With the numbers of coronavirus infections on the rise, one of the groups with the highest incidence today is that of the youngest children, who until now did not have a free pass from the health authorities to be able to be vaccinated. Today, the EMA’s Committee for Human Medicines (CHMP) has recommended granting an extension of the indication for the COVID-19 Comirnaty vaccine to include its use in children aged 5 to 11 years. The vaccine, developed by BioNTech and Pfizer, is already approved for use in adults and children age 12 and older.
In children aged 5 to 11 years, the dose of Comirnaty will be lower than that used in persons aged 12 years and over (10 µg versus 30 µg). As in the older age group, it is given as two injections into the muscles of the upper arm, three weeks apart.
A main study in children aged 5 to 11 years showed that the immune response to Comirnaty given at a lower dose (10 µg) in this age group was comparable to that seen with the higher dose (30 µg) in the age range. 16 to 25 years of age (measured by the level of antibodies against SARS-CoV-2). The effectiveness of Comirnaty was calculated in almost 2,000 children aged 5 to 11 years who had no signs of previous infection. These children received either the vaccine or a placebo (a dummy injection). Of the 1,305 children who received the vaccine, three developed COVID-19 compared to 16 of the 663 children who received placebo. This means that, in this study, the vaccine was 90.7% effective in preventing symptomatic COVID-19 (although the true rate could be between 67.7% and 98.3%).
The dose of Pfizer vaccine for children 5 to 11 years of age will be lower than that used in people 12 years of age or older
The most common side effects in children ages 5 to 11 are similar to those in people ages 12 and older. They include pain at the injection site, tiredness, 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, the CHMP concluded that the benefits of Comirnaty in children aged 5 to 11 outweigh the risks, particularly in those with conditions that increase the risk of severe COVID-19.
The safety and efficacy of the vaccine in both children and adults will continue to be closely monitored as it is used in vaccination campaigns in EU Member States through the EU pharmacovigilance system and ongoing and additional studies. carried out by the company and the European authorities.
The CHMP will now send its recommendation to the European Commission, which will issue a final decision.
In Spain, after the meeting of the Interterritorial Council of the National Health System (CISNS), the Minister of Health Carolina Darias assured yesterday that “Spain is prepared to vaccinate children under 12 against COVID-19” as soon as authorized by the European Medicines Agency. It is estimated that around 3,350,000 children will now be able to receive this double injection.
How the Comirnaty vaccine works in young children
Comirnaty, as Pfizer’s COVID vaccine is now known, works by preparing the body to defend itself against COVID-19. It contains a molecule called messenger RNA (mRNA) that has instructions for making the spike protein. This is a protein on the surface of the SARS-CoV-2 virus that the virus needs to enter cells in the body. When a person receives the vaccine, some of his cells will read the instructions on the mRNA and temporarily produce the spike protein. The person’s immune system will recognize this protein as foreign and will produce antibodies and activate T-cells (white blood cells) to attack it.
If the person later comes into contact with the SARS-CoV-2 virus, their immune system will recognize it and be ready to defend the body against it. The mRNA from the vaccine does not stay in the body, but it breaks down shortly after vaccination.
On October 29, 2021, the FDA approved the Comirnaty vaccine for children 5 to 11 years of age. The vaccine approved for these ages contains only one third (10 µg) of the mRNA of the vaccines approved for older children and adults (30 µg), and in addition the phosphate has been replaced by tromethamime as a buffer. This same vaccine has also been approved in Canada.
According to a statement from the Spanish Association of Pediatrics (AEP), once the vaccine is approved by the Spanish Agency for Medicines and Health Products (AEMPS), the CAV of the AEP recommends the vaccination of all children in this age group , following the strategies set by the Ministry of Health.
It is also necessary to take into account that currently the cumulative incidence of SARS-CoV-2 infections is higher in children under 11 years of age than in any other age group. Considering that the occurrence of myocarditis associated with mRNA vaccines decreases with the age of children, and taking into account the lower amount of mRNA in the children’s preparation, it is very likely that the risk of this complication is much lower than after vaccination of adolescents and young adults, thus improving the benefit/risk balance of vaccination in children aged 5-11 years.
Source: EMA
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