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Non-clinical safety evaluation of vaccine: Strategic considerations to accelerate clinical development


PharmaLex, Noida, Uttar Pradesh, India


Vaccines represent the most diverse class of product candidates in the pharmaceutical industry. While the basic principles laid out for the safety evaluation of non-vaccine pharmaceuticals applies to vaccines, there are fundamental differences between vaccines and other pharmaceuticals which necessitates careful tailor-made strategy that suits the individual type of vaccine being developed.

This white paper gives an overview of regulatory expectations on non-clinical development of vaccines, especially on requirements for safety evaluation, key differences when compared to safety evaluation strategy for non-vaccine pharmaceuticals, the recommended product-specific consideration that needed to be considered during the non-clinical development of different vaccine types, and incorporation of elements of ‘3R’ concept to ‘Reduce, Refine, and Replace’ use of animals in vaccine testing.


Vaccines are medicinal products intended to elicit an immune response(s) that can prevent (prophylactic vaccine) and / or lessen the severity (therapeutic vaccine) of a given disease. Vaccination involves priming the immune system of a host with an infectious agent or components of an infectious agent, modified in a manner to ensure that the vaccine does not cause any harm or disease to the host, but ensures that when the host is confronted with that infectious agent, its immune system can respond adequately to control the invading organism before it causes any ill effect (1).


Like other non-vaccine pharmaceuticals, the development of vaccine is also a step-wise process comprising preclinical proof of concept, non-clinical development (efficacy, quality, and safety), and clinical development; the data generated in the initial stages guides the strategy for the next stage, until it is proven efficacious and safe in the well conducted clinical trials in the target human population.



The decision to approve a drug is taken after careful weig ...

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