The European Medicines Agency (EMA) has recommended granting conditional marketing authorization for Novavax’s COVID-19 vaccine, NVX-CoV2373.

Millie Nelson, Editor

December 21, 2021

2 Min Read
Novavax COVID-19 vaccine wins EMA approval
Image: Stock Photo Secrets

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.

ISS_18964_03068-300x208.jpg

Image: Stock Photo Secrets

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.

90% efficacy

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.

About the Author(s)

Millie Nelson

Editor, BioProcess Insider

Journalist covering global biopharmaceutical manufacturing and processing news and host of the Voices of Biotech podcast.

I am currently living and working in London but I grew up in Lincolnshire (UK) and studied in Newcastle (UK).

Got a story? Feel free to email me at [email protected]

You May Also Like