Biotechnology made in Cuba shows its strengths once again. The Center for Genetic Engineering and Biotechnology (CIGB) has submitted the technical file of their first vaccine candidate against COVID-19 to the State Center for the Control of Medicines, Medical Equipment and Devices (CECMED).
This step is essential to request authorization for clinical trials in humans, sources of the BIOCUBAFARMA business group report.
It was also revealed that the first Cuban vaccine candidate against this lethal disease, also known as SOBERANA 1, had promising preliminary results. The source explained that no adverse or serious side effects were reported, but it still remain to assess the behavior of the trial and to process the samples to see if the vaccine actually created antibodies, as expected.
In late August, the Finlay Institute for Vaccines (IFV in Spanish), the leading institution in the research and manufacture of vaccines in Cuba, started the clinical trials of the first Cuban vaccine candidate against the new coronavirus, named Soberana 1.
Dagmar García Rivera, head of Research at the IFV, informed in her Twitter account that the phase I of clinical trials of the second vaccine candidate, named Soberana 2, starts today, following its approval by CECMED. This is the only project of a conjugated vaccine against this pandemic.
“Everything is ready to start the clinical trials of SOBERANA 2. Professionalism, rigor and ethics are at the essence. Our commitment with the health of our people…We will get there and we will prevail,” she tweeted.
“Once more, we will serve as an example of how the government-health-science alliance can achieve anything, when the health of the people is their priority,” the scientists wrote.
Eduardo Martínez Díaz, president of BIOCUBAFARMA, said that the strategy to obtain new vaccines against COVID -19 is going well. “We will have four candidates in clinical trials before 2020 ends.”
“In 2021, our population will be immunized against this virus. Cubans can trust their scientists and their commitment to the Homeland,” he added.
Martínez Díaz explained that there are many researchers working hard, putting their expertise, work and heart into the efforts.
“Just like we ask our people to trust their scientists, we would like to ask them, as long as there is no vaccine against COVID-19, to follow all measures established in the phase we are in. We can not let our guard down, not even a bit,” he said.
In Cuba, every batch of vaccine must undergo a rigorous assessment process, and once it is declared ready, it is certified for use.
(Taken from Granma)