The EMA Committee for Medicinal Products for Human Use (CHMP) recommended expanding the indication of COVID-19 Nuvaxovid vaccine to include its use in children aged 12 to 17 years. The vaccine, developed by Novavax CZ, a.s., has already been approved for use in people aged 18 years and older.
The use of the vaccine in adolescents is the same as in adults, with administration as two injections in the upper arm muscles, three weeks apart.
A pivotal study involving more than 2,200 children aged 12 to 17 years is being conducted under the vaccine's Pediatric Investigation Plan (PIP), which was approved by the EMA's Pediatric Disease Committee (PDCO).
This study showed that in adolescents the immune response to Nuvaxovid, measured by the level of anti-SARS-CoV-2 antibodies, was comparable to the response observed in young adults aged 18 to 25 years (who were part of the main study used to evaluate the efficacy of the vaccine in adults). The study was conducted when the SARS-CoV-2 Delta variant was prevalent and showed that the vaccine was approximately 80% effective in preventing COVID-19 disease. Six of 1,205 adolescents who received Nuvaxovid developed COVID-19 disease compared with 14 of 594 who received placebo (placebo injections). CHMP considered these results to be consistent with those observed in adults.
The most common adverse events in adolescents are mostly similar to those in people aged 18 years and older. These include tenderness, pain, redness and swelling at the injection site, headache, muscle and joint pain, fatigue, general malaise, vomiting and fever. Fever occurs more frequently in adolescents than in adults. These effects are usually mild or moderate and improve within a few days of vaccination.
Therefore, the CHMP considered that the benefits of Nuvaxovid in adolescents aged 12 to 17 years outweigh the risks associated with it.
The safety and efficacy of the vaccine in both adolescents and adults will continue to be closely monitored as the vaccine is used in vaccination campaigns in Member States, through the EU pharmacovigilance system, ongoing and additional studies by the company and by European authorities.
How Nuvaxovid works
Nuvaxovid is administered as two injections, usually in the upper arm muscle, 3 weeks apart. Its action is to prepare the body to defend itself against COVID-19 infection. The vaccine contains a laboratory version of a protein found on the surface of the SARS-CoV-2 virus (spike protein). It also contains an "immune booster", a substance that helps boost immune responses to the vaccine.
When a person receives the vaccine, their immune system will recognise the protein as foreign and produce natural defences - antibodies and T cells - against it. If the vaccinated person later comes into contact with the SARS-CoV-2 virus, the immune system will recognise the spike protein in the virus and be ready to defend itself. The immune system's antibodies and cells can protect against COVID-19 disease by killing the virus through synergy, preventing it from entering the body's cells and destroying infected cells.
Where to find more information
The product information for Nuvaxovid has been approved by the CHMP and contains information for healthcare professionals, an instruction sheet for the public and details of the vaccine's licensing conditions.
An assessment report, detailing the evaluation for the use of Nuvaxovid in adolescents by the EMA, will be published. The clinical trial data submitted by the company in the application for the paediatric extension of the indication will be published on the Agency's clinical data website in due course.
Further information is available in a plain language summary of the vaccine, including a description of the benefits and risks of the vaccine and the reasons why the EMA recommended its licensing in the EU.
Nuvaxovid safety monitoring
According to the EU safety monitoring plan for COVID-19 vaccines, Nuvaxovid 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 adverse reactions may occur as more and more people receive the vaccine. In addition, independent studies on COVID-19 vaccines coordinated by the EU authorities will provide more information on the long-term safety and benefits of the vaccine in the general population.
These measures will allow regulators to quickly assess data from a range of different sources and take appropriate regulatory action to protect public health, if necessary.
(AF)
Contents of this article including associated images are owned by PIO
Views & opinions expressed are those of the author and/or PIO
Source
