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Novavax Files to EMA for Covid Vaccine Nod

18.11.2021 - The European Medicines Agency (EMA) has begun evaluating a formal application from US biotech Novavax for conditional marketing authorization of the company’s Covid-19 vaccine, now branded as Nuvaxovid. The EU’s health regulator said it will accelerate the approval process and issue an opinion “within weeks” if the data submitted are sufficiently robust and complete to show the efficacy, safety and quality of the vaccine.

EMA said the short approval timeframe is only possible because it already reviewed a substantial portion of the data on the vaccine during a rolling review that began in early February. Reports at the time said Novavax might be close to a supply deal with the European Commission (EC), though this took until August to finalize.

In the finalized advance purchase agreement, the EC ordered an initial 100 million doses of the Novavax vaccine, combined with an option to take an additional 100 million doses by 2023.  In late October, the US company filed to the UK’s Medicines and Health Regulatory Authority MHRA) for approval. It has not yet filed with the US Food and Drug Administration (FDA), though after several delays it has hinted at a filing in the last quarter of this year.

During its review of the shot, the EMA’s human medicines committee CHMP assessed non-clinical data from lab studies and information on the quality of the vaccine and the production process, in addition to data on the vaccine’s safety, immunogenicity and efficacy against Covid-19 from clinical studies in adults.

In parallel, the regulator’s safety committee (PRAC) completed the preliminary assessment of Novavax’s  risk management plan, and its committee on medicines for children (PDCO) issued an opinion on the company’s pediatric investigation plan (PIP), which describes how the medicine should be developed and studied for use in children.

If the EMA concludes that the benefits of Nuvaxovid outweigh its risks in protecting against Covid 19, it will recommend that the Commission fast-track the approval process toward a conditional marketing authorization valid in all EU and EEA member states. This could be granted “within days.”

Author: Dede Williams, Freelance Journalist

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