IMMUNIZATIONS Authors: Kayleigh Yaeger(PharmD Student), Brenden Yoon (PharmD Student), Alex Plumer (PharmD Student)
I n t r o d u c t i o n
Spring 2020
Immunizations are an amazing advancement in healthcare that greatly decreases the chance of getting a disease. There are many issues with the concept of immunizations that hinder the potential of this aspect in modern healthcare. Here, we have touched on just the surface of the problems that are reducing the benefit to an advancement in healthcare that has so much potential and could help the world to become overall healthier.
Education of Vaccinations
Vaccines have been a topic of conversation that is increasing in popularity of the last decade. It has been said that vaccines can cause health conditions to anyone who gets them with little to no evidence. This claim has caused a decrease in the amount of people receiving vaccines and has weakened the herd immunity that has been built up over decades. According to Renee Slade from Rush University Medical Center, “there’s no relationship between any vaccine and autism.” The article continues to state that “autism is determined before birth” which means that vaccines have no part in this determination. Another concern many consumers have when it comes to vaccinations is that the disease they are trying to protect the consumer against can actually cause the disease. According to Rush University, “vaccines do not contain active virus,” therefore the vaccine cannot cause the disease. This is slightly correct because some viruses do contain active virus, but it is not a large enough amount to potentially cause the disease the vaccine is treating against. When it comes to global vaccine practices, some countries have stricter reigns on their population. According to an article by Charlotte Moser from the Children’s Hospital of Philadelphia, “Latvia and Slovenia have mandatory vaccine programs which yield vaccination rates of over ninety-five percent.” This is something that has kept the countries’ herd immunity strong for mandatory vaccines and incidence rates low. According to the article, the Latvian government pays for the required vaccines and is a big factor in why vaccine rates are so high. This is important because it can be inferred that the government has educated the population on why these vaccines are important. When it comes to some underdeveloped countries throughout the world, patient education is very poor in regard to vaccines. According to an article written by Mandip Jheeta and James Newell for the World Health Organization, “parents’ knowledge about vaccination is poor, and the knowledge they do have is often wrong.” This is important to address because the quality of life of these people and their children is something that is much lower than it can be. One issue that comes with this though, countries like India, Ethiopia, and the Philippines lack the resources that are necessary for proper vaccine practices. With the lack of resources, patient education cannot be conducted the way that it should be and each country has suffered because of it. Opinion: Vaccines are a crucial part of maintaining a country’s immune system. Without large numbers of citizens participating in immunization practices, the country’s herd immunity begins to weaken. A reason for this weakening is a lack of education on why vaccines are important and the role that they play in a country’s health. It is not only a lack of education that causes this weakening, it is also being able to decipher between fact and fiction when it comes to the information presented. By making consumers more aware of how vaccines work and how they help, this can in turn increase a country’s health. ~KYaeger
Legislation
People’s motivation shows the same patterns all around the globe. They do not want to be threatened, but also they do not like to be forced to do something even if that something is the right thing to do until they pay for the consequences. This same concept applies to immunization. The main reason vaccine preventable diseases always come back and make a spread is due to the unvaccinated population. To alter this tricky business and ultimately improve the health and decrease mortality of our humanity, governments all around the world implemented policies regarding immunization. The answers to increasing the rate of immunization may vary around the globe. Currently in the United States, all states require vaccinations to attend schools, including preschool programs, but there’s always a minority group that may not be vaccinated for one reason or another. The U.S. is currently adequately established in immunization policy and has relatively high vaccination rates compared to other countries. Dr. Tim Lahey, a professor at Dartmouth Institute for Health Policy and Clinical Practice, stated ”this policy has been effective and increased the likelihood that children get immunized.” People generally do not see the requirement as a punishment but positive reinforcement since vaccination and school are positives that people want for their children.In comparison, European immunization rates are high overall. However, it has constantly shown that vaccine preventable diseases such as measles, continue to spread where vaccination rates have declined, said WHO in 2016. France contributed 3% of these cases, but the majority of cases occurred in Italy (37%), Romania (35%), Germany (9%), and United Kingdom (5%), according to the same report. To address issues, Italy essentially followed the lead of the United States, which requires vaccination for school attendance, with a few twists. Parents have to provide proof of vaccination when enrolling their children in government-run nurseries or preschools, just as is done in the United States. But the parents of children who have not been vaccinated will be fined. Similarly, Germany introduced legislation recently that made immunization mandatory for all kindergartens to report to the health authority if parents have not submitted proof of vaccination counseling for their children. This policy marked a vest change in German law, which had required parents to submit proof that they have attended vaccination counseling before enrolling their children in kindergarten. In addition, in Asia, as many as one in four children remain under-immunized. We can see that South Asia and West and Central Africa are the lowest in vaccinations. In 2012, 8 million of the world’s 23 million under-immunized children lived in South Asia, most of them in India, Pakistan, and Afghanistan. The main problem with these countries is being unable to supply because they do not have the resources to endorse healthcare. The temporary solution is to get support from UNICEF and other agencies. This has shown some improvements on vaccination rates, however, their numbers are still extremely low.Unless people are part of third world countries, the challenge the U.S. and most European countries face is the small minority groups that react against the incentive and refuse to get immunizations for their children. Dr. Lahey claimed that if government authority cannot change these groups, perhaps it is best to encourage people in their social circle to put vaccination forward as “a social norm, that, does seem to encourage people to be more likely to get vaccination.”
Sherry Young/stock.adobe.com
Discovery & Research
The first major step in vaccine development is called the exploratory stage, which is governmental or academic research trying to identify the antigens on the microbe that is the target for the vaccination. This could consist of toxins, weakened microbes, weakened viruses, or just certain parts of the microbe that would still stimulate an immune response. This takes about 2-4 years normally. Then, the second step of the process is called the “pre-clinical stage.” This is where the cell culture studies and animal studies take place. This is where the vaccine is assessed for its ability to stimulate an immune response, as well as the safety of the formulation. This part of the process takes roughly 1-2 more years on average. After the formulation has been tested a substantial amount of times in the animal studies, the company that has produced the vaccine must submit an IND application. This stands for an investigational new drug application, which will allow the formulation to enter Phase I trials.The phase 1 vaccine trials are tested in about 20-80 patients, which is testing the safety and efficacy in humans. If the vaccine is made for children, it will be given to adults first and then worked down into children. The study assesses what kind of immune response the vaccine stimulates in the body, if any. If the vaccine has a promising turnout in phase I, it will advance to Phase II trials. Phase II trials will consist of hundreds, and maybe even thousands, of patients. This part of the process is here to assess the vaccine’s safety, immunogenicity, proposed doses, schedule of immunizations, and method of delivery. Phase III trials are just a more intense version of Phase II. This step consists of tens of thousands of people, but the outcome is trying to figure out the rare side effects that may not be observed in a smaller population. The efficacy is also assessed again in this step.After all this testing, the vaccine developer will submit a Biologics License Application to the FDA. Then the Federal Drug Administration will inspect the factory where the vaccine will be made and approve the labeling of the vaccine. After the drug has been approved for distribution, the FDA will continue to monitor the facility. The vaccines must continue to stay effective, safe, and pure. Opinion: I believe that we have a huge potential to benefit from developing vaccines for the diseases that affect a large number of the population. Preventative care for individuals will help to reduce the amount of money spent on healthcare in the nation, as well as improve the quality of life for those who may have been affected if they had not received the vaccine. People who live in developing countries may not have close access to the site that gives vaccinations, which may lead to a decreased herd immunity, leading to a larger prevalence in the preventable disease. Something that causes the vaccination development process to be so difficult is the amount of cost and the time commitment, which is also hard to weigh the benefit because the diseases may decline or mutate while the development of the vaccine occurs. ~APlumer
THE ENTIRE PROCESS TAKES ABOUT 10-15 YEARS.
https://www.gsk.com/en-gb/research-anddevelopment/development/how-we-develop-new-vaccines/
Opinion: Not everyone prefers to get vaccinated due to various reasons including false facts about vaccinations and lack of trust with pharmaceutical companies or personal preferences that lead to refusal of immunization. However, this becomes a problem when it affects others in the population, herd immunity. There are so many factors to consider to account for every individual’s preferences when we try to increase the rate of vaccinations. There are multiple ways to implement vaccinations, however the most effective and efficient way to encourage people to get immunized is to make vaccination as a requirement. By enforcing this new policy, people who want to attend or work in public with others, they are obligated to get immunized. Ergo, this will result in an increase in the rate of vaccinations and improves global health issues overall. ~BYoon
R e f e r e n c e s
Slade R. 7 Myths About Vaccines. Rush. https://www.rush.edu/health-wellness/discover-health/7-myths-about-vaccines. Accessed February 18, 2020. Dadonaite B, Roser M, Vanderslott S. Vaccination. Our World in Data. https://ourworldindata.org/vaccination. Published July 2015. Updated December 2019. Accessed February 18, 2020. Moser C. Children's Hospital. Around the World: Vaccine Requirements Vary From Country to Country. Children's Hospital of Philadelphia. https://www.chop.edu/news/vaccine-requirements-vary-country-country. Published March 17, 2015. Accessed February 24, 2020. Gracia JN. Vanderslott S, Dadonaite B, Roser M. Vaccination. Our World in Data. https://ourworldindata.org/vaccination. Published May 10, 2013. Accessed February 24, 2020. Jheeta M, Newell J. Childhood vaccination in Africa and Asia: the effects of parents’ knowledge and attitudes. World Health Organization. https://www.who.int/bulletin/volumes/86/6/07-047159/en/. Published June 2008. Accessed February 18, 2020.
Scutti S. Encouraging vaccination around the world. CNN. Pushed January 2, 2018. Accessed March 19, 2020. Benzie A. How we discover new vaccines. GSK India. https://india-pharma.gsk.com/en-in/research/our-approach/how-we-discover-newvaccines/. Accessed February 24, 2020. Offit, P. Vaccine Development, Testing, and Regulation. History of Vaccines. https://www.historyofvaccines.org/index.php/content/articles/vaccine-development-testing-and-regulation. Accessed February 24, 2020. Hasman A, Noble DJ. Childhood immunization in South Asia – overcoming the hurdles to progress. Perspectives in Public Health. 2016;136(5):273-277. Moser CA. Around the World: Vaccine Requirements Vary From Country to Country. Children’s Hospital of Philadelphia. https://www.chop.edu/news/vaccine-requirements-vary-country-country. Published March 17, 2015. Accessed February 18, 2020.
