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Assaying the Potency of Influenza Vaccines.

Minor PD - Vaccines (Basel) (2015)

Bottom Line: The potency of vaccines must be determined to ensure that the appropriate dose is given.Single radial diffusion has been used for decades and provides a relatively simple way to measure the amount of biologically active materials present in the vaccine.It requires reagents, which are updated on a regular, frequently yearly, basis and alternative methods continue to be sought.

View Article: PubMed Central - PubMed

Affiliation: National Institute for Biological Standards and Control/MHRA, Blanche Lane, Potters Bar, Hertfordshire EN6 3QG, UK. Philip.Minor@nibsc.org.

ABSTRACT
The potency of vaccines must be determined to ensure that the appropriate dose is given. The manufacture and assessment of influenza vaccines are complicated by the continuously changing nature of the pathogen, which makes efficacy estimates difficult but also confounds attempts to produce a well-validated, consistent potency assay. Single radial diffusion has been used for decades and provides a relatively simple way to measure the amount of biologically active materials present in the vaccine. It requires reagents, which are updated on a regular, frequently yearly, basis and alternative methods continue to be sought.

No MeSH data available.


Related in: MedlinePlus

Calendar of influenza vaccine production in the European Union showing roles of the public sector bodies and vaccine manufacturers and the interactions between them.
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vaccines-03-00090-f001: Calendar of influenza vaccine production in the European Union showing roles of the public sector bodies and vaccine manufacturers and the interactions between them.

Mentions: Until recently there was a statutory requirement in the EU for assessment of serological responses by each manufacturer through a clinical immunogenicity study before a new season’s influenza vaccine was licensed. This requirement will be removed from 2015 [15] because it delays the process of getting vaccines onto the market (Figure 1) and the studies in small groups of healthy adults rather than the target groups had little or no benefit in assuring the quality of the vaccines. The studies were complicated in the same ways as studies of clinical efficacy: the age of the clinical trial participants was not the same as the common target group and the impact of previous exposure to vaccine or infection was not known. A further factor is the impossibility of developing reference materials to help in standardising serological assays every year for a continuously changing agent although the need is clear [16]. The difficulties encountered were mainly due to the changes in the strains of interest; influenza vaccine is essentially a new product every year in contrast to vaccines against other agents where the clinical properties of the product can be established with confidence over many years.


Assaying the Potency of Influenza Vaccines.

Minor PD - Vaccines (Basel) (2015)

Calendar of influenza vaccine production in the European Union showing roles of the public sector bodies and vaccine manufacturers and the interactions between them.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4494238&req=5

vaccines-03-00090-f001: Calendar of influenza vaccine production in the European Union showing roles of the public sector bodies and vaccine manufacturers and the interactions between them.
Mentions: Until recently there was a statutory requirement in the EU for assessment of serological responses by each manufacturer through a clinical immunogenicity study before a new season’s influenza vaccine was licensed. This requirement will be removed from 2015 [15] because it delays the process of getting vaccines onto the market (Figure 1) and the studies in small groups of healthy adults rather than the target groups had little or no benefit in assuring the quality of the vaccines. The studies were complicated in the same ways as studies of clinical efficacy: the age of the clinical trial participants was not the same as the common target group and the impact of previous exposure to vaccine or infection was not known. A further factor is the impossibility of developing reference materials to help in standardising serological assays every year for a continuously changing agent although the need is clear [16]. The difficulties encountered were mainly due to the changes in the strains of interest; influenza vaccine is essentially a new product every year in contrast to vaccines against other agents where the clinical properties of the product can be established with confidence over many years.

Bottom Line: The potency of vaccines must be determined to ensure that the appropriate dose is given.Single radial diffusion has been used for decades and provides a relatively simple way to measure the amount of biologically active materials present in the vaccine.It requires reagents, which are updated on a regular, frequently yearly, basis and alternative methods continue to be sought.

View Article: PubMed Central - PubMed

Affiliation: National Institute for Biological Standards and Control/MHRA, Blanche Lane, Potters Bar, Hertfordshire EN6 3QG, UK. Philip.Minor@nibsc.org.

ABSTRACT
The potency of vaccines must be determined to ensure that the appropriate dose is given. The manufacture and assessment of influenza vaccines are complicated by the continuously changing nature of the pathogen, which makes efficacy estimates difficult but also confounds attempts to produce a well-validated, consistent potency assay. Single radial diffusion has been used for decades and provides a relatively simple way to measure the amount of biologically active materials present in the vaccine. It requires reagents, which are updated on a regular, frequently yearly, basis and alternative methods continue to be sought.

No MeSH data available.


Related in: MedlinePlus