Module 9 2024

03/09/2024

Vaccines are Biological Mixtures of Several Components

Vaccines contain more than one component and are biologically synthesized 1,2

Core components of a vaccine may include:*

Antigen(s) 1,2

Carrier protein(s) 1

Adjuvant(s) 1 may have > 2 components

In contrast to drugs, vaccines are mixtures of heterogeneous biologicals , which makes them subject to variation in yield 1,3

Drugs are typically composed of a single chemical product 2,3

*Not all vaccines contain carrier proteins or adjuvants – they may also contain preservatives, additives, and trace components from the manufacturing process. 1 1. National Centre for Immunisation Research and Surveillance. Factsheet: vaccine components. May 2013; 2. International Federation of Pharmaceutical Manufacturers and Associations. The complex journey of a vaccine. 2014. Available at: http://www.ifpma.org/resource-centre/the-complex-journey-of-a-vaccine-2/. Accessed Apr 2023; 3. Milstien JB et al. Health Nutrition and Population Discussion Paper. 2005.

The Organisation for Professionals in Regulatory Affairs

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Approaches for Vaccine Development

Inactivation

Inactivated vaccine

Nucleic vaccine (incl. mRNA Vx)

Pathogen

Attenuation Purification

Nucleic acid

Expression plasmid

Live attenuated vaccine

Mutagenesis

Sequence

Molecular Cloning (expression)

Epitope mapping

Synthetic Peptide

Insersion into vector

purification

Live recombinant vaccine (incl. adenovirus Vx)

Subunit (recombinant) vaccine

Peptide vaccine

The Organisation for Professionals in Regulatory Affairs

Adapted from: Paul - Henri Lambert, Vaccines for the World: Major Challenges for the future, G.P.I., WHO, Geneva

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