WHO Technical Report Series, No. 927, 2005

8
Average: 8 (1 vote)

2.3.1. Pharmacology

No secondary pharmacodynamic, safety pharmacology or pharmacodynamic drug interaction studies have been conducted with BNT162b2 due to the nature of the RNA-based vaccine product, which is according to applicable guidelines (WHO guideline on nonclinical evaluation of vaccines, WHO Technical Report Series, No. 927, 2005).

https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf

WHO Technical Report Series, No. 927, 2005

https://www.who.int/biologicals/publications/trs/areas/vaccines/nonclinical_evaluation/ANNEX%201Nonclinical.P31-63.pdf

WHO Guidelines for Assuring the Quality of DNA Vaccines - 1998

https://www.sciencedirect.com/science/article/abs/pii/S1045105698901555?via%3Dihub

Nothing about synthetic ex-vivo RNA for vaccine and may be nothing about lipid capsule!