Biomedical Engineering Reference
In-Depth Information
13.1
Background on Vaccines
Vaccines are biological pharmaceuticals. Like other biologicals such as insulin, the
active components of vaccines are extracted from living organisms and then isolated
through separation technologies. What differentiates vaccines from other biologicals
is their distinctive mechanism of action: they work by stimulating or restoring the
immune system's ability to fi ght infections and disease.
Until recently, all vaccines were preventive or prophylactic vaccines, 1 that is,
they were developed to prevent a future infection or attenuate its effects. In April
2010, the FDA approved Provenge, the fi rst therapeutic vaccine, for use in male
patients with metastatic prostate cancer. 2 Other therapeutic vaccines are under
development, including vaccines against other types of cancers and Alzheimer's
(Shirvill 2010 ; Andrews 2011 ). Figure 13.1 shows how vaccines are related to other
types of pharmaceuticals.
Therapeutic vaccines, besides representing only a very small share of vaccine
sales at this time, pose pricing and reimbursement issues (Provenge costs $93,000
for a course of treatment) and marketing challenges which are similar to those of
other therapeutic biologics. 3 Preventive vaccines, however, face distinctive
marketing challenges and a somewhat different market environment.
Pharmaceuticals
Biologicals
Chemicals
Vaccines:
work by stimulating
the immune system
Non-vaccine
biologicals
(e.g., insulin)
Preventative
(prophylactic)
vaccines
e.g., flu vaccines
Therapeutic
vaccines
e.g., prostate cancer vaccine
Fig. 13.1
Types of pharmaceutical products
1 Some vaccines can be used both for prevention and treatment. For example, rabies vaccines can
also be administered after an individual has been exposed to the virus (e.g., following a bite by a
rabid dog).
2 Provenge's sales have proven disappointing so far. http://blogs.wsj.com/health/2011/08/04/
dendreon-shares-plummet-as-company-withdraws-provenge-sales-forecast/ .
3 Their slower onset of action compared with other therapeutic biologics represents a specifi c
challenge for therapeutic vaccines.
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