The efficacy achieved in clinical trials by two of the formulas that Cuba is investigating against covid-19, 62% and 92%, about the possibility that one of them will become the first vaccine of this type developed in Latin America.
The preliminary results of the third and final stage of testing of the vaccine candidates Soberana 02 and Abdala were released between Saturday and Monday, unleashing euphoria in Cuba, which has bet everything on its own vaccines by not entering the WHO Covax mechanism or buying them on the international market.
The World Health Organization (WHO) establishes that for a vaccine candidate to be considered a vaccine it must demonstrate an efficacy equal to or greater than 50%.
Soberana 02, from the Finlay Vaccine Institute (IFV), showed 62% efficacy in the volunteers, while Abdala, from the Center for Genetic Engineering and Biotechnology (CIGB), was tested with a sample of 48,000 people in a scheme of three dose and reached an efficiency of 92.2%, sAccording to data disclosed by those institutions.
A dose of Sovereign II against covid-19 in the Vaccine Container and Aseptic Processing Plant of the Finlay Institute in Havana (Cuba). Photo EFE
Both are subunit vaccines based on receptor binding site (RBD) of the virus protein S, although in the case of Soberana 02 this element binds to the inactivated tetanus virus to enhance the body’s immune response.
Emergency use
“The efficacy of Abdala for symptomatic cases it’s an impressive index which is positioned at levels similar to those obtained with vaccines that use novel technologies such as messenger RNA or adenoviral vectors, “the Cuban molecular biologist and researcher at the University of the State of Sao Paulo (UNESP) Amilcar Pérez Riverol told EFE.
The scientist, a former CIGB researcher, stressed that the formulas “have already proven to be effective in reducing cases, hospitalizations and deaths” and added that the results obtained by Soberana 02 with two doses are a good indicator that suggests that with the application of a third dose of Soberana Plus (another of the Cuban candidates under investigation) “It should increase to rates close to or even higher than 80%.”
The responsible institutions have announced that will request authorization shortly of emergency use to the regulatory body in Cuba, the Center for State Control of Medicines, Equipment and Medical Devices (Cecmed).
Both formulas already are being administered to tens of thousands of Cubans under the figure of health intervention studies and in parallel to clinical trials, as a strategy to curb infections on the island, which is going through the third and worst wave of the pandemic.
Once the green light of the Cecmed is obtained, the process to get international validation of the two Cuban vaccines.
A nurse applies a dose of the Soberana-02 vaccine candidate to a man at a health center in the El Vedado neighborhood of Havana. Photo Xinhua
“Almost all the other vaccines already approved produced a well detailed press kit of the interim phase 3 analysis that led to the efficacy announcement. This would be highly recommended it would not be necessary to wait for the time required for publication in peer-reviewed scientific journals, which is usually longer, “the expert considered.
Clear suspicions
He also recalled that “the publication in this type of magazines of the results of Phase 1/2” is pending and warned that “it is vital that there begins to be reviewable data “ on these types of platforms. Then, “in a less immediate but very important period, there would be the sending of the files to obtain the certification of the World Health Organization (WHO), explained Pérez Riverol.
Although these steps are not essential for the use of Cuban vaccines on the island, they would contribute to clear the doubts of critical groups with the Cuban Government who question the veracity of these results, especially given the serious crisis that the country is going through.
This situation has resulted in a rampant shortage of commodities, including drugs, which has led many to wonder how it is possible for Cuba to develop vaccines when antibiotics and even aspirin are lacking.
“The lack of basic medicines is regrettable because, like covid-19, has a profound impact on people’s health. But synthesizing an antibiotic and making a vaccine are different processes, “said the scientist.
Thus, he recalled that Cuba has a history of “more than 35 years of investment in human capital, experience in working with vaccines and investment in infrastructure for research, development and production of vaccines and equipment associated with this type of technology “.
“That is what has allowed that when the pandemic arrived, Cuba was in perfect condition to develop a vaccine against covid “without having to make a large investment or divert resources from other imports, he added.
Another “crucial” element, according to the expert, is that due to state centralization there is a “very strong intercom among all the institutions that can contribute to obtaining this result “, and at the same time with the Ministry of Public Health.” Without that it would not have been possible to carry out clinical trials so quickly, and without clinical trials you have nothing “, added.
These results also open the door to potential exports of Soberana 02 and Abdala, in which countries such as Argentina and Venezuela have already shown interest, to which is added the recent announcement by Iran that this week it would approve the emergency use of the first of them.
Source: EFE
PB
source https://pledgetimes.com/the-effectiveness-of-cuban-formulations-of-vaccines-against-the-coronavirus-opens-up-hope-for-latin-america/
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