On 30 March 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval of the protein-based SARS-CoV-2 vaccine Bimervax (formerly COVID-19 vaccine HIPRA) as a booster vaccine for persons aged 16 years and older. Bimervax was developed by HIPRA Human Health S.L.U. and contains as an antigen a protein that was produced in the laboratory and consists of part of the spike protein of the alpha and beta virus variants. Based on the available data, the CHMP concluded that the benefits of Bimervax outweigh the risks and recommended that it be granted a standard marketing authorisation in the EU. The European Commission followed the recommendation on the same day.
The main trial of Bimervax was an immunobridging trial comparing the immune response elicited by this vaccine with that elicited by BioNTech/Pfizer's Comirnaty mRNA vaccine (developed against the original Wuhan strain of SARS-CoV-2).
The study included 765 adults who had previously received an initial two-dose vaccination with Comirnaty, followed by a booster vaccination with either Bimervax or Comirnaty. Compared with Comirnaty, antibody levels (titres) against the original (Wuhan) strain of SARS-CoV-2 were lower after booster vaccination with Bimervax. In contrast, antibody titres against the beta and omicron variants were higher after the booster with Bimervax than after the booster with Comirnaty, and comparable antibody levels were measured against the delta variant.
Supporting data were presented from an ongoing study involving 36 adolescents aged 16 to17 years. Immune response data were available for eleven of the adolescents. The study showed that a booster dose of Bimervax elicited an adequate immune response in these adolescents, with induced antibody levels comparable to those in adults. Therefore, the CHMP concluded that a booster dose of Bimervax provides at least as effective protection against COVID-19 as a booster dose of Comirnaty in persons aged 16 years and older.
The most common adverse reactions observed with Bimervax vaccination were injection site pain, headache, tiredness and muscle aches. These were generally mild to moderate in severity and resolved within a few days after vaccination. This is consistent with experience with the other COVID-19 vaccine products.
As with the other COVID-19 vaccine products, the safety and efficacy of the vaccine will continue to be monitored during its use in the EU through the EU pharmacovigilance system and additional studies by the company and the European authorities.
Updated: 31.03.2023
