After the approval of the ANMAT, they will expand the use of the Moderna vaccine for children from 6 to 11 years old

The Drug Evaluation and Registration Directorate (DERM) dependent on the National Institute of Medicines, completed the evaluation of the documentation provided in a timely manner by the producer laboratory ModernaTX Inc. on the clinical study corresponding to girls and boys between 6 and 11 years old Eduardo Sanz – Europe Press

The Ministry of Health of the Nation will expand the use of the Moderna vaccine for children between 6 and 11 years of age. The decision is based on the analysis carried out by the National Institute of Medicines (ANMAT) based on the clinical evidence that demonstrates the viability of its application. In the coming days, the technical guidelines for the use of this vaccine in this age group will be established.

The Directorate for the Evaluation and Registration of Medicines (DERM) under the National Institute of Medicines, The evaluation of the documentation provided in a timely manner by the manufacturing laboratory ModernaTX Inc. on the clinical study corresponding to girls and boys between 6 and 11 years of age was completed.

According to the results obtained, ANMAT has now recommended (according to report IF-2022-22630342-APN-DERM#ANMAT) the incorporation of the mRNA vaccine against SARS COV-2 in the reference age group. Thus, the aim is to further expand the options for vaccination in the pediatric population against COVID-19, not only due to the positive impact that this promotes individually, but also to sustain protection at the community level.

The studies conclude that the effectiveness of the vaccine in girls and boys of 6 a 11 years meets the success criteria that have been specified in terms of immunogenicity and safety.

The studies conclude that the effectiveness of the vaccine in girls and boys aged 6 to 11 years meets the success criteria that have been specified in terms of immunogenicity and safety REUTERS/Dado Ruvic/Illustration/File Photo
The studies conclude that the effectiveness of the vaccine in girls and boys aged 6 to 11 years meets the success criteria that have been specified in terms of immunogenicity and safety REUTERS/Dado Ruvic/Illustration/File Photo

The data regarding safety and efficacy support the administration of a primary scheme consisting of two doses of the aforementioned vaccine with an interval of at least 28 days between both applications.

The authorization in Argentina of the vaccine against COVID-19 in girls and boys between 6 and 11 years of age from the Moderna laboratory adds to that already granted by the European Medicines Agency (EMA) and Australia.

Once the consensus meetings have been held with ministers and the committee of experts to define the technical guidelines and recommendations, it will be available to continue strengthening vaccination in this age group.

In this way, Argentina continues to strengthen instances to achieve high levels of coverage throughout its population, which has generated a positive health impact that is reflected in the decrease in hospitalizations and deaths from COVID-19 and the reduction in the tension of the sanitary system.

The ANMAT had authorized the use of the COVID-19 vaccine from the Pfizer/BioNTech laboratory for children between 5 and 11 years of age in mid-January of this year
The ANMAT had authorized the use of the COVID-19 vaccine from the Pfizer/BioNTech laboratory for children between 5 and 11 years of age in mid-January of this year

The ANMAT had authorized the use of the COVID-19 vaccine from the Pfizer/BioNTech laboratory for children between 5 and 11 years of age in mid-January of this year.

In November 2021, a trial carried out with the laboratory’s COVID-19 vaccine was revealed Pfizer in children aged 5 to 11 years found high efficacy, estimated at 91%, in addition to a strong immune response and no serious side effects. The analysis was carried out in 2,268 participantsas published on November 9 by its authors in the magazine The New England Journal of Medicinereported then the prestigious American cardiologist Eric Topol.

The scientist highlighted, through his Twitter account, that the data indicated “very high efficacy (91%, 95% CI 68.98) a strong immune response and absence of serious side effects among 2,268 participants”

The results of the study carried out by the laboratory itself showed that 91% efficacy with two 10-μg doses, spaced 21 days apart. It was a randomized trial of the Pfizer messenger RNA platform vaccine for children 5 to 11 years of age.

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The ANMAT approved the use of the Pfizer vaccine for children aged 5 to 11 years

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