So far, only the covid-19 vaccine Developed by the pharmaceutical companies Pfizer and BioNTech, it has been authorized by the European Medicines Agency (EMA) to be administered to adolescents from 12 years of age. It was in May and since then Spain prioritized adolescents and pre-adolescents at high risk of becoming seriously ill from COVID-19 or dependent on their immunization strategy. Moderna’s vaccine, also based on messenger RNA, is still pending approval from the US regulator (FDA) and the EMA for 12 to 18-year-olds. But what about the boys and girls under 12 years old? Will they also be vaccinated against covid? The Minister of Health, Carolina Darias, has conditioned this next step to the availability of scientific evidence.
At the moment only the companies Pfizer/BioNTech have obtained the approval of their vaccine in adolescents up to 12 years of age and, according to company sources, the phases 2/3 of clinical trials to evaluate the safety, tolerability and immunogenicity of its vaccine (BNT162b2) in boys and girls from 5 to 11 years. What’s more, plans to start studies in minors 6 months to 5 years “In the next weeks”.
The forecasts of the pharmaceutical company, consulted by 20minutos, point out that, if the safety and immunogenicity of the vaccine are confirmed in these age groups, they calculate that will present your vaccine for a possible approval from the US FDA “sometime in September-October” for minors between 5 and 11 years old, “and shortly afterwards” for those between 6 months and 5 years old. Considering that the approval for the 12-15 band was done almost in parallel at the FDA and the EMA, experts believe that the same will happen for those under 12 years of age. According to an FDA member cited by NBCNews, the subsequent authorization could arrive “in the middle of winter”.
Pfizer’s vaccine pediatric clinical trial program began earlier this year. Together with their partner BioNTech, they have already completed phase 1, “which has allowed us to know the best dose of the vaccine for children under 11 years old.” Currently, phase 2/3 studies have begun in boys and girls between 5 and 11 years of age and the forecast is to start studies in babies aged 6 months and even under five years of age “in the next few weeks.”
Some 560 Spanish children participate in the trial of Pfizer’s covid vaccine for children under 12 years of age and up to six months of life
Spain is one of the countries that is participating in this trial, which is multicenter and is carried out with small groups in each hospital. The hospitals St. John of God in Barcelona and 12 de Octubre de Madrid are two of the centers participating in this trial, which aims to have a total of about 560 Spanish participants and about 4,600 worldwide. The pediatrician and researcher of the clinical trials unit of the Hospital 12 de Octubre Manuel Gijón is one of the coordinators of the trial that is carried out with approximately 60 volunteers at the Madrid center.
In statements to 20minutos, Dr. Gijón explains that the trial is divided into three groups So what, Of the 60 participants, 43 have already been vaccinated. The first group includes participants from 5 to 12 years old and “it was completed very quickly”; the second, to children from 2 to 5 years old -also with full quota-; and a third cohort of volunteers is between 24 and six months old, and in this “there is still some vacancy.”
The researcher points out that the established age cuts respond to an “arbitrary” criterion established by the pharmacist “based on the data they want to obtain, the doses they want to select, etc. and the approximate weight of the participants”. Under six months, he adds, “it doesn’t make much sense” to carry out trials for this type of vaccine – against an epidemic virus – because normally the antibodies that a baby has up to six months are those that the mother has transferred to it during pregnancy through the placenta.
The two doses are also 21 days apart and the side effects being seen are “minor and milder” than those seen in the adult population.
Gijón details that the interval studied in minors is also 21 days between the two doses, and that these are a third of the adult guideline (30 micrograms) for those between 5 and 12 years old and ten times less for the youngest, from five years to six months.
With trials they seek two outcomes: efficacy and safety. Efficacy is measured by assessing immunogenicity (production of antibodies) and disease prevention, which requires a follow-up of months. Safety is observed in side effects, which they are seeing are “less and milder” than in the adult population, because the immune system of the smallest is more immature and the response to vaccines is “less powerful” (as happens to the oldest, in that case because their immune system is more weakened). In addition to because the dose is lower.
Modern and Janssen
As to Modern, currently approved to be administered to those over 18 years of age, requested approval from the FDA and the EMA in June for these regulators to urgently authorize the use of their vaccine for minors from 12 to 17 years old. As explained by the American pharmacist in a release, Phase 2/3 of the ‘TeenCOVE’ study of Moderna’s vaccine in adolescents ended in May. The trial, in which 3,732 adolescents aged 12 and under 18 years from the USA participated, found that the efficacy of the vaccine was between 100% and 93%. Regarding children under 12 years of age, the latest information available dates back to March 16, when Moderna announced that it was starting phase 2/3 of the ‘KidCOVE’ trials, in which it hoped to include 6,750 participants aged 6 months to less than 12 years from the US and Canada.
“The much sought after group immunity is not going to be achieved by excluding 15-20% of the population, which are those under 15 years of age”
AstraZeneca interrupted their rehearsals with minors after regulators recognized a “possible link” of their injection with the rare thrombi combined with thrombocytopenia in the adult population.
And regarding Janssen, the company is currently studying the safety and immune response of its single-dose vaccine in adolescents aged 12 to 17 years in a trial that is also being carried out in part in five centers in Spain. It started in April and the pharmaceutical reported that he will extend his research with pregnant women and children under 12 and up to two years “in the near future” once finished with group 12-17.
Covid data in children in Spain
According to him latest report epidemiological study prepared by the Carlos III Health Institute (ISCIII), with data up to July 14, 2021, since the start of the pandemic a total of 117,956 children under the age of five have been infected with covid-19 in Spain, 157,901 between five and nine years and they have registered 485,883 cases in people between 10 and 19 years old. In total, adding the data of all age groups, a total of 4,189,136 infections have been identified in Spain since the beginning of the pandemic and until July 20, 2020.
Regarding serious cases, the aforementioned ISCIII report includes for the age group of under five years a total of 1,487 hospitalizations (1.3% of the cases in this cohort) 54 admissions to the ICU and four deaths. Between the under five to nine years have registered 576 admissions (0.4% of the cases in this age group), 44 admissions to the ICU and five deaths. Finally, for the 10 to 19-year-old group, 2,495 hospitalizations, 140 ICU admissions and 13 deaths have been recorded.
Although the severity of covid decreases with age, the little ones are not exempt from suffering complications. A study carried out in Spanish hospitals with 202 pediatric patients in the ICU due to covid found that three-quarters, without previous pathologies, developed Multisystemic Inflammatory Syndrome (MIS-C), a serious condition that has characterized the serious pediatric affectation by covid and that “surprisingly does not manifest itself in adults”, highlighted the coordinator of the study, Rafael González Cortés, from the Gregorio Marañón Hospital in Madrid.
Vaccination will depend on group immunity
Both Manuel Gijón and the pediatrician and also epidemiologist Quique Bassat point to the percentage needed to achieve group immunity to determine up to what age it will be necessary to vaccinate against covid.
After carrying out “an exercise with a group of modelers to understand at what level of vaccination of adults it would be possible to dispense with the vaccination of children”, Bassat points out that “the problem is that with the more infectious variants that we have now, the herd immunity threshold goes from 70% to 85-90%“. That is why he believes that” necessarily “it will be necessary to vaccinate almost all adolescents up to 12 years of age. However, he estimates that the youngest ones” probably get rid of generalized vaccination “, although he does not rule out that many do” For caution”.
For his part, Manuel Gijón emphasizes that “the much sought after group immunity will not be achieved by excluding 15-20% of the population, which are those under 15 years of age“He further defends that,” provided that the benefit for those vaccinated and for public health outweighs the risk and it is shown that the vaccine is safe and prevents contagion and disease, and if we want to control the pandemic, avoid contagion, avoid isolates, avoid restrictions and above all prevent the vulnerable from catching the disease, it will make sense that we are all vaccinated. “