Here are the data and studies on which the opinion of the EMA is based, which approved Pfizer's vaccine also for children between 5 and 11 years old
The opinion of the European Medicines Agency (Ema) on the use of the Pfizer / BioNTech vaccine for children between 5 and 11 years was scheduled for November 29 but, as hypothesized yesterday by the president of the Italian drug agency (Aifa) , Giorgio Palù, arrived early.
The Ema, through a note , has in fact just approved Pfizer's request, which can now therefore be administered to even the smallest.
THE TWEET OF THE EMA
EMA recommends approval of BioNTech / Pfizer's # COVID19vaccine , Comirnaty, for children aged 5 to 11.
In this population, the dose of #Comirnaty will be lower than that used in people aged 12 and above.
– EU Medicines Agency (@EMA_News) November 25, 2021
The effectiveness of Comirnaty has been calculated in nearly 2,000 children between the ages of 5 and 11 who had no previous infection. Some received the vaccine, others a placebo.
Of the 1,305 children who received the vaccine, 3 developed Covid compared to 16 of the 663 children who received the placebo. This means that the vaccine was found to be 90.7% effective in preventing symptomatic Covid.
RESULTS OF THE STUDY
A study in children aged 5-11 showed that the immune response to Comirnaty given at a lower dose (10 µg) is comparable to that seen at the higher dose (30 µg) in patients aged 16 and 25 years old.
INSTRUCTIONS FOR USE
In children between the ages of 5 and 11, the note reads, the dose of Comirnaty, Pfizer's vaccine, will be lower than that used in people aged 12 years and older (10 µg versus 30 µg). But as in the older age group, it will be given as two injections into the muscles of the upper arm, three weeks apart.
THE UNDESIRABLE EFFECTS
"The most common side effects in children aged 5 to 11 years" given the Pfizer / BioNTech vaccine "are similar to those seen in people aged 12 years and older" and " include pain at the injection site, fatigue, headache, redness and swelling at the injection site, pain and chills ", the European Medicines Agency specified in the opinion that it gave the green light to the administration of the Pfizer vaccine to children between the ages of 5 and 11.
"These effects are generally mild or moderate and improve within a few days of vaccination," the experts said. Therefore, the EMA concluded "that the benefits of Comirnaty for children between the ages of 5 and 11 outweigh the risks, particularly in those with conditions that risk risking severe Covid-19"
The EMA will now send its recommendation to the European Commission, which will issue a final decision.
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/ok-ema-a-pfizer-per-i-bambini-da-5-a-11-anni-segna-una-svolta/ on Thu, 25 Nov 2021 14:10:55 +0000.