The EMA's Committee on Human Drugs (CHMP) has recommended extending the vaccine indication COVID-19 Nuvaxovid for use in children 12 to 17 years of age. The vaccine, developed by Novavax CZ, as, has already been approved for use in people 18 years of age and older.
The use of the vaccine in adolescents is the same as in adults, given as two injections into the muscles of the upper arm, at intervals of three weeks.
A major study involving more than 2.200 children aged 12 to 17 years is being conducted in accordance with the Vaccine Pediatric Research Plan (PIP) approved by the EMA Pediatric Committee (PDCO).
This study showed that in adolescents the immune response to Nuvaxovid, measured by the level of antibodies to SARS-CoV-2, 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 performed when the SARS-CoV-2 Delta variant was prevalent and showed that the vaccine was approximately 80% effective in preventing the disease COVID-19. Six of the 1.205 teens who took Nuvaxovid developed the disease COVID-19 compared with 14 of the 594 who received placebo (placebo injections). The CHMP found that these results were consistent with those observed in adults.
The most common side effects in teens are mostly similar to those in people aged 18 and over. 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 often 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 12 to 17 years of age outweigh the associated risks.
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 the Member States, through the EU pharmacovigilance system, ongoing and additional studies by the company and the European authorities. .
How Nuvaxovid works
Nuvaxovid is given as two injections, usually in the muscle of the upper arm, 3 weeks apart. Its action concerns the preparation of the organism to defend itself against the infection COVID-19. 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 "adjuvant", a substance that helps boost the immune response to the vaccine.
When a person receives the vaccine, their immune system will recognize the protein as foreign and produce natural defenses - antibodies and T cells - against it. If later, the vaccinated person comes in contact with the SARS-CoV-2 virus, their immune system will recognize the spike protein in the virus and will be ready to defend itself. Antibodies and immune system cells can protect against disease COVID-19 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 is approved by the CHMP and contains information for healthcare professionals, a leaflet for the general public and details of the vaccine licensing conditions.
An evaluation report, detailing the evaluation of Nuvaxovid use in adolescents by the EMA, will be published. The clinical trial data submitted by the company in the application for the pediatric extension of the indication will be published on the website of the clinical data of the Organization in due time.
More information is available in a summary of the vaccine in plain language, including a description of the benefits and risks of the vaccine and the reasons why the EMA recommended that it be licensed in the EU.
Monitoring the safety of Nuvaxovid
According to the EU Vaccine Safety Monitoring Plan COVID-19, Nuvaxovid is closely monitored and subject to various vaccine-specific activities COVID-19. Although a large number of people have already received vaccines against it COVID-19, some side effects may occur as more and more people are getting the vaccine. In addition, independent studies on vaccines COVID-19 coordinated by EU authorities will provide more information on the long-term safety and benefits of the vaccine to the general population.
These measures will allow regulators to quickly evaluate data from a variety of sources and take appropriate regulatory measures to protect public health, if needed.