Against vaccine assay secrecy

Figures & data

Table 1. Ten vaccines licensed by Health Canada encompassed in our access to information request

Vaccine		Manufacturer	Date of Most Recent Canadian Licensing	Drug Identification Number
Zostavax II	Zoster vaccine live,attenuated [Oka/Merck]-	Merck Canada Inc.	31 October 2011	02375516
Zostavax		Merck Canada Inc.	22 August 2008	02315939
Varivax III	live, attenuated, univalent varicella virus vaccine, (Oka/Merck)	Merck Frosst Canada Inc.	19 June 2002	02246081
Varivax II		Merck Frosst Canada Inc.	26 August 1999	02240776
Varivax		Merck Frosst Canada Ltd.	2 December 1998	02239199
Pentacel	Diphtheria(D)-tetanus(T)-acellular pertussis(aP)-inactivated poliovirus(P) and Haemophilus influenza(Hib)	Sanofi Pasteur Ltd.	12 May 1997	02231343
Quadracel	DTaP-IPV	Sanofi Pasteur Ltd.	20 March 1997	02230946
Tripacel	DTP	Sanofi Pasteur Ltd.	10 July 1996	02230273
Cervarix	Human Papilloma Virus(HPV), bivalent	Glaxosmithkline Inc.	3 February 2010	02342227
Gardasil	HPV, quadrivalent	Merck Frosst Canada Ltd.	10 July 2006	02246081

Table 2. Vaccine assay information encompassed by the access to information request.

Laboratory Assay Standard Operating Procedures
1. Sample collection
2. Sample preparation
3. Reference standard for comparison
4. Assay methods
5. Reagents
6. Equipment
7. Instrumentation
8. Quality control
9. Verification of results
Assay Validation Data
1. Accuracy: closeness of the mean test result to the true value
2. Precision: closeness of individual measures when repeated multiple times on multiple aliquots of a single specimen
3. Analytical Specificity: ability to differentiate and measure the target in the presence of other components in the sample
4. Analytical Sensitivity: The lowest measurement at which the assay can quantify the target with accuracy and precision.
5. Reproducibility: the precision between 2 laboratories or between the same laboratory over time.
6. Clinical Sensitivity: ability to identify specimens that are true positives based on the reference method or “gold standard”(i.e., immune)
7. Clinical Specificity: ability to correctly identify those that are true negatives based on the reference method (i.e. non-immune)
8. Stability: the stability of the measured target in various conditions in which it will be stored or assayed.
References
Food and Drug Administration: Guidance for Industry, Bioanalytical Method Validation. US Department of Health and Human Services, May 2001.

Figure 1. Number of access to information requests processed and partially or fully denied by Health Canada, and number of exemptions relied upon to partially or fully deny such requests, 1991-2012. *Figure 1 was compiled using information contained in Health Canada's annual reports regarding access to information requests, which are publicly available. Data for fiscal years 1992-1993, 1996-1997, 1997-1998, and 1998-1999 is not publicly available, and only some data is available for fiscal years 2007-2008, 2009-2010, and 2011-2012).