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The Clinical Trial Milestone on Soberana 02 Vaccine through over 44010 Volunteers

2021-04-06 19:34:42 / web@radiorebelde.icrt.cu / JC Caballero Puig

The Clinical Trial Milestone on Soberana 02 Vaccine through over 44010 Volunteers

As part of the clinic essay of the third Phase of the Cuban Soberana 02 vaccine strain, it was achieved in only 18 days to complete the related
recruitment of 44010 subjects, and concluding the first dosage administration of the first vaccine dosage to all the volunteers.

Ph.D. María Eugenia Toledo Romani, who is the main researcher of the clinical essay, considers a milestone of a research that has involved 31
sites and 48 vaccines.

“It has been a great effort of the local health system to have research equipment ready to check the subjects before entering the vaccination
process, checking each one of the diseases suffered by the volunteers, clarify their doubts, getting the informed consent of those people who can
get or not a Placebo. We did not lack subjects and we did not lack people who say: I also want to be part of it.”

The cooperation between local institutions of the *BioCubaFarma* group, the *GeoCuba´s *support, the support by three universities, including the one by the *Medical Science University*, *CUJAE* and the University of Havana, as well as the Party and Government of Havana city, and 8 municipalities, has been decisive.

“28 days after the first dosage, the participants will get their second one, and the ones who are part of the three administrations program of that
vaccine, 56 days after the first day, they will get the third dosage.” Dr*. *María Eugenia Toledo Romani from the Kouri Tropical Medicine Institute
(IPK) said.

“We have two groups, a group of subjects that is going to get two dosages of the local *Soberana *02 vaccine, and another one will get the Placebo.” She said.

The Clinical Trial Milestone on Soberana 02 Vaccine through over 44010 Volunteers

As part of the daily conference about the covid-19 situation, the aforementioned expert explained the Placebo procedure for those who will be
getting it. 

“The people who were vaccinated the Placebo at the end of the research will be benefited through the program including the best results in terms
of efficiency and individuals who got two dosages, if it is proven what wat the best program of the three ones, then they will get the third dosage
left.” She highlighted.

Regarding the time of the third phase of which its main purpose is measuring the efficiency, the main researcher recalled that it is about a
study with an adaptive design, which means partial cuts of the results.

“It is very likely not to get to the final of the research to know about its efficiency, and we could then present the file to register that vaccine
that opens the path to be used for all the population.” She said.

The adverse events registered are the expected ones such as the redness of the zone vaccinated, a general unease and fever, while it is considered as serious the fact about being hospitalized in the middle of a clinical essay because of a covid-19 infection in that case.

“It is possible to be infested by the covid-19, especially when the three dosages are not finished, which with the expected antibodies levels are
achieved.” Doctor, María Eugenia Toledo Romani pointed out.

The Clinical Trial Milestone on Soberana 02 Vaccine through over 44010 Volunteers

“The idea is that a person does not get to that disease´s serious stage by getting into asymptomatic forms or non-intense ones.” She said.

Dr*. *María Eugenia Toledo Romani considered as encouraging the related results which are being obtained thus far.

“There is a lot of confidence by the population because there is also a lot of rigor in the science that is being applied into these researches. There
are very encouraging results of the First and Second Phases, and after 44000 dosages applied.” She said.

Though the use of the local Soberana 02 Vaccine strain, it is carried out a controlled research that involves 74665 health workers, and the ones of the BioCubaFarma business group, and according to Twitter account of BioCubaFarma there were 47266 subjects who had got the first dosage until
March 27th.

By Claudia Díaz Pérez

© Radio Rebelde - 2020
© Radio Rebelde - 2020