Considerations for setting the specifications of vaccines

Abstract

The specifications of vaccines are determined by the particular product and its method of manufacture, which raise issues unique to the vaccine in question. However, the general principles are shared, including the need to have sufficient active material to immunize a very high proportion of recipients, an acceptable level of safety, which may require specific testing or may come from the production process, and an acceptable low level of contamination with unwanted materials, which may include infectious agents or materials used in production. These principles apply to the earliest smallpox vaccines and the most recent recombinant vaccines, such as those against HPV. Manufacturing development includes more precise definitions of the product through improved tests and tighter control of the process parameters. Good manufacturing practice plays a major role, which is likely to increase in importance in assuring product quality almost independent of end-product specifications.

Keywords::

• human papillomavirus
• influenza
• polio
• smallpox
• viral vaccines
• WHO guidelines

Financial & competing interests disclosure

P Minor is an employee of the National Institute for Biological Standards and Control, which interacts with industry on a number of levels, including the independent assessment of products before they are released to the market, for which companies are charged less than full cost. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.