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Gaithersburg’s Novavax officially files for FDA vaccine approval

Gaithersburg, Maryland-based Novavax, which began developing its protein-based COVID-19 vaccine candidate almost two years ago, has officially filed for approval with the U.S. Food and Drug Administration for its use in the U.S.

The final FDA filing Monday comes months after Novavax had originally intended, and, while it may seem the company is late to the vaccine game, it sees its vaccine filling a void, particularly internationally. It does not require sub-zero storage, making it potentially more accessible to developing countries and remote areas.

It is also not an mRNA vaccine, such as those approved for Pfizer and Moderna.

“We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic,” said CEO Stanley Erck.

The Novavax vaccine has shown an overall efficacy of 90% in clinical trials. It conducted two Phase 3 trials with 30,000 participants in the U.S. and Mexico and a trial with almost 15,000 participants in the U.K.

To date, Novavax has received conditional approval authorization from the European Union and Emergency Use Listing from the World Health Organization. It has also received authorization in India, and its two-dose vaccine is already being distributed in Indonesia and the Philippines.

Last week, Israel’s Ministry of Health agreed to purchase up to 10 million doses of the COVID-19 vaccine, pending necessary authorizations.

The Novavax filing with the FDA comes the same day the FDA gave full authorization to Moderna’s vaccine, moving it from emergency use authorization. Pfizer received full FDA authorization for its COVID vaccine in August.

America 250: How people ordered their ready-to-assemble homes from a catalog

For decades, Americans could browse a catalog, choose a home and order it by mail. Sears, Roebuck and Company was a prominent manufacturer of mail-order homes. The company sold about 70,000 to 75,000 homes from 1908 to 1940, according to the Sears Archives. Its catalogs offered more than 400 different house styles and the listed prices could range from around $200 to $6,000. Customers even had the option of designing their own home and submitting the blueprint to Sears.
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