EU regulators delay approval of Novavax's variant-tailored COVID vaccine: Report

European Union (EU) regulators have postponed their decision on granting approval for Novavax's COVID-19 vaccine tailored to target the XBB variant, according to a report by the Financial Times. The European Medicines Agency (EMA), originally set to approve the updated vaccine last Friday, has requested additional information from the company, causing the delay.

The EMA has raised questions about the potency of the latest version of the vaccine and wants to ensure that its characteristics remain consistent across different production sites."As part of the ongoing review process, (the EMA) has additional questions, which we are answering expeditiously," Novavax told the Financial Times.

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This information comes from a source familiar with the matter cited in the FT report.

Novavax responds

Novavax stated that it is actively addressing the EMA's additional queries as part of the ongoing review process.

However, neither Novavax nor the EMA have made any official statement over this.Novavax announced on Friday (Oct 13) that its updated COVID-19 vaccine is now available at US pharmacies like CVS and Rite Aid.

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The Financial Times report said that the EMA would grant approval for Novavax's variant-tailored COVID-19 vaccine within the next four weeks.

Food and Drug Administration granted emergency use authorisation for Novavax's new Covid vaccine in individuals aged 12 years and older on October 3.

XBB variant has been responsible for a surge in COVID-19 cases, hospitalisations, and fatalities across US.

Priced at $130 per dose, this vaccine is now available in US.

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For those who have previously received any COVID-19 vaccine, a single dose can be administered at least two months after their last COVID-19 shot. Unvaccinated individuals can receive two doses, with each dose spaced three months apart.

Novavax's authorisation comes in the wake of the full approval of Moderna and Pfizer-BioNTech's monovalent vaccines for individuals aged 12 and older, targeting the latest coronavirus variant. Notably, the FDA had recently granted emergency use authorization for the Moderna and Pfizer vaccines for children between six months and 11 years of age.

(With inputs from agencies)

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