On March 31, the European Commission authorized the marketing of the Bimervax vaccine, developed by the Spanish biotech Hipra, one day after the recommendation approved by the European Medicines Agency (EMA), after having completed the scientific evaluation that began on March 20. of March. This Friday, the pharmaceutical company has officially delivered to the Spanish Agency for Medicines and Health Products (AEMPS), under the Ministry of Health, the 3.2 million doses of Bimervax purchased, according to the agreement of the Council of Ministers on 8 February November.
As has been the case since the beginning of the Vaccination Campaign, the next steps to follow correspond to the Report on the Vaccination Program and Registry, which must prepare the pertinent recommendations for review and agreement by the Public Health Commission and proceed, where appropriate, to update the Vaccination Strategy against COVID-19 in Spain.
Who will be able to receive Hipra as a booster dose
The HIPRA vaccine is indicated as a reinforcement dose or ‘booster’ for those people, from 16 years of age, who have received the primary vaccination schedule with an mRNA vaccine, at least 6 months after the last dose of a vaccine received. .
Bimervax is based on a heterodimeric recombinant protein that contains the receptor binding site of the S protein of the alpha and beta variants of SARS-CoV-2, thus containing information to induce an antibody response against two variants of the SARS-CoV-2. virus. Likewise, this antigen is accompanied by an adjuvant that increases the immune response.
The main study carried out with Bimervax is a clinical trial that compared the immune response of this new vaccine with that triggered by the BioNTech/Pfizer Comirnaty licensed mRNA vaccine against SARS-CoV-2 in its original variant (Wuhan); trial that received the approval of the Spanish Agency for Medicines and Health Products (AEMPS) on February 1, 2022.
It should be remembered that interim data from another ongoing clinical trial involving 36 adolescents aged 16 to 17 years were also presented for evaluation. This study revealed that the Hipra vaccine, administered as a ‘booster’, produces an adequate immune response in these adolescents, with antibody production comparable to that observed in adults. Likewise, other clinical trials authorized by the AEMPS have been carried out: on March 11, 2022, on November 15, 2021, and on August 11, 2021.