Mexico will apply the Cuban Abdala vaccine to children under 11 years of age in full controversy over its quality

The recent announcement by President López Obrador that the Abdala vaccine will be the biological one used to immunize children under 11 against covid-19 has sparked controversy over the safety, efficacy and quality of the vaccine for this population. Specialists warn that there is little information available on the quality and safety of the vaccine in minors and insist that the biological still does not have the approval of the World Health Organization (WHO) or authorization for pediatric use. the Federal Commission for the Protection against Sanitary Risks (Cofepris).

In the balance of his tour of Central America and the Caribbean made earlier this week, López Obrador reported that as part of the cooperation agreement on health, access to doses of the Abdala vaccine for minors was agreed. “We are going to acquire a vaccine that they are producing for very young children that has given them very good results. They are vaccines for children, for little ones, basically for covid-19 from two years of age and older in the first stage, ”he declared at the National Palace, without giving more details.

The president has taken for granted the acquisition and application of this biological in this age group, despite the fact that the Committee of New Molecules of Cofepris —made up of a group of external specialists— has not yet issued the authorization for the emergency use of this biological in minors. In Mexico, the only vaccine endorsed so far for children over 5 years of age is Pfizer, however, the Government does not have sufficient supplies to start their immunization against the coronavirus.

Andreu Comas, doctor and academic from the Autonomous University of San Luis Potosí (UASLP) warns that there is a risk that there is no public evidence of the phase one and two studies of the Abdala vaccine in minors. “It’s still safe and effective, but without the evidence we can’t make decisions,” he says. For the doctor, it is worrying that one of the main arguments of the Government to endorse its acquisition is only the massive use of the biological in the Cuban population.

The infectologist Alejandro Macias considers that at this time there is not enough evidence on the effectiveness of Abdala. “I do not doubt that the Abdala vaccine can be safe and effective, however, safety is acquired through knowledge of the studies that support a biological product and I believe that in this case they are not enough, unfortunately. We do not have these elements of the vaccine, particularly in children”, he refers.

Mauricio Rodríguez, spokesman for the University Commission for the Attention of the Coronavirus Emergency, UNAM, points out that the Abdalá vaccine is in the process of being evaluated by the WHO. The expert specified that the biological developed in Cuba uses a platform of recombinant proteins that is used in many other vaccines, for example, in the hepatitis B vaccine. “In Mexico, they will surely submit the information they have on this group of age to the group of specialists external to Cofepris that evaluates the information and whether or not it is sufficient to know whether or not it can be used in minors and they are the same committees that have evaluated Pfizer’s vaccines, all the ones we have. Suddenly there is an unnecessary concern of trusting Cofepris for some things and not trusting Cofepris for others”, he comments.

The specialist specified that the publication of the results of clinical studies is desirable and necessary from the technical and scientific point of view, but it is not a regulatory requirement for the authorization of vaccines. “One thing is that they have the information, but do not make it public and do deliver it to the regulatory authority, another thing is that they do not have it, then the regulatory authority is precisely what has to be reviewed. It is also not right that doubts be raised about this Abdala vaccine, which may possibly bring it, because people are not going to want to use it. That they do not have an article published in Lancet it does not mean that the vaccine does not work ”, ditch.

Rodríguez emphasizes that the work of reviewing the pediatric use or not of the Abdala vaccine will be carried out by Cofepris, above all, he added, considering that there are not enough biologicals for minors in the world and that Pfizer cannot afford to immunize children. all the countries. “I am giving the benefit of the doubt (to the Abdala vaccine) so that my regulatory entity is in charge of evaluating it,” he concludes.

The Center for State Control of Medicines (Cecmed) of Cuba approved the application of this vaccine in its population since July 2021, after verifying an efficacy of 92.28% against covid-19. Venezuela, whose government maintains ties with the Cuban regime, included Abdala in its immunization campaign since the summer and months later, Nicaragua joined the list of countries that gave their support to the Cuban biological in adults and children.

Cofepris authorized the use of the Abdala vaccine in adults since December 2021. At that time, the regulatory entity announced in writing that the biological meets the requirements of “quality, safety and efficacy.” The scheme for a person over 18 years of age of this biological requires three doses, so, if used in the population of 5 to 11 years in Mexico, a supply of around more than 33 million vaccines per year would be required.

Since the beginning of the pandemic, the vaccination of minors has not been a priority for the federal government, considering that they are not a population at risk. As of May 9, Mexico registered 97,642 minors infected with coronavirus and 956 deaths. 56% of the confirmed cases were registered in children between 12 and 17 years old, 25% in children between 6 and 11 years old and the rest in children between 0 and 5 years old, according to figures from the National System for Comprehensive Protection of Girls, Boys and Adolescents.

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