The pharmaceutical company Novavax has announced that its COVID-19 vaccine, which is updated to combat new variants of the XBB strain, has been authorized by the European Commission. It is the only updated COVID-19 vaccine in non-mRNA proteins available in all member countries of the European Union indicated for people aged 12 years or older.
The decision to approve NuvaxovidTM XBB.1.5 has been based on non-clinical data demonstrating that this vaccine induces functional immune responses against the XBB.1.5, XBB.1.16 and BA.2.86, EG.5.1 FL.1.5.1 and XBB.1.16.6 of recent appearance.
To make the decision to recommend its authorization, the committee for human medicines (CHMP) of the European Medicines Agency (EMA) has evaluated laboratory data showing that the adapted vaccine is capable of triggering an adequate immune response against XBB.1.5, which It is currently the dominant subvariant in Spain, with 405 of the cases detected associated with the one known as the Kraken variant, according to the report from the end of October ‘Update on the epidemiological situation of SARS-CoV-2 variants in Spain’. The CHMP also took into account data from a study in previously vaccinated adults showing that when Nuvaxovid was adapted to attack another related strain, Omicron BA.5, it was able to trigger a strong immune response against this strain.
The safety profile of Nuvaxovid -19 from Novavax (NVX-CoV2373) have been headache, nausea, muscle pain, joint pain, injection site tenderness, fatigue and malaise.”
How NuvaxovidTM XBB.1.5 Vaccine Works
This adapted vaccine works by preparing the body to defend itself against COVID-19. It contains a version of the spike protein from the omicron subvariant XBB.1.5, which has been produced in the laboratory. It also contains an ‘adjuvant’, a substance that helps the vaccine strengthen the immune response.
When a person receives the vaccine, their immune system will identify the protein in the vaccine as foreign and produce natural defenses (antibodies and T cells) against it. If the vaccinated person subsequently comes into contact with SARS-CoV-2, their immune system will recognize the spike protein on its surface and will be prepared to attack it. Antibodies and immune cells can protect against COVID-19 by working together to kill the virus, preventing it from entering the body’s cells, and destroying infected cells.
This vaccine was developed to combat Omicron XBB in accordance with the recommendations of the EMA Emergency Task Force (ETF), as well as other international regulators and the World Health Organization (WHO). As Omicron XBB.1.5 is closely related to other variants in circulation, the vaccine is expected to help maintain optimal protection against COVID-19 caused by these other variants, as well as Omicron XBB.1.5.
As with other COVID-19 vaccines, national authorities in EU Member States will determine how to use this vaccine in national vaccination campaigns, taking into account factors such as infection and hospitalization rates, risk to vulnerable people and the availability of the vaccine.
Sources: Novavax and EMA
