H1N1 vaccine licensure depends on adjuvant
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Efforts are under way to expedite H1N1 flu vaccine development for a potential voluntary vaccination campaign in the fall. How FDA handles registration of the vaccine depends on whether an adjuvant is used - if it is manufactured using the same process as the seasonal flu vaccine, the vaccines will be licensed for use as a strain change, the same way FDA approves new strains of the seasonal vaccine. If an adjuvant is used, the products would be registered under an Emergency Use Authorization. FDA announced the licensure of the seasonal flu vaccine for the 2009-2010 flu season on July 20, and clarified that it will not protect against H1N1. The same five manufacturers that produce seasonal vaccine are working on the swine flu vaccine
You may also be interested in...
Mustang Bio Enters Race For CAR-T In Autoimmune Disease
The biotech company’s CEO talked to Scrip about plans to bring the CD20-targeting CAR-T MB-106 into an investigator-sponsored Phase I trial later this year.
Aldeyra Hopes To Refile Dry Eye Drug Reproxalap Later In 2024
Following an FDA complete response letter last November, Aldeyra has agreed with the agency on a trial design to demonstrate efficacy in ocular discomfort, which the company can complete this year.
Colorado Price Cap Plan For Enbrel Draws Amgen Lawsuit; Cosentyx, Stelara ‘Affordability’ Reviews Pending
However, the state's recently formed prescription drug affordability board found Gilead’s Genvoya and Vertex’s Trikafta to be affordable.