European medicines watchdog clears COVID-19 vaccine for use in 5-11 age group
The human medicines committee (CHMP) of the European Medicines Agency (EMA) has on Thursday recommended granting an extension of indication for the COVID-19 vaccine Comirnaty to include use in children aged 5 to 11. The vaccine, developed by BioNTech and Pfizer, is already approved for use in adults and children aged 12 and above.
If there is a vaccine for the 5-12 age group, those affected may organise another vaccination campaign week,
said Zoltán Maruzsa, state secretary in charge of public education, earlier this week. He estimated that the approval for this age group (in fact, this is the 5-11 age group) could arrive in the following weeks.
Israel officially started to inoculate children aged 5-11 against SARS-CoV-2 on Tuesday, becoming the second country after the United States to do so.
In children from 5 to 11 years of age, the dose of Comirnaty will be lower than that used in people aged 12 and above (10 µg compared with 30 µg). As in the older age group, it is given as two injections in the muscles of the upper arm, three weeks apart.
A main study in children aged 5 to 11 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 16- to 25-year-olds (as measured by the level of antibodies against SARS-CoV-2).
The efficacy of Comirnaty was calculated in almost 2,000 children from 5 to 11 years of age who had no sign of previous infection. These children received either the vaccine or a placebo (a dummy injection). Of the 1,305 children receiving the vaccine, three developed COVID-19 compared with 16 out of the 663 children who received placebo.
This means that, in this study,
the vaccine was 90.7% effective at preventing symptomatic COVID-19
(although the true rate could be between 67.7% and 98.3%).
The most common side effects in children aged 5 to 11 are similar to those in people aged 12 and above. They include pain at the injection site, tiredness, headache, redness and swelling at the site of injection, muscle pain and chills. These effects are usually mild or moderate and improve within a few days of vaccination.
The CHMP therefore 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 monitored closely as it is used in vaccination campaigns in EU Member States through the EU pharmacovigilance system and ongoing and additional studies conducted by the company and by European authorities.
The CHMP will now send its recommendation to the European Commission, which will issue a final decision.
How Comirnaty works
Comirnaty works by preparing the body to defend itself against COVID-19. It contains a molecule called messenger RNA (mRNA) which has instructions for making the spike protein. This is a protein on the surface of the SARS-CoV-2 virus which the virus needs to enter the body’s cells.
When a person is given the vaccine, some of their cells will read the mRNA instructions and temporarily produce the spike protein. The person’s immune system will then recognise this protein as foreign and produce antibodies and activate T cells (white blood cells) to attack it.
If, later on, the person comes into contact with the SARS-CoV-2 virus, their immune system will recognise it and be ready to defend the body against it.
The mRNA from the vaccine does not stay in the body but is broken down shortly after vaccination.
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