Ch.4 — The Pharmaceutical Industry • 69 
coli, so that a \accine witli se\eral antigens 
might he produced in one fei'inentation.' 
Tu o more \ iral diseases deser\ e at least brief 
comment. .Appro.ximately 800 million doses of 
foot-and-mouth disease \ irus (FMD\ ) \ accine 
are annually used worldwide, making it the 
largest \ olume \ accine produced. This vaccine 
must be given frequently to livestock in areas 
where the disease is endemic, which includes 
most of the world outside of North .America. 
The present methods of producing the vaccine 
require that enormous (juantities of hazardous 
\ irus he contained. Many outbreaks are attrib- 
uted to incompletely inactivated vaccine or to 
the escape of the virus from factories. (See 
figure 23.) 
Molecular cloning of the antigen could pro- 
duce a stable vaccine at considerably less ex- 
pense, vv ithout the risk of the virus escaping. On 
the basis of that potential, R.AC has approved a 
joint program between the U.S. Department of 
Agriculture (L'SDA) and Genentech to clone 
pieces of the FMD\’ genome to produce pure an- 
tigen. The RAC decision marked the first excep- 
tion to the N'lFl prohibition against cloning DNA 
that is derived from a virulent pathogen.^ FMDV 
vaccine made by molecular cloning will prob- 
ably be distributed commercially by 1985, al- 
though not in the United States. It will be the 
first vaccine to achieve that status, and illus- 
trates the potential veterinary uses of genetic 
technologies. 
Hepatitis has also received significant atten- 
tion. Vaccines against viral hepatitis, which af- 
fects some 300,000 Americans each year, may 
be produced by molecular cloning. This disease 
is second only to tuberculosis as a cause of 
death among reportable infectious diseases. It is 
extremely difficult to cultivate the causative 
agents. Hepatitis A has a good chance of being 
the first human viral disease for which the in- 
itial preparation of experimental vaccine will in- 
volve molecular cloning. A vaccine against hepa- 
titis B, made from the blood of chronic carriers, 
'For other aspects of vaccine production see: Office of Technol- 
ogy .Assessment, U.S. Congress, Working Papers, The Impacts of 
Genetics, \ol. 2. (Springfield, Va.: X'ational Technical Information 
Service, 1981). 
-Ibid. 
Figure 23. — Recombinant DNA Strategy for Making 
Foot-and-Mouth Disease Vaccine 
Growing E. coli bacteria may produce VPs for use as vaccine 
for foot-and-mouth disease. No virus or infectious RNA is 
produced by the harmless bacteria strain. 
*VPs is the protein from the shell of the virus, which can act 
as a vaccine for immunizing livestock against foot-and- 
mouth disease. The idea outlined above is to make this VPs 
protein without making any virus or infectious RNA. 
SOURCE: Office of Technology Assessnnent. 
is in the testing stage, but cloning is being in- 
vestigated as a better source of an appropriate 
antigen. The causative agent for a third form of 
hepatitis has not even been identified. Since at 
least 16 million U.S. citizens are estimated to be 
at high risk of contracting hepatitis, there is 
keen interest in the development of vaccines 
among academic and industrial researchers.® 
’Ibid. 
