The Ethics behind the Norwalk Potato Vaccine

Ethics & New Genetics

Dr. Janine Idziak and Dr. Fred Schnee
November 30, 2015

Kari Frantzis

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Humans come into contact with diseases almost daily. Scientific technology created the
vaccine, which has saved millions. Bioengineering, a newer scientific technology, creates the
possibility of putting a vaccine into food. This food would be considered genetically modified. A
genetically modified food is any food that has a gene from another species (Singer 2007).
Genetic modifications could include putting viral genes that code for a protein into food to create
a vaccine. If these were the correct sequences, a person would receive a small amount of viral
proteins to create antibodies but not come down with the illness, and thus they would have
increased immune response to that virus. This increase will help the person to fight off the
infection, and potentially save his/her life like Modern vaccines already do. A Norwalk vaccine
potato is in clinical trials currently, and subjects have shown increased immunity after eating the
genetically modified food. The Norwalk potato vaccine has the viral gene coding for the
Norwalk Virus Capsid Protein (NVCP) inserted into its DNA (Tacket et al. 2000). In this paper I
will examine whether it is ethically permissible to genetically modify food to contain a vaccine
against Norwalk virus. Using the ethical theory of utilitarianism, I will argue that it is ethically
permissible to genetically modify a potato to contain a Norwalk vaccine.
The Norwalk potato vaccine depends on two scientific processes: genetic modification
and vaccination. Genetic modification of food is a scientific process by which transgenic foods
are produced. Transgenic foods are foods that contain genes from another species (Singer 2007).
Creating a transgenic food occurs in a lab. The first step in creating transgenic products requires
a desired trait in an organism to be traced back to the correct gene. Then the gene is isolated from
organism A. The gene codes for a protein that will be useful. This gene from organism A is then
inserted into the DNA sequence of organism B. Organism B is the transgenic product. Genetic
modification was first done in 1972, and has been used on bacteria and foods since (Singer
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2007). Genetic modification of food is done for a variety of reasons such as improving nutrition
of the food, increasing yield, and reducing the use of pesticides. There are many genetically
modified foods in supermarkets today. Since the introduction of genetically modified foods, there
has been public backlash in fear of the safety of the food.
Vaccines are a preventative medical method that introduces the immune system to a virus.
The virus that is injected into the body is weakened, dead, or small component of the virus which
is usually a protein. The interaction of the vaccine with the immune system allows the immune
system to fight off the virus. The immune system is then able to produce antibodies specific to
the virus in the vaccine. These antibodies are important because they allow the person to better
fight off a full-strength version of the virus. To sum up, if the immune system is trained to
recognize a pathogen prior to infection, the disease can be prevented when the actual pathogen is
encountered (Mandy 2005). Vaccines help to reduce the death rate of many viral diseases,
improving the lives of millions. Additionally, vaccines are one the few methods that can be used
to overcome viral disease. The only other medical treatment method involves the use of
antivirals. Antivirals have only been developed for hepatitis, herpes, and influenza (Razonable
2011). Antivirals only have clinical use if administered within a narrow time frame. The
influenza antiviral drug, for example, is only effective if prescribed within twenty-four hours of
contracting the virus. For this reason, vaccination is the most common form of medical
intervention for viral illness. Vaccine safety has been questioned recently. Studies done by
independent experts and WHO have shown that vaccines are far safer than therapeutic
medicines (Andre et al. 2008). Though vaccines are extremely useful, they have many limits.
They only work to give immunity against viruses and will only protect individuals if
administered before exposure (Andre et al. 2008). Development of vaccines are a difficult
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process. The virus must be studied to determine what would be the best form of the virus to give
a person immunity. The vaccine must also be the correct dose, which requires clinical human
trials. Once the vaccine is made, it must be stored to prevent degradation. The vaccine is usually
injected with a needle into the body of a patient, though there have been recent vaccines that can
be introduced nasally.
The process to genetically modify a food to contain a vaccine is the same process used in
genetically modified foods on the market today; a different species gene is inserted into the
foods DNA. The Norwalk potato vaccine has the Norwalk Virus Capsid Protein gene inserted
into its DNA (Tacket et al. 2000). The NVCP gene that is inserted into the potato is the cDNA of
the viral RNA. When the NVCP gene is produced under recombinant techniques in insects, the
protein is called recombinant Norwalk Virus-like particles. The recombinant Norwalk Virus-like
particles have been shown to be morphologically similar to authentic viral particles (Jiang et
al. 1992). The capsid protein is what the immune system interacts with when a person is infected
with the Norwalk virus to produce antibodies. Immunoprecipitation and enzyme-linked
immunosorbent assays have linked both the NVCP and the recombinant protein to antigenic
properties (Jiang et al. 1992). The recombinant capsid protein has shown high levels of
antibodies corresponding to the Norwalk virus in mice, guinea pigs, and rabbits when injected
into the blood (Jiang et al. 1992). The Norwalk virus causes acute epidemic gastroenteritis, and is
spread by the fecal-oral route (Tacket et al. 2000; Jiang et al. 1992). The Norwalk virus is
estimated to cause at least 42% of outbreaks of nonbacterial gastroenteritis in the United States
(Jiang et al. 1992). The Norwalk potato vaccine would act as a vaccine if the patient ate the
potato.

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There are positives and negatives to every scientific advancement. Utilitarianism is an

ethical theory that considers all of the consequences of an action for making a moral judgment.
The consequences can be positive or negative, and must be considered for all people affected by
the action. To act ethically using utilitarianism, one must decide to act so as to produce the best
consequence possible (West). Considering the action, the severity of the consequence and the
number of people affected factor into how large of a role each consequence plays. The more
people affected by an action or the more severe the consequence, the larger the magnitude. By
considering the numbers assigned to each consequence, an ethical decision can be made. Making
a potato that contains the Norwalk vaccine would have positive consequences for some people,
and negative consequences for others.
The positive consequences of making a Norwalk vaccine in a potato would include the
easier distribution of the vaccine. Currently, vaccines require refrigeration. In poorer parts of the
world, refrigeration is not readily available. The lack of refrigeration creates the problem where
the people who most need a vaccine cannot get it (Mandy 2005). This impacts the availability
of vaccines in areas that have less medical access already. Those with less medical access are at a
disadvantage. Overall, vaccines have clear benefits for the disadvantaged (Andre et al. 2008).
Potatoes do not need refrigeration, thus there would be increased access to the vaccine. This
would help the developing world the most. Another problem with distribution is the need for
sterile supplies. Vaccines are usually injected into the body using a needle. In certain parts of the
world, sterile needles are not a priority. In Southeast Asia, nearly 80 percent of injections that
are given are with non-sterilized equipment. The next highest rate is found in Africa, which is a
shade under 80 per cent and then Easter Europe with nearly 70 percent injections with unsafe
equipment (WHO Watch 2010). Though the non-sterile equipment doesnt seem detrimental, it
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has a huge impact on the health of people. The needle must pierce the skin. Using a non-sterile
needle may introduce pathogens into the body. Unsafe injection practices have serious largescale consequencesEach year the over-use of injection and re-use of dirty syringes and needles
combine to cause an estimated 8-18 million hepatitis B virus infections, 2.3-4.7 million hepatitis
C virus infections and 80,000-160,000 infections with HIV/AIDS worldwide (WHO Watch,
2010). These non-sterile needles have contributed to the spread of HIV and Hepatitis. A potato
vaccine would not require a needle to introduce the virus into the body, thus eliminating this
issue. By reducing the spread of hepatitis and HIV, the lives of millions would be improved.
Vaccines also require a medical professional to administer. Immunization techniques require
training. Administering a potato vaccine would not require the same level of training, thus
reducing some costs for the people receiving the vaccine. Overall, an oral vaccine incorporated
into a plant bypasses the need for sterile syringes, costly refrigeration to injection, or multiple
injections (Mandy 2005). This would be a positive consequence for everyone in the world, but
especially for those with a lowered income.
The Norwalk virus enters the body most frequently through the oral-fecal route (Neale
2011). Historically, vaccines have been introduced to the body via injection into the blood. The
best method for creating immunity in the human body is one that enter the body through the
gastrointestinal tract, a vaccine that is ingested may actually provide the best protection because
it mimics the natural route of infection (Mandy 2005). A vast majority of the deadly diseases in
third world countries enter the body through the oral-fecal route (Mandy 2005). The more people
that can get access to the vaccine, the more people who would have immunity against Norwalk.
Norwalk is not usually a severe disease, but it causes 1.1 million hospitalizations in the U.S.
yearly and 218,000 deaths worldwide (Neale 2011). The Norwalk virus vaccine would decrease
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the severity of the disease, and improve the lives of thousands. Putting a vaccine into food would
increase the availability of the vaccine for the developing world.
Scientific discoveries lead to large changes in the scientific community, which lead to
changes in all of society. The invention of the vaccine revamped the medical world in the 1700s.
Putting the Norwalk virus into a potato could act as a precedent for the creation of other
transgenic vaccines in food. There is one group lead by the ideas of Dr. Charles Arntzen who has
focused on creating the Norwalk potato vaccine (Tacket et al. 2000). The Norwalk potato vaccine
is the only transgenic vaccine that is being studied at this point in time. Making a transgenic
vaccine in food requires a scientific risk. Creation of a vaccine is a difficult process, and putting
the vaccine into a potato greatly complicates the process. No other transgenic vaccines in foods
are being pursued at this time because of this. Though the Norwalk virus is not extremely deadly,
creating a transgenic vaccine in food could lead to more vaccines being adapted to be in food. If
this method was proven to work, then other researchers could apply it to more deadly viruses. If
the Norwalk potato vaccine is successful, the medical world could undergo another revolution.
This precedent could help the future of society as a whole.
Increasing access to a vaccine also has the positive consequence of reducing long-term
costs of healthcare. Immunization programs require an input of money to pay for the production
and purchase of vaccine, as well as the staff able to give the vaccine (Andre et al. 2008). The
input of money seems like a detriment to society, but when the mortality and morbidity
prevented by the administration of vaccines is factored in, there is a long-term cost savings and
potential economic growth (Andre et al. 2008). The estimated economic cost of vaccines in
2003 is tens of billions of US dollars in direct savings (Andre et al. 2008). Instigating a more
comprehensive vaccination policy would also help the developing world. Malaria, for example,
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cost sub-Saharan Africa $100 billion worth of lost annual gross domestic products (Andre et
al. 2008). The economy of the countries affected by instigating a vaccine policy would improve.
Increasing the access to vaccines and reducing the number of risks of secondary infections would
help the economy even more. Thus, creating a vaccine in food would further the economic status
of all countries affected by the Norwalk virus, which would be a positive consequence for all of
society.
One negative consequence is that the there is no way to predict exactly what the effects of
genetic modifications are on humans. There is a risk that inserting a gene from a different
organism may create an allergen, a toxin, or other substance that has adverse effects for humans.
Before any genetically modified food makes it to market, it must be shown to contain no known
toxins, pass an allergy test, and be shown to have the same chemical composition. Though these
tests are in place, there is a chance that the modified organism will have an unknown allergen or
toxin that was not tested for before making it to the market. For this reason, there is no guarantee
that a genetically modified organism will be completely safe. But genetic modification has been
done using classical breeding methods for centuries, and using biotechnology is no riskier than
conventional planting methods (Wang 2012). While creating transgenic foods has been done for
decades, putting viral DNA into food has not been done before. The effects of putting a virus in
the food could lead to any of the risks from GM food or a completely unknown risk. Current
vaccines also have the possibility of causing severe reactions. Vaccines work by antagonizing the
immune system with a weakened virus, so that it is prepared for the full-strength virus. Though a
severe reaction is rare, that chance still exists. A transgenic vaccine in food would have that same
risk of adverse reaction from the viral protein. Research on the Norwalk potato vaccine suggests
that these effects would not occur. Clinical trials have been performed on mice, guinea pigs, and
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rabbits without harm to the animals (Tacket et al. 2000). Human trials have indicated no harm
thus far (Tacket et al. 2000). The human trials have only been done in preliminary stages.
Because the dose is not finalized, it is not for certain that it is completely safe. Overall, tt is more
likely to be safe to humans than not due to the results of the clinical trials.
The Norwalk virus is not that dangerous. A majority of people make a full recovery in a
matter of days (Vasikari and Blazivek 2015). A severe case, one where hospitalization is
required, is rare. The normal treatment is anti-diarrheals, anti-nauseas, and keeping hydrated.
There are current trials of an intranasal vaccine in progress. This intranasal vaccine has shown
promise in humans, by reducing the severity of the infection (Vasikari and Blazivek 2015). A
problem with the Norwalk virus is that it is easily spread, and infects the gastrointestinal tract.
There is an estimated 267 million infected per year, with 200,000 deaths. The majority of the
deaths come from underdeveloped countries, elderly, young, and immunosuppressed. Developed
countries have the higher contraction rates of the Norwalk virus, and a majority of the cases of
Norwalk virus are contracted from hospitals. Most of these people have access to basic medical
care. An alternative solution to making the Norwalk vaccine potato would be to work on the
intranasal Norwalk vaccine. The intranasal Norwalk vaccine would help to decrease the spread
of HIV and hepatitis, but would still require refrigeration and a medical professional.
Like every new medical treatment, creating a vaccine in food requires clinical testing.
Clinical trials of the Norwalk potato vaccine have been able to induce similar antibody levels as
exposure to the wild type virus does in mice, guinea pigs, and rabbits (Tacket et al. 2000). Trials
in chimpanzees have been unsuccessful, as the Norwalk virus doesnt infect this species. Trials
involving humans thus far have shown success in decreasing severity of symptoms (Tacket et al.
2000). Testing on humans thus far have been done on volunteers in the United States. Any study
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that is to be performed on humans must be ethical. In the United States, there are guidelines for
ethical experimentation. In most developed countries, there are some guidelines to prevent
unethical experiments. In the developing world, there are not these guidelines. As a result, there
have been many unethical medical studies performed in the developing world. There are
pervasive double standards in research ethics, health-care safety and professional rigor that exist
in the developing world (WHO Watch 2010) which negatively impact the people in the
developing world. In Masaka, a town in Uganda, researchers monitored HIV transmissions from
HIV-positive adults who did not know they were infected to their spouses and children (WHO
Watch 2010). The HIV positive adults were never told that they had the disease. Another
unethical study was the Zimbabwe Vitamin A for Mothers and Babies (ZVITAMBO) study
tested and followed over 4400 HIV-positive women and their newborn children, observing HIV
infections and deaths in the children. Mothers could learn their [HIV test] results at any time
(WHO Watch 2010). The mothers in this study were also not made aware of their HIV-positive
result. This study has been compared to the Tuskegee syphilis experiment in terms of how
unethical it was. The developing world has been used in unethical experiments both in the past
and today. Those who would benefit the most from a vaccine in a food would be those in
developing countries with little medical access. It is possible that the development of a vaccine in
food could lead to more unethical experimentation in these areas. It would be fairly easy to test
safety of the transgenic vaccines in the food by giving them to people without telling them and
monitoring their health. Many other unethical experiments could arise from this technology. But
Dr. Charles Arntzen, the lead scientist on the Norwalk potato vaccine project, is determined to
have his vaccine pass the rigorous requirements of the FDA before it makes the market (Mandy
2005). This indicates that the researchers on the Norwalk potato vaccine would not likely pursue

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unethical testing. This does not completely remove the risk to the developing world, who may
still be at risk of future exploitation with transgenic vaccines in food.
There is significant controversy surrounding both genetically modified foods and
vaccines. Genetically modified foods have been called frankenfoods. These people question if
humans are justified in altering an organisms most intimate characteristic, its genetic code
(Wade 2012). Majority of the general public does not know what a genetically modified food is,
but they do not want to eat a genetically modified food. Some believe that genetic modification
is unnatural, and will harm humans. Vaccines are even more controversial, as claims have been
made that vaccines cause autism. The research behind vaccine causing autism has been shown to
be faked, but many in the public still believe it does. Vaccines have polarized the nation into provax and anti-vax. As more people chose to not vaccinate their children, there is a greater chance
of disease outbreak. The Norwalk vaccine potato would be controversial in both aspects. There
would likely be media uproar about genetic modification, and its dangers. Many would become
suspicious of genetically modified foods. The anti-vax groups would dislike the potato even
more. If the Norwalk vaccine potato fails, or doesnt live up to its promises, it may destroy the
reputation of both genetically modified foods and vaccines.
Creating and using the Norwalk potato vaccine would be ethical under the framework of
utilitarianism. The overall positive consequences outweigh the negative consequences for this
action. The negative consequences are the unknown risk when manipulating DNA, the
destruction of the reputation of GMOs and vaccines, the potential for exploitation of the
developing world, and the fact that this is an easily treatable viral disease. The positive
consequences are that a genetically modified vaccine would be easier to distribute to
underdeveloped countries, the vaccine mode of introduction would reduce current disease
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spreading practices in underdeveloped countries, setting a precedent for future transgenic food
vaccines, and that it would be an economic help to the world. The positive consequences would
help a larger population of people, and the risks faced by using the Norwalk potato vaccine are
much less likely to occur. As a society we must uphold responsibility and consider the
consequences of each technological advancement (Wade 2012). Thus, it is ethical to use the
Norwalk potato vaccine.

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