- It is the first recombinant protein vaccine against Covid-19 to be authorized in the European Union.
- A booster dose of the bivalent recombinant protein vaccine allows long-lasting immunization in people over 16 years of age.
- In Mexico and the rest of Latin America it will be distributed by Exeltis, which is a division of Insud Pharma.
On March 30, the HIPRA biologic received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). It’s about the first bivalent vaccine against Covid-19 that obtains authorization for its commercialization in the countries that make up the European Union. Although that is not all because now it is expected that it will also reach Latin America.
In this case, the immunization in question bears the name BIMERVAX® and it is the first of its kind developed in Spain. Although first it is worth answering a key question.
What is a bivalent vaccine?
The term arose during the pandemic and refers to the most recent version of the booster vaccine against Covid-19. The name originates from the fact that it contains two protective components that allow a better immune response of the organism against an infection. With this in mind, it works against both the original virus and the Omicron Variant.
However, the distributor in Latin America of the input will be Exeltiswhich is a division of Insud Pharma. The agreement includes the marketing and distribution of the biological. Up to now, it is planned to arrive at Mexico, Argentina, Uruguay, Colombia, Chile, Peru, Paraguay, Venezuela, Bolivia and Ecuador.
Process to start with its distribution and application in Mexico
according to Dr. Alfonso Moguel, Medical Director of Exeltis in Mexico, this is very good news. The sanitary process in each nation will begin shortly with the hope that it will be approved for application as soon as possible.
In this sense, once it is approved by the Federal Commission for the Protection against Sanitary Risks (Cofepris), Mexicans will have access to an effective and safe vaccine, as indicated by the studies reviewed by the EMA to issue its opinion.
HIPRA considers that “it is positive that health systems around the world have a catalog of vaccines of different technologies because it is a key aspect in the implementation of vaccination programs, be they periodic booster vaccination plans or for the control of a eventual outbreak of the pandemic.
Who can receive it?
BIMERVAX® is a bivalent adjuvanted vaccine that contains a recombinant protein based on the Beta and Alpha variants of SARS-CoV-2 and is indicated as a booster dose for people over 16 years of age. It’s the first bivalent vaccine of adjuvanted recombinant protein that is authorized in the European Union against the virus.
The EMA’s positive opinion comes after concluding that it has sufficient robust data on the quality, immunogenicity and safety of the vaccine. In phase IIb and III studies, it has been shown that it is a safe, low-reactogenic vaccine with a broad capacity to neutralize the main variants of SARS-CoV-2, including the Omicron variants.
In the comparative study versus the mRNA vaccine required by the EMA, it is shown that, 6 months after receiving the booster dose, people vaccinated with the HIPRA vaccine present higher levels of neutralizing antibodies against all the variants studied. suggesting longer lasting protection. In the same comparative study, it is shown to have less reactogenicity than the mRNA vaccine.
The vaccine is kept at a refrigerated temperature between 2oC and 8oC, facilitating its logistics and distribution. It is a “ready-to-use” vaccine, that is, it does not need to be reconstituted before use, thus facilitating the task for healthcare personnel.
Also read:
Bivalent vaccine against Omicron, what is it and who can receive it?
This is the first bivalent vaccine approved against the Omicron Variant
WHO updates the vaccination guide against Covid-19: These are the new indications