FDA Authorizes Novavax Covid Vaccine for Adults as the First New Shots in U.S. in More Than a Year

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FDA Authorizes Novavax Covid Vaccine for Adults as the First New Shots in U.S. in More Than a Year
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FDA authorization of Novavax’s vaccine was delayed for weeks as the agency reviewed changes to the company’s manufacturing process.

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Pfizer and Moderna's vaccines use mRNA, a molecule encoded with genetic instructions, to tell human cells to produce copies of a virus particle called the spike protein. The immune system responds to these copies of the spike, which prepares the human body to attack the actual virus. The Novavax vaccine also uses an additional ingredient called an adjuvant, which is extracted and purified from the bark of a tree in South America, to induce a broader immune response. The shots consist of 5 micrograms of the spike copy and 50 micrograms of the adjuvant.Two doses of the Novavax vaccine were 90% effective at preventing illness from Covid across the board and 100% effective at preventing severe illness, according to clinical trial data from the U.S. and Mexico.

Novavax published data in December showing that a third shot boosted the immune response to levels comparable to the first two doses which had 90% effectiveness against illness. The company plans to ask the FDA to authorize a third dose of its vaccine.

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