Novavax has announced that its updated COVID-19 vaccine, Nuvaxovid XBB.1.5, has been approved by the European Commission (EC) for active immunisation in individuals aged 12 and older.

The decision follows a positive opinion for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).

Developed to target the Omicron XBB sublineage, the updated vaccine prepares the body’s defences against COVID-19 and contains a version of the spike protein of the Omicron XBB.1.5 subvariant, as well as Matrix-M adjuvant to strengthen immune response.

The approval was based on non-clinical data which showed that the vaccine induced functional immune responses against the COVID-19 variants XBB.1.5, XBB.1.16 and XBB.2.3.

Additionally, the updated vaccine induced neutralising antibody responses to newly emerging subvariants of the SARS-CoV-2 virus, BA.2.86, EG.5.1, FL.1.5.1 and XBB.1.16.6, as well as strong CD4+ polyfunctional cellular (T-cell) responses against EG.5.1 and XBB.1.16.6.

Based on previous recommendations by the EMA and the European Centre for Disease Prevention and Control, both adults and adolescents from the age of 12 should receive a single dose, irrespective of their COVID-19 vaccination history.

John Jacobs, president and chief executive officer at Novavax, said: "[The] approval of the only updated protein-based non-mRNA COVID-19 vaccine in the EU is an important milestone as the need for vaccination continues.

"Novavax is working closely with national authorities to have our updated vaccine delivered and available in Europe in the coming weeks."

In July, Nuvaxovid received full marketing authorisation by the EC for use as a primary series in individuals aged 12 and older for COVID-19 prevention and as a booster dose in adults aged 18 and older.

The EC’s decision was supported by positive results from the phase 3 PREVENT trial, which evaluated the safety, immunogenicity and efficacy of Nuvaxovid.

Most recently, the updated version of the vaccine received Emergency Use Authorisation from the US Food and Drug Administration (FDA) for use in individuals aged 12 years and older in October.

The FDA determined that the vaccine’s known and potential benefits outweighed the vaccine’s known and potential risks.

https://www.pmlive.com/pharma_news/novavaxs_xbb.1.5-adapted_covid-19_vaccine_receives_ec_approval_1503217