The European Medicines Agency (EMA) has given the green light to the Hipra vaccine against covid as a booster dose for people over 16 years of age who have previously been immunized with a messenger RNA vaccine. Hipra's product, which will be marketed as Bimervax, will thus become the first coronavirus vaccine developed in Spain to hit the market.
The EMA's favorable decision is based on a clinical trial that has shown that Hipra's product is no less effective than Pfizer's original vaccine as a booster dose.
Bimervax contains a laboratory-produced protein that consists of part of the SARS-CoV-2 S protein from the Alpha and Beta variants of the virus.
The EMA's Committee for Medicinal Products for Human Use (CHMP) concluded that sufficiently robust data on the quality, safety and immunogenicity of the vaccine are now available to recommend its marketing authorization in the EU.
The main study conducted with Bimervax is an immunobridation trial, in which the immune response elicited by this new vaccine was compared with that elicited by the licensed Comirnaty mRNA vaccine, directed against the parent protein (Wuhan) of SARS-CoV-2 spike shaped.
The study included 765 adults who had previously completed primary vaccination with 2 doses of Comirnaty and who subsequently received a booster dose of Bimervax or Comirnaty. Although Bimervax caused 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 and comparable levels against the Delta variant.
An ongoing 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, provided supporting data. The study revealed that Bimervax given as a booster dose produced an adequate immune response in these adolescents, with antibody production comparable to that seen in adults receiving Bimervax.
Therefore, the CHMP concluded that a booster dose of Bimervax is expected to be at least as effective as Comirnaty in restoring protection against Covid-19 in people aged 16 years and over.
Bimervax's safety profile 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. They are usually mild to moderate and disappear within a few days of vaccination.
The safety and efficacy of the vaccine will continue to be monitored as it is used in the EU, through the EU pharmacovigilance system and additional studies by the company and European authorities.
Based on the available evidence, the CHMP concluded that Bimervax's benefits outweigh its risks and recommended granting a standard marketing authorization in the EU.
Bimervax 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. The spike 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, prevent its entry into body cells, and destroy infected cells.
A booster injection of Bimervax is given into the muscle, usually in the upper arm, at least 6 months after the last dose of a Covid-19 mRNA vaccine.
In line with the EU's Covid-19 vaccine safety surveillance plan, Bimervax will be closely monitored and will undergo several activities that apply specifically to Covid-19 vaccines.
The company is required to provide regular security updates. In addition, independent studies of the Covid-19 vaccines coordinated by the EU authorities will provide more information on the safety and long-term benefits of the vaccines in the general population.
