Cuban pneumococcal vaccine near to apply for sanitary registration

Cuban pneumococcal vaccine near to apply for sanitary registration
Fecha de publicación: 
27 January 2023
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The Cuban anti-pneumococcal vaccine, Quimi-Vio, is about to apply for sanitary registration before the National Regulatory Authority, the Finlay Vaccine Institute (IFV) reported today.

According to Yuri Valdes Balbin, deputy director of the institution, in the completed trials, the vaccine proved to be safe, as it generated mild adverse events at local level, the IFV explained on Twitter.

Valdes Balbin told Granma newspaper that this vaccine candidate is a heptavalent product which, in its production process, has faced a high scientific, chemical, analytical and technological complexity.

It protects against seven of the most infectious and highly prevalent worldwide serotypes of the pneumococcus bacteria (that is, it is as if seven vaccines were developed in one), the pathogen that causes most pneumonia and bacterial meningitis in children, as well as bloodstream infections, otitis media, sinusitis and bronchitis, he said.

In terms of adverse events, the expert added, it only 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 seen was fever, in some cases.

As regards efficacy, there was clear evidence of immunogenicity with impact on the disease, which confirms the protection of the vaccine candidate against pneumococcus.

When the vaccine obtains its sanitary registration, it will be applied first in the one to five year-old age group and, subsequently, in infants in the first semester of life.

Quimi-Vio grants the country technological sovereignty to combat diseases caused by this bacterium which, according to the World Health Organization (WHO), causes around 1.6 million deaths worldwide every year, most of them in children under five years of age.

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