The Finlay Institute of Vaccines (IFV) is about to start the application process to obtain the sanitary registration of the National Regulatory Authority for the vaccine Cuban anti-pneumococcus Quimi-Vio, official media reports on the island.
After the pause generated by the priority granted to vaccines against COVID-19, the scientists of that institution will resume the pending clinical trials and the completion of the file to request that registration, according to a note published by the official newspaper Granma.
Cuban anti-pneumococcal vaccine, close to requesting registration.
Quimi-Vio consists of a seven-valent conjugate vaccine candidate that, in its production process, has faced a high scientific, chemical, analytical and technological complexity.#CubaForLife pic.twitter.com/MWSBsaPCg5– Finlay Vaccine Institute (@FinlayInstituto) January 27, 2023
Dr. Yuri Valdés Balbín, deputy director of the IFV, explained that Quimi-Vio is a seven-valent conjugate vaccine candidate that has faced a high scientific, chemical, analytical, and technological complexity in its production process.
The drug protects against seven of the most infectious and highly prevalent serotypes of pneumococcus bacteria worldwide, the pathogen that causes most pneumonia and bacterial meningitis in children, as well as bloodstream infections, otitis media, sinusitis, and bronchitis. .
The expert added that in the completed trials, the injectable product demonstrated safety, generating only mild expected adverse events at the local level.
The publication refers that the analyzes indicate that it caused the same reactions as any other vaccine, particularly pain in the area where it was applied and redness, while from the systemic point of view the most common was fever, in some cases.
Regarding efficacy, notorious evidence of immunogenicity with an impact on the disease was observed, confirming the protection of the vaccine candidate against pneumococcus.
Among the clinical trials undertaken, the intervention study carried out in the province of Cienfuegos between 2017 and 2018 stands out, led by Doctor of Science Dunia Chávez Amaro, from the Paquito González Pediatric Hospital, which covered more than 90% of children aged one to five years with the possibility of being vaccinated (more than 16,000).
A clinical trial of protective efficacy (Phase II-III) was also carried out with the Cuban anti-pneumococcal vaccine candidate, which contains tetanus toxoid as a carrier protein, with 1,135 children between one and five years of age, from which a similar safety profile was obtained. .
In addition, it was shown that it is not inferior, in terms of immunogenicity, to the commercial vaccine Prevenar 13®, used in that research itself as a comparative element. Its access was achieved through the Pan American Health Organization (PAHO).
accurate Granma that once the Quimi-Vio vaccine obtains its sanitary registration, it will initially be applied in the age group of one to five years, and later in infants of the first semester of life.
The publication that Quimi-Vio grants the country technological sovereignty to combat diseases caused by a bacterium that, according to estimates by the World Health Organization (WHO), annually causes around 1.6 million deaths worldwide, stands out.
A good part of these deaths occur in children under five years of age, the majority in developing countries.
The media reminds that the novel drug appears in the first WHO report on immunogens under development to prevent infections caused by bacteria resistant to antimicrobial drugs.
The document from the world health organization was published together with an urgent call to improve the use of existing vaccines, develop new ones and accelerate those that are in the last stages of development, since antimicrobial resistance is currently a great public health problem that is increasing internationally.
