The next stop in vaccination will be the girls and boys. The Public Health Commission, made up of technicians from the Ministry of Health and the communities, has given the green light this Tuesday to the immunization of minors between 5 and 11 years old, for whom there was still no authorized vaccine against COVID . After the approval of the European Medicines Agency (EMA for its acronym in English) and the favorable position of the experts of the Vaccine Conference, Spain has decided to administer it at a time when this age group leads the infections.
EMA approves Pfizer vaccine for children 5 to 11 years old
This has been one of the compelling reasons that has made technicians opt, since pediatric vaccination opens a scientific and ethical debate because the effects of the coronavirus in children are different from those in adults. However, the next step is for the Interterritorial Council to endorse the decision soon and the vaccines arrive, which are expected in mid-December. These are the main keys:
What vaccine is it?
The only one that the regulatory agencies have so far authorized is Comirnaty, the one developed by Pfizer-BioNTech, the first that obtained favorable results in the trials. However, the European Medicines Agency is already evaluating the pediatric use of Spikevax, Moderna’s vaccine.
How effective is it?
The trials gave a vaccine efficacy of 90.7% in preventing infection in minors.
What dose will they be given?
For younger children, the serum contains 10 micrograms (µg), one-third of the dose used for all other age groups, which is 30 micrograms. Two doses will be administered eight weeks apart and will be dispensed in different vials than those used for the adult population.
The arrival of the first batch of vaccines is scheduled for December 13, so Health expects the campaign to begin two days later, on December 15.
How many boys and girls?
In total, there are about 3.3 million minors in this age group registered in Spain, according to the INE. The distribution of vaccines to the autonomous communities will be done, as has been done from the beginning, depending on the target population in each territory.
What side effects can they have?
As with any vaccine and also in the adult population, the trials saw mild and moderate side effects: pain at the injection site, fatigue, headache, myalgia, and general malaise that disappeared within 24-48 hours. .
Its application in adolescents has led to some cases of myocarditis not observed in trials, generally brief and generally resolved with little treatment. Based on this, the European Medicines Agency (EMA) has done a risk-benefit analysis in children under 12 years of age in which it compares the cases, hospitalization and deaths from COVID avoided with the vaccine with the risks of myocarditis. His conclusion is that vaccinating them is favorable in all scenarios, but, above all, in those with a high incidence.
The Spanish Association of Pediatrics, which has published a positioning in which he recommends the vaccine points out that the chances of suffering one of these adverse events “decrease with the age of children” – most have occurred in men over 16 years of age -, which added to the fact that the number of doses for the pediatric vaccine it is lower “it is very likely that the risk of this complication is much lower than in adolescents”.
What is your level of contagion?
Currently they are the population group that leads the infections, as can be seen in the graph.
How will it be done?
As advanced by the Minister of Health, Carolina Darias, the autonomous communities will be in charge of establishing “the modality” of vaccination. Some, like Murcia, have already indicated that it will take place in the so-called ‘vaccination fields’, something that Galicia is also considering, but most are now finalizing the details of the plan.
Are there countries where children are already being vaccinated?
In the United States, Canada, China or Israel they have begun to immunize children under 12 years of age with Pfizer. Chile, a pioneer in pediatric vaccination, began the administration of the Chinese drug Sinovac weeks ago. In Europe, some like Germany or France have already decided that they will do it when the doses arrive.
What has been the debate?
The point is that, as the age decreases, the chances of becoming seriously ill from COVID-19 and dying are also less. Children do not suffer the consequences of the coronavirus in the same way as adults, so the risk-benefit balance is different. Adverse effects from vaccines are extremely rare, but they are not zero. The chances of minors suffering from severe COVID are not non-existent either, but they are very rare and most occur in minors who have previous pathologies.
To evaluate the decision, to this we must also add the role they play in the control of the transmission. According to the review made by pediatricians of a dozen Spanish hospitals and research networks published in the journal of the Spanish Association of Pediatrics (AEP), minors are not great contagion of COVID: “They rarely cause supercontagion events and appear to be less infectious than adults. ” However, they currently lead the incidence of the sixth wave.
What reasons does Sanidad give?
The objective for which the Public Health Commission is committed to extending vaccination is to “reduce the burden of disease” in this age group “and transmission in the family environment, educational centers and the community.” He also believes that it can protect “not only against the disease in its acute facet”, but also “against possible future conditions and against the persistent COVID syndrome.”
What do the experts think?
“The risk-benefit balance is different than in adults, but it is clearly favorable”, points out Francisco Álvarez, coordinator of the Vaccine Advisory Committee of the Spanish Association of Pediatrics. Among the reasons: “the vaccine has been authorized, we need children to achieve herd immunity and to reduce the circulation of the virus and the disease is mild in them, but the risks are not zero. Why are we going to run them if do we have a safe and effective product? “he asks. There is also another reason: the need to “normalize” their school life, which is still subject to restrictions, and thereby promote their “psycho-emotional well-being”.
A good part of the expert voices are opting for pediatric vaccination due to the current level of incidence of infections, with the sixth wave on the rise. Quique Bassat, epidemiologist and pediatrician at the Barcelona Institute for Global Health, thinks that the decision should be conditioned by the epidemiological moment, and now believes that “if we do not vaccinate children, it will cost us more to straighten the curve.” Like other specialists, a few months ago “I believed that it should be an option for each family and not so much a mass public health recommendation”, but now “it is different; the incidence is growing steadily, children are the protagonists of new infections and there are evidence of an outbreak in schools “.
Will it be key to controlling the transmission?
The pediatrician and epidemiologist points out that “it is still not very urgent to vaccinate them to protect them”, but “things change at the collective level.” And even more so “given the potential risk of new, more infectious variants, we cannot trust that they are not very contagious and that they will transmit little because right now reality is telling us that new infections are leading, something that had not happened.”
The European Center for Disease Prevention and Control (ECDC), which issued a technical document on the matter last week, he also made this point and assures that the data indicate that childhood vaccination “could reduce transmission in the entire population.” An impact that will be more pronounced in those countries that, like Spain, have high levels of vaccine acceptance. Still, ECDC insists that “the top priority” in controlling the pandemic must remain to increase the overall vaccination rate.