Soberana 02 in phase III clinical trials. What does it mean?
The excellent results obtained so far with the Cuban vaccine candidate in phases I and II have allowed it to be one of the 23 that have started phase III of clinical trials in the world.
Tahimi Arboleya
On March 3, the Center for the State Control of Medicines, Equipment and Medical Devices (CECMED) gave authorization for one of the Cuban vaccine candidates that are being developed to begin phase III of clinical trials in humans. Several of the main world media: The New York Times, CNN, BBC, El País reported the news. And the thing is that Cuba is included in a small list of countries—almost all of the first world—that have been able to develop vaccine candidates against SARS-CoV-2, and the first country in Latin America to reach this advanced phase of trials.
In order to be approved, vaccines must follow a strict protocol that includes the exploration stage, the pre-clinical trials and the clinical trials in humans, the latter, in turn, consisting of three phases.
Final approval for the use of vaccines in humans is granted by regulatory bodies in each country. These must have the status of Competent Authority for the vaccine regulatory system granted by the World Health Organization (WHO).
What has happened to the COVID-19 vaccines and what is an approval for emergency use?
The scientific community—public and private entities, research centers, universities, pharmaceutical companies, enterprises and NGOs—has collaborated as never before in the history of science and health to achieve a cure for a pandemic crisis. More than 100,000 scientific articles have been published on this subject. More than 4,800 ongoing studies on treatments and vaccines are registered. We know more about SARS-CoV-2 and COVID-19 than about other diseases that the scientific community has been studying for decades.
According to the WHO, until March 5 against were 79 COVID-19 vaccine candidates in clinical trials and 182 in pre-clinical trials. Several of these have been approved by the regulatory bodies of some countries and two vaccines (Pfizer and AstraZeneca/Oxford) are approved for emergency use by the WHO.
The development and approval of a vaccine is usually a long process that can take between 5 and 15 years, so many are surprised that just over a year after the start of what became the COVID-19 pandemic, there already are vaccines against the disease.
Several factors have influenced this: the priority given to it, the collaboration among the international scientific community, the achievement of rapid funding, the response of the regulatory bodies to redesign protocols that allow the overlap of some phases, and the development achieved by biotechnology in the world.
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