Cuba is officially the first Latin American country with its own vaccine against covid-19. The Center for State Control of Medicines, Equipment and Medical Devices (CECMED) - the Cuban regulatory authority - authorized this Friday the emergency use of Abdala, one of the five vaccine candidates developed on the island, which showed an effectiveness of more than 92 % with the application of three doses in the last phase of clinical trials, according to data from the Center for Genetic Engineering and Biotechnology (CIGB). Thus, Cuba takes the first step to request the WHO prequalification and international validation of Abdala, a procedure that requires rigorous reviews, scientific verifications and exchanges, and can last months.The approval of Abdala by the Cuban regulatory authority is announced when the island suffers the worst outbreak of the epidemic, with thousands of daily cases and dozens of deaths, a dramatic and upward curve that broke all records yesterday, with 6,422 infected and 28 deaths, almost double than the previous day.
The authorization for the emergency use of Abdala, created by the CIGB, was issued once confirmed by the regulatory authority "that it meets the requirements and parameters demanded in terms of quality, safety and efficacy."
CECMED claimed to have carried out a "rigorous evaluation process of the file presented on Adbala", including inspections of the plants involved in the production process of the drug and the analysis of data from the clinical trials of phases I, II and III (this last still running), to which the vaccine was subjected.
According to the regulatory authority, clinical trials have shown an efficacy of 92.28% "in the prevention of symptomatic forms of covid-19", and also that Abdala has "an adequate safety profile, supported by the number of doses applied in the clinical trials carried out, the intervention study in risk populations and the health intervention carried out in the country ”.
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Cuba is currently working on several vaccine candidates against covid-19: Soberana 01, Soberana 02 and Soberana Plus, which are developed by the Finlay Vaccine Institute (IFV);
in addition to Abdala and Mambisa (the latter has the peculiarity of being administered by nasal spray), created by the CIGB.
All Cuban prototypes are protein subunit vaccines, which are based on inoculating a protein from the coronavirus spike, the part that binds to the cells it infects, to produce an immune response.
The difference is that in the three of IFV the antigen is made in mammalian cells, while the CIGB develops the protein fraction of the coronavirus in yeast cells.
On Thursday it was announced that Sovereign 02, the other most advanced vaccine candidate, has shown an effectiveness of 91.2% in the third phase of clinical trials - not yet concluded - with the combination of two doses of Sovereign 02 and a booster of a dose of Soberana Plus. In the coming weeks, its emergency use could also be approved, with which the island would have two vaccines against covid-19.
In a recent interview with EL PAÍS, the representative on the island of the Pan American Health Organization (PAHO), José Moya, assured that CECMED is considered one of the eight reference centers in the region, and that after its validation of these vaccines can be marketed internationally, even without being prequalified by the WHO. “Countries have autonomy to make bilateral agreements. If there is a country interested in acquiring Cuban vaccines, PAHO and WHO do not participate because those are direct agreements, ”Moya indicated. “At the WHO there is a follow-up, and once the vaccines are approved in Cuba [which has just happened with Abdala] the other step is to publish the data in scientific journals and request prequalification. If approved by WHO,Cuban vaccines could be part of those distributed by the COVAX mechanism or by the PAHO Revolving Fund, ”said the Peruvian epidemiologist. "If all goes well, before the end of the year Cuban vaccines could join the eight already prequalified so far in the world," said Moya.
This scientific success contrasts with the serious epidemiological situation facing the country, the worst since the beginning of the pandemic. For months the island managed to contain the spread of the coronavirus, maintaining the number of infections in only dozens of daily cases, but in recent months infections have multiplied exponentially. First there were hundreds of daily cases, and in recent days there are already thousands (on Thursday 6,442, on Wednesday more than 3,800). This has caused the collapse of medical services in provinces such as Matanzas, with an incidence rate of more than 1,000 cases per 100,000 inhabitants in the last 15 days. This situation is further exacerbated by the rampant crisis that the country is experiencing,plunged for more than a year in a draconian shortage that forces people to queue for hours to buy basic necessities and when the most basic medicines, such as antibiotics or painkillers, are lacking.
The situation in Matanzas is extremely difficult, to the point that the Government has sent to help members of the Henry Reeve medical brigades, which Cuba usually sends on international missions when there are humanitarian catastrophes.
They had never been deployed within the country before.
More than one million of the 11.2 million Cubans have received the complete Abdala or Soberana 02 regimen as part of clinical trials and "intervention studies" in populations and territories at higher risk.
The purpose of the health authorities is to have 70% of the island's inhabitants vaccinated in September, and 100% before the end of the year.
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