The Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the US Food and Drug Administration (FDA) has voted 21 to 0 recommending the grant of Emergency Use Authorization (EUA) for Novavax’s Covid-19 vaccine, NVX-CoV2373, for people of the age 18 years and above.

A protein-based vaccine, NVX-CoV2373 is created from the genetic sequence of the initial SARS-CoV-2 strain and is adjuvanted with saponin-based Matrix-M. 

On obtaining the FDA EUA, NVX-CoV2373 would become the first protein-based Covid-19 vaccine to be offered in the US.

The committee considered the findings from the Phase III PREVENT-19 clinical trial that enrolled nearly 30,000 subjects of the age 18 years and above in the US and Mexico.

According to the trial data, the vaccine offered an efficacy of 90.4% with a reassuring safety profile. 

The number of serious and severe adverse events was minimal and balanced between vaccine and placebo arms. 

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Headache, nausea, myalgia, arthralgia, tenderness/pain at the injection site, fatigue and malaise were the most common adverse reactions reported in the trial.

Furthermore, the results showed that the rate of myocarditis was balanced between the vaccine and placebo groups overall while in the post-crossover segments of the trials, the reported cases were all within the anticipated rate.

The FDA takes the recommendations made by the VRBPAC into account while making decisions on the EUA.

Novavax president and CEO Stanley Erck said: “The advisory committee’s positive recommendation acknowledges the strength of our data and the importance of a protein-based Covid-19 vaccine developed using an innovative approach to traditional vaccine technology. 

“In the VRBPAC meeting, we heard the overwhelming support for our vaccine from physicians, healthcare organisations and consumers who are eagerly anticipating a protein-based vaccine option.” 

The company obtained authorisation for usage of the vaccine in people aged 18 years and above in over 40 countries and Emergency Use Listing from the World Health Organization.

In May this year, Novavax sought expansion of authorisation from the Medicines and Healthcare products Regulatory Agency for its Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), for use in adolescents aged 12 to 17 years in Great Britain.