Vaccination of children under 12 against Covid-19 is considered crucial to reduce contagion and fight the Delta variant, but regulators are still waiting for the results of clinical trials to make a decision.
For now, the European Medicines Agency (EMA, its acronym in English) confirmed to Lusa that it has not yet received any request from pharmaceutical companies to approve the vaccination of children under 12 years.
"So far, no request has been presented to the EMA to extend the indication for the use of a Covid-19 vaccine in children under 12," said a source at the European regulator, adding that this assessment is always carried out in accordance with a pediatric investigation plan.
Pediatric clinical trials are generally structured so that a vaccine is studied first in adolescents and progressively in children under 12 years of age.
Once the data from an age group show that the vaccine is safe and that it provides a good immune response, the drug companies can send the data to the EMA for its approval in that age group, the same source said.
The two messenger RNA (mRNA) technology vaccines approved by the EMA and being administered in the European Union (EU) can be used in children, but, for now, only from 12 years of age.
On 28 May, the vaccine from the Pfizer/BioNTech consortium was approved for use in children aged 12 to 15 in the EU, and on 27 July, the one from the pharmaceutical company Moderna received the “green light” from the EMA to immunize adolescents among the 12 and 17 years old.
"We will continue to monitor this matter and try to understand if these vaccines can be used in children under 12," said on Thursday, 9 September, the head of vaccination strategy at EMA, Marco Cavaleri, admitting that the first data may reach the regulator during the fall.
The EMA specialist also warned that in the United States, with the spread of the Delta variant, there is a "great increase in hospitalizations that affect mostly adolescents who are not vaccinated", a concern that the American Academy of Pediatricians (AAP, in the acronym in English) also sharing.
The organization, which brings together some 67 pediatricians, wrote in August to the US regulator (FDA) asking that “Covid-19 vaccines for children be authorized as soon as possible, so that children of all ages can benefit from them'.
The spread of the Delta variant of the SARS-CoV-2 coronavirus, which is also the predominant one in the United States, is at the base of the challenge launched by this pediatric association to the FDA, given that, according to its data, in August it was verified. if the "highest percentage increase per week in pediatric cases of Covid-19 since the onset of the pandemic".
"The Delta variant has created a new and urgent risk for children and adolescents across the country, as well as for unvaccinated adults," warned the association, stating that, since the beginning of the pandemic, children accounted for 14,3% of the population. total cumulative cases of new coronavirus infection, a percentage that has recently increased to 19% in the United States.
In Portugal, recent data from the Directorate-General for Health indicate that the incidence of new infections in young people per 100 thousand inhabitants accumulated over 14 days is decreasing, despite continuing to present quite high values.
Since the beginning of the pandemic, there have been five deaths of children and young people up to the age of 19 and a total of 117.281 infections, which represents about 11% of the total of more than one million positive cases reported across the country.
In recent weeks, minors have been the main target of vaccination in Portugal, with more than half a million young people between 12 and 17 years old already with the first dose taken – which represents more than 80% of this group – and almost 160 thousand with full immunization (25%).
To the question whether children should be vaccinated against SARS-CoV-2, virologist José Miguel Pereira answers that the benefits of this immunization outweigh the risks, bearing in mind that “a vaccinated child is less one that gets sick and is also a source of minor contagion'.
The researcher from the Unit of Host-Pathogen Interaction of the Medicine Research Institute (iMed.ULisboa) of the University of Lisbon told Lusa that if children are vaccinated, the «infection by SARS-CoV-2 will be gradually less transmitted with all benefits that can be anticipated from there'.
According to the virology specialist, although an infected child has a lower risk of contracting a severe form of Covid-19 than an adult, vaccination allows them to be "less able to transmit the infection" to others, since your viral load, if any, will be lower than if you had not been immunized.
In addition, due to their habits and behavior, «children under the age of 12 are always prone to transmit infections that have respiratory secretions as a source of contagion», mainly in two environments: at home and at school, warned José Miguel Pereira.
"In any case, the situation is more important the less vaccinated there are in each of these environments," warned the virologist.
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