EMA’s human medicines committee (CHMP) has recommended granting an extension of indication for the COVID-19 vaccine Nuvaxovid to include use in adolescents aged 12 to 17 years.
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The vaccine, developed by Novavax CZ, a.s., is already approved for use in adults aged 18 and above.
The use of the vaccine in adolescents is the same as in adults, with two injections given in a muscle, three weeks apart.
A main study including over 2,200 children aged 12 to 17 years is being carried out in accordance with the paediatric investigation plan (PIP) for the vaccine, which was agreed by EMA's Paediatric Committee (PDCO).
This trial showed that the immune response to Nuvaxovid in adolescents, which was measured as the level of antibodies against SARS-CoV-2, was comparable to the response in young adults aged 18 to 25 years (who were part of the main study used to assess effectiveness of the vaccine in adults).
The trial was carried out when the SARS-CoV-2 Delta variant was dominant and showed that the vaccine was almost 80% effective at preventing COVID-19; six out of the 1,205 adolescents who received Nuvaxovid developed COVID-19 compared to 14 out of 594 who received placebo (dummy injections).
The CHMP considered that these results are in line with those seen in adults.
The most common side effects in adolescents are mostly similar to those in people aged 18 and above. They include tenderness, pain, redness and swelling at the injection site, headache, muscle and joint pain, tiredness, generally feeling unwell, feeling sick or vomiting and fever.
Fever is seen more frequently in adolescents than in adults. These effects are usually mild or moderate and improve within a few days of vaccination.
CHMP therefore considered that the benefits of Nuvaxovid in adolescents aged 12 to 17 outweigh its risks.
In the 12 through 17 year-old population, emergency use authorization has been granted in India.
The Novavax COVID-19 vaccine (NVX-CoV2373) has not yet been authorized for use in the U.S. and the trade name Nuvaxovid has not yet been approved by the U.S. Food and Drug Administration.
Nuvaxovid is given as two injections, usually into the muscle of the upper arm, 3 weeks apart. It works by preparing the body to defend itself against COVID-19.
The vaccine contains a version of a protein found on the surface of SARS-CoV-2 (the spike protein), which has been produced in the laboratory. It also contains an ‘adjuvant’, a substance that helps strengthen the immune responses to the vaccine.
When a person is given the vaccine, their immune system will identify the protein as foreign and produce natural defences — antibodies and T cells — against it.
If, later on, the vaccinated person comes into contact with SARS-CoV-2, the immune system will recognise the spike protein on the virus and be prepared to attack it. The antibodies and immune cells can protect against COVID-19 by working together to kill the virus, prevent its entry into the body’s cells and destroy infected cells. ■