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The effectiveness of Cuban Hepatitis B vaccine HeberNasvac - born of the intellect of Cuban scientists and approved for use in the country eight years ago -, has been endorsed by the results of studies carried out in several nations worldwide.
In collaboration with the French company Abivax, the immunogen has traveled to South Korea, New Zealand, Singapore, Australia, Philippines, Taipei, Thailand and Hong Kong, where its impact on the treated subjects translated into receiving the endorsement of the countries’ regulatory authorities.
New studies are now underway in Japan and Bangladesh, which already corroborate the value of the only vaccine against a chronic infectious disease, and the only therapeutic vaccine administered nasally.
This information was confirmed to the Cuban News Agency by Doctor in Biological Sciences Gerardo Guillén Nieto, head of Biomedical Research at the Center for Genetic Engineering and Biotechnology (CIGB in Spanish), the birthplace of the vaccine, who also offered valuable examples of the information provided by the clinical studies, completed and ongoing, which support the effectiveness of the vaccine.
For example, in 80% of the subjects treated, the presence of the virus in the blood considerably decreased, to less than 10,000 particles per milliliter. This means that, although the patient is still infected, the risk of suffering complications such as fibrosis, which can derived in cirrhosis and liver cancer, is reduced.
Guillén Nieto also shared that 80 % of the individuals keep the viral load under control and in 50 %, this load is not detectable, even five years after administering the vaccine.
In the case of Bangladesh, said the also member of the BioCubaFarma-Ministry of Public Health (MINSAP) Innovation Committee and of the MINSAP’s Science Advisory Group, it has been proved that, in the presence of the positive E antigen marker, common in Southeast Asian patients, 60% of those vaccinated created antibodies against that antigen. Other studies are heading there, in conjunction with gastroenterologists, and the patients of the efficacy study carried out in that country are being followed up.
Meanwhile, in Japan, the second clinical study is already underway, involving more than 300 volunteers, to determine the efficacy of the vaccine in a new formulation and in different clinical scenarios, including patients who did not respond to antiviral treatment and patients for whom no treatment is currently available, the doctor said.
HeberNasvac has been recognized for its effectiveness in hepatitis B therapy at the Annual Congress of the American Society of Liver Diseases. Likewise, the prestigious Cuban scientist highlighted that they are collaborating with institutes and companies from Germany, Japan and France to boost the immune response based on new formulations of the vaccine.
This immunogen, whose scheme in Cuba consists of nasal administration, combined with the subcutaneous route, is not only effective but also highly safe, with very few adverse reactions, and an administration period of five months, much shorter than that of iInterferon, administered for a year, and antivirals, which are necessary for life.
The decrease in the incidence of hepatitis B in Cuba implies that it is not considered a health problem, and that our country aspires to its total elimination by 2030, in line with the request of the World Health Organization. (Correspondents' Editor)
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