Chapter 7 Vaccine Additives and Manufacturing Residuals in Vaccines Licensed in the United States

Question 1

Name seven (7) pieces of information regarding additives and residuals that must be affixed to the product label.

Answer 1

1. Preservative used and its concentration.
2. Known sensitizers.
3. Type and amount of added antibiotics.
4. Inactive ingredients (when safety is a concern).
5. Adjuvant.
6. Source of the product (for safe administration).
7. Identity of each microorganism used in manufacture.

Question 2

What is the main role of preservatives in vaccines?

Answer 2

Prevent the growth of bacteria and fungi that may inadvertently be introduced in the vaccine during use.

Question 3

In what type of product are preservatives mandatory?

Answer 3

Multidose vaccines.

Question 4

Name five (5) microorganisms that are used to challenge the effectiveness of a preservative in vaccines.

Answer 4

1. Candida albicans.
2. Aspergillus brasiliensis.
3. Escherichia Coli.
4. Staphylococcus aureus.
5. Pseudomonas aeruginosa.

Question 5

Name four (4) preservatives currently in use.

Answer 5

1. Phenol.
2. Benzothium chloride + formaldehyde.
3. 2-phenoxyethanol.
4. Thimerosal.

Question 6

Define lyophilization.

Answer 6

Process of freeze-drying vaccines and/or their components.

Question 7

What is the main role of stabilizers in vaccines?

Answer 7

Provide a bulk matrix for the vaccine, since the amount of immunogen is typically very small and alone, would not constitute a usable vaccine.

Question 8

Name the three (3) main classes of stabilizers.

Answer 8

1. Sugars.
2. Amino acids.
3. Proteins.

Question 9

Name the two (2) proteins are currently approved and used as stabilizers.

Answer 9

1. Human serum albumin.
2. Gelatin (porcine or bovine).

Question 10

Name three (3) concerns linked to the use of proteins as stabilizers.

Answer 10

1. Allergic reactions.
2. Adventitious agents, especially since serum albumin is blood-derived.
3. Bovine spongiform encephalopathy (for gelatin).

Question 11

Name three (3) sugars used as stabilizers.

Answer 11

1. Sucrose.
2. Lactose.
3. Sorbitol.

Question 12

Name two (2) amino acids used as stabilizers.

Answer 12

1. Glycine.
2. Glutamic acid.

Question 13

Name the two (2) main types of residuals in vaccines.

Answer 13

1. Inactivation residuals.
2. Cell culture residuals.

Question 14

Name three (3) inactivation residuals.

Answer 14

1. Formaldehyde.
2. Glutaraldehyde.
3. ß-propiolactone.

Question 15

What is the main cell culture residual in vaccines?

Answer 15

Antibiotics.

Question 16

Name four (4) residual antibiotics found in vaccines.

Answer 16

1. Streptomycin.
2. Polymyxin B
3. Neomycin.
4. Gentamicin.

Question 17

Name thirteen (13) potential sensitizing agents contained in vaccines.

Answer 17

1. Residual bacterial proteins.
2. Residual chicken proteins.
3. Reisudal bovine/porcine proteins.
4. Residual egg proteins.
5. Residual yeast proteins.
6. Residual insect proteins.
7. Residual milk proteins (mostly casein).
8. Latex.
9. Ammonium sulfate.
10. Polydimethylsiloxane.
11. LPS/endotoxin.
12. Prions.
13. Live infectious agents.