EMA Considers Licencing New COVID-19 Vaccine From Novovax

Dawn O'Shea

November 23, 2021

The European Medicines Agency (EMA) has started reviewing data on a new COVID-19 vaccine, Nuvaxovid (also known as NVX-CoV2373), which has been developed by Novovax. Data on the effectiveness and safety of the vaccine is being evaluated under an accelerated timeline, and a decision could be issued within weeks.

In February 2021, the EMA initiated a rolling review of findings from non-clinical and clinical trials of Nuvaxovid, in order to assess emerging data on the quality of the vaccine, along with its safety, immunogenicity and efficacy against COVID-19.

If the EMA concludes that the benefits of Nuvaxovid outweigh its risks in protecting against COVID‑19, it will recommend granting a licence for the use of the vaccine in the European Union/European Economic Area. The European Commission will then fast-track its decision-making process with a view to granting conditional marketing authorisation within days.

The agency has also begun reviewing data on Paxlovid (PF-07321332/ritonavir), an oral treatment for COVID-19 developed by Pfizer. Preliminary results from studies suggest that Paxlovid reduces the risk of hospitalisation or death compared with placebo when treatment is initiated 3-5 days after the onset of symptoms. The EMA will also review data on the medicine’s quality and safety.

European Medicines Agency. EMA receives application for conditional marketing authorisation of Novavax’s COVID-19 vaccine, Nuvaxovid. 17 November 2021. https://www.ema.europa.eu/en/news/ema-receives-application-conditional-marketing-authorisation-novavaxs-covid-19-vaccine-nuvaxovid

European Medicines Agency. EMA starts review of Paxlovid for treating patients with COVID-19. 19 November 2021. https://www.ema.europa.eu/en/news/ema-starts-review-paxlovid-treating-patients-covid-19

 

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