Today, Thursday March 30, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended that a marketing authorization be granted to BIMERVAX®, the HIPRA COVID-19 vaccine – a Spanish biotech pharmaceutical company focused on prevention for animal and human health–, as a booster dose in people over 16 years of age who have been previously vaccinated with an mRNA vaccine against COVID-19, at least 6 months after the last dose of a received vaccine.
Bimervax is a bivalent adjuvanted vaccine containing a recombinant protein based on the Beta and Alpha variants of SARS-CoV-2. After an evaluation that began on March 20, the EMA has concluded that it already has sufficiently robust data on the quality, safety and immunogenicity of the vaccine to recommend its marketing authorization in the EU.
The Minister of Health, José Miñones, has valued the recent approval of the HIPRA Spanish vaccine recommendation against COVID-19, as an unprecedented scientific and health milestone that shows our country’s commitment to improving health of people, leaving no one behind.
What is the Spanish Hipra vaccine like: safety and effects
The main trial conducted with BIMERVAX® compared the immune response elicited by the HIPRA vaccine with that elicited by Pfizer’s Comirnaty mRNA vaccine against SARS-CoV-2 in the original Wuhan variant. Following the results, the EMA has concluded that the benefits of the HIPRA vaccine outweigh its risks and recommends granting a standard marketing authorization in the EU.
It included 765 adults who had previously completed primary vaccination with two doses of Comirnaty and who subsequently received a booster dose of Bimervax or Comirnaty. Although Bimervax triggered the production of lower levels of antibodies against the parent strain of SARS-CoV-2 than Comirnaty, it led to higher levels of antibodies against the beta and omicron variants, as well as comparable levels against the delta variant.
Bimervax has been shown to be as effective as Comirnaty in restoring protection against COVID-19 in people over 16 years of age.
In addition, interim data from another ongoing clinical trial involving 36 adolescents aged 16-17 years have been presented for evaluation, with immune response data available for 11 of them. The study concluded that Bimervax given as a boost produces an adequate immune response in these adolescents, with antibody production comparable to that seen in adults (18 years and older) receiving Bimervax. Additionally, other clinical trials authorized by the AEMPS have been carried out.
As one of its benefits, José Gómez Rial, immunologist at the Hospital Clínico Universitario de Santiago, points out in statements to the Science Media Center that “I am convinced that very good results will be obtained with it. This vaccine should be especially indicated, which uses a different platform, for those people who have not responded efficiently to the initial regimen with an mRNA vaccine and, therefore, take advantage of a heterologous combination, which has shown such good results so far.” While the main disadvantage compared to some already exist, Gómez Rial points out that “Hipra uses a technology (recombinant protein) that does not allow rapid adaptation to changes in the virus. In this sense, mRNA technology is always more flexible and faster, and this is precisely one of the advantages of mRNA technology compared to those that exist up to now.”
On the other hand, the safety profile of Bimervax is comparable to that of other vaccines against COVID-19. The most common side effects observed were pain at the injection site, headache, tiredness, and muscle pain. These were usually mild to moderate and disappeared within a few days after vaccination.
The safety and efficacy 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. More information can be found in the Bimervax SmPC, which contains data for healthcare professionals, a package leaflet for the general public and details about the vaccine’s licence.
Source: EMA, Hipra and AEMPS
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