Bavarian Nordic A/S said the U.S. Food and Drug Administration extended the review period for its smallpox vaccine by three months as it needed more time to evaluate the amount of data submitted.
The Denmark-based biotechnology company was granted priority review in December 2018 for the liquid-frozen version of MVA-BN for active immunization against smallpox in adults.
MVA-BN has a unique ability to block the replication cycle of viruses and if approved would be the first and only nonreplicating smallpox vaccine in the U.S.
The FDA's priority review period is usually six months, Due to the extension, however, it will now decide by September whether to approve the biologics license application, which is backed by data from 22 clinical studies.
Bavarian Nordic will still be eligible for a priority review voucher if the vaccine is approved by the U.S. regulator and noted in its March 11 news release that the delay will not impact its operations.
President and CEO Paul Chaplin said that while the review process has not raised any significant concerns to date, the company understands that the application is unusually large due to the FDA requiring more time to complete the review. Chaplin added that the company has already manufactured 28 million doses of the vaccine before approval.