Pfizer anti covid vaccine, starting from tomorrow the administrations for the 5-11 age group. After the opening of the reservations, the pediatric vaccination campaign officially begins also in Italy. But what will be the doses and times of administration? And what does the drug leaflet say about efficacy and side effects? Here is the Ema’s answer.
DOSES AND TIMES – In children aged between 5 and 11 years – reminds the European Medicines Agency Ema – the dose to be administered will be lower than that used in people aged 12 years or older (10 micrograms compared to 30 µg). As in the older age group, the vaccine is injected with two injections into the muscles of the upper arm, 3 weeks apart.
LIE, EFFECTIVENESS, SIDE EFFECTS – The CHMP Committee for Human Medicinal Products of the European Medicines Agency EMA “concluded that the” benefits of Pfizer / BioNTech’s anti-Covid Comirnaty vaccine “in children aged 5 to 11 years outweigh the risks, in particularly in those with conditions that increase the risk of serious Covid “.
The recommendation – explains the EMA – was based on an examination of the available data. In detail, “a main study in children aged 5-11 showed that the immune response to Comirnaty given at a lower dose (10 µg) in this age group was comparable to that seen at the higher dose (30 µg) in patients aged between 16 and 25 years (measured by the level of antibodies against Sars-CoV-2) “. The effectiveness of Comirnaty – recalls the agency – has been calculated in almost 2 thousand children between the ages of 5 and 11, who did not show signs of previous infection. These children received the vaccine or a placebo (a dummy injection). Of the 1,305 children who received the vaccine, three developed Covid compared to 16 of the 663 children who received the placebo. “This means that, in this study, the vaccine was 90.7% effective in preventing symptomatic Covid (although the real rate could be between 67.7% and 98.3%).”
The most common side effects in this age group “are similar to those seen in people 12 years of age and older,” confirms the EMA. They include pain at the injection site, fatigue, headache, redness and swelling at the injection site, muscle pain, and chills. These effects are usually mild or moderate and improve within a few days of vaccination. “The safety and efficacy of the vaccine in both children and adults will continue to be closely monitored” while this product is used in Member States’ vaccination campaigns, “through the EU pharmacovigilance system and ongoing and ongoing studies. additional actions conducted by the company and the European authorities “, assures the regulatory body. An assessment report, with details of the Ema assessment of the use of Comirnaty in young children, will be posted online on the agency’s website.
PUBERAL DEVELOPMENT AND MYOCARDITES: WHAT PEDIATRICIANS SAY – No interference of the anti-Covid vaccine on pubertal development: “The news that is circulating, and that has also circulated during the vaccination campaign of the over 12s, is not based on any scientific evidence. There is no interference with the hormonal axis. . This has been amply demonstrated “. This was assured by Annamaria Staiano, president of the Italian Society of Pediatrics (Sip), during the press conference at the Ministry of Health on the start of vaccination in children aged 5-11.
In the young 5-11 year olds vaccinated in the United States, where they are in greater number, “it has been seen that the rate of side effects in this age group is lower than in the over 12 age group – he highlighted – Even myocarditis, so feared , in this age group, after the two doses of vaccine, has a lower percentage than the older ones “. According to published data, “myocarditis as a side effect of Sars-CoV-2” was “4 times higher than the double dose of vaccine”, concludes Staiano.