Despite the harmony shown between the Mexican president, Andres Manuel Lopez Obradorand the Cuban, Miguel Diaz-Canelthe health agreements signed between the two rulers are encountering difficulties typical of the Mexican administration and authorities in the field.
Such is the case of Mexico’s commitment to acquire a vaccine developed by Cuban scientists (Abdala) for the prevention of coronavirus in children two years of age and older, included in the agreements recently signed in Havana.
During López Obrador’s visit, the heads of Public Health of both governments signed “a collaboration agreement that makes it easier to take advantage of all the health and scientific potentialities, of joint efforts and wills” between the two countries in the field of health.
“The World Health Organization (WHO) He has said absolutely nothing about the Cuban vaccine (Abdala). Cofepris has not approved it to be applied to children two years of age and older and we do not know if it will be done, because nothing has been said, and until there is something concrete [no] we can evaluate and give our opinion about it,” said Miguel Ángel Piza Jiménez, head of Health at the Federal Commission for the Protection against Sanitary Risks (Cofepris).
At the end of last December, the entity granted the Emergency Use Authorization for the Abdala vaccine, which thus became the tenth immunological drug applied by that country against the coronavirus. However, Cofepris has not approved the use (even emergency) of the Cuban vaccine in children two years of age and older.
While said authorization arrives, the state government will focus on the application of the Pfizer vaccine among the population aged 12 to 17, he told Page 24 the official of the entity.
At the end of April, Mexican pediatricians expressed their concern about the possible application of the Abdala vaccine against COVID-19 in children five years and older in that country. “The Abdala vaccine could be an excellent option,” said the Mexican Undersecretary of Health, Hugo López-Gatell.
However, Mexican pediatric specialists consulted by the newspaper Excelsior They were alarmed at this possibility.
“The only vaccine against COVID-19 that has been published, that has been reviewed by health authorities and that has been approved for use in children aged 5-11 years is Pfizer with a dose of 10 mcgs. Any other vaccine, Abdala included, has not been authorized by the authorities in charge of monitoring and reviewing its safety and efficacy in this age group,” said Cipatli Ayuzo, a member of the Mexican Academy of Pediatrics.
According to Ayuzo, it would not be “ethical to vaccinate Mexican children with a vaccine that has not met all the requirements.” “Parents should be very aware of this, consult with their pediatrician and only accept Pfizer, regardless of whether Gatell decides to buy Cuban vaccines,” concluded the doctor.
Likewise, the pediatric endocrinologist Oscar Flores pointed out the importance that “all medications and vaccines, especially in children, have the relevant certifications.” And he added: “For now, as pediatricians, we can only recommend Pfizer / Biontech.”
The results of phases I and II of the Abdala clinical trials in adults, carried out at the Saturnino Lora Hospital, in Santiago de Cuba, have just been published in the British medical journal The Lancetbut there is no information on the effects of phase III nor on the application in children.
Its administration is still not validated by the WHO, although countries such as Vietnam or Venezuela have already used it. “They are ideologically playing with health and risking the lives of hundreds of thousands, perhaps millions of Mexicans. This vaccine does not have the required protocols to be approved anywhere,” tweeted Felipe Calderón, Mexican president from 2006 to 2012.
At the end of last January, the Cuban Center for Genetic Engineering and Biotechnology (CIGB) had announced the start of a clinical study to determine if the Abdala coronavirus vaccine could be administered to children under two years of age.
For his part, the president of the Cuban state biopharmaceutical complex BioCubaFarma, Eduardo Martínez Díaz, recognized at the end of April the responsibility of Cuba in the delay to obtain the WHO opinion on the Abdala vaccine.
“The WHO is a serious organization” that “is not delaying the process,” the official said at a press conference, admitting that the cause of the “small delay” was due to an “internal element” of his institution.
Martínez explained that Cuba focused on its “own strategy” that prioritized the manufacture of vaccines and their massive application. For this reason, the decision was made to concentrate the production of vaccines in a new plant located in Mariel, which must be inspected by the WHO as part of the validation process of this organization.
The transfer of the production of these vaccines to Mariel caused delays in the delivery of documentation by Cuba, which has had to be adapted to reflect the characteristics of the new facilities.
Cofepris is the reference National Regulatory Authority (rRNA) in Mexico and is qualified by the Pan American Health Organization (PAHO), and its decisions are recognized by various countries in the region, so the vaccines it approves for use are likely to be used in other nations.
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