Risk Assessment Commitment for COVID-19 mRNA Vaccine

Direct quote from the EMA EPAR EMEA/H/C/005791 Revision 29: SPIKEVAX (COVID-19 mRNA vaccine [nucleoside modified]), 19-Sep-2022

“The applicant provided a preliminary risk evaluation regarding potential nitrosamine contaminations in the finished product, which is considered acceptable but should be complemented with a quantitative risk assessment, especially focusing on nanoparticle constituents. (REC)”


@Annu @Nikhilrautela @Minkyung

Simultaneous determination of 13 nitrosamine impurities in biological medicines using salting-out liquid-liquid extraction coupled with liquid chromatography tandem mass spectrometry

J Pharm Biomed Anal. 2022 Sep 5;218:114867. doi: 10.1016/j.jpba.2022.114867. Epub 2022 Jun 2.

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