TUESDAY, SEPTEMBER 27, 2016

FDA gives priority status to PaxVax's cholera vaccine

The U.S. Food and Drug Administration (FDA) recently gave a priority review status to a Biologics License Application for filing and reviewing a single-dose oral cholera vaccine known as Vaxchora.

If the vaccine receives a license, it will be the only one that has been licensed for cholera in the U.S. It will also be PaxVax’s second vaccine to receive licensure; the first was Vivotif, which is designed to protect people from typhoid fever.

Vaxchora is manufactured by PaxVax Inc., a fully integrated specialty vaccine company that strives to create and sell novel vaccines to protect people from infectious diseases. PaxVax Bermuda Ltd., an affiliate of the company, produces the vaccine.

“Travelers residing in the U.S. currently have very few options to protect themselves against cholera when going abroad, and we are pleased with the progress we are making in bringing an effective single-dose cholera vaccine to the U.S. market,” PaxVax Chief Executive Officer Nima Farzan said. “We are also pleased to announce that Vaxchora has been granted priority review status, a critical step in the process of being awarded a Priority Review Voucher. The potential of being granted a voucher has been an important incentive for PaxVax and our decision to bring this vaccine to the U.S. market.”

Organizations in this story

PaxVax 3985A Sorrento Valley Blvd San Diego, CA 92121

U.S. Food and Drug Administration (FDA) 10903 New Hampshire Ave Silver Spring, MD 20903

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