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Bavarian Nordic wins US FDA approval for smallpox, monkeypox vaccine Jynneos

Bavarian Nordic A/S' smallpox and monkeypox vaccine won U.S. Food and Drug Administration's approval for use in adults, including people with weak immune systems and those with eczema.

The vaccine, known as Jynneos, or MVA-BN, becomes the first and only nonreplicating smallpox virus vaccine approved in the U.S. and the first approved monkeypox vaccine in the world, according to the company. Traditional smallpox vaccines are based on replicating vaccinia virus strains, which have been associated with a higher risk of adverse reactions.

The U.S. regulator's approval for smallpox is based on results from 22 clinical studies, including research that showed Jynneos performs as well as Emergent BioSolutions Inc.'s ACAM2000, the current U.S. licensed vaccine for smallpox. The U.S. government recently entered into a 10-year contract potentially worth over $2 billion with Emergent BioSolutions to buy supplies of ACAM2000 for the nation's emergency stockpile.

Previously, Bavarian Nordic's biologics license application for Jynneos as a smallpox vaccine was granted a priority review by the FDA, which was later extended by three months.

The regulator also granted the Danish biotechnology company a priority review voucher under the Material Threat Medical Countermeasure Priority Review Voucher program. The voucher can be used to accelerate the FDA's evaluation of future human drug applications and is also transferable. The company plans to sell the voucher to a third party.

Jynneos is already approved in Canada and the EU for immunization against smallpox and is sold under the names Imvamune and Imvanex, respectively.