Vaccination against the coronavirus for children between the ages of five and 11 began this Wednesday in Spain. The pediatrician Ignacio Salamanca de la Cueva leads from the Hispalense Institute of Pediatrics (IHP) in Seville one of the 80 centers around the world that are participating in the clinical trial of the Pfizer preparation, which is inoculated to these children. The doctor has been working with 3,100 children for six months and in the interview he has given to EL PAÍS he sends a message of reassurance about the effectiveness of the vaccine and the importance of applying it in this age group. “The vaccine is safe and is 97% effective, and clinical trials are much more demanding than in adults because we are talking about the most sensitive and vulnerable population,” he says. The pediatrician also draws attention to the importance that these children attach to being vaccinated: “They have the right to regain their normalcy and they have the feeling that they are protected.” The next step is to study your degree of immunization against the virus.
Ask. What were the clinical trials at the IHP to test the vaccine in children ages 5 to 12?
Answer. We have worked with vaccination from five to 12 years, which is the age cohort that was chosen for the clinical trial. But it is a study that does not only focus on vaccination. The children who have participated, from which the first data have been obtained that have led to the authorization of the vaccine by the FDA (Food and Drug Administration of the United States) and by the EMA (European Medicines Agency), they will continue in the clinical trial to study everything that has to do with the persistence of immunity. The follow-up will be 26 months.
P. How many children are they working with?
R. With about 3,100. The effectiveness that has been determined is 97%
P. Were you fine-tuning with the specific dose to apply at these ages or were you already clear about what it should be?
R. This is a practice that is done in all clinical trials in which we go from adults and healthy to the goal of vaccinating the youngest. To guarantee your safety, we go from older to younger and then a dose escalation is made, the minimum dose that is effective and efficient and that also has fewer side effects is sought. In this case, the choice in children has been 1000 picograms because that is the dose that has the most effect or that supposes sufficient efficacy and that guarantees that they are well tolerated, as has been seen in this way. [la dosis que se aplica a niños es un tercio de la administrada a adultos].
P. Are the side effects similar to those of adults?
R. They are practically the same: headache, possibility of fever, sensation of muscle aches … What we have noticed and we have been surprised is that, in our case, practically the children had no side effects, that is, they have tolerated the vaccine better. than adults
In our case, the children had practically no side effects
P. In view of the new strains, what do you recommend?
R. That is a decision of the health authorities. From a research point of view, what we do is try to provide answers and data on everything that has to do with vaccination, to which future data on persistence must be added. This week, six months after the start of the investigation, we will do a preexistence test on the children and we will do it again when they complete one year of vaccination and when they turn two. We will have data to verify how and when antibodies exist in children
P. Therefore, it is not yet known if the effects of the vaccine last longer in children of this age group?
R. Indeed. It will take a year or two. These children, as I said, are going to be generously involved to give us data, in this case of the persistence of antibodies, and it will be extremely important to see if and when a third dose will be necessary. We will provide all this from clinical trials
The covid vaccine is compatible with the rest of the vaccination schedule
P. Is the covid vaccine compatible with the rest of the vaccination schedule?
R. Yes. No vaccine that is already specified should be delayed.
P. What would you say to parents who are reluctant to vaccinate their young children?
R. All vaccines that are authorized are because they are safe and in this case this vaccine is safe and well tolerated. We know this from clinical trials. But one important thing is that we will not be the first to vaccinate. There are countries like the United States, with more than five million vaccinated children who are being closely monitored and that also gives us a lot of security. Another important thing is that, although it is true that children are not the age group that has suffered the most from the disease, there is a small percentage of complications that concern us from pediatrics and in this case it is worth it. if we have a preventive tool, protect the pediatric population, because they are part of society and may be at risk.
And I think there is an important concept and that is that children also have the right to regain their normality under the protection of the vaccine. The emotional shock they get when they see themselves vaccinated is brutal. During the clinical trial, children who have lived through this pandemic see vaccination as part of the solution to this pandemic. And finally, obviously if we want group immunity we have to vaccinate children because right now we are in the pandemic of the unvaccinated. We cannot have a population group that we do not vaccinate because they do not suffer from the disease to a great extent.
The pediatric population is worth protecting because they are part of society and may be at risk
P. Has it been clarified whether children are a major vector of transmission of the virus or affects them to a lesser extent?
R. Now we know that most of the infections in children have come from adults. And children are the age group in which, since they are not vaccinated, the virus will especially circulate. From pediatrics, what we have seen is that the number of cases in children in recent months has increased, just as the rest of infectious diseases have increased.
P. That emotional impact of the vaccine on children that you referred to earlier, is it the general feeling that you have felt with the children during the trials?
R. It is the first time that when we have explained to the children what we were going to do, we have seen that they came absolutely motivated. You asked them why they wanted to get vaccinated and the answers were exciting: because I want to see my grandfather and I don’t want to infect him, because I want to protect myself, so that my little brother is calm… We have found that all children had a concept of altruism, of getting vaccinated for the good of others.