Vaccino Valneva, green light Ema from 18 to 50 years

Green light from the European drug agency Ema to the anti-Covid vaccine of the French Valneva. The EU regulatory body recommends granting a marketing authorization (Aic) for the product – based on inactivated, adjuvanted virus – for primary vaccination from 18 to 50 years of age. After an in-depth evaluation – informs the agency – the CHMP Committee for Medicinal Products for Human Use has concluded that the data on the vaccine are “solid” and meet the EU criteria for “efficacy, safety and quality”. The ‘ball’ now passes to the European Commission, which “will hasten the decision-making process on a standard MA for the Valneva vaccine, allowing it to be included in vaccination programs implemented across the EU.” di Valneva – explains Ema – is a so-called immunobridging trial. This is the definition of studies that compare the immune response induced by a new vaccine with that stimulated by an authorized vaccine that has been shown to be effective against the target disease, in this case Covid-19. According to the EMA, “a standard MA is considered appropriate for this vaccine since the immunobridging study has achieved its objectives and the data provided is considered sufficient.”