On Thursday 30 March, the European Commission authorised the Covid-19 mRNA vaccine Bimervax developed by HIPRA Human Health S.L.U. (see EUROPE 12922/21) as a booster dose for people aged 16 years and older, who have previously received a Covid-19 mRNA vaccination.
The vaccine is suitable for both Alpha and Beta variants of SARS-CoV-2.
This authorisation is based on the positive recommendation of the European Medicines Agency (EMA) of 30 March for the approval of the vaccine.
Indeed, the EMA’s Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Bimervax outweighed its risks. Bimervax is expected to be at least as effective as Comirnaty in restoring protection against Covid-19 in people aged 16 years and over. The EMA considers that the safety profile of Bimervax is comparable to that of other Covid-19 vaccines.
The Agency also stresses that the safety and efficacy of Bimervax will continue to be monitored throughout the EU.
Bimervax has been evaluated in the framework of ‘OPEN ’, an initiative launched in 2020 to strengthen international collaboration in the review of Covid-19 vaccines and treatments by the EMA. Indeed, OPEN allows regulators from third countries (Australia, Canada, Japan and Switzerland) as well as the WHO to participate as independent observers in the EMA’s scientific evaluation.
Link to the vaccine consent form: https://aeur.eu/f/65i (Original version in French by Emilie Vanderhulst)