The EMA's Committee for Medicinal Products for Human Use (CHMP) recommended expanding the indication of the COVID-19 vaccine Spikevax to include its use in children aged 6 to 11 years. The vaccine, developed by Moderna, is already approved for use in adults and children aged 12 years and older.
The dose of Spikevax in children aged 6 to 11 years will be lower than that used in people aged 12 years and older (50 μg compared to 100 μg). As in the older age group, the vaccine will be given as two injections into the upper arm muscles, four weeks apart.
A main study in children aged 6 to 11 years showed that the immune response to the lowest dose of Spikevax (50 μg) was comparable to that observed with the highest dose (100 μg) in people aged 18 to 25 years, as measured by anti-SARS-CoV-2 antibody level.
The most common adverse reactions in children aged 6 to 11 years are similar to those in people aged 12 years and older. They include pain, redness and swelling at the injection site, fatigue, headache, chills, nausea, vomiting, enlarged or hypersensitive lymph nodes under the arm, fever, and muscle and joint pain. These effects are usually mild or moderate and improve within a few days of vaccination.
Evidence suggests that the efficacy and safety of Spikevax in children aged 6 to 11 years is comparable to that of adults. Therefore, the CHMP concluded that the benefits of Spikevax in this age group outweigh the risks, particularly in children with conditions that increase the risk of severe COVID-19 disease.
As the vaccine is used in vaccination campaigns in EU Member States, its safety and efficacy in both children and adults will continue to be closely monitored through the EU pharmacovigilance system and current and additional studies being conducted by the company and European authorities.
The CHMP will now send its recommendation to the European Commission, which will issue a final decision.
[BR][BR]How Spikevax works
Spikevax 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 that 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, the person comes into contact with the SARS-CoV-2 virus, their immune system will recognise it and the body will be ready to defend itself against it.
If, later, the person comes into contact with the SARS-CoV-2 virus, their immune system will recognise it and the body will be ready to defend itself against it. .
The mRNA from the vaccine does not remain in the body but breaks down shortly after vaccination.
Where to find more information
The product information approved by the CHMP for Spikevax contains prescribing information for healthcare professionals, an instruction sheet for the public and details of the vaccine's licensing conditions.
The assessment report, detailing the EMA's assessment of the use of Spikevax in children, will be published on the EMA website.
Studies in children were conducted in accordance with the Spikevax Paediatric Investigation Plan (PIP), which was agreed by the EMA Paediatric Division Committee (PDCO). he clinical trial data submitted by the company in the paediatric extension application will be published on the Agency's clinical data website in due course.
More information is available in an overview of the vaccine in plain language, including a description of the benefits and risks of the vaccine and why the EMA recommended its licensing in the EU.
Spikevax safety monitoring
According to the EU safety monitoring plan for COVID-19 vaccines, Spikevax is closely monitored and subject to several activities specific to COVID-19 vaccines. Although a large number of people have already received COVID-19 vaccines, some side effects may occur as more people receive the vaccine.
The company marketing this vaccine in the EU is required to provide regular updates and conduct studies to monitor the safety and efficacy of the vaccine as it is used by the public. Authorities also conduct additional vaccine monitoring studies.
These measures allow regulators to quickly assess data from a range of different sources and take appropriate regulatory action to protect public health, if necessary.
Contents of this article including associated images are belongs Cyprus Times
Views & opinions expressed are those of the author and/or Cyprus Times
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