Rome, 26 November – The CHMP, the EMA’s Committee for Medicinal Products for Human Use, has recommended extending the indication for Comirnaty, the Covid 19 vaccine developed by BioNTech and Pfizer and already approved for adults and children from 12 years of age to include its use in children aged 5 to 11 years.
In the age group 5-11 years, its dose Comirnaty will be lower than that used in people 12 years of age and older (10 μg vs. 30 μg). As in the .12 age group, the vaccine is given as two injections into the upper arm muscle, three weeks apart.
A major study in children aged 5 to 11 years showed that the immune response to Comirnaty, which was administered at a lower dose (10 μg) in this age group, was comparable to that observed at the higher dose (30 μg) in the 16- to 25-year-old age group (measured by the level of antibodies to Sars CoV 2). Its effectiveness Comirnaty was estimated in approximately 2,000 children aged 5 to 11 years who showed no signs of previous infection. The children received the vaccine or placebo (placebo injection). Of the 1,305 children who received the vaccine, none developed Covid 19, compared with 16 of the 663 children who received placebo. This means that, in this study, the vaccine was 90.7% effective in preventing symptomatic disease (although the actual rate could be between 67.7% and 98.3%).
The most common side effects seen in children aged 5 to 11 years are similar to those seen in people aged 12 years and older. These include injection site pain, 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. Therefore, Chmpha considered the benefits of Comirnaty are greater than the risks in children aged 5 to 11 years, especially if they have conditions that increase the risk of serious illness.
The safety and efficacy of the vaccine in both children and adults will continue to be closely monitored during use as part of vaccination campaigns in all EU Member States, through the European Pharmacovigilance System and ongoing studies. and add-ons carried out by the company and the European authorities.
The CHMP recommendation will be forwarded to the European Commission, which will make the final decision.
Comirnaty, as known, is a mRNA-based vaccine, a nucleotide that has the function of carrying to the cells the information necessary to carry out protein synthesis. Specifically, the mRNA present in the vaccine has the function of producing a protein present in Sars CoV 2, the spike protein, which the virus uses to penetrate human cells. Basically, once the vaccine is injected, the cells of the human body will read the “instructions” of the mRna and temporarily produce the spike protein. The immune system of the vaccinated person will recognize this protein with Sars CoV 2, their immune system will recognize the virus and will be ready to fight it. The mRNA of the vaccine does not remain in the body but is degraded shortly after vaccination.
The evaluation report, which contains the details of the evaluation of its use Comirnaty for children, conducted by the EMA, will be published on the European Agency’s website. The studies in children were performed according to its Pediatric Investigation Plan (PIP) Comirnaty, approved by the EmaMA Pediatric Committee (Pdco). The data of clinical trials submitted by the company in the application for extension of the indication for pediatric use will be published in due time on the website of the relevant Agency.
More information is available in a general vaccine document for the general public, which contains a description of the benefits and risks of the vaccine itself and the reasons why the EMA recommended its EU approval.