratory and clinical studies suggest that PHH-1V may be effective as Comirnaty against SARS-CoV-2, including against variants of concern.
The start of the review means that the EMA will evaluate data as they become available, to decide if the benefits of the vaccine outweigh the risks. The rolling review will continue until enough evidence is available for a formal marketing authorisation application.
PHH-1V contains two versions of the receptor-binding domain of the spike protein: one version corresponds to the spike protein of the Alpha variant, and the other corresponds to that of the Beta variant.
In addition to PHH-1V, the EMA is currently carrying out rolling reviews on three other vaccines; the inactivated Vero Cell vaccine from Sinovac, the Sputnik V Gam-COVID-Vac developed by Russia’s Gamaleya National Centre of Epidemiology and Microbiology, and VLA2001, which is being developed by Valneva.