The European Medicines Agency (EMA) on 29 March 2022 initiated a rolling review process of PHH-1V, a vaccine against SARS-CoV-2 developed by the Spanish pharmaceutical company HIPRA.
The vaccine is intended to be administered intramuscularly as a booster dose in adults who have already completed a first vaccination schedule with another SARS-CoV-2 vaccine using a different technology.
PHH-1V is a recombinant protein vaccine. It contains two synthetic versions of fragments of the SARS-CoV-2 ‘spike’ protein (one corresponding to the B.1.1.7 ‘alpha’ variant and the other to the B.1.351 ‘beta’ variant of SARS-CoV-2) and an adjuvant.
The vaccine could be stored between 2°C and 8°C, which is logistically beneficial.
The EMA’s rolling review process is a mechanism to speed up the assessment phase prior to the formal application for market authorisation of a medicinal product in times of health emergencies. HIPRA has already provided the EMA with a first set of laboratory and clinical study data in adults.
According to the EMA, initial results suggest that the vaccine would be effective against SARS-CoV-2 and variants of concern such as Omicron.
HIPRA estimates that market authorisation could be granted in May 2022, but the EMA does not confirm any timeline.
HIPRA says it is prepared to produce the vaccine within days. It says it has the capacity to produce 600 million doses of the vaccine by 2022 and could double that capacity by 2023. (Original version in French by Émilie Vanderhulst)