The president of the business group BioCubaFarma, Eduardo Martinez, announced that by the year 2021 all Cubans will be vaccinated against COVID-19.
On October 31, the Center for Genetic Engineering and Biotechnology (CIGB) presented documentation to the Cuban Regulatory Authority of Medicines, Equipment and Medical Devices (CECMED) for the registration of the third Cuban vaccine.
It is expected that by year-end, there will be four Cuban vaccines against COVID-19 at various stages of clinical trials.
According to Cuban news reports, a second meeting took place where the representatives of the CIGB presented the documentation. If it is approved, CIGB will begin Phases I, II, and III clinical trials.
CIGB’s vaccine candidate is the first one that is not injectable. It is delivered nasally. The SARS-CoV-2 which causes COVID-19 is a respiratory agent infecting through the nasopharynx mucosa.
According to Gerardo Guillen, Director of Biomedical Research of CIGB, immunization by this route favors the development of a local response. The objective is to prevent the disease through colonization and transmission of the pathogen.
The new vaccine candidate is based on a protein of the hepatitis B virus, produced through recombinant genetic engineering in bacteria and yeast in the form of particles, whose properties also enhance the immune system.
The new vaccine Soberana 01 and 02 use the platform of sub-units based on specific proteins obtained from biotechnological methods.
“This platform by sub-unit is perhaps the one that takes more time to provide a vaccine candidate, but it has the advantage of safety because it does not work with a virus or with a complex mixture where there can be toxic compounds or which generate unexpected effects in the organism,” said Dr. Guillen.
It was also reported the trials of Soberana 01 and 02 have had satisfactory results without serious side effects. It still needs to be determined the level of antibodies the vaccine generates in volunteers.
Once the specialists have evaluated the new vaccination compound, a meeting will be held to analyze the results.
Each lot of vaccine manufactured or imported by Cuba has to pass an evaluation process, and once it is ready, its use is certified.