The Minister of Health, José Miñones, has recognised the work of the researchers who made possible Bimervax, the first Spanish vaccine against COVID-19, developed by the biotechnology company HIPRA.
“I am the best example of Marca España”, as responsible for a milestone that places our country “at the vanguard of world research”, Miñones underlined, after the pharmaceutical company had officially handed over to the Agency The Spanish Medicines and Health Products (AEMPS) the 3.2 million doses of Bimervax, according to the agreement of the Council of Ministers last November 8.
“Today is a great day. A great day for the scientific community, a great day for Spanish citizens, a great day for the National Health System, and a great day to remember the importance of investing in public health and research”, the minister said.
As has been happening since the beginning of the Vaccination Campaign, the next steps to follow correspond to the Presentation of the Program and Registry of Vaccinations, which must elaborate the relevant recommendations for review and agreement, by the Public Health Commission and proceed to the update of the Vaccination Strategy against the COVID-19 in Spain.
Last March 30, the European Medicines Agency (EMA) recommended that a marketing authorisation be granted to Bimervax, a vaccine against COVID-19 developed by the biotechnological pharmaceutical company HIPRA, based in Amer (Girona), after having completed the scientific evaluation started on March 20.
One day later, on March 31, the European Commission (EC) authorised the marketing of this vaccine, so that it could be distributed in all EU member states, as it happens with the rest of the medicines authorised by a centralized procedure.
Booster dose for people with mRNA primary vaccination
The HIPRA vaccine is indicated as a booster dose for those people, from the age of 16, 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 binding site to the S protein receptor of the alpha and beta variants of SARS-CoV-2, which contains information to induce an antibody response against two variants of the 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 the one triggered by the authorised mRNA vaccine Comirnaty, from BioNTech/Pfizer 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, for its evaluation, intermediate data from another ongoing clinical trial that included 36 adolescents aged 16 to 17 were also presented. This study revealed that the Hipra vaccine, administered as a ‘booster’, produces an adequate immune response in these adolescents, with a production of antibodies comparable to that observed in adults.
Likewise, other clinical trials authorised by the AEMPS were carried out: on March 11, 2022, November 15, 2021, and August 11, 2021.
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