In the most simplified terms a vaccine is a biological therapeutic agent

In the most simplified terms, a vaccine is a biological therapeutic agent which offers active acquired immunity against a disease. Unlike most medications that treat diseases, vaccines have a sole purpose of prevention (Better Health, 2018). There are various types of vaccines. These include live-attenuated, inactivated, subunit, and toxoid. Most vaccines include four fundamental ingredients, these are: antigens, adjuvants, preservatives and stabilizers (U.S Department of Health & Human Services, 2019). Vaccines are not a recent biological advancement as immunisation techniques were discovered over two centuries ago. When smallpox was an infectious disease, claiming the lives of 300 million innocent people, an eighteenth-century doctor by the name of Edward Jenner noticed that farmers who contracted mild cowpox were immune to smallpox. With his keen observations, he scraped off the dried cowpox sores, grinded them and inoculated civilians with the powder (Children’s Hospital of Philadelphia, 2019). Since 1796, there has been a multitude of vaccines now available for public usage (Better Health, 2018). Whilst conventional types of vaccines such as attenuated, inactivated and toxoid vaccines have been recognised for successfully protecting hosts from various fatal diseases, advances in immunology and genomics have added recombinant vaccines into the vaccinology field. As there is not a lot of public attention on recombinant vaccines, there is still some debate concerning its safety and its ethical aspects. This presentation will discuss why human manipulation of viral pathogenic genes, specifically in recombinant vaccines, are not dangerous as the practices are safe and there are no current ethical issues.A handful of sceptics argue that recombinant vaccines are not safe as they do not have adequate research. However, this is not the case. The most well-established recombinant vaccine is the Hepatitis B vaccine. Hepatitis B (HPV), according to the CDC is “a contagious virus that is transmitted through blood, blood products, and other fluids…Symptoms include a sudden fever, tiredness, loss of appetite, nausea, vomiting, stomach pain, dark urine, joint pain, and yellowing of the skin and eyes”. It is a part of the Australian National Immunisation Program and is recommended within the 24 hours after birth. When the Hepatitis B vaccine was in development, there were many obstacles that had to be overcome however there was rigorous research and testing regarding safety. The research company, Merck Sharp & Dohme Research Laboratories, tested the vaccine on chimpanzees, mice and guinea pigs for 20 years before proceeding with human trials (Science Direct, 2016). All the tests demonstrated that the hosts were 100% protected against the disease and displayed no symptoms. The vaccine was then licensed by the Federal Republic of Germany in May 1986 and later by the American Food and Drug Administration (FDA) and Centres for Disease Control and Prevention (CDC) on the 23rd of July in the same year (Science Direct, 2016). Even after being successfully registered, each batch of the vaccine is regularly monitored on 3 aspects: Potency (the vaccine functions as it is meant to), purity (certain ingredients used during production have been removed) and sterility (it contains no foreign bacteria) (U.S. Department of Health & Human Services, 2019). Therefore, it is unfair to argue that recombinant vaccines are dangerous as there was considerable research including multiple animal and human trials which supports the vaccine’s safety.In addition to being constantly monitored, another factor which reassures the vaccine’s safety is how vaccines are administered. There are numerous ways of administering a vaccine such as injecting straight into the bloodstream (injection), pills that are swallowed (oral) and spraying a liquid up the nose (nasal) (National Institution of Allergy and Infectious Diseases Government, 2011). Australia has very specific rules and procedures regarding the administration of vaccines. It must be at a licensed medical clinic such as a pharmacy, hospital or medical centre and completed by a licensed nurse or doctor. The practitioner must use an alcoholic wipe to disinfect the injection area to decrease the chances of infection and reduces the likelihood of irritation at the injection site. Each vaccine has a specific needle gauge which is required, an angle which the needle is meant to be injected and a location of the injection for example the hepatitis B vaccine requires a 26, 27 gauge or 10mm needle (Better Health, 2018). It is clear there are many safety procedures completed to ensure the patient’s safety and proves that manipulation of viral genes is not a dangerous endeavour.Another critical factor which demonstrates human manipulation of genes is not dangerous is the scientific background regarding recombinant vaccines. An ethical concern regarding recombinant vaccines is the possibility it may cause the patient to catch the disease. However this thought can be disregarded as the vaccine excludes blood products. Recombinant vaccines work by extracting the specific genome section of the viruses’ genes responsible for evoking an immune system response and combining it with an empty plasmid to form a plasmid with the foreign gene. In the case of the hepatitis B vaccine, the gene coding responsible to evoking an immune response or “S” gene was isolated and embedded into an empty yeast (Saccharomyces cerevisiae) plasmid capable of efficiently synthesising large quantities of the antigen HBsAg (Science Direct, 2016). This means that antigens are synthetic, mimicking the HBsAg antigen but it cannot reproduce sufficiently within the host’s body. The antigen would not survive for extended periods of time thus it is impossible to catch the disease from the vaccine. Similarly, another ethical concern is allergies. Some people fear that getting the vaccine may cause severe allergies and even death. The organisation of Public Health suggests that the chances of reacting extremely to the vaccine is 1 in 1,000,000 (Hep Mag, 2013). The chances are very low and would only occur if the patient has a compromised immune system. On the other hand, according to Hep Mag, the annual risk of contracting the hepatitis B virus naturally in the United States is approximately 1 in 62,500 (Hep Mag, 2013). Obviously, the risks of not getting vaccinated outweigh the risks of extreme reactions.Ultimately, human manipulation of viral pathogenic genes is not dangerous as practices are totally safe and the present-day ethical concerns regarding recombinant vaccines have been debunked. The recombinant vaccine had extensive research and monitoring for decades before being registered available to the public, there are highly strict regulations and procedures regarding the vaccine’s administration and the chances of contracting the disease or having extreme allergic reactions from the vaccine are very low. As the advancement of technology and the understanding of recombinant vaccines deepen, it is most likely that there will not be a rise in any ethical issues in the future either.

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