The EMA approves the HIPRA vaccine against COVID-19 as a booster dose

MADRID, 30 Mar. (EUROPA PRESS) -

The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) has given its go-ahead to the authorization of Hipra's COVID-19 vaccine, commercially known as 'Bimervax', as doses booster in people over 16 years of age who have been previously vaccinated at least six months before with a Pfizer or Moderna vaccine.

Through a statement, the EMA has confirmed that the Spanish company's vaccine "already has sufficiently solid data on the quality, safety and immunogenicity of the vaccine to recommend its marketing authorization in the EU." "The benefits of 'Bimervax' outweigh its risks," the agency has wielded.

After this scientific endorsement by the European regulatory body, the European Commission will have to definitively approve its use, as established by the procedure. Normally, this process is usually short, just a few days.

The Commission already signed a joint purchase contract with the Spanish pharmaceutical company last year to ensure the supply of 250 million doses of the vaccine, from which up to 14 Member States may benefit, including Spain, France or Austria.

In addition to the EU countries, whose purchase and delivery schedule will be specified from now on, Hipra is in contact with other regions with which it is already in contact, for example the United States and Latin America, in order to export the vaccine. The main interest of the vaccine for these countries is its conservation conditions, since they are more favorable for export, as they are kept between 2 and 8 degrees and do not need freezing during transport and storage.

After reviewing all of the company's documentation, a process that has taken months, the EMA has finally concluded that Hipra's booster dose is "at least as effective" as one from Pfizer in restoring protection against COVID-19. in people 16 years of age or older.

Specifically, in the main study carried out with the Hipra vaccine, the immune response triggered by this new vaccine was compared with that triggered by the original Pfizer vaccine.

The study involved 765 adults who had previously completed primary vaccination with 2 doses of Pfizer and who subsequently received a booster dose of Hipra or Pfizer.

The EMA details that, although the Hipra vaccine caused the production of lower levels of antibodies against the original strain of SARS-CoV-2 than that of Pfizer, "it led to higher levels of antibodies against the Beta and omicron variants and levels comparable against the Delta variant".

The company is also conducting a study involving 36 adolescents between the ages of 16 and 17, and for which data on the immune response of 11 of them were available. For the moment, the investigation has concluded that the Hipra vaccine as a booster dose produces an "adequate" immune response in these adolescents, with antibody production "comparable to that observed in adults who received the vaccine."

Similarly, the EMA has ensured that the safety profile of the Hipra vaccine "is comparable to that of other vaccines against COVID-19". The most common side effects were pain at the injection site, headache, tiredness, and muscle pain. "They are usually mild to moderate and disappear a few days after vaccination," says the European body.

HOW DOES THE HIPRA VACCINE WORK?

The Hipra vaccine works by preparing the body to defend itself against COVID-19. It contains part of the SARS-CoV-2 spike protein from the Alpha and Beta variants of the virus, which have been combined into a single protein in the laboratory.

This protein is found on the surface of SARS-CoV-2 (the virus that causes COVID-19) and is used by the virus to enter cells in the body. The vaccine also contains an "adjuvant," a substance that helps boost the immune response to the vaccine.

When a person receives the vaccine, their immune system will identify the combined protein in the vaccine as foreign and will produce natural defenses (antibodies and T cells) against it.

If the vaccinated person comes into contact with SARS-CoV-2 later, the immune system will recognize the spike protein of the virus and be prepared to attack it. Antibodies and immune cells can protect against COVID-19 by working together to kill the virus, keep it from entering body cells, and destroy infected cells.

In line with the EU's COVID-19 vaccine safety surveillance plan, the EMA recalls that this vaccine "will be closely monitored and will undergo several activities that apply specifically to COVID-19 vaccines. 19".

In addition, Hipra is obliged to provide regular security updates. European authorities will also carry out independent studies of the vaccine to obtain "more information on the safety and long-term benefits in the general population."