The company leading the investigation would have proposed to install a vaccine plant in the country with private money; the Government manages its own initiative.
In June next year will conclude on clinical study phase 3 of the Zifivax vaccine against coronavirus from Chinese genetic engineering technology company Anhui Zhifei Longcom of which Ecuador is part.
The study seeks to evaluate the efficacy and safety of the vaccine in people over 18 years of age. In the country, the investigation is carried out by the medical services company Biodimed.
Worldwide, 30,000 people participated and in Ecuador about 5,000 patients, who are currently being evaluated after having received or three doses of the vaccine (day zero, day 30 and day 60) or placebo.
Once phase 3 is over, you go to regulatory approval for sale.
There was announcement to interested parties through databases. They signed an informed consent as the benefits and risks were explained to them. Pregnant women, minors, people with active cancer, people with a history of allergies to vaccines, among others, were not part of it.
To carry out clinical studies requires the authorization, approval, review of the Agency for Regulation, Control and Sanitary Surveillance (Arcsa) and an ethics committee, indicated Hugo Vergara, manager Biodimed.
Iván Sisa, who chairs the Ethics Committee for Research in Human Beings (CEISH) of the Universidad San Francisco de Quito (CEISH-USFQ), mentioned that the entity reviewed and approved the study protocol that referred to how the study will be carried out, objectives, methodology, analysis, follow-up of participants.
“You see if there are COVID cases, you see how the antibodies are doing, you see if there are adverse events associated with the administration of the vaccine, etc., as with all other vaccines worldwide. Our experience has been that we have not seen a single adverse event seriously associated with the administration of the vaccine (…) your arm can always hurt a little, some discomfort, temperature … ”, said Vergara.
Sisa added that it is the first study of its kind to be carried out in the country and opens the door to incentivize research high level.
The first day of vaccination with a recombinant dose against COVID-19 was given with the first volunteers in Quito and Guayaquil
Vergara added that according to preliminary results, this drug is 100% effective for prevent -in general- serious cases and mortality from coronavirus.
Worldwide they have been vaccinated more than 200 million people from China, Uzbekistan, Malaysia, Indonesia, but in Ecuador it could not be done because does not have a health registry and that could be obtained once it is included in the list of the World Health Organization (WHO) where it is not yet recorded.
According to Vergara, this Chinese company has expressed interest in installing a production plant of vaccines against the coronavirus for 90 million doses annually without local investment. Ecuador would have preferential prices. The condition would be that the authorization for emergent use is extended and commit to purchasing 5 million doses each year. He affirmed that there has been no response from either the previous or current government.
In December 2020, the Ministry of Public Health in the administration of the Government of Lenín Moreno, announced that Ecuador will participate in this clinical research project. In addition, a technology transfer process was being negotiated with the Zhifei company for the subsequent manufacture of this vaccine and possibly others.
For a vaccine manufacturing plant in Ecuador there would be a strategic partner and international support
On November 24, the Minister of Health, Ximena Garzón, He noted that they were working on a vaccine factory assembly plan.
“We are going to work on the legal part. We have already we have an excellent proposal together with INSPI (National Institute for Public Health Research), ESPE (University of the Armed Forces); We are working very quickly on our assembly plan for the vaccine factory and also for biosimiles ”, he mentioned to the official.
Garzón added that the regime is developing the proposal for the construction and implementation of the plant and being a proposal for a public-private relationship are open to countries such as United States, China, Israel, Belgium They can collaborate and the Executive will determine what are the best options for a strategic partner.
It is not ruled out to extend the clinical study project so that those who received the placebo have access to the vaccine.
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