Pfizer covid vaccine for children aged 5-11, the opinion of the Technical Scientific Commission (CTS) of the Italian pharmaceutical agency Aifa is likely expected between today and tomorrow – according to Adnkronos Health.
The meeting of the CTS during which the issue will be addressed, following the green light received last week by the European Medicines Agency Ema, will begin today 1 December and will continue until Friday 3. The experts are convened for all three days from 9 to 19.
Ema
The green light from Ema, the European drug agency, for Pfizer’s covid vaccine for children aged 5-11 arrived on 25 November. The benefits, according to the institution, outweigh the risks. The agency’s Committee for Medicinal Products for Human Use (CHMP) recommended granting an extension of the indication for Pfizer / BioNTech’s Covid Comirnaty vaccine. The vaccine is already approved for ages 12 and up.
In children between the ages of 5 and 11 – recalls the agency – the dose to be administered will be less than that used in people 12 years of age and 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. The CHMP will now send its recommendation to the European Commission, which will issue a final decision. 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 “. This is explained by the European Medicines Agency Ema, after the green light of the experts of the EU regulatory body to extend the use of the vaccine in children.
Risks, benefits and side effects
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%).”
The most common side effects in this age group “They 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.
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