The Quality Lowdown: What Happens When The Wrong Ingredients Are Used
Some ingredient risks to consider: IV castor oil hypersensitivity; oral liquid bioburden; elm in the coconut.
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US FDA considering approach that is similar to, but more stringent than, influenza strain changes, CBER Director Marks says. Meanwhile, vaccine developers face challenge of when to change antigens to get the best results, NIH’s Graham notes. As FDA and sponsors gain more experience with tweaking the vaccines to account for new coronavirus variants and strains, the process may be expedited further.
Agency’s struggle to meet user fee commitments despite travel restrictions expected to worsen as pandemic continues into 2021.