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Because Aifa approves the use of the Moderna vaccine for adolescents

Because Aifa approves the use of the Moderna vaccine for adolescents

Aifa approves the use of Moderna's Spikevax Covid-19 vaccine for the age group between 12 and 17 years. All the details

Aifa green light for the Moderna vaccine for adolescents.

On 26 July the Aifa Technical Scientific Commission (Cts) approved the extension of the indication of use of the Spikevax (Moderna) vaccine for the age group between 12 and 17 years.

The agency thus fully accepted the opinion expressed by the European Medicines Agency (Ema).

According to the CTS, in fact, the available data demonstrate the efficacy and safety of the vaccine even for subjects included in this age group.

Moderna said in May that his vaccine was found to be safe and effective in teenagers.

All the details.

AIFA EXTENDS MODERN VACCINE THERAPEUTIC INDICATION

As stated in the Official Gazette , "the therapeutic indication of the anti Covid-19 mRNA vaccine called Spikevax is modified as follows:" Spikevax "is indicated for active immunization for the prevention of Covid-19, a disease caused by the SARS virus- CoV-2, in subjects aged 12 years or older ”.

EMA'S OPINION WELCOMED

In fact, on 23 July, the EMA had already authorized the Spikevax vaccine for children and young people aged 12 to 17. The vaccine was already licensed for use in people aged 18 or over.

FOLLOWING THE EU STUDY

The effects of Spikevax on younger people were examined in a study involving 3,732 boys and girls between the ages of 12 and 17. The investigation complied with the pediatric plan for the vaccine in question, approved by the Pediatric Committee of the European Medicines Agency.

The study showed that the vaccine produces an antibody response – measured at the level of antibodies against the Sars-CoV-2 coronavirus – in young adults aged 12-17, comparable to that seen in young adults aged 18-25.

EFFECTIVENESS

None of the 2163 minors who were given the vaccine contracted Covid. Contrary to four of the 1073 young people who received a fictitious injection.

THE UNDESIRABLE EFFECTS

As reported by Sky tg24 , “among the most common side effects seen in adolescents, similar to those seen in people aged 18 and over, pain and swelling in the injection area were noted; tiredness; headache; muscle and joint pain; swollen lymph nodes; chills; nausea; vomiting and fever. These are effects defined as "generally mild or moderate" and which tend to pass within a few days from the date of vaccination, managed with two injections, four weeks apart ".

THE SPIKEVAX VACCINE FOR ADOLESCENTS

For some European countries, vaccinating adolescents is important to achieve herd immunity as the highly contagious Delta variant continues to spread .

Now also the Italian Medicines Agency has confirmed the approval for the use of the anti-Covid Spikevax vaccine for this specific age group.

LIKE THAT PFIZER

The vaccine from Pfizer and German partner BioNTech received approval for adolescent use as early as May.


This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/perche-aifa-approva-luso-del-vaccino-moderna-per-gli-adolescenti/ on Wed, 28 Jul 2021 10:37:56 +0000.