Pfizer vaccine 5-11 years, ok Ema: leaflet, side effects

Pfizer vaccine 5-11 years, EMA green light. Today the EU regulatory body’s Committee for Medicinal Products for Human Use (CHMP) recommended granting an extension for Pfizer / BioNTech’s Comirnaty after approval from 12 years of age. But what does the leaflet say and what could be the side effects? What will the dose be? The European Medicines Agency itself responds. Read also DOSES AND TIMES In children between the ages of 5 and 11 – the agency reminds – 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. European Medicines Agency Ema “concluded that the benefits” of Pfizer / BioNTech’s anti-Covid Comirnaty * vaccine in children aged 5 to 11 outweigh the risks, particularly in those with conditions that increase the risk of Covid. serious”. 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 with 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%).” common in this age group “are similar to those seen in people aged 12 years 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.