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Stability Genius: How CMC Section Of COVID-19 Vaccine Guidance Speeds EUAs Safely

 
• By Bowman Cox

By focusing on short-term stability, US FDA paves way for quicker emergency use authorization without compromising on quality.

Doctor, nurse, scientist hand in blue gloves holding flu, measles, coronavirus, covid-19 vaccine disease preparing for child, baby, adult, man and woman vaccination shot, medicine and drug concept.
stable enough for quicker jab

The US Food and Drug Administration is prepared to authorize emergency use of COVID-19 vaccines based on a much quicker stability assessment than it will require for biologics license applications.

For products that should be flying off the shelves once they’re authorized, the agency has set aside the question of long-term stability for BLA reviews that can

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