EU CHMP recommends approval of Bimervax vaccine for COVID-19

Bimervax, developed by HIPRA Human Health S.L.U., contains a protein produced in the laboratory that consists of part of the SARS-CoV-2 spike protein from the Alpha and Beta virus variants. The CHMP concluded that sufficiently robust data on the quality, safety and immunogenicity of the vaccine are now available to recommend its marketing authorisation in the EU.

The CHMP therefore concluded that a booster dose of Bimervax is expected to be at least as effective as Comirnaty at restoring protection against COVID-19 in people aged 16 years and older. Based on the available evidence, the CHMP concluded that the benefits of Bimervax outweigh its risks and recommended granting a standard marketing authorisation in the EU.

An assessment report with details of EMA’s evaluation of Bimervax will be published shortly and clinical trial data submitted by the company in the application for marketing authorisation will be published on the Agency’s clinical data website in due course.

The main study carried out with Bimervax is an immunobridging trial, which compared the immune response triggered by this new vaccine with that triggered by the authorised mRNA vaccine Comirnaty that targets the original (Wuhan) SARS-CoV-2 spike protein. The study involved 765 adults who had previously completed primary vaccination with 2 doses of Comirnaty and who were subsequently given a booster dose of either Bimervax or Comirnaty. Although Bimervax triggered the production of lower levels of antibodies against the original strain of SARS?CoV?2 than Comirnaty, it led to higher levels of antibodies against the Beta and Omicron variants and comparable levels against the Delta variant. Supportive data were provided from an ongoing study that included 36 adolescents aged 16 to 17 years old, with immune response data available for 11 of them. The study found that Bimervax given as a booster produced an adequate immune response in these adolescents, with antibody production comparable to that seen in adults who received Bimervax. The safety profile of Bimervax is comparable to that of other COVID-19 vaccines. The most common side effects seen with Bimervax were pain at the injection site, headache, tiredness and muscle pain. These were usually mild to moderate and cleared within a few of days after vaccination. The safety and effectiveness of the vaccine will continue to be monitored as it is used across the EU, through the EU pharmacovigilance system and additional studies by the company and European authorities.