The European Medicines Agency (EMA) has recommended granting conditional marketing authorization for Novavax’s COVID-19 vaccine, NVX-CoV2373.
Novavax’ COVID-19 vaccine, known as Nuvaxovid, is the fifth vaccine recommended in the European Union (EU) for preventing SARS-CoV-2. Additionally, the firm claims it is the first protein-based COVID-19 vaccine approved for use in Europe.
Nuvaxovid is made using Novavax’ proprietary nanoparticle technology and Matrix–M adjuvant – to market and the firm received $1.6 billion of US government assistance through the ‘Operation Warp Speed’ program in July to help secure large-scale manufacturing of the vaccine.
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The approval follows the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommendation to authorize Nuvaxovid, which is applicable in 27 EU member states.
The EMA said the results of two studies showed that Nuvaxoid had a vaccine efficacy of around 90% and was effective at preventing COVID-19 in people from 18 years old.
The identified side effects were often mild or moderate and subsided within a couple days after vaccination and the data surrounding the vaccine met the EU criteria for safety, quality, and efficacy.
Novavax conducted two studies, which involved over 45,000 people in total.
The first study, in Mexico and the US, had a total of 90.4% reduction in the number of symptomatic COVID-19 cases from one week after the second dose of Nuvaxoid. The second study, located in the UK, revealed similar results with a vaccine efficacy of 89.7%.
The EMA said Novavax’ vaccine safety and effectiveness will be monitored as it is rolled out across the EU. Furthermore, there is limited data available on Nuvaxovid’s efficacy against variants of concern, such as Omicron.
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