European approval for third adapted COVID-19 vaccine

The European Commission has authorised the Nuvaxovid XBB.1.5-adapted COVID-19 vaccine, developed by Novavax for this autumn and winter season.

The vaccine, known as Nuvaxovid XBB.1.5, is to be used for preventing COVID-19 in adults and children from 12 years of age. It was developed to target Omicron XBB in line with recommendations from the European Medicines Agency’s Emergency task force (ETF) as well as other international regulators and the World Health Organization.

In its decision to recommend the authorisation, the EMA’s human medicines committee (CHMP) assessed laboratory data showing that the adapted vaccine is able to trigger an adequate immune response against XBB.1.5.

CHMP also considered data from a non-clinical study in previously vaccinated adults showing that when Nuvaxovid was adapted to target another related strain, Omicron BA.5, it was able to trigger a strong immune response against this strain. Based on these data, the Committee concluded that Nuvaxovid XBB.1.5 is expected to trigger an adequate immune response against XBB.1.5.

The safety profile of the adapted vaccine is expected to be like that of the originally authorised Nuvaxovid, EMA said.

The most common side effects with Nuvaxovid XBB.1.5 are pain and tenderness at the injection site, tiredness, headache, muscle pain and feeling generally unwell, EMA said.

“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,” said John C. Jacobs, President and Chief Executive Officer, Novavax.

“Novavax is working closely with national authorities to have our updated vaccine delivered and available in Europe in the coming weeks,” he added.

Nuvaxovid was first authorised in the European Union in December 2021. Adapted versions of Nuvaxovid targeting the Omicron variant BA.5 were developed but not submitted for marketing authorisation.

Novavax’s vaccine is also authorised for use in the US and is currently under review in other markets.

The European Commission authorised Moderna’s Spikevax XBB.1.5-adapted COVID-19 vaccine in mid September. The Comirnaty XBB.1.5-adapted COVID-19 vaccine, developed by BioNTech-Pfizer was recommended for authorisation by CHMP in August and authorised by EC in September.