Novavax Shares Gain Following FDA Advisory Committee's Positive Vote On Emergency Use Authorization (EUA) For COVID-19 Vaccine

Novavax’s NVAX COVID-19 vaccine (NVX-CoV2373) receives positive vote from U.S. Food and Drug Administration Vaccines and Related Biological Products Advisory Committee (VRBPAC), recommending FDA to grant Emergency Use Authorization (EUA) for individuals aged 18 years and over.

The Advisory Committee’s decision was supported by data readout from the pivotal Phase 3 clinical trial, PREVENT-19, which enrolled approximately 30,000 participants aged 18 years and older in the United States.

Stanley C. Erck, President and Chief Executive Officer, said, "In today's VRBPAC meeting, we heard the overwhelming support for our vaccine from physicians, healthcare organizations, and consumers who are eagerly anticipating a protein-based vaccine option. Consistent with submissions to regulatory authorities worldwide, we have already submitted an amendment with updated manufacturing information for the EUA to the FDA for review. We look forward to collaborating with the FDA as it makes its final decision."

The regulatory agency considers the recommendations of Advisory Committee when making decisions on Emergency Use Authorization (EUA).

The Novavax COVID-19 vaccine has received authorization for people aged 18 years and older from more than 40 countries, but it has not yet been authorized for use in the United States.

Novavax is trading high 19 percent at $56.35 in the after hours session.

Posted In: FDA ADCom RecommendationBiotechNewsHealth CareMovers & ShakersFDAGeneral

Ad Disclosure: The rate information is obtained by Bankrate from the listed institutions. Bankrate cannot guaranty the accuracy or availability of any rates shown above. Institutions may have different rates on their own websites than those posted on Bankrate.com. The listings that appear on this page are from companies from which this website receives compensation, which may impact how, where, and in what order products appear. This table does not include all companies or all available products.

All rates are subject to change without notice and may vary depending on location. These quotes are from banks, thrifts, and credit unions, some of whom have paid for a link to their own Web site where you can find additional information. Those with a paid link are our Advertisers. Those without a paid link are listings we obtain to improve the consumer shopping experience and are not Advertisers. To receive the Bankrate.com rate from an Advertiser, please identify yourself as a Bankrate customer. Bank and thrift deposits are insured by the Federal Deposit Insurance Corp. Credit union deposits are insured by the National Credit Union Administration.

Consumer Satisfaction: Bankrate attempts to verify the accuracy and availability of its Advertisers' terms through its quality assurance process and requires Advertisers to agree to our Terms and Conditions and to adhere to our Quality Control Program. If you believe that you have received an inaccurate quote or are otherwise not satisfied with the services provided to you by the institution you choose, please click here.

Rate collection and criteria: Click here for more information on rate collection and criteria.